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ondansetron

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Description

Ondansetron is a selective serotonin 5-HT3 receptor antagonist. It was synthesized in the 1980s by scientists at GlaxoSmithKline. Ondansetron is primarily used to prevent and treat nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. Its mechanism of action involves blocking the action of serotonin (5-HT3) in the gastrointestinal tract, which is responsible for triggering the vomiting reflex. Ondansetron is also effective in treating nausea and vomiting associated with migraine headaches and motion sickness. It is a highly effective antiemetic and is widely used in clinical practice. Ondansetron is studied to understand its efficacy in various settings, its potential side effects, and to develop new and improved antiemetic therapies. It is also being investigated for its potential use in treating other conditions, such as irritable bowel syndrome and anxiety disorders.'

Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID4595
CHEMBL ID46
CHEBI ID7773
SCHEMBL ID4542
MeSH IDM0026254

Synonyms (137)

Synonym
9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-2,3-dihydro-1h-carbazol-4(9h)-one
BRD-A19736161-001-01-8
BRD-A19736161-003-03-0
gtpl2290
gr-38032f/gr-38032
OPREA1_435466
BSPBIO_001016
NCI60_022780
zofran odt
zuplenz
eur-1025
9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4h-carbazol-4-one
zudan
4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-
gr 38032x
ondansetron (zofran)
1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-4h-carbazol-4-one
brn 3622981
gr 38032
(rs)-1,2,3,9-tetrahydro-9-methyl-3-(2-methylimidazol-1-ylmethyl)carbazol-4-one
zofran
TIMTEC1_001750
CBDIVE_008994
PRESTWICK2_001058
BPBIO1_001118
AB00373674
STK370548
C07325
ondansetron
99614-02-5
DB00904
D00456
zofran odt (tn)
ondansetron (jan/usp/inn)
ondansetron, (+,-)-isomer
PRESTWICK0_001058
SPBIO_002938
PRESTWICK1_001058
OPREA1_852372
PRESTWICK3_001058
HMS2090H16
L000456
CHEMBL46
gr-38032
a04aa01
nsc-757870
chebi:7773 ,
desmethylondansetron
AKOS000599484
99614-01-4
9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1h-carbazol-4-one
NCGC00179341-02
HMS3259H08
odansetron [common misspelling of ondansetron]
ondansetron [usp:inn:ban]
unii-4af302esos
4af302esos ,
nsc 757870
ondansetron injection
hsdb 8304
dtxsid8023393 ,
cas-99614-02-5
dtxcid803393
tox21_113048
cas_68647
nsc_68647
bdbm85330
BCP9001025
FT-0631004
9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-2,3,4,9-tetrahydro-1h-carbazol-4-one
S1996
AKOS016340526
HMS3371E18
ondansetron [usp-rs]
ondansetron [orange book]
ondansetron [mart.]
ondansetron [usp monograph]
4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)- (+/-)-
ondansetron [who-dd]
ondansetron [jan]
gr-c507/75
(+/-)-2,3-dihydro-9-methyl-3-((2-methylimidazol-1-yl)methyl)carbazol-4(1h)-one
ondansetron [mi]
ondansetron [vandf]
ondansetron [inn]
AB00373674-15
HY-B0002B
9-methyl-3- (2-methyl-imidazol-1ylmethyl)-1,2,3,9-tetrahydro-carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-4h- carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazole-1-yl)methyl]-4h-carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-4h-carbazol-4-one
1,2,3,9,-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-4h-carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1yl)methyl]-4h-carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazole-1 -yl)methyl]-4h-carbazol-4-one
FELGMEQIXOGIFQ-UHFFFAOYSA-N
NC00706
SCHEMBL4542
NCGC00179341-04
tox21_113048_1
KS-5227
AB00373674-17
smr001307702
MLS006011928
9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro-4h-carbazol-4-one
AC-28927
AB00373674_19
AB00373674_18
116002-70-1
mfcd00833882
sr-01000763250
SR-01000763250-4
1,2,3,4-tetrahydro-9-methyl-3-(2-methyl-1h-imidazol-1-ylmethyl)carbazol-4-one
NCGC00179341-07
gr 38032f;gr-c507/75
gr38032
BCP28911
Q410011
gr 38032 (hydrochloride);sn 307 (hydrochloride)
EN300-117273
'9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1~{h}-carbazol-4-one'
9-methyl-3-[(2-methyl-1h-imidazolyl)methyl]-1,2,3,9-tetrahydro-4h-carbazole-4-one
nsc-791005
nsc791005
NCGC00179341-12
ondansetron(base and/or unspecified salts)
Z1501485364
4h-carbazol-4-one,?1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-
odansetron (common misspelling of ondansetron)
4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-(+/-)-
2,3-dihydro-9-methyl-3-((2-methylimidazol-1-yl)methyl)carbazol-4(1h)-one
ondansetron (usp monograph)
ondansetron (usp:inn:ban)
ondasetron
ondansetron (usp-rs)
ondansetronum
ondansetronodt
ondansetron (mart.)

Research Excerpts

Overview

Ondansetron (ODS) is an effective antiemetic drug which suffers from limited solubility and bioavailability during oral administration due to first-pass metabolism. It is a 5HT3 receptor antagonist, used to mitigate the effects of nausea and vomiting after chemotherapy or surgery.

ExcerptReferenceRelevance
"Ondansetron is an indirect dopaminergic modulator that has shown efficacy in alcohol use disorder, particularly in phenotypic and genotypic subgroups, and was found to be efficacious in a pilot dose-finding trial for CUD."( A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis.
Ait-Daoud, N; Blevins, D; Johnson, BA; Seneviratne, C; Wang, XQ, 2021
)
1.59
"Ondansetron is a highly effective antiemetic for the treatment of nausea and vomiting. "( A pharmacogenomic investigation of the cardiac safety profile of ondansetron in children and pregnant women.
Berger, H; Brodie, SM; Brown, J; Carleton, BC; Chaudhry, S; Drögemöller, BI; Groeneweg, GSS; Higginson, M; Israels, S; Ito, S; Jong, G'; Magee, LA; Miao, F; Rassekh, SR; Ross, CJD; Sanatani, S; Shaw, K; Staub, M; Trueman, J; West, N; Whyte, SD; Wright, GEB, 2022
)
2.4
"Ondansetron (ODS) is an effective antiemetic drug which suffers from limited solubility and bioavailability during oral administration due to first-pass metabolism. "( Ondansetron/Cyclodextrin inclusion complex nanofibrous webs for potential orally fast-disintegrating antiemetic drug delivery.
Celebioglu, A; Durgun, E; Emin Kilic, M; Hsiung, E; Uyar, T, 2022
)
3.61
"Ondansetron is a 5HT3 receptor antagonist widely used to treat hyperemesis gravidarum, although its safety is still questionable. "( Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats.
Aquino, AM; Arena, AC; Jorge, BC; Kassuya, CAL; Manoel, BM; Moreira, SDS; Reis, ACC; Scarano, WR; Stein, J; Valente, LC, 2023
)
2.67
"Ondansetron is a 5HT3 receptor antagonist, used to mitigate the effects of nausea and vomiting after chemotherapy or surgery. "( Embryo-fetal safety evaluation of ondansetron in rats.
Arena, AC; da Silva Moreira, S; de Matos Manoel, B; Jorge, BC; Perdão, CB; Reis, ACC; Stein, J, 2023
)
2.63
"Ondansetron is a widely administered medication for nausea and vomiting of pregnancy. "( Ondansetron Use During Pregnancy: Birth Defects and Obstetric Outcomes.
Azab, AN; Betesh-Abay, B; Hadar, E; Masarwe, S; Peleg, N; Shvartsur, R, 2023
)
3.8
"Ondansetron is a commonly used antiemetic in the emergency department despite a 2011 FDA warning regarding dose-related QTc prolongation and torsades des pointes (TdP). "( QT prolongation, torsades des pointes, and cardiac arrest after 4 mg of IV ondansetron.
Cole, JB; Fuchs, RT; Fushianes, GD; Lee, SC; Orozco, BS, 2023
)
2.58
"Ondansetron is a potent anti-emetic drug showing promising results as an analgesic."( Effect of ondansetron compared to lidocaine and placebo for reducing propofol injection pain: A systematic review and meta-analysis of randomized controlled trials.
AbdelQadir, YH; Adly, MH; Alnaji, AA; Aly, AA; Ammar, MF; Eguzo, MA; Elfar, WH; Elshanbary, AA; Elsnhory, AB; Farhat, AM; Hamza, MM; Hana, K; Hussein, TA; Mahmoud, AM; Morsy, MH; Shah, J; Shamshoon, KF; Zaazouee, MS, 2023
)
2.03
"Ondansetron is a specific I"( Effects of ondansetron on apamin-sensitive small conductance calcium-activated potassium currents in pacing-induced failing rabbit hearts.
Chen, M; Chen, PS; Chen, Z; Everett, TH; Kamp, NJ; Lin, SF; Rubart-von der Lohe, M; Shen, C; Tian, Z; Wang, Z; Wu, AZ; Xu, D; Yang, N; Yin, D, 2020
)
2.39
"Ondansetron is an effective antiemetic employed to prevent vomiting in children with gastroenteritis in high-income countries; data from low- and middle-income countries are sparse."( Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial.
Bhutta, ZA; Dawoud, F; Freedman, SB; Siddiqui, E; Soofi, SB; Willan, AR; Williamson-Urquhart, S; Xie, J, 2019
)
2.47
"Ondansetron HCl (OSH) is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with radiotherapy (adults: 8 mg, t.i.d) and/or chemotherapy (adults: 8 mg, b.i.d to t.i.d) and prevention of postoperative nausea and/or vomiting (adults: 8 mg, b.i.d). "( Sustained release formulation of Ondansetron HCl using osmotic drug delivery approach.
Gundu, R; Kulkarni, D; Pekamwar, S; Shelke, S; Shep, S, 2020
)
2.28
"ondansetron is an effective antiemetic in children with gastroenteritis, but data from low- and middle-income countries are sparse."( Effect of ondansetron on vomiting associated with acute gastroenteritis in a developing country: a meta-analysis.
Wu, HL; Zhan, X, 2020
)
1.68
"Ondansetron is a 5-HT₃ receptor antagonist that has been approved for the prevention of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and surgery. "( Major Congenital Malformation Risk After First Trimester Gestational Exposure to Oral or Intravenous Ondansetron.
Andrade, C, 2020
)
2.22
"Ondansetron is an effective antiemetic that is being widely used as a second-line treatment option for severe nausea and vomiting of pregnancy in accordance with clinical guidelines. "( Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC).
Cassina, M; Damkier, P; Diav-Citrin, O; Kaplan, YC; Shechtman, S; Weber-Schoendorfer, C, 2021
)
3.51
"Ondansetron is an effective antiemetic drug widely used to prevent CINV; however, the effective administrative dosing strategies among pediatrics remain unclear."( Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial.
Lertvivatpong, N; Monsereenusorn, C; Photia, A; Rujkijyanont, P; Ruktrirong, J; Traivaree, C, 2021
)
1.59
"Ondansetron has proven to be a safe and effective adjunct in children with vomiting."( Clinical Pathway Produces Sustained Improvement in Acute Gastroenteritis Care.
Brown, JC; Klein, EJ; Rutman, L, 2017
)
1.18
"Ondansetron is a serotonin 3 receptor antagonist widely used to prevent nausea and vomiting in pregnancy and in patients receiving chemotherapy. "( Ondansetron - a promising adjunctive treatment for persistent schizophrenia.
Gavrilidis, E; Gurvich, C; Hudaib, AR; Kulkarni, J; Thomas, N, 2018
)
3.37
"Ondansetron is a 5-HT₃ receptor antagonist commonly used as an antiemetic to prevent nausea and vomiting associated with anti-cancer drugs, cancer radiotherapy or postoperatively. "( Cardiac safety concerns for ondansetron, an antiemetic commonly used for nausea linked to cancer treatment and following anaesthesia.
Doggrell, SA; Hancox, JC, 2013
)
2.13
"Ondansetron is a serotonin (5-HT3) receptor antagonist widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer."( Ondansetron and simvastatin added to treatment as usual in patients with schizophrenia: study protocol for a randomized controlled trial.
Chaudhry, IB; Deakin, B; Drake, R; Dunn, G; Hallak, J; Hamirani, MM; Husain, MO; Husain, N; Kazmi, A; Kiran, T; Mehmood, N; Rahman, Ru; Stirling, J, 2013
)
2.55
"Ondansetron is a 5-HT3 receptor antagonist that is an effective anti-emetic in cats. "( Oral, subcutaneous, and intravenous pharmacokinetics of ondansetron in healthy cats.
Gustafson, DL; Hansen, RJ; Lake, RC; Lunghofer, PJ; Quimby, JM, 2014
)
2.09
"Ondansetron is a potent antiemetic drug that has been commonly used to treat acute and chemotherapy-induced nausea and vomiting (CINV) in dogs. "( Pharmacokinetic modeling and Monte Carlo simulation of ondansetron following oral administration in dogs.
Baek, IH; Kang, J; Kwon, KI; Lee, BY, 2015
)
2.11
"Ondansetron is an experimental alternative for such patients."( Ondansetron augmentation of serotonin reuptake inhibitors as a treatment strategy in obsessive-compulsive disorder.
Andrade, C, 2015
)
2.58
"Ondansetron is a 5-HT3 receptor antagonist which is generally used for the prophylactic management of nausea and vomiting; however, studies have found that ondansetron might decrease the incidence of PDPH."( Effect of ondansetron on post-dural puncture headache (PDPH) in parturients undergoing cesarean section: a double-blind randomized placebo-controlled study.
Fattahi, Z; Hadavi, SM; Sahmeddini, MA, 2015
)
1.54
"Ondansetron is a substrate of cytochrome P450 (CYP) 3A4 (primary metabolic pathway), 2D6, and 1A2, all of which are altered during pregnancy."( Ondansetron Exposure Changes in a Pregnant Woman.
Caritis, SN; Haas, DM; Hankins, GD; Hebert, MF; Lemon, LS; Venkataramanan, R; Zhang, H, 2016
)
2.6
"Ondansetron is a 5-HT3 receptor antagonist, reported to attenuate cocaine and methamphetamine-induced behavioral sensitization, but no reports are available on its role in ethanol-induced behavioral sensitization."( The 5-HT3 receptor antagonist, ondansetron, blocks the development and expression of ethanol-induced locomotor sensitization in mice.
Bhutada, PS; Jain, NS; Mundhada, YR; Raut, VS; Umathe, SN, 2009
)
1.36
"Ondansetron is a carbazol with antiemetic properties that acts as a competitive and selective antagonist for the 5 HT3 serotonin receptors. "( Ondansetron: design and development of oral pharmaceutical suspensions.
Gallardo Lara, V; Gallardo, ML; Morales Hernandez, ME; Ruiz Martinez, MA, 2009
)
3.24
"Ondansetron is a 5-HT3 receptor antagonist with potent antiemetic, analgesic, and antiphlogistic effects. "( Ondansetron attenuates hepatic injury via p38 MAPK-dependent pathway in a rat haemorrhagic shock model.
Liu, FC; Liu, FW; Yu, HP, 2011
)
3.25
"Ondansetron is an antiemetic known for its safety profile. "( Ondansetron-induced dystonia, hypoglycemia, and seizures in a child.
Manchanda, S; Mittal, S; Patel, A; Puliyel, JM, 2011
)
3.25
"Ondansetron is a potent antiemetic and a competitive antagonist at serotonin receptors, which are also involved in modulation of pain. "( Effect of intravenous ondansetron on sensory and motor block after spinal anaesthesia with hyperbaric bupivacaine.
Bala, I; Chopra, K; Podder, S; Samra, T, 2011
)
2.13
"Ondansetron is a 5-HT3 receptor antagonist commonly prescribed to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery but may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm and recently raised FDA concerns and warnings."( Nifedipine blocks ondansetron electrophysiological effects in rabbit purkinje fibers and decreases early after depolarization incidence.
Gerard, JL; Hanouz, JL; Lemoine, S; Plaud, B; Puddu, PE; Rouet, R; Salle, L; Worou, ME, 2012
)
1.43
"Ondansetron is a highly selective 5-hydroxytryptamine 3 (5-HT(3)) receptor antagonist used as antiemetic agent for chemotherapy-, and radiotherapy-induced nausea and vomiting."( Evaluation of anticonvulsant and nootropic effect of ondansetron in mice.
Agarwal, NB; Jain, S; Mediratta, PK; Sharma, KK, 2012
)
1.35
"Ondansetron is an antiemetic 5-HT3 receptor antagonist with proven efficacy in central balance disorder. "( A protective effect of 5-HT3 antagonist against vestibular deficit? Metoclopramide versus ondansetron at the early stage of vestibular neuritis: a pilot study.
Biboulet, R; Mondain, M; Uziel, A; Venail, F, 2012
)
2.04
"Ondansetron is a 5-HT3 receptor antagonist with potent antiemetic, analgesic, and antiphlogistic effects. "( The anti-aggregation effects of ondansetron on platelets involve IP3 signaling and MAP kinase pathway, but not 5-HT3-dependent pathway.
Day, YJ; Liao, HR; Liou, JT; Liu, FC; Mao, CC; Yang, P, 2012
)
2.11
"Ondansetron is an antagonist of 5-HT3 receptors mostly used as an antiemetic yet known to modulate metabolism and appetite. "( Differential effects of 5-HT3 receptor antagonist on lipid profile in spontaneously hypertensive rat and chromosome 8 congenic strain.
Kren, V; Krenova, D; Krupkova, M; Liska, F; Seda, O; Sedova, L, 2012
)
1.82
"Ondansetron is a serotonin 5-HT3 receptor antagonist used primarily to control nausea and vomiting arising from cytotoxic chemo- and radiotherapy."( Circadian rhythms in toxic effects of the serotonin antagonist ondansetron in mice.
Ben Attia, M; Boughattas, NA; Bouzouita, K; Chouchane, L; Gadacha, W; Khedhaier, A; Mechkouri, M; Reinberg, A; Sani, M, 2003
)
1.28
"Ondansetron (Zofran) is a drug used for the treatment of nausea and vomiting caused by cancer chemotherapy. "( The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study.
Einarson, A; Kennedy, D; Koren, G; Maltepe, C; Navioz, Y; Tan, MP, 2004
)
2.13
"Ondansetron is a carbazol with antiemetic properties. "( Physical characteristics of polymer complexes in suspension obtained from cellulosic latexes with ondansetron.
Gallardo, V; Llácer, JM; Morales, E; Ruiz, A, 2004
)
1.98
"Ondansetron is a potent antiemetic drug that acts through inhibition of the 5HT3 receptors for serotonin. "( The pronociceptive effect of ondansetron in the setting of P-glycoprotein inhibition.
Flood, P; Scott, JA; Wood, M, 2006
)
2.07
"Ondansetron is an effective adjunctive agent in enhancing the effectiveness and reducing some adverse side effects of antipsychotic therapy for chronic, treatment-resistant schizophrenia, particularly for negative and cognitive symptoms."( Beneficial effects of ondansetron as an adjunct to haloperidol for chronic, treatment-resistant schizophrenia: a double-blind, randomized, placebo-controlled study.
Kang, WH; Li, Q; Ma, AQ; Wang, XY; Yao, SM; Zhang, ZJ, 2006
)
2.09
"Ondansetron is a commonly used medication in the treatment of nausea and vomiting arising from many etiologies, including chemotherapy. "( Ondansetron-associated hypokalemia in a 2-year-old with pre-B-cell ALL.
Pinsk, M; Turner, SR, 2008
)
3.23
"Ondansetron is an effective prophylactic antiemetic agent for children undergoing dental surgery. "( Effect of antiemetic therapy on recovery and hospital discharge time. A double-blind assessment of ondansetron, droperidol, and placebo in pediatric patients undergoing ambulatory surgery.
Davis, PJ; Hoffmann, P; Landsman, I; Maloney, K; McGowan, FX, 1995
)
1.95
"Ondansetron appears to be a safe and efficacious antiemetic during conditioning for BMT."( Antiemetic efficacy and pharmacokinetics of intravenous ondansetron infusion during chemotherapy conditioning for bone marrow transplant.
Agura, ED; Brown, MC; Donaldson, G; Schaffer, R; Shen, DD, 1995
)
1.26
"Ondansetron is a potent and highly selective serotonin 5-HT3-receptor antagonist which has demonstrated important antiemetic activity and good tolerability in the prevention of chemotherapy-induced nausea and vomiting. "( Ondansetron clinical pharmacokinetics.
Del Favero, A; Roila, F, 1995
)
3.18
"Ondansetron is a selective 5-HT3 receptor antagonist which has previously been reported in the Journal to be a promising new agent for use as prophylaxis against nausea and vomiting caused by chemotherapy and radiotherapy. "( Ondansetron. An update of its therapeutic use in chemotherapy-induced and postoperative nausea and vomiting.
Markham, A; Sorkin, EM, 1993
)
3.17
"Oral ondansetron is an effective therapy for the prevention of emesis induced by TBI."( Randomized double-blind, placebo-controlled evaluation of oral ondansetron in the prevention of nausea and vomiting associated with fractionated total-body irradiation.
Bryson, JC; Cirenza, E; Dubois, A; Foelber, R; Kunka, RL; Plagge, PB; Spitzer, TR; Stout, C; Wallerstadt, M, 1994
)
1.04
"Ondansetron is a competitive serotonin 5-HT3 receptor blocker that has proved useful in the prevention of emesis due to cisplatin and other cancer chemotherapeutic agents. "( Ondansetron absorption in adults: effect of dosage form, food, and antacids.
Bozigian, HP; Gooding, AE; Pakes, GE; Pritchard, JF, 1994
)
3.17
"Ondansetron is a selective serotonin antagonist which has been shown to be an effective antiemetic agent for patients undergoing radiation or chemotherapy treatment. "( Influence of ondansetron on thermoregulation during exercise in the heat wearing combat clothing.
Bateman, WA; Ducharme, MB; McLellan, TM, 1994
)
2.1
"Ondansetron is a well tolerated, efficacious antiemetic which has a similar side effect profile to placebo."( Single dose intravenous ondansetron for the 24-hour treatment of postoperative nausea and vomiting.
Claybon, L, 1994
)
1.32
"Ondansetron is a new selective serotonin-3-receptor antagonist which has proved to be effective in chemotherapy-induced nausea and vomiting. "( [Ondansetron--a new anesthesia relevant antiemetic?].
Bach, A; Böhrer, H; Martin, E, 1994
)
2.64
"Ondansetron appears to be a very effective antiemetic drug for use in selected intoxicated patients."( Ondansetron for treating nausea and vomiting in the poisoned patient.
Marx, CM; Reed, MD, 1994
)
3.17
"Ondansetron is a 5-hydroxytryptamine receptor antagonist which has shown activity in the prevention of emesis following cytotoxic and radiation therapy for cancer. "( Ondansetron for efficient emesis control during total body irradiation.
König, V; Riess, H; Schmid, H; Schmidt-Wolf, I; Schwella, N; Schwerdtfeger, R; Siegert, W, 1994
)
3.17
"Ondansetron is an antiemetic drug that can be used in the perioperative period without concern for potentiation of nondepolarizing neuromuscular blockade, change in atracurium maintenance dose, or change in rate of neostigmine-induced recovery from neuromuscular blockade with atracurium."( The effect of ondansetron on atracurium-induced neuromuscular blockade.
Embree, PB; Gadalla, F; Kudlak, TT; Lien, CA; Savarese, JJ; Sharp, GJ,
)
1.93
"Ondansetron is a potent and highly specific antagonist of the 5-HT3 serotonin receptor."( The addition of ondansetron to the combination of metoclopramide, dexamethasone, and lorazepam did not improve vomiting prevention in patients receiving high-dose cisplatin.
Baltzer, L; Kris, MG; Pisters, KM; Rigas, JR; Tyson, LB, 1994
)
1.36
"Ondansetron is a serotonin antagonist that recently has been introduced as a preventive agent for chemotherapy-induced nausea and vomiting. "( Comparison of intermittent ondansetron versus continuous infusion metoclopramide used with standard combination antiemetics in control of acute nausea induced by cisplatin chemotherapy.
Kilgore, JR; Navari, RM; Perrine, GM; Province, WS, 1993
)
2.03
"Ondansetron (ODS) is a new carbazole which exerts selective and potent antagonism on serotoninergic neurotransmission at serotonin 3 (5-HT3) receptors. "( [Clinical pharmacology of ondansetron].
Robak, T, 1993
)
2.03
"Ondansetron is a 5-HT3 antagonist and its antiemetic properties have been established in adults receiving chemotherapy."( The efficacy and safety of ondansetron in the prophylaxis of cancer-chemotherapy induced nausea and vomiting in children.
Hewitt, M; McQuade, B; Stevens, R, 1993
)
1.3
"Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy."( Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. The Ondansetron Study Group.
Beck, TM; Chang, A; Ciociola, AA; Galvin, D; Hart, NE; Harvey, WH; Jones, SE; Tchekmedyian, NS, 1993
)
1.14
"Ondansetron hydrochloride is a new serotonin receptor antagonist that is effective in preventing emesis associated with cancer chemotherapy. "( Ondansetron: a novel antiemetic agent.
Dukes, GE; Figg, WD; Graham, CL; Hak, LJ, 1993
)
3.17
"Ondansetron (Zofran), is a 5-HT3 antagonist, which produces its pharmacological effect by competing with 5-HT receptors at the synapse."( Fluoxetine treatment comprises the antiemetic efficacy of ondansetron in cancer patients.
Koriech, OM, 1995
)
1.26
"Ondansetron appears to be a potentially useful adjunct in the management of nausea and vomiting associated with acetaminophen poisoning."( The use of ondansetron in the treatment of nausea and vomiting associated with acetaminophen poisoning.
Chen, R; Clark, RF; Harchelroad, F; Johnson, CL; Williams, SR, 1996
)
2.13
"Ondansetron is a serotonin receptor antagonist that is effective in preventing and treating PONV."( Ondansetron: perioperative use of a serotonin receptor antagonist for the prevention and treatment of nausea and vomiting.
Charbonneau, J; Early, TE; Jenkins, P; McKnight, G, 1995
)
2.46
"Ondansetron appears to be a beneficial and safe method of relieving pruritus associated with intrathecal morphine."( The use of ondansetron to treat pruritus associated with intrathecal morphine in two paediatric patients.
Arai, L; Dorsey, A; Schwartz, R; Stayer, S, 1996
)
1.41
"Ondansetron appears to be an effective drug in about 50% of patients with FM. "( Pathogenetic aspects of responsiveness to ondansetron (5-hydroxytryptamine type 3 receptor antagonist) in patients with primary fibromyalgia syndrome--a preliminary study.
Hrycaj, P; Mennet, P; Müller, W; Stratz, T, 1996
)
2
"Ondansetron is a selective antagonist at 5-HT3 receptors."( Clinical pharmacokinetics of ondansetron. A review.
Hicks, FM; Simpson, KH, 1996
)
1.31
"Ondansetron is a serotonin (5HT) receptor antagonist at both peripheral and central 5-HT3 receptor sites with no known action on dopamine-mediated activity."( Droperidol/ondansetron combination controls nausea and vomiting after tubal banding.
Hamilton, DL; McKenzie, R; Riley, TJ; Uy, NT, 1996
)
1.41
"Ondansetron is a 5-hydroxytryptamine receptor antagonist which is known to be a highly effective anti-emetic drug for chemotherapy-associated nausea and vomiting and for postoperative nausea. "( Treatment of hyperemesis gravidarum with the 5-HT3 antagonist ondansetron (Zofran).
Johnstone, MJ; Tincello, DG, 1996
)
1.98
"Ondansetron proved to be an effective medicament for relieving nausea and vomiting during total body irradiation. "( [Acute tolerance in hyperfractionated accelerated whole-body irradiation].
Latz, D; Schraube, P; Wannenmacher, M, 1996
)
1.74
"Ondansetron was shown to be a well-tolerated antiemetic and seems to have a higher reductive effect on PONV when given in a single dose and not repetitively."( [Prevention of postoperative nausea and vomiting with single and repeat administration of ondansetron--review of the literature on different administration forms].
Buhre, W; Kazmaier, S; Mühr, C; Neumann, P; Saur, P, 1996
)
1.24
"Ondansetron is a drug used to prevent vomiting, especially in cancer patients after chemotherapy. "( Ondansetron exhibits the properties of a local anesthetic.
Hunt, TE; Mui, WC; Ren, J; Wu, WH; Ye, JH; Zbuzek, VK, 1997
)
3.18
"Ondansetron is a selective 5-hydroxytryptamine-3 receptor antagonist, which reduces the cholera toxin-evoked fluid accumulation in pig jejunum."( Effect of ondansetron on Salmonella typhimurium-induced net fluid accumulation in the pig jejunum in vivo.
Grøndahl, ML; Hansen, MB; Jensen, GM; Nielsen, CG; Olsen, JE; Skadhauge, E, 1997
)
1.42
"Ondansetron is an effective medication for the treatment and prevention of postoperative nausea and vomiting, and a dose of ondansetron 0.05 mg/kg is as effective as 0.1 mg/kg and 0.15 mg/kg. "( Ondansetron dose response curve in high-risk pediatric patients.
Kymer, PJ; Lawhorn, CD; Shirey, R; Stewart, FC; Stoner, JM; Volpe, P, 1997
)
3.18
"Ondansetron is a relatively new drug whose optimal use is dependent on an understanding of its characteristics and role relative to traditional antiemetics. "( A prospective survey of knowledge and perceptions of ondansetron: what do health care workers know about this drug?
Jewesson, P; Marra, C; Nimmo, CR, 1995
)
1.98
"Ondansetron is an antiemetic agent metabolized by cytochrome P450 (CYP) enzymes. "( The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron.
Kivistö, KT; Neuvonen, PJ; Villikka, K, 1999
)
1.98
"Ondansetron is an effective and well-tolerated antiemetic, which is used for the prevention of both chemotherapy and radiotherapy-induced emesis and nausea."( Efficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tab
Coster, B; Feyer, P; Franzén, L; Goedhals, L; Graham, E; Haigh, C; LeBourgeois, JP; Marzecki, Z; McKenna, CJ; Mitchell, T; Souhami, L; Stewart, A; Tønnessen, F; Wilkinson, JR, 1999
)
1.38
"Ondansetron is a peripherally active antagonist of the serotonin receptor 5-HT3, and is marketed for prevention of vagally-mediated emesis caused by cancer chemotherapeutic agents."( Effect of decreasing afferent vagal activity with ondansetron on symptoms of bulimia nervosa: a randomised, double-blind trial.
Banerjee-Stevens, D; Daughters, RS; Eckert, ED; Faris, PL; Goodale, RL; Hartman, BK; Hofbauer, RD; Kim, SW; Marshall, AM; Meller, WH; Oakman, SA, 2000
)
1.28
"Ondansetron is a carbazol with antiemetic properties. "( Adsorption-desorption of ondansetron on latex particles.
Gallardo, V; Llácer, JM; Parera, A; Ruiz, MA, 2000
)
2.05
"Ondansetron (OND) is a 5-HT3 receptor antagonist that is used therapeutically for the prevention of nausea and vomiting associated with emetogenic cancer therapy. "( Nasal absorption of ondansetron in rats: an alternative route of drug delivery.
Dakkuri, A; Hussain, AA; Itoh, S, 2000
)
2.07
"Ondansetron is a kind of drug which is used for the treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. "( [Determination of Ondansetron in injection by high performance capillary zone electrophoresis].
Li, H; Shi, W; Yang, Y; Zou, H, 1998
)
2.08
"Ondansetron is a selective 5-hydroxytryptamine(3) (5-HT(3)) receptor antagonist that has been introduced to clinical practice as an antiemetic for cancer treatment-induced and anesthesia-related nausea and vomiting. "( Ondansetron: a selective 5-HT(3) receptor antagonist and its applications in CNS-related disorders.
Ponnudurai, R; Schaefer, R; Ye, JH, 2001
)
3.2
"Ondansetron is a carbazol antiemetic that acts as a competitive, selective inhibitor of 5-HT3 serotonin receptors."( X-ray diffraction and electron microscopy in the polymorphism study of ondansetron hydrochloride.
Delgado, R; Gallardo, V; Llácer, JM; Martin, D; Párraga, J; Ruiz, MA, 2001
)
1.27
"Ondansetron is a highly selective 5-HT3 antagonist, which has recently become available for the control of chemotherapy-induced emesis. "( [Ondansetron--the first highly selective 5-HT3 antagonist in therapy of psychiatric diseases].
Broocks, A, 1992
)
2.64
"Ondansetron appears to be an excellent antiemetic for use in combination programs because of its highly selective, 5-hydroxytryptamine (5-HT3)-blocking properties and its proven single-agent effectiveness and safety."( Rationale for combination antiemetic therapy and strategies for the use of ondansetron in combinations.
Kris, MG, 1992
)
1.24
"Ondansetron is a selective 5-hydroxytryptamine type 3 receptor antagonist effective as an antiemetic in patients experiencing post-operative or cancer chemotherapy-induced nausea and vomiting. "( Ondansetron does not affect alfentanil-induced ventilatory depression or sedation.
Dershwitz, M; Di Biase, PM; Joslyn, AF; Rosow, CE; Sanderson, PE; Wilson, RS, 1992
)
3.17
"Ondansetron hydrochloride is a selective serotonin subtype 3 (5HT3) receptor antagonist that has been shown to be an effective antiemetic in patients receiving cisplatin chemotherapy."( Phase III double-blind comparison of intravenous ondansetron and metoclopramide as antiemetic therapy for patients receiving multiple-day cisplatin-based chemotherapy.
Einhorn, L; House, K; Nagy, C; Sledge, GW, 1992
)
1.98
"Ondansetron is a 5-HT3 receptor antagonist which is effective and well tolerated as an antiemetic for emesis induced by cancer chemotherapy and radiation therapy, and in the prevention and treatment of postoperative nausea and vomiting. "( Clinical pharmacology of ondansetron in postoperative nausea and vomiting.
Baber, N; Frazer, NM; Palmer, JL; Pritchard, JF, 1992
)
2.03
"Ondansetron is a highly potent and selective antagonist at 5-HT3 receptors. "( Pharmacology of ondansetron.
Naylor, RJ; Rudd, JA, 1992
)
2.07
"Ondansetron is a novel 5-HT3 receptor antagonist used for the treatment of cytotoxic-induced emesis and postoperative nausea and vomiting. "( Safety of ondansetron.
Castle, WM; Greenstreet, YL; Griffiths, CJ; Jukes, AJ; Roden, SM, 1992
)
2.13
"Ondansetron is a cost effective and safe antiemetic in children receiving chemotherapy and total body irradiation, minimises weight loss on treatment and enables outpatient chemotherapy in some cases."( Ondansetron antiemetic therapy for chemotherapy and radiotherapy induced vomiting in children.
Abbott, GD; Robinson, BA; Sullivan, MJ, 1992
)
3.17
"Ondansetron is a new 5-HT3-antagonist with antiemetic properties."( The effect of ondansetron on radiation-induced emesis and diarrhoea.
Franzén, L; Henriksson, R; Israelsson, G; Lomberg, H; Zackrisson, B, 1992
)
1.37
"Ondansetron is a 5-hydroxytryptamine 3-receptor antagonist which has shown activity in the prevention of cytotoxic-induced emesis. "( Results of a randomized, double-blind comparative study of ondansetron and metoclopramide in the prevention of nausea and vomiting following high-dose upper abdominal irradiation.
Adams, M; Collis, CH; Lucraft, H; Priestman, S; Priestman, TJ; Roberts, JT; Upadhyaya, BK, 1990
)
1.97
"Ondansetron (GR 38032F) is a highly selective 5-HT3 receptor antagonist, one of a new class of compounds which may have several therapeutic applications. "( Ondansetron. Therapeutic use as an antiemetic.
Heel, RC; Milne, RJ, 1991
)
3.17
"Ondansetron appears to be a promising antiemetic for the prevention of postoperative nausea and vomiting."( Prevention of postoperative nausea and vomiting using ondansetron, a new, selective, 5-HT3 receptor antagonist.
Leeser, J; Lip, H, 1991
)
1.25
"Oral ondansetron is an effective and safe antiemetic for patients receiving noncisplatin cyclophosphamide-doxorubicin-based chemotherapy, and its antiemetic activity appears to be dose-related."( Evaluation of three oral dosages of ondansetron in the prevention of nausea and emesis associated with cyclophosphamide-doxorubicin chemotherapy.
Ciociola, A; Esparza, L; Fraschini, G; Holmes, FA; Hortobagyi, GN; Templeton, D; Walters, RS, 1991
)
1.01
"Ondansetron is a safe and effective antiemetic drug."( Oral ondansetron (GR38032F) for the control of acute and delayed cyclophosphamide-induced emesis.
Campora, E; Cetto, G; Fosser, V; Marangolo, M; Oliva, C; Rosso, R,
)
1.37
"Ondansetron hydrochloride is a specific antagonist of serotonin type 3 (5-HT3) receptors, both in the chemoreceptor trigger zone and in the GI tract."( Ondansetron--the first of a new class of antiemetic agents.
Chaffee, BJ; Tankanow, RM, 1991
)
2.45
"Ondansetron (OND) is a new 5-HT3 receptor antagonist that give complete protection from emesis/nausea in approximately 50% of cisplatin (CDDP)-treated patients. "( Prevention of cisplatin-induced emesis: a double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone.
Amadori, D; Bella, MA; Cognetti, F; Cortesi, E; Donati, D; Favalli, G; Gramazio, V; Marangolo, M; Roila, F; Tonato, M, 1991
)
1.94
"Ondansetron is a selective 5-HT3 antagonist with significant antiemetic properties in patients receiving cytotoxic chemotherapy. "( Reduction of carboplatin induced emesis by ondansetron.
Dickson, DS; Evans, BD; Harvey, VJ; Langley, GB; Mak, D; Mitchell, PL; Neave, LM, 1991
)
1.99
"Ondansetron appears to be a safe and effective antiemetic when administered during a multiple-day cisplatin-containing chemotherapy regimen."( Ondansetron (GR 38032F): a novel antiemetic effective in patients receiving a multiple-day regimen of cisplatin chemotherapy.
Bryson, JC; Finn, AL; Hainsworth, JD; Khojasteh, A; Omura, GA, 1991
)
2.45
"Ondansetron is a selective 5-HT3 antagonist and has clear anti-emetic capabilities."( Effective emetic control during conditioning of children for bone marrow transplantation using ondansetron, a 5-HT3 antagonist.
Cornish, J; Hewitt, M; Oakhill, A; Pamphilon, D, 1991
)
1.22
"Ondansetron is a safe and highly effective antiemetic agent."( Control of refractory, chemotherapy-induced emesis with the serotonin antagonist ondansetron (GR38032F).
Ardizzoni, A; Campora, E; Oliva, C; Rosso, R; Vidili, G, 1991
)
1.23
"Ondansetron is a specific antagonist of 5-HT3 serotonin receptors."( [Ondansetron: a specific 5-HT3 serotonin receptor inhibitor, a new antiemetic in oncology].
Aubert, B; Bons, J; d'Allens, H; Pappo, M, 1991
)
1.91
"Ondansetron is a 5-hydroxytryptamine3 receptor antagonist for the treatment of chemotherapy- and radiotherapy-induced nausea and emesis. "( Determination of ondansetron in plasma and its pharmacokinetics in the young and elderly.
Colthup, PV; Felgate, CC; Palmer, JL; Scully, NL, 1991
)
2.06
"Ondansetron is a highly effective non-sedative antiemetic that justifies further assessment in combination with other antiemetics in patients receiving cytotoxic drugs associated with the production of severe nausea and vomiting."( Ondansetron--a new safe and effective antiemetic in patients receiving high-dose melphalan.
Butcher, ME; Gore, ME; McElwain, TJ; Selby, PJ; Viner, CV; Wootton, CM; Zulian, GB, 1990
)
2.44
"Ondansetron is an investigational serotonin antagonist that has documented effectiveness for cancer chemotherapy-induced emesis."( Ondansetron: a new entity in emesis control.
Graves, T, 1990
)
2.44
"Ondansetron (GR38032F) is a selective antagonist of 5-hydroxytryptamine (5-HT) type 3 receptors. "( Colonic transit in man is slowed by ondansetron (GR38032F), a selective 5-hydroxytryptamine receptor (type 3) antagonist.
Brownless, SM; Gilmore, IT; Gore, S; Haigh, CG; Morris, AI; Stockdale, H, 1990
)
2
"Ondansetron is a highly selective and potent antagonist for this receptor type."( Pharmacological and anti-emetic properties of ondansetron.
Bunce, KT; Humphrey, PP; Tyers, MB, 1989
)
1.26
"Ondansetron is a 5-HT3 receptor antagonist which has shown activity in the prevention of nausea and vomiting resulting from cytotoxic therapy. "( Clinical studies with ondansetron in the control of radiation-induced emesis.
Priestman, TJ, 1989
)
2.03
"Ondansetron injection is an aqueous solution containing ondansetron base as the hydrochloride dihydrate. "( Pharmaceutical development of ondansetron injection.
Leak, RE; Woodford, JD, 1989
)
2.01

Effects

Ondansetron has a shelf life of about 3 hr; hence, it is a matter of great interest to determine the ideal adsorption-desorption conditions for this drug on latex particles. The drug has a major role in preparing patients for BMT.

Ondansetron has been shown to reduce the incidence of hypotension and vasopressor requirement during spinal anesthesia for obstetric and nonobstetric surgery. It has been found to significantly delay the onset of emesis, and reduce the number of retches and vomits in ferrets receiving cisplatin or cyclophosphamide.

ExcerptReferenceRelevance
"Ondansetron has a preventive effect on PAS without a paralleled side effect of bradycardia."( Efficacy and safety of ondansetron in preventing postanesthesia shivering: a meta-analysis of randomized controlled trials.
He, K; Liang, SR; Mou, JH; Su, GZ; Tie, HT; Yuan, HW, 2014
)
2.16
"Ondansetron has a half-life of approximately 4 h, hence it is a matter of great interest to determine the ideal conditions for the formation of a drug-polymer complex in order to prolong the duration of the therapeutic action."( Physical characteristics of polymer complexes in suspension obtained from cellulosic latexes with ondansetron.
Gallardo, V; Llácer, JM; Morales, E; Ruiz, A, 2004
)
1.26
"Ondansetron has a shelf life of about 3 hr; hence, it is a matter of great interest to determine the ideal adsorption-desorption conditions for this drug on latex particles for designs of formulations (oral suspensions) containing polymers with the aim of delivering different drugs in a prolonged and controlled fashion."( Adsorption-desorption of ondansetron on latex particles.
Gallardo, V; Llácer, JM; Parera, A; Ruiz, MA, 2000
)
1.33
"Ondansetron has a well documented antiemetic prophylactic effect, whereas in most studies of postoperative nausea and vomiting (PONV), metoclopramide is less efficacious. "( Incidence and severity of postoperative nausea and vomiting are similar after metoclopramide 20 mg and ondansetron 8 mg given by the end of laparoscopic cholecystectomies.
Quaynor, H; Raeder, JC, 2002
)
1.97
"Ondansetron has a major role in preparing patients for BMT."( Effective emetic control during conditioning of children for bone marrow transplantation using ondansetron, a 5-HT3 antagonist.
Cornish, J; Hewitt, M; Oakhill, A; Pamphilon, D, 1991
)
1.22
"Ondansetron has been shown to reduce the incidence of hypotension and vasopressor requirement during spinal anesthesia for obstetric and nonobstetric surgery. "( A Prospective, Randomized, Double-Blinded Study of the Effect of Intravenous Ondansetron on the Effective Dose in 50% of Subjects of Prophylactic Phenylephrine Infusions for Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Delivery.
Chang, X; Chen, X; Ngan Kee, WD; Shen, H; Wei, C; Xiao, F; Xue, L; Zhang, Y, 2020
)
2.23
"Ondansetron has also been studied in the treatment of many neuropsychiatric and medical conditions."( Major Congenital Malformation Risk After First Trimester Gestational Exposure to Oral or Intravenous Ondansetron.
Andrade, C, 2020
)
1.5
"Ondansetron has been used to deal with the problem of neuraxial morphine-induced pruritus (NMIP)."( Ondansetron for neuraxial morphine-induced pruritus: A meta-analysis of randomized controlled trials.
Sun, L; Wang, W; Zhou, L, 2017
)
2.62
"Ondansetron has proven to be a safe and effective adjunct in children with vomiting."( Clinical Pathway Produces Sustained Improvement in Acute Gastroenteritis Care.
Brown, JC; Klein, EJ; Rutman, L, 2017
)
1.18
"Ondansetron has been shown to decrease admission rate and the need for intravenous fluids among pediatric emergency department (ED) patients with acute gastroenteritis, but there is limited evidence regarding its use after ED discharge. "( Ondansetron Prescription for Home Use in a Pediatric Emergency Department.
Furnival, RA; Gray, JM; Hendrickson, MA; Lunos, SA; Maewal, JD, 2020
)
3.44
"Ondansetron has been reported to reduce the incidence of SAIH in patients undergoing cesarean section."( Does prophylactic ondansetron reduce norepinephrine consumption in patients undergoing cesarean section with spinal anesthesia?
Biricik, E; Büyükkurt, S; Karacaer, F; Ünal, İ; Ünlügenç, H, 2018
)
1.54
"Ondansetron has a preventive effect on PAS without a paralleled side effect of bradycardia."( Efficacy and safety of ondansetron in preventing postanesthesia shivering: a meta-analysis of randomized controlled trials.
He, K; Liang, SR; Mou, JH; Su, GZ; Tie, HT; Yuan, HW, 2014
)
2.16
"Ondansetron has negligible effect on uremic pruritus and is expensive."( Comparison of pregabalin with ondansetron in treatment of uraemic pruritus in dialysis patients: a prospective, randomized, double-blind study.
Jiao, S; Meng, J; Ren, W; Xiao, Y; Yue, J; Zhao, T, 2015
)
1.43
"Ondansetron use has increased significantly; however, 'real-world' studies of effectiveness have documented less impressive clinical impacts."( Ondansetron and probiotics in the management of pediatric acute gastroenteritis in developed countries.
Finkelstein, Y; Freedman, SB; Schnadower, D, 2015
)
2.58
"Ondansetron has been shown to decrease postanesthesia shivering in adults, but this effect has never been studied in children. "( Preventative effect of ondansetron on postanesthesia shivering in children undergoing caudal anesthesia: a randomized double-blinded clinical trial.
Hu, Y; Huang, W; Jin, Z; Lin, H; Wang, J, 2016
)
2.19
"Ondansetron has been proved to be valid in preventing postanaesthesia shivering (PAS) in several studies."( Efficiency and safety of ondansetron in preventing postanaesthesia shivering.
He, K; Zhao, H; Zhou, HC, 2016
)
1.46
"Ondansetron has been suggested as an adjunctive treatment."( Ondansetron in acute food protein-induced enterocolitis syndrome, a retrospective case-control study.
Bersani, G; Campbell, D; Cerchiara, G; Lee, E; Mehr, S; Miceli Sopo, S; Monaco, S, 2017
)
2.62
"Ondansetron has been shown to reduce pruritus but the effect is short-lived."( Reduction of severity of pruritus after elective caesarean section under spinal anaesthesia with subarachnoid morphine: a randomised comparison of prophylactic granisetron and ondansetron.
Carey, M; Choroszczak, P; Immani, S; Ojo, R; Tan, T, 2010
)
1.28
"Ondansetron use has increased significantly and is associated with reductions in the use of intravenous rehydration, emergency department revisits, and length of stay. "( Time-series analysis of ondansetron use in pediatric gastroenteritis.
Chan, KJ; Cho, D; Freedman, SB; Rumantir, M; Tung, C, 2012
)
2.13
"Ondansetron has emerged as a promising medication for the treatment of alcohol dependence, mainly among early-onset alcoholics. "( A pilot study of full-dose ondansetron to treat heavy-drinking men withdrawing from alcohol in Brazil.
Baltieri, DA; Corrêa Filho, JM, 2013
)
2.13
"Ondansetron has been shown to be an effective treatment for early-onset alcoholism. "( Ondansetron reduces mood disturbance among biologically predisposed, alcohol-dependent individuals.
Ait-Daoud, N; Johnson, BA; Ma, JZ; Wang, Y, 2003
)
3.2
"Ondansetron has been used widely in plastic surgery to prevent postoperative nausea and vomiting. "( Ondansetron for the prevention of postoperative nausea and vomiting: which is the best dosage for aesthetic plastic surgery?
Barbosa, MV; Bariani, RL; Farah, AB; Ferreira, LM; João, BB; Nahas, FX,
)
3.02
"Ondansetron has a half-life of approximately 4 h, hence it is a matter of great interest to determine the ideal conditions for the formation of a drug-polymer complex in order to prolong the duration of the therapeutic action."( Physical characteristics of polymer complexes in suspension obtained from cellulosic latexes with ondansetron.
Gallardo, V; Llácer, JM; Morales, E; Ruiz, A, 2004
)
1.26
"Ondansetron has been shown to be effective in the treatment of early-onset adult alcohol dependence. "( A prospective, open-label trial of ondansetron in adolescents with alcohol dependence.
Ait-Daoud, N; Cornelius, JR; Dawes, MA; Johnson, BA; Ma, JZ, 2005
)
2.05
"Ondansetron has been well tolerated when used to control nausea and vomiting in patients receiving chemotherapy."( Ondansetron for acute gastroenteritis in children.
Goldman, RD; Mehta, S, 2006
)
2.5
"Ondansetron has had a major impact on the prevention of emesis in patients receiving chemotherapy. "( A randomized trial of the effects of pharmacist intervention on the cost of antiemetic therapy with ondansetron.
Dranitsaris, G; Puodziunas, A; Warr, D, 1995
)
1.95
"Ondansetron has been shown to be highly effective in preventing nausea and vomiting in children treated with chemotherapy and/or radiotherapy."( Variation in the use of ondansetron as an antiemetic drug in children treated with chemotherapy.
Kurtin, P; Ninane, J; Ozkaynak, MF; Siegel, SE, 1995
)
1.32
"Oral ondansetron has shown efficacy in such trials, but the standard of care for preventing chemotherapy-induced emesis is not placebo."( Oral ondansetron for preventing nausea and vomiting.
Cooke, CE; Mehra, IV, 1994
)
1.26
"Ondansetron has shown its activity and safety also in multiple-day cisplatin regimens."( Cisplatinum based chemotherapy: role of the antiserotoninergic ondansetron in prevention of emesis.
D'Antona, A; Locatelli, MC; Luporini, G, 1993
)
1.25
"Ondansetron has been shown to be more active and less toxic than high-dose metoclopramide in patients submitted to cisplatin chemotherapy."( Ondansetron.
Ballatori, E; Basurto, C; Bracarda, S; Del Favero, A; Lupattelli, M; Picciafuoco, M; Roila, F; Sassi, M; Tonato, M, 1993
)
2.45
"Ondansetron has also been found to be effective in the prevention or treatment of postoperative nausea and vomiting and other studies are underway to investigate its potential use in other clinical settings."( Global experience with ondansetron and future potential.
Butcher, ME,
)
1.16
"Ondansetron has proven to be appropriate as a single agent or as an addition to standard antiemetic therapy (ie, corticosteroids, benzodiazepines, neurotransmitter blockers) in preventing and treating acute chemotherapy-induced emesis (CIE)."( Ondansetron: a novel antiemetic agent.
Dukes, GE; Figg, WD; Graham, CL; Hak, LJ, 1993
)
2.45
"Ondansetron use has improved the control of post-chemotherapy nausea, vomiting, and retching."( Nurses' perceptions of antiemetic effectiveness.
Johnson, M; McDaniel, RW; Rhodes, VA; Simms, SG, 1995
)
1.01
"Ondansetron has been used to treat the pruritus in patients with cholestatic diseases or renal insufficiency, suggesting that pruritus may be mediated by serotonin."( Treatment of opioid-induced pruritus with ondansetron: report of four patients.
Goldberg, ME; Larijani, GE; Rogers, KH,
)
1.12
"Ondansetron has also been used to manage nausea and vomiting in other patients."( Use of ondansetron in palliative medicine.
Cooney, NJ; Coughlan, M; Currow, DC; Fardell, B, 1997
)
1.47
"Ondansetron availability has been associated with changes in the clinical management of cancer patients receiving chemotherapy and with overall cost savings compared with previously available antiemetic therapy."( Costs of treating and preventing nausea and vomiting in patients receiving chemotherapy.
Coyle, D; Dahrouge, S; Evans, WK; Stewart, DJ, 1999
)
1.75
"Ondansetron has a shelf life of about 3 hr; hence, it is a matter of great interest to determine the ideal adsorption-desorption conditions for this drug on latex particles for designs of formulations (oral suspensions) containing polymers with the aim of delivering different drugs in a prolonged and controlled fashion."( Adsorption-desorption of ondansetron on latex particles.
Gallardo, V; Llácer, JM; Parera, A; Ruiz, MA, 2000
)
1.33
"Ondansetron has been approved for the treatment and prevention of postoperative emesis. "( Failure of prevention against postoperative vomiting by ondansetron or prochlorperazine in patients undergoing gynecological laparoscopy.
Buerkle, H; Hsu, TY; Lee, TC; Lee, TH; Lin, CR; Mao, CC; Yang, LC, 2000
)
2
"Ondansetron has shown good efficacy in the prevention of acute nausea and vomiting in children receiving moderately or highly emetogenic chemotherapy and/or irradiation, particularly when combined with dexamethasone. "( Ondansetron: a review of its use as an antiemetic in children.
Bhana, N; Culy, CR; Plosker, GL, 2001
)
3.2
"Ondansetron has a well documented antiemetic prophylactic effect, whereas in most studies of postoperative nausea and vomiting (PONV), metoclopramide is less efficacious. "( Incidence and severity of postoperative nausea and vomiting are similar after metoclopramide 20 mg and ondansetron 8 mg given by the end of laparoscopic cholecystectomies.
Quaynor, H; Raeder, JC, 2002
)
1.97
"Ondansetron (Zofran) has proven benefit in preventing postoperative nausea and vomiting if given before general anesthesia in a variety of surgical procedures."( The prevention of emesis in plastic surgery: a randomized, prospective study.
Chao, JD; Few, JW; Fine, NA; Marcus, JR; Mustoe, TA, 2002
)
1.04
"Ondansetron (GR 38032) has potent and highly selective antagonist properties at the 5-hydroxytryptamine (5-HT, serotonin) 5-HT3 receptor. "( Pharmacology and preclinical antiemetic properties of ondansetron.
Tyers, MB, 1992
)
1.97
"Ondansetron has also been shown to be effective in children and the elderly in the control of cytotoxic-induced emesis."( Experience with ondansetron in chemotherapy- and radiotherapy-induced emesis.
Dicato, MA; Freeman, AJ, 1992
)
1.35
"Ondansetron has also been shown to be effective in controlling nausea and vomiting in patients receiving cyclophosphamide with an anthracycline and in patients receiving combination therapy with cyclophosphamide, methotrexate, and fluorouracil."( Ondansetron--the first of a new class of antiemetic agents.
Chaffee, BJ; Tankanow, RM, 1991
)
2.45
"Ondansetron has a major role in preparing patients for BMT."( Effective emetic control during conditioning of children for bone marrow transplantation using ondansetron, a 5-HT3 antagonist.
Cornish, J; Hewitt, M; Oakhill, A; Pamphilon, D, 1991
)
1.22
"Ondansetron has marked activity against emesis associated with cisplatin and other highly emetogenic drugs."( Ondansetron: a serotonin receptor (5-HT3) antagonist for antineoplastic chemotherapy-induced nausea and vomiting.
Goldspiel, BR; Kohler, DR, 1991
)
2.45
"Ondansetron has been found to significantly delay the onset of emesis, and reduce the number of retches and vomits in ferrets receiving cisplatin, cyclophosphamide, or radiation, at much lower doses than metoclopramide and without the associated side effects."( Pharmacological and anti-emetic properties of ondansetron.
Bunce, KT; Humphrey, PP; Tyers, MB, 1989
)
1.26

Actions

Ondansetron did not cause any worsening in basic PD symptoms or levodopa efficacy and was well tolerated with no major side effects. The ondansetton group had a lower nausea and vomiting scores, and more patients were free from nausea and vomitting than the control group. OndansETron is known to cause QT interval prolongation, but this effect has not been prospectively studied in adult emergency department (ED) patients.

ExcerptReferenceRelevance
"Ondansetron does not inhibit subarachnoid morphine-induced pruritus."( Comparison of droperidol and ondansetron prophylactic effect on subarachnoid morphine-induced pruritus.
Behrensdorf, AP; Boabaid, R; Brião, FF; de Barros, GA; Horta, BL; Horta, ML; Nunes, MA; Real, A; Severo, I,
)
1.87
"Ondansetron is known to cause QT interval prolongation, but this effect and clinical significance has not been prospectively studied in adult emergency department (ED) patients. "( Intravenous Ondansetron and the QT Interval in Adult Emergency Department Patients: An Observational Study.
Cartwright, L; Grossart, EA; Kang, CS; Moffett, PM; O'Keefe, D, 2016
)
2.26
"Ondansetron can cause dose-dependent QT prolongation effects, which are more clinically relevant when other proarrhythmic elements are present. "( Fatal Cardiac Arrest in 2 Children: Possible Role of Ondansetron.
Boucher, J; Brenner, SM, 2016
)
2.13
"Ondansetron did not inhibit behavior in control animals."( Ondansetron given in the acute withdrawal from a repeated cocaine sensitization dosing regimen reverses the expression of sensitization and inhibits self-administration.
Davidson, C; Ellinwood, EH; Lee, TH; Xiong, Z, 2002
)
2.48
"The ondansetron group had a lower nausea and vomiting scores, and more patients were free from nausea and vomiting than the control group (41 vs."( Antiemetic effect of ondansetron 0.2 mg mL-1 in PCA morphine solution.
Boonmak, P; Boonmak, S; Bunsaengjaroen, P; Nonlhaopol, D; Poomsawat, S; Srichaipanha, S, 2007
)
1.14
"Ondansetron did not cause any worsening in basic PD symptoms or levodopa efficacy and was well tolerated with no major side effects."( Psychosis in advanced Parkinson's disease: treatment with ondansetron, a 5-HT3 receptor antagonist.
Friedberg, G; Livneh, M; Melamed, E; Zoldan, J, 1995
)
1.26

Treatment

Ondansetron treatment reduced the severity of NOWS symptoms and could reduce the length of stay. The group treated showed a greater need for re-administration of the medication (50.6% vs. 50.6%) Ondansettingron pretreatment did not have a significant effect on the imaging correlates of opioid withdrawal.

ExcerptReferenceRelevance
"Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay."( Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial.
Adeniyi-Jones, S; Argani, C; Cohane, C; Drover, D; Govindaswami, B; Jansson, LM; Jegatheesan, P; Khan, S; Kraft, WK; Peltz, G; Shafer, S; Wang, M; Wu, M, 2023
)
3.8
"The ondansetron-treated group showed a greater need for re-administration of the medication (50.6% vs."( Ondansetron or promethazine: Which one is better for the treatment of acute peripheral vertigo?
Kazemnejad-Leili, E; Nemati, S; Pourshafie, SH; Saberi, A; Sayad-Fathi, S; Sutohian, S,
)
2.05
"Ondansetron pretreatment did not have a significant effect on the imaging correlates of opioid withdrawal."( Acute opioid withdrawal is associated with increased neural activity in reward-processing centers in healthy men: A functional magnetic resonance imaging study.
Alva, H; Chu, LF; Clark, JD; Clemenson, A; Encisco, E; Erlendson, M; Hoang, D; Lin, JC; Sun, J; Younger, JW, 2015
)
1.14
"Ondansetron treatment caused a statistically significantly higher Cmax of metformin compared with placebo (18.3 ± 5.05 versus 15.2 ± 3.23; P = 0.006) and apparently decreased the renal clearance of metformin by 37% as compared with placebo (P = 0.001)."( Effect of Ondansetron on Metformin Pharmacokinetics and Response in Healthy Subjects.
Guo, D; Li, Q; Polli, JE; Shu, Y; Yang, H; Zhang, T; Zhou, H, 2016
)
1.56
"Ondansetron treatment restored phos-p38 MAPK expression as compared with vehicle-treated haemorrhaged rats."( Ondansetron attenuates hepatic injury via p38 MAPK-dependent pathway in a rat haemorrhagic shock model.
Liu, FC; Liu, FW; Yu, HP, 2011
)
2.53
"Ondansetron treatment did not affect basal gastric tone (173 ± 14 vs 156 ± 12 mL), neither did it affect the amplitude of the meal-induced relaxation (160 ± 52 vs 131 ± 43 mL) or the maximum volume increase after the meal (264 ± 54 mL vs 234 ± 51 mL)."( Influence of the 5-HT3 receptor antagonist ondansetron on gastric sensorimotor function and nutrient tolerance in healthy volunteers.
Janssen, P; Tack, J; Van Oudenhove, L; Vos, R, 2011
)
1.35
"Ondansetron pretreatment may be used to reduce the incidence of pain on injection of propofol, an advantage added to the useful prevention of postoperative nausea and vomiting."( Ondansetron pretreatment reduces pain on injection of propofol.
Maleki, A; Rostami, G; Zahedi, H, 2012
)
2.54
"The ondansetron treated rats showed only a non-significant decrease in break point."( Ondansetron given in the acute withdrawal from a repeated cocaine sensitization dosing regimen reverses the expression of sensitization and inhibits self-administration.
Davidson, C; Ellinwood, EH; Lee, TH; Xiong, Z, 2002
)
2.24
"Ondansetron treatment also resulted in fewer patients requiring rescue medication or assumed to have had rescue upon early discontinuation from the study during the postoperative period (ondansetron, 5%; placebo, 10%) and less emesis (0 of 6) after rescue medication when compared with placebo (7 of 21)."( A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia.
Anschuetz, GC; Ansermino, JM; Blackburn, LM; Bolos, ME; Brooks, PB; Cohen, IT; Coté, CJ; Davis, PJ; Hannallah, RS; Khalil, SN; Roth, AG; Russo, MW; Simhi, E, 2005
)
1.32
"In ondansetron-pretreated group, insulin administration could produce only mild acceleration of SIT (23.5%)."( An inherent acceleratory effect of insulin on small intestinal transit and its pharmacological characterization in normal mice.
Dkhar, SA; Naveen, AT; Peddyreddy, MK; Ramaswamy, S; Shewade, DG, 2006
)
0.85
"The ondansetron-treated group had a significantly higher proportion of patients with a 30% or greater baseline-to-endpoint reduction in PANSS total score than placebo."( Beneficial effects of ondansetron as an adjunct to haloperidol for chronic, treatment-resistant schizophrenia: a double-blind, randomized, placebo-controlled study.
Kang, WH; Li, Q; Ma, AQ; Wang, XY; Yao, SM; Zhang, ZJ, 2006
)
1.13
"Ondansetron-treated patients had significantly shorter hospital stays than droperidol-treated patients, but recovery parameters were similar between the ondansetron- and placebo-treated patients."( Effect of antiemetic therapy on recovery and hospital discharge time. A double-blind assessment of ondansetron, droperidol, and placebo in pediatric patients undergoing ambulatory surgery.
Davis, PJ; Hoffmann, P; Landsman, I; Maloney, K; McGowan, FX, 1995
)
1.23
"The ondansetron-treated patients experienced only a mild headache as their only toxicity and had significantly (P 0.0026) less diarrhea, akathisia, and acute dystonic reactions than the patients receiving the metoclopramide regimen."( Comparison of intermittent ondansetron versus continuous infusion metoclopramide used with standard combination antiemetics in control of acute nausea induced by cisplatin chemotherapy.
Kilgore, JR; Navari, RM; Perrine, GM; Province, WS, 1993
)
1.06
"Ondansetron pretreatment significantly reduced their plasma cortisol response to m-CPP without affecting the other plasma hormone responses."( Behavioral, physiological and neuroendocrine responses in healthy volunteers to m-chlorophenylpiperazine (m-CPP) with and without ondansetron pretreatment.
Baldemore, D; Briggs, NC; Broocks, A; Canter, SK; Hill, JL; Murphy, DL; Pigott, TA; Tolliver, TJ, 1997
)
1.22
"Ondansetron-treated patients reached criteria for home readiness one-half hour sooner than placebo-treated patients (P < 0.05)."( Single-dose ondansetron prevents postoperative vomiting in pediatric outpatients.
Cohen, IT; Colingo, K; Creed, MR; Davis, PJ; Donlon, JV; Ferrari, LR; Haberkern, CM; Hannallah, RS; McGowan, FX; Orr, RJ; Parasuraman, TV; Patel, RI; Prillaman, BA; Rimar, S, 1997
)
1.4
"Ondansetron pretreatment did not alter the pentagastrin-induced cortisol increase but significantly prolonged the pentagastrin-induced increase in ACTH."( Effects of the 5-HT3 antagonist, ondansetron, on the behavioral and physiological effects of pentagastrin in patients with panic disorder and social phobia.
Geraci, M; McCann, UD; Morgan, CM; Murphy, DL; Post, RM; Slate, SO, 1997
)
1.3
"Ondansetron pretreatment had no effect on the prolactin response to clomipramine challenge. "( The effects of serotonin3 receptor blockade on the psychobiological response to intravenous clomipramine in healthy human subjects.
Bebchuk, JM; Carson, SW; Ekstrom, RD; Golden, RN; Heine, AD; Leatherman, ME, 1999
)
1.75
"Ondansetron treatment was associated with a significant decrease in the severity of tics."( Ondansetron treatment in patients with Tourette's syndrome.
Cohen, DJ; Laor, N; Toren, P; Weizman, A; Wolmer, L, 1999
)
2.47
"Ondansetron treats intrathecal morphine-induced pruritus after cesarean delivery, particularly in patients suffering from both nausea/vomiting and pruritus."( Ondansetron for treatment of intrathecal morphine-induced pruritus after cesarean delivery.
Charuluxananan, S; Kyokong, O; Nimcharoendee, K; Somboonviboon, W,
)
3.02
"Ondansetron-treated subjects had fewer emetic episodes (p less than 0.001) and lower subjective nausea scores (p less than 0.001)."( Ondansetron is effective in decreasing postoperative nausea and vomiting.
Dershwitz, M; Di Biase, PM; Joslyn, AF; Rosow, CE; Sanderson, PE, 1992
)
2.45
"Pre-treatment with ondansetron 4 mg IV was compared against placebo on nausea and vomiting following the standard (20.25 h) regimen, or a novel 12 h NAC regimen in paracetamol poisoning."( Scottish and Newcastle antiemetic pre-treatment for paracetamol poisoning study (SNAP).
Bateman, DN; Coyle, J; Dear, JW; Eddleston, M; Gray, A; Lewis, S; Sandilands, EA; Thanacoody, HK; Thomas, SH; Webb, DJ, 2013
)
0.71
"Pretreatment with ondansetron, a serotonin 5-HT3 receptor antagonist, which is used to treat nausea in patients in chemo- or radiation therapy, attenuated hypothermia by ~30%."( Thermoregulatory correlates of nausea in rats and musk shrews.
Cerri, M; Corrigan, JJ; Del Vecchio, F; Dragic, AS; Kamphee, A; Nalivaiko, E; Ngampramuan, S; Romanovsky, AA; Rudd, JA, 2014
)
0.73
"Treatment with ondansetron was started on day 15."( Ondansetron attenuates depression co-morbid with obesity in obese mice subjected to chronic unpredictable mild stress; an approach using behavioral battery tests.
Gupta, D; Kurhe, Y; Radhakrishnan, M, 2014
)
2.18
"Treatment with ondansetron was associated with decreased odds of postanesthesia shivering symptoms compared to the control group. "( Preventative effect of ondansetron on postanesthesia shivering in children undergoing caudal anesthesia: a randomized double-blinded clinical trial.
Hu, Y; Huang, W; Jin, Z; Lin, H; Wang, J, 2016
)
1.1
"Treatment with ondansetron compared with placebo increased the chance for vomiting cessation up to 1 h after drug administration, relative risk, RR, 1.49 (95% confidence interval 1.17-1.89), but there was no difference between the groups after 4, 24 and 48 h."( Systematic review with meta-analysis: ondansetron for vomiting in children with acute gastroenteritis.
Kołodziej, M; Szajewska, H; Tomasik, E; Ziółkowska, E, 2016
)
1.05
"Treat with ondansetron is safe, and may reduce PAS. "( Meta-analysis of randomized controlled trials on the efficacy and safety of ondansetron in preventing postanesthesia shivering.
Hu, X; Li, K; Li, M; Tan, Y; Tang, Z; Yang, B, 2016
)
1.05
"Pretreatment with ondansetron or metoclopramide does not reduce oral contrast solution ingestion time."( Pretreatment of patients requiring oral contrast abdominal computed tomography with antiemetics: a randomized controlled trial of efficacy.
Bamber, D; Chohan, J; Garra, G; Singer, AJ; Thode, HC; Troxell, R, 2009
)
0.69
"Pre-treatment with ondansetron abolished the accelerating effect of erythromycin by restoring the emptying times to placebo levels."( Octreotide enhances the accelerating effect of erythromycin on gastric emptying in healthy subjects.
Athanasakis, E; Chrysos, E; Karkavitsas, N; Tsiaoussis, J; Xynos, E; Zoras, OJ, 2002
)
0.63
"Pretreatment with ondansetron, Y-25130, fluphenazine and their combination significantly attenuated COC-induced behaviors during repeated treatment but not on the test for sensitization. "( Pretreatment with serotonin 5-HT(3) receptor antagonists produces no observable blockade of long-term motor sensitization to cocaine in rats.
Frys, KA; Kalivas, PW; Szumlinski, KK, 2003
)
0.65
"Pretreatment with ondansetron or MDL 72222 reduced the increase in striatal DA release induced by 10 mg/kg morphine but not by 1 mg/kg morphine, haloperidol, amphetamine or cocaine."( Conditional involvement of striatal serotonin3 receptors in the control of in vivo dopamine outflow in the rat striatum.
De Deurwaerdère, P; Moison, D; Porras, G; Spampinato, U, 2003
)
0.64
"The treatment with ondansetron may also have effects on the pruritus of patients with cholestasis."( [Pathogenesis and treatment of pruritus in patients with cholestasis].
Blumenstein, I; Schirrmacher, S; Stein, J, 2003
)
0.64
"Pre-treatment with ondansetron, at doses of 2 and 4 mg/kg, did not affect the antinociceptive activity of paracetamol in the hot-plate test and in the paw pressure test. "( Differential involvement of central 5-HT1B and 5-HT3 receptor subtypes in the antinociceptive effect of paracetamol.
Pini, LA; Sandrini, M; Vitale, G, 2003
)
0.65
"Treatment with ondansetron was necessary in seven low-risk and 37 high-risk patients with a complete response rate of 71% (low-risk) and 43% (high-risk)."( A risk adapted approach reduces the overall institutional incidence of postoperative nausea and vomiting.
Apfel, CC; Biedler, A; Dethling, J; Kunitz, O; Müller, A; Wermelt, J; Wilhelm, W, 2004
)
0.66
"Treatment with ondansetron (1.0 mg/kg) significantly reduced the scopolamine-induced working memory deficits."( Ondansetron amelioration of scopolamine induced cognitive deficits in three-panel runway apparatus in rats.
Kela, AK; Kumar, N, 2004
)
2.11
"Pretreatment with ondansetron (0.5 mM) antagonized the m-CPBG (2.0 mM)-induced reduction of REMS and of the number of REM periods."( Activation of the serotonin 5-HT3 receptor in the dorsal raphe nucleus suppresses REM sleep in the rat.
Jantos, H; Monti, JM, 2008
)
0.67
"Treatment with ondansetron significantly reduced the number of episodes of nausea and vomiting, as well as the urinary values for serotonin and 5-HIAA."( Ondansetron, an antagonist of 5-HT3 receptors, in the treatment of antineoplastic drug-induced nausea and vomiting in children.
Calabria, C; Casale, F; Di Tullio, M; Indolfi, P; Lampa, E; Lucarelli, C; Matera, MG; Rossi, F, 1993
)
2.07
"Pretreatment with ondansetron significantly attenuated several of the subjective pleasurable effects of alcohol, and also decreased the subjective desire to drink."( Attenuation of some alcohol-induced mood changes and the desire to drink by 5-HT3 receptor blockade: a preliminary study in healthy male volunteers.
Campling, GM; Cowen, PJ; Griffiths, P; Johnson, BA, 1993
)
0.61
"Pretreatment with ondansetron failed to significantly affect either the number of reinforcers obtained or the ISRT."( Parameters of self-administration of cocaine in rats under a progressive-ratio schedule.
Depoortere, RY; Emmett-Oglesby, MW; Lane, JD; Li, DH, 1993
)
0.61
"Pretreatment with ondansetron inhibited cisplatin-induced kaolin intake."( Pica in rats is analogous to emesis: an animal model in emesis research.
Hasegawa, S; Matsunaga, T; Morita, M; Takeda, N, 1993
)
0.61
"Pretreatment with ondansetron, however completely blocked the analgesic effect of nifedipine, with tail-flick latency remaining at baseline throughout the measurement period."( Ondansetron blocks nifedipine-induced analgesia in rats.
Hunt, TE; Wu, W; Zbuzek, VK, 1996
)
2.06
"A treatment with ondansetrone was considered to be safe in this patient."( [The clinicopharmacological case (5). serotonin reuptake inhibitor and 5-HT3-receptor antagonists: are there clinically relevant interactions?].
Fattinger, K; Kind, B; Krähenbühl, S; Meier-Abt, PJ, 1996
)
0.62
"Pretreatment with ondansetron did not affect peak behavioral responses to m-CPP, but was associated with a significantly earlier return to baseline levels of ratings of anxiety and functional deficit as well as a summary measure of overall behavioral effects."( Behavioral, physiological and neuroendocrine responses in healthy volunteers to m-chlorophenylpiperazine (m-CPP) with and without ondansetron pretreatment.
Baldemore, D; Briggs, NC; Broocks, A; Canter, SK; Hill, JL; Murphy, DL; Pigott, TA; Tolliver, TJ, 1997
)
0.83
"Pretreatment with ondansetron (0.01 and 1 microgram/kg i.p.) but not with tropisetron (1, 10, and 30 micrograms/kg i.p.) reversed scopolamine-induced memory deficits in the step-through passive avoidance task."( Different effects of tropisetron and ondansetron in learning and memory paradigms.
Borsini, F; Pitsikas, N, 1997
)
0.89
"Pretreatment with ondansetron (1 X 10(-5) mg/kg, i.p.) enhanced the antidepressant-like effects of sub-active doses of the selective serotonin reuptake inhibitors."( Partial role of 5-HT2 and 5-HT3 receptors in the activity of antidepressants in the mouse forced swimming test.
Bourin, M; Redrobe, JP, 1997
)
0.62
"Pretreatment with ondansetron or ICS 205-930, in doses ranging from 0.001 to 0.1 mg/kg (s.c), did not modify ethanol or cocaine induced stimulation of activity."( Effects of 5-HT3, D1 and D2 receptor antagonists on ethanol- and cocaine-induced locomotion.
Higgins, G; Lê, AD; Quan, B; Sellers, EM; Tomkins, D,
)
0.45
"Treatment with ondansetron was well tolerated, onset of action was rapid, and response rates were high and sustained over time."( Use of ondansetron in palliative medicine.
Cooney, NJ; Coughlan, M; Currow, DC; Fardell, B, 1997
)
1.09
"Pretreatment with ondansetron did not affect any of the self-rated behavioral symptoms."( Acute intravenous administration of ondansetron and m-CPP, alone and in combination, in patients with obsessive-compulsive disorder (OCD): behavioral and biological results.
Broocks, A; Canter, S; Grady, TA; Hill, JL; L'Heureux, F; Murphy, DL; Pigott, TA, 1998
)
0.9
"Pretreatment with ondansetron (0.01 and 0.1 mg/kg, s.c.) effectively attenuated this ethanol-induced place preference."( Roles of 5-HT3 and opioid receptors in the ethanol-induced place preference in rats exposed to conditioned fear stress.
Matsuzawa, S; Misawa, M; Nagase, H; Suzuki, T, 1999
)
0.63
"Pretreatment with ondansetron totally reversed all of the effects of erythromycin to the placebo state."( The effect of erythromycin on human esophageal motility is mediated by serotonin receptors.
Athanasakis, H; Chrysos, E; Epanomeritakis, E; Koutsoumbi, P; Tsiaoussis, J; Vassilakis, JS; Xynos, E; Zoras, O, 2000
)
0.63
"Pretreatment with ondansetron attenuated the effects of amphetamine on hunger and subjective state, but not on blood pressure or psychomotor performance tests."( Ondansetron, a 5-HT3 receptor antagonist, partially attenuates the effects of amphetamine: a pilot study in healthy volunteers.
Cowen, PJ; Johnson, B; Oldman, D; Silverstone, PH, 1992
)
2.05
"Pre-treatment with ondansetron (0.01-1 mg/kg SC) or MDL 72,222 (1-3 mg/kg SC) failed to affect the incidence of these responses except weight loss, which was attenuated by both treatments."( Effects of 5-HT3 receptor antagonists on behavioural measures of naloxone-precipitated opioid withdrawal.
Higgins, GA; Joharchi, N; Nguyen, P; Sellers, EM, 1991
)
0.6
"Pretreatment with ondansetron (0.1 mg kg-1 and 1 mg kg-1 s.c., 15 min before amphetamine) failed to modify the effects of amphetamine."( 5-HT3 receptor antagonist ondansetron does not alter effects of amphetamine on DA metabolism.
Hietala, J; Koulu, M; Lappalainen, J; Sjöholm, B; Virtanen, R, 1990
)
0.9

Toxicity

Ondansetron may be safe in lower doses used to prevent nausea and vomiting in radiation treatment or postoperatively. In adult patients receiving single-day chemotherapy, the incidence of adverse events was 45% with IV ondansetrons and 59% with metoclopramide.

ExcerptReferenceRelevance
" From the above, Ondansetron injection which showed sufficient anti-emetic effects on acute emesis and delayed emesis induced by a high single dose or lower multiple doses of cisplatin with its once daily intravenous dose given for 3-5 consecutive days, were considered a safe and clinically useful anti-emetic."( [Anti-emetic effect and safety of consecutive use of ondansetron injection in cisplatin-induced nausea and emesis].
Akasaka, Y; Ariyoshi, Y; Furue, H; Ikeda, M; Niitani, H; Ohta, J; Ota, K; Suminaga, M; Taguchi, T; Tsukagoshi, S, 1992
)
0.87
" Adverse events (headache and constipation) were observed in 1 case and abnormal change in clinical laboratory findings (increase in eosinophil count) in another case."( [Examination of anti-emetic effect and safety of multiple intravenous doses of ondansetron in patients receiving nonplatinum anti-cancer drugs].
Akasaka, Y; Ariyoshi, Y; Furue, H; Ikeda, M; Niitani, H; Nukariya, N; Ohta, J; Ota, K; Taguchi, T; Tsukagoshi, S, 1992
)
0.51
" In adult patients receiving single-day chemotherapy, the incidence of adverse events was 36% with ondansetron (n = 647) and 50% with metoclopramide (n = 498)."( Toxicity and side effects of ondansetron.
Finn, AL, 1992
)
0.79
" From the above, ondansetron which exerted adequate anti-emetic effect in 4 mg once daily doses was considered as a useful and safe anti-emetic in treatment of nausea and emesis associated with cancer chemotherapy."( [Examination of inhibitory effect, safety and usefulness of SN-307 (ondansetron) administered orally once daily for 3-5 consecutive days on nausea and emesis associated with non-platinum anti-cancer drugs].
Akasaka, Y; Ariyoshi, Y; Furue, H; Ikeda, M; Niitani, H; Ohta, J; Ota, K; Suminaga, M; Taguchi, T; Tsukagoshi, S, 1992
)
0.86
"During late 1991, a series of severe adverse events involving thrombocytopenia, renal insufficiency and thrombotic episodes was observed in patients receiving emetogenic chemotherapy."( Severe vascular adverse effects with thrombocytopenia and renal failure following emetogenic chemotherapy and ondansetron.
Childs, A; Coates, AS; Cox, K; Forsyth, C; Grygiel, JJ; Joshua, DE; McNeil, E, 1992
)
0.5
" In adult patients receiving single-day chemotherapy, the incidence of adverse events was 45% with IV ondansetron (n = 317) and 59% with metoclopramide (n = 279)."( Clinical safety of ondansetron.
Bryson, JC, 1992
)
0.83
" Ondansetron was well tolerated, with no significant drug-related adverse events."( [Gastrointestinal toxicity induced by anticancer drugs--including new antiemetic drugs].
Sampi, K; Taguchi, T, 1990
)
1.19
" This selective 5HT3 antagonist is effective and safe in the control of ifosfamide-induced emesis, even in patients resistant to high-dose metoclopramide."( The efficacy and safety of GR38032F in the prophylaxis of ifosfamide-induced nausea and vomiting.
Challoner, T; Green, JA; Griggs, J; Hammond, P; Watkin, SW, 1989
)
0.28
" None of the protective drugs inhibited the initial 5-HT loss following MDMA, rendering unlikely any proposal that they are protective because they inhibit 5-HT release and the subsequent formation ofa toxic indole derivative."( A study of the mechanism of MDMA ('ecstasy')-induced neurotoxicity of 5-HT neurones using chlormethiazole, dizocilpine and other protective compounds.
Colado, MI; Green, AR, 1994
)
0.29
"15 mg/kg every 4 to 6 hours appears to be effective and safe as an antiemetic drug in children during pretransplant conditioning with chemotherapeutic agents."( Efficacy and safety of ondansetron in pediatric patients undergoing bone marrow transplantation.
Hui, LN; Koepke, J; Nahata, MC,
)
0.44
" Thus, controlling the adverse side effects associated with radiation therapy is critical to optimal patient care."( Controlling the toxicity of palliative radiotherapy: the role of 5-HT3 antagonists.
Priestman, TJ, 1996
)
0.29
" Fewer patients from the OND group (13%) reported adverse events compared with the MET group (21%)."( A randomised, double-blind, parallel-group study to compare the efficacy and safety of ondansetron (GR38032F) plus dexamethasone with metoclopramide plus dexamethasone in the prophylaxis of nausea and emesis induced by carboplatin chemotherapy.
Andersson, H; Capstick, V; du Bois, A; Kitchener, H; Lahousen, M; McKenna, CJ; Pinter, T; Wilkinson, JR,
)
0.35
" Relevant end points were prevention of early PONV (within 6 h after surgery) and late PONV (within 48 h) and adverse effects."( Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials.
McQuay, HJ; Moore, RA; Reynolds, DJ; Tramèr, MR, 1997
)
0.57
" Of these 100, three will have elevated liver enzymes and three will have a headache who would not have had these adverse effects without the drug."( Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials.
McQuay, HJ; Moore, RA; Reynolds, DJ; Tramèr, MR, 1997
)
0.57
" Safety assessment was based on the type and frequency of adverse experiences reported by the patient at 24 and 48 hours after chemotherapy began."( Comparable safety and antiemetic efficacy of a brief (30-second bolus) intravenous granisetron infusion and a standard (15-minute) intravenous ondansetron infusion in breast cancer patients receiving moderately emetogenic chemotherapy.
Friedman, C; Kalman, L; Kaywin, P; Lembersky, B; Perez, EA; Yocom, K,
)
0.33
" Nausea, emetic episodes, adverse events, and patient satisfaction were analyzed for the 0 to 2 h and 0 to 24 h postoperative periods."( A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups.
Creed, MR; Duncan, B; Fortney, JT; Gan, TJ; Glass, PS; Graczyk, S; Khalil, S; McKenzie, R; Melson, T; Moote, C; Parasuraman, TV; Parrillo, S; Wermeling, D; Wetchler, B, 1998
)
0.54
" The overall risk of adverse effects was not different among drug combinations."( Comparative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis.
Anderson, EA; Domino, KB; Polissar, NL; Posner, KL, 1999
)
0.58
" The overall risk of adverse effects did not differ."( Comparative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis.
Anderson, EA; Domino, KB; Polissar, NL; Posner, KL, 1999
)
0.58
" The incidence of adverse events such as headache, dizziness, and increased liver enzyme levels (number needed to harm = infinity) was similar in both groups."( The safety and efficacy of prophylactic ondansetron in patients undergoing modified radical mastectomy.
Kannan, TR; Kathirvel, S; Mohan, V; Sadhasivam, S; Saxena, A; Trikha, A, 1999
)
0.57
" We analyzed more meaningful "true" and "therapeutic" outcome measures, and we conclude that prophylactic ondansetron is safe and effective and that its routine use is justified."( The safety and efficacy of prophylactic ondansetron in patients undergoing modified radical mastectomy.
Kannan, TR; Kathirvel, S; Mohan, V; Sadhasivam, S; Saxena, A; Trikha, A, 1999
)
0.78
" Oral granisetron and ondansetron are safe and effective for the prevention of nausea and vomiting resulting from TBI."( Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation.
Bushnell, W; Frankel, SR; Friedman, CJ; Raschko, J; Spitzer, TR, 2000
)
0.84
" Two cases of adverse reactions (hiccups and elevation of ALT and BUN) were observed in the DEX group; however, since the symptoms were all mild, we did not consider there was any problem in safety."( [Examination on efficacy and safety of concurrent use of ondansetron hydrochloride and steroid in lung cancer patients on cisplatin].
Furue, H; Horichi, N; Ikeda, M; Taguchi, T; Tsukakoshi, S, 2001
)
0.56
" Adverse reactions were observed in 2 cases (2 reports of headache) in the OND group and 5 cases (2 reports of hiccups, 2 headache, 2 diarrhea, one constipation, one hot facial flushes and one elevation of gamma-GTP) in the DEX group; however, since the symptoms were all mild, we did not consider there was any problem in safety."( [Examination on efficacy and safety of concurrent use of ondansetron hydrochloride and steroid in gynecological cancer patients on cisplatin].
Eguchi, F; Furue, H; Ikeda, M; Taguchi, T; Tsukakoshi, S, 2001
)
0.56
"Heptaplatin is a newly developed platinum derivative which has been reported to be less toxic than cisplatin."( Nephrotoxicity of heptaplatin: a randomized comparison with cisplatin in advanced gastric cancer.
Ahn, JH; Bahng, H; Chang, HM; Kang, WC; Kang, YK; Kim, TW; Kim, WK; Lee, JS; Park, JS, 2002
)
0.31
" Measures to more effectively prevent nephrotoxicity should be developed for the safe use of heptaplatin."( Nephrotoxicity of heptaplatin: a randomized comparison with cisplatin in advanced gastric cancer.
Ahn, JH; Bahng, H; Chang, HM; Kang, WC; Kang, YK; Kim, TW; Kim, WK; Lee, JS; Park, JS, 2002
)
0.31
"The aim of the study was to learn whether the lethal and the motor incoordination (ataxia) side effect of ondansetron (Zophren) administration is dosing-time dependent."( Circadian rhythms in toxic effects of the serotonin antagonist ondansetron in mice.
Ben Attia, M; Boughattas, NA; Bouzouita, K; Chouchane, L; Gadacha, W; Khedhaier, A; Mechkouri, M; Reinberg, A; Sani, M, 2003
)
0.77
" Emetic episodes, doses of rescue medications to treat breakthrough nausea or vomiting, and occurrence of adverse events were recorded."( Safety and efficacy of a continuous infusion, patient-controlled antiemetic pump for children receiving emetogenic chemotherapy.
Cartwright, J; Frangoul, H; Ho, RH; Jones, E; Koyama, T; Kuttesch, J; Shankar, S; Whitlock, JA, 2007
)
0.34
" Adverse events were also evaluated."( Comparison of the efficacy and safety of combinations of metopimazine or ondansetron with methylprednisolone in the prevention of delayed emesis in patients receiving chemotherapy.
Bloch, J; Delgado, A; Khayat, D; Meric, JB; Rixe, O, 2005
)
0.56
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" Ondansetron was well tolerated, causing no serious adverse events."( A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of cocaine dependence.
Ait-Daoud, N; Bloch, DA; Elkashef, A; Harrison, JM; Javors, MA; Johnson, BA; Li, SH; Mojsiak, J; Roache, JD, 2006
)
1.46
"Data were collected for analysis of the therapeutic effect in 47 cases and for adverse events in 50 cases."( Ramosetron versus ondansetron in the prevention of chemotherapy-induced gastrointestinal side effects: A prospective randomized controlled study.
Ai, B; Dong, M; Han, X; He, X; Huang, D; Liu, P; Shi, Y; Yang, S; Zhang, C; Zhou, S, 2007
)
0.67
"Ramosetron is a long-lasting and safe antiemetic agent."( Ramosetron versus ondansetron in the prevention of chemotherapy-induced gastrointestinal side effects: A prospective randomized controlled study.
Ai, B; Dong, M; Han, X; He, X; Huang, D; Liu, P; Shi, Y; Yang, S; Zhang, C; Zhou, S, 2007
)
0.67
" Ondansetron was well tolerated and was less likely than placebo to be associated with serious adverse events."( A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of methamphetamine dependence.
Ait-Daoud, N; Bloch, DA; Elkashef, AM; Johnson, BA; Kahn, R; Li, SH; Smith, EV; Vocci, F, 2008
)
1.47
" Adverse events (AE) definitely, probably, or possibly related to OLD were studied, excluding AE not or unlikely related to the OLD."( Safety of ondansetron loading doses in children with cancer.
Ammann, RA; Hasler, SB; Hirt, A; Leibundgut, KK; Ridolfi Luethy, A, 2008
)
0.75
" seem to be safe in infants, children, and adolescents."( Safety of ondansetron loading doses in children with cancer.
Ammann, RA; Hasler, SB; Hirt, A; Leibundgut, KK; Ridolfi Luethy, A, 2008
)
0.75
" All active doses seemed to be well tolerated; headache, dizziness, and constipation were the most frequently reported adverse events."( Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients.
Blackburn, L; Chung, F; Johnson, B; Kutsogiannis, DJ; Lane, SR; Levin, J; Pergolizzi, JV; Singla, NK; Singla, SK, 2010
)
0.56
" Safe use of granisetron as an antiemetic after skin prick, oral, and intravenous challenge tests is presented."( Anaphylactic reaction owing to ondansetron administration in a child with neuroblastoma and safe use of granisetron: a case report.
Batu, ED; Büyükpamukçu, M; Civelek, E; Demir, HA; Saçkesen, C; Yalçın, B, 2010
)
0.65
" Prospectively defined outcome measures were 1) efficacy as measured by a quantitative visual analog nausea scale and 2) incidence of adverse effects."( Ondansetron is safe and effective for prehospital treatment of nausea and vomiting by paramedics.
Brazzel, D; Burdick, M; Luoto, M; Salvucci, AA; Squire, B; Vaezazizi, R,
)
1.57
"Ondansetron is safe and effective for out-of-hospital treatment of nausea and vomiting when administered by paramedics via the IV, IM, or oral route."( Ondansetron is safe and effective for prehospital treatment of nausea and vomiting by paramedics.
Brazzel, D; Burdick, M; Luoto, M; Salvucci, AA; Squire, B; Vaezazizi, R,
)
3.02
" Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy."( Motherisk update. Is ondansetron safe for use during pregnancy?
Koren, G, 2012
)
0.97
" This suggests that ondansetron may be safe in lower doses used to prevent nausea and vomiting in radiation treatment or postoperatively."( Cardiac safety concerns for ondansetron, an antiemetic commonly used for nausea linked to cancer treatment and following anaesthesia.
Doggrell, SA; Hancox, JC, 2013
)
1.01
" It is treated with intravenous acetylcysteine, but the standard regimen is complex and associated with frequent adverse effects related to concentration, which can cause treatment interruption."( Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial.
Bateman, DN; Butcher, I; Cooper, JG; Coyle, J; Dear, JW; Eddleston, M; Gray, A; Lewis, SC; Rodriguez, A; Sandilands, EA; Thanacoody, HK; Thomas, SH; Veiraiah, A; Vliegenthart, AD; Webb, DJ, 2014
)
0.4
"Ondansetron has a preventive effect on PAS without a paralleled side effect of bradycardia."( Efficacy and safety of ondansetron in preventing postanesthesia shivering: a meta-analysis of randomized controlled trials.
He, K; Liang, SR; Mou, JH; Su, GZ; Tie, HT; Yuan, HW, 2014
)
2.16
"The purpose of this article is to outline the risk of cardiac adverse events (AEs) from 5-HT3-RAs, with focus on the three most commonly used, ondansetron, granisetron and palonosetron."( 5-Hydroxytryptamine3 receptor antagonists and cardiac side effects.
Brygger, L; Herrstedt, J, 2014
)
0.6
"Postoperative nausea and vomiting is a common side effect of general anesthesia."( Efficacy and safety of ramosetron versus ondansetron for postoperative nausea and vomiting after general anesthesia: a meta-analysis of randomized clinical trials.
Cao, G; Gao, C; Li, B; Lv, F; Wang, F; Wang, H; Wu, G; Xu, L, 2015
)
0.68
" The incidence of treatment-related adverse events during cycles 2-6 was similar in rolapitant (5."( Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting over multiple cycles of moderately or highly emetogenic chemotherapy.
Arora, S; Chasen, M; Navari, R; Powers, D; Rapoport, B; Schnadig, I; Schwartzberg, L, 2016
)
0.43
"Chemotherapy-induced nausea and vomiting are adverse effects responsible for worsening quality of life in cancer patients."( Efficacy, safety and effectiveness of ondansetron compared to other serotonin-3 receptor antagonists (5-HT3RAs) used to control chemotherapy-induced nausea and vomiting: systematic review and meta-analysis.
Acúrcio, Fde A; Andrade, EI; Cherchiglia, ML; De Araújo, VE; Marra, LP; Reis, IA; Simino, GP, 2016
)
0.71
" The overall incidence of adverse events was similar between the two treatment groups (p > ."( Efficacy and safety of triple therapy with aprepitant, ondansetron, and prednisone for preventing nausea and vomiting induced by R-CEOP or CEOP chemotherapy regimen for non-Hodgkin lymphoma: a phase 2 open-label, randomized comparative trial.
Song, Z; Wang, H; Yang, F; Zhang, H; Zhang, M; Zhao, K, 2017
)
0.7
" For the duration of 4 months, weight, body mass index, and the occurrence of adverse events was documented."( The safety and efficacy of the procedureless intragastric balloon.
Al Haddad, E; Al Kendari, M; Al-Subaie, S; Almulla, A; Alsabah, S; Ekrouf, S, 2018
)
0.48
" The groups were analyzed and compared for frequency of vomiting, administered doses of on-demand antiemetic dimenhydrinate and adverse events during the acute (0-24 h after chemotherapy administration) and delayed (> 24 h-120 h) CINV phases."( Efficacy, safety and feasibility of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric patients receiving moderately and highly emetogenic chemotherapy - results of a non-interventional observation study.
Binder, V; Blaeschke, F; Cabanillas Stanchi, KM; Döring, M; Feucht, J; Feuchtinger, T; von Have, M; Willier, S, 2019
)
0.51
" The occurrence of adverse events did not significantly differ between the two groups (p > 0."( Efficacy, safety and feasibility of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric patients receiving moderately and highly emetogenic chemotherapy - results of a non-interventional observation study.
Binder, V; Blaeschke, F; Cabanillas Stanchi, KM; Döring, M; Feucht, J; Feuchtinger, T; von Have, M; Willier, S, 2019
)
0.51
"The addition of olanzapine to ondansetron and dexamethasone significantly improved CINV prevention and was safe in patients receiving HEC."( The efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.
Angspatt, P; Chenaksara, P; Parinyanitikun, N; Poovorawan, N; Sakdejayont, S; Sriuranpong, V; Sukprakun, S; Tanasanvimon, S; Thawinwisan, W; Vimolchalao, V; Vinayanuwatikun, C; Wongchanapai, P, 2020
)
1.09
" Preanesthetic inhaled ketamine is also reported effective and safe in children."( Preanesthetic nebulized ketamine vs preanesthetic oral ketamine for sedation and postoperative pain management in children for elective surgery: A retrospective analysis for effectiveness and safety.
Chen, C; Cheng, X; Fu, F; Lin, L, 2021
)
0.62
" These biologically-relevant findings represent the first step towards understanding this adverse event with the overall goal to improve the safety of this commonly used antiemetic medication."( A pharmacogenomic investigation of the cardiac safety profile of ondansetron in children and pregnant women.
Berger, H; Brodie, SM; Brown, J; Carleton, BC; Chaudhry, S; Drögemöller, BI; Groeneweg, GSS; Higginson, M; Israels, S; Ito, S; Jong, G'; Magee, LA; Miao, F; Rassekh, SR; Ross, CJD; Sanatani, S; Shaw, K; Staub, M; Trueman, J; West, N; Whyte, SD; Wright, GEB, 2022
)
0.96
"Ondansetron is safe in regard to QTc prolongation in patients with head trauma."( Ondansetron Safety Regarding Prolong QTc for Children with Head Trauma.
Assaad, R; Pratt, RE; Qiao, H; Territo, HM; Wrotniak, BH, 2023
)
3.8

Pharmacokinetics

The pharmacodynamic interaction between paracetamol and ondansetron coadministration does not block but instead increase par acetamol analgesia. This could reduce the postoperative analgesic requirement, and improve the post operative comfort level.

ExcerptReferenceRelevance
" The method has been used to assay several thousand samples from subjects included in pharmacokinetic studies."( The determination in plasma and pharmacokinetics of ondansetron.
Colthup, PV; Palmer, JL, 1989
)
0.53
" Pharmacokinetic variables were determined with use of standard noncompartmental techniques."( Pharmacokinetics of intravenous ondansetron in healthy children undergoing ear, nose, and throat surgery.
Jorch, U; Lerman, J; Palmer, J; Sikich, N; Spahr-Schopfer, IA, 1995
)
0.57
" The elimination half-life of ondansetron increases in parallel with age."( Pharmacokinetics of intravenous ondansetron in healthy children undergoing ear, nose, and throat surgery.
Jorch, U; Lerman, J; Palmer, J; Sikich, N; Spahr-Schopfer, IA, 1995
)
0.86
" Values of Tmax and Cmax were also not significantly different among the nonparenteral routes."( Comparison of the pharmacokinetics of an ondansetron solution (8 mg) when administered intravenously, orally, to the colon, and to the rectum.
Barr, WH; Bozigian, HP; Griffin, RH; Hsyu, PH; Krishna, G; Lloyd, TL; Pritchard, JF; Shamburek, R, 1994
)
0.55
"We investigated the pharmacokinetic profile and the efficacy of ondansetron (day 1) given as 16 mg suppository once a day, as compared with ondansetron 8 mg tablets twice daily, in patients receiving moderately emetogenic chemotherapy."( Pharmacokinetic profile and clinical efficacy of a once-daily ondansetron suppository in cyclophosphamide-induced emesis: a double blind comparative study with ondansetron tablets.
Beijnen, JH; de Boer-Dennert, M; de Wit, R; Schellens, JH; van Tellingen, O; Verweij, J, 1996
)
0.77
" Analysis of the derived pharmacokinetic parameters showed no differences between the treatments described above."( The effect of ondansetron on the pharmacokinetics and pharmacodynamics of temazepam.
Keene, ON; Palmer, JL; Preston, GC, 1996
)
0.65
"We investigated the hypothesis that distributions of continuous pharmacokinetic variables are positively skewed in nature and that logarithmic transformation of these variables restores normality."( Common noncompartmental pharmacokinetic variables: are they normally or log-normally distributed?
Bye, A; Keene, ON; Lacey, LF; Pritchard, JF, 1997
)
0.3
" A two compartment pharmacokinetic model with a zero order input was used to describe the pharmacokinetics of ondansetron."( Population pharmacokinetics of ondansetron: a covariate analysis.
Aarons, L; de Alwis, DP; Palmer, JL, 1998
)
0.8
" Weight was found to have a strong positive linear relationship with all four pharmacokinetic parameters."( Population pharmacokinetics of ondansetron: a covariate analysis.
Aarons, L; de Alwis, DP; Palmer, JL, 1998
)
0.59
"The stepwise search procedures potentially are capable of considerably reducing the time required to develop population pharmacokinetic models."( Population pharmacokinetics of ondansetron: a covariate analysis.
Aarons, L; de Alwis, DP; Palmer, JL, 1998
)
0.59
" The purpose of this study was to evaluate the potential pharmacokinetic interactions between ondansetron and high-dose alkylating agent chemotherapy."( Pharmacokinetic interaction between ondansetron and cyclophosphamide during high-dose chemotherapy for breast cancer.
Berry, D; Cavanaugh, C; Fehdrau, R; Gilbert, CJ; Hussein, A; McKinstry, C; Peters, WP; Petros, WP; Ross, M; Rubin, P; Vredenburgh, J, 1998
)
0.79
" Pharmacokinetic monitoring of each drug used in the high-dose chemotherapy regimen was conducted."( Pharmacokinetic interaction between ondansetron and cyclophosphamide during high-dose chemotherapy for breast cancer.
Berry, D; Cavanaugh, C; Fehdrau, R; Gilbert, CJ; Hussein, A; McKinstry, C; Peters, WP; Petros, WP; Ross, M; Rubin, P; Vredenburgh, J, 1998
)
0.58
"001]) and the elimination half-life (t1/2) by 38% (P < ."( The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron.
Kivistö, KT; Neuvonen, PJ; Villikka, K, 1999
)
0.54
" We evaluated the possibility of a pharmacokinetic (PK) drug-drug interaction between the antiemetic agents and high-dose cyclophosphamide, cisplatin and BCNU (CPA/cDDP/BCNU)."( Modification of the pharmacokinetics of high-dose cyclophosphamide and cisplatin by antiemetics.
Bearman, SI; Cagnoni, PJ; Day, TC; Jones, RB; Matthes, S; Shpall, EJ, 1999
)
0.3
" Plasma ondansetron concentrations were determined by HPLC and the pharmacokinetic parameters were analyzed by non-compartmental analysis."( Pharmacokinetics and bioequivalence testing of generic ondansetron preparations in healthy Thai male volunteers.
Kumsorn, B; Manorot, M; Rojanasthien, N, 1999
)
0.99
" Ketamine exerts differential pharmacodynamic effects on behavior in animals stratified according to a measure of central serotonergic turnover."( Ondansetron modulates pharmacodynamic effects of ketamine on electrocardiographic signals in rhesus monkeys.
Bennett, AJ; Dee Higley, J; DePetrillo, PB; Karimullah, K; Shoaf, SE; Speers, D; Suomi, SJ, 2000
)
1.75
"Two studies were conducted to determine whether concomitant administration of aprepitant altered the pharmacokinetic profiles of ondansetron and granisetron, two 5-HT(3)-receptor antagonists commonly used as antiemetic therapy for CINV."( Effects of aprepitant on the pharmacokinetics of ondansetron and granisetron in healthy subjects.
Blum, RA; Busillo, J; Goldberg, MR; Gottesdiener, KM; Greenberg, HE; Hesney, M; Hustad, CM; Kraft, WK; Lates, C; Majumdar, A; McCrea, J; Murphy, MG; Orlowski, LH; Panebianco, D; Petty, KJ; Van Buren, S; Waldman, SA, 2003
)
0.78
" Individual plasma samples were used to estimate area under the plasma concentration-time curve from time zero to infinity (AUC(0- infinity )), peak plasma concentration, and apparent terminal elimination half-life (t(12)) of both ondansetron and granisetron."( Effects of aprepitant on the pharmacokinetics of ondansetron and granisetron in healthy subjects.
Blum, RA; Busillo, J; Goldberg, MR; Gottesdiener, KM; Greenberg, HE; Hesney, M; Hustad, CM; Kraft, WK; Lates, C; Majumdar, A; McCrea, J; Murphy, MG; Orlowski, LH; Panebianco, D; Petty, KJ; Van Buren, S; Waldman, SA, 2003
)
0.76
"019), with no significant effect on peak concentration at the end of the infusion (360."( Effects of aprepitant on the pharmacokinetics of ondansetron and granisetron in healthy subjects.
Blum, RA; Busillo, J; Goldberg, MR; Gottesdiener, KM; Greenberg, HE; Hesney, M; Hustad, CM; Kraft, WK; Lates, C; Majumdar, A; McCrea, J; Murphy, MG; Orlowski, LH; Panebianco, D; Petty, KJ; Van Buren, S; Waldman, SA, 2003
)
0.57
"Concomitant administration of aprepitant had no clinically significant effect on the mean pharmacokinetic characteristics of either ondansetron or granisetron in these healthy subjects."( Effects of aprepitant on the pharmacokinetics of ondansetron and granisetron in healthy subjects.
Blum, RA; Busillo, J; Goldberg, MR; Gottesdiener, KM; Greenberg, HE; Hesney, M; Hustad, CM; Kraft, WK; Lates, C; Majumdar, A; McCrea, J; Murphy, MG; Orlowski, LH; Panebianco, D; Petty, KJ; Van Buren, S; Waldman, SA, 2003
)
0.78
" Complete pharmacokinetic data of vinorelbine administered alone and with the aprepitant antiemetic regimen were obtained in 12 patients."( Aprepitant when added to a standard antiemetic regimen consisting of ondansetron and dexamethasone does not affect vinorelbine pharmacokinetics in cancer patients.
de Bruijn, P; de Wit, R; Freedman, SJ; Gambale, JJ; Li, S; Loos, WJ; Murphy, GM; Van Dyck, K; van Noort, C; Verweij, J, 2007
)
0.57
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"The pharmacokinetic parameters of ondansetron were evaluated after its intravenous (at doses of 1, 4, 8 and 20 mg/kg) and oral (4, 8 and 20 mg/kg) administration to rats."( Dose-independent pharmacokinetics of ondansetron in rats: contribution of hepatic and intestinal first-pass effects to low bioavailability.
Lee, MG; Yang, SH, 2008
)
0.9
" The purpose of this study was to report the pharmacokinetic interaction between tamoxifen and ondansetron in rats."( Pharmacokinetic interaction between tamoxifen and ondansetron in rats: non-competitive (hepatic) and competitive (intestinal) inhibition of tamoxifen metabolism by ondansetron via CYP2D subfamily and 3A1/2.
Lee, MG; Suh, JH; Yang, SH, 2010
)
0.83
"A rapid, sensitive and selective high performance liquid chromatography-electrospray ionization-tandem mass spectrometry method (HPLC-ESI-MS/MS) was developed and validated for the determination and pharmacokinetic investigation of dexmedetomidine (DMED) in human plasma."( Determination of dexmedetomidine in human plasma using high performance liquid chromatography coupled with tandem mass spectrometric detection: application to a pharmacokinetic study.
Chen, Y; Feng, S; Li, W; Tian, Y; Wu, L; Zhang, Z, 2009
)
0.35
" Pooled data from 124 patients, including 745 pharmacokinetic samples, were analyzed using nonlinear mixed-effects modeling."( Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1-48 months.
Adamson, PC; Barrett, JS; Coté, CJ; Croop, JM; Haberer, LJ; Hoke, JF; Johnson, BM; Mondick, JT; Russo, MW; Sale, ME, 2010
)
0.62
" A maturation process with a half-life of approximately 4 months was incorporated to describe a decrease in clearance (CL) in infants."( Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1-48 months.
Adamson, PC; Barrett, JS; Coté, CJ; Croop, JM; Haberer, LJ; Hoke, JF; Johnson, BM; Mondick, JT; Russo, MW; Sale, ME, 2010
)
0.62
"The population pharmacokinetic analysis of ondansetron allows for characterization of individual patients based on body weight and age."( Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1-48 months.
Adamson, PC; Barrett, JS; Coté, CJ; Croop, JM; Haberer, LJ; Hoke, JF; Johnson, BM; Mondick, JT; Russo, MW; Sale, ME, 2010
)
0.89
" In this study, fexofenadine, verapamil, risperidone, ondansetron, and imipramine were used as model compounds to investigate the effectiveness of MIM in pharmacokinetic studies."( Development of a novel high-throughput analytical methodology, multiple injection method, for quantitative analysis in drug metabolism and pharmacokinetic studies using liquid chromatography with tandem mass spectrometry.
Ohkawa, T; Tanaka, Y; Yasui, H, 2011
)
0.62
" The half-life and clearance of dinaciclib were similar, with or without aprepitant."( Effect of aprepitant on the pharmacokinetics of the cyclin-dependent kinase inhibitor dinaciclib in patients with advanced malignancies.
Bannerji, R; Kantesaria, B; Mita, M; Poon, J; Shapiro, GI; Small, K; Statkevich, P; Tzontcheva, A; Zhang, D; Zhu, Y, 2012
)
0.38
" This study was conducted to investigate the pharmacokinetic interactions between ondansetron and tamoxifen after intravenous and oral administration of ondansetron (both 8 mg/kg) and/or tamoxifen (2 and 10 mg/kg for intravenous and oral administration, respectively), in rats bearing 7,12-dimethylbenz[a]anthracene (DMBA)-induced mammarian tumors (DMBA rats), used as an animal model of human breast cancer."( Pharmacokinetic drug interactions between ondansetron and tamoxifen in female Sprague-Dawley rats with DMBA-induced mammary tumor.
Kim, SH; Lee, MG; Suh, JH; Yang, SH, 2013
)
0.88
" Subsequently, Sprague-Dawley rats were used to compare pharmacokinetic parameters of the formulated films with oral administration of pure drug solution."( Comparative pharmacokinetic studies of fast dissolving film and oral solution of ondansetron in rats.
Chhalotiya, UK; Choudhary, DR; Kundawala, AJ; Patel, HV; Patel, VA, 2013
)
0.62
" Noncompartmental pharmacokinetic modeling and dose interval modeling were performed."( Oral, subcutaneous, and intravenous pharmacokinetics of ondansetron in healthy cats.
Gustafson, DL; Hansen, RJ; Lake, RC; Lunghofer, PJ; Quimby, JM, 2014
)
0.65
"Based on preclinical results in minipigs, a Phase I study was designed to assess the tolerability and pharmacokinetic properties of subcutaneous ondansetron + rHuPH20 compared with intramuscular, intravenous, or oral ondansetron monotherapy in healthy volunteers."( Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers.
Bahn, JD; DeNoia, E; Dychter, SS; Fellows, D; Harrigan, R; Haughey, DB; Maneval, DC; Printz, MA; Sugarman, BJ, 2014
)
0.86
" Primary tolerability end points (administration-site observations, systemic adverse events [AEs], and subject-assessed pain) were assessed, and pharmacokinetic parameters (AUC, Cmax, Tmax, t½) were computed to compare relative rate and extent of systemic exposure."( Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers.
Bahn, JD; DeNoia, E; Dychter, SS; Fellows, D; Harrigan, R; Haughey, DB; Maneval, DC; Printz, MA; Sugarman, BJ, 2014
)
0.66
" The Cmax (45."( Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers.
Bahn, JD; DeNoia, E; Dychter, SS; Fellows, D; Harrigan, R; Haughey, DB; Maneval, DC; Printz, MA; Sugarman, BJ, 2014
)
0.66
" The aim of this study was to perform a pharmacokinetic analysis of ondansetron in dogs following oral administration of a single dose."( Pharmacokinetic modeling and Monte Carlo simulation of ondansetron following oral administration in dogs.
Baek, IH; Kang, J; Kwon, KI; Lee, BY, 2015
)
0.9
" The present study was intended to understand the pharmacodynamic interaction between paracetamol and ondansetron in postoperative patients."( Randomized, double-blind, placebo-controlled study to investigate the pharmacodynamic interaction of 5-HT3 antagonist ondansetron and paracetamol in postoperative patients operated in an ENT department under local anesthesia.
Bhosale, UA; Kale, J; Khobragade, R; Naik, C; Yegnanarayan, R, 2015
)
0.84
"The pharmacodynamic interaction between paracetamol and ondansetron coadministration does not block but instead increase paracetamol analgesia, reduce the postoperative analgesic requirement, and improve the postoperative comfort level."( Randomized, double-blind, placebo-controlled study to investigate the pharmacodynamic interaction of 5-HT3 antagonist ondansetron and paracetamol in postoperative patients operated in an ENT department under local anesthesia.
Bhosale, UA; Kale, J; Khobragade, R; Naik, C; Yegnanarayan, R, 2015
)
0.87
"05), and is characterized by rapid transplacental transfer and longer elimination half-life in neonates compared to their mother."( Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome.
Carvalho, B; Clavijo, C; Drover, DR; Elkomy, MH; Galinkin, JL; Peltz, G; Sultan, P; Wu, M, 2015
)
1.86
" For analysis of pharmacokinetic properties, including the peak concentration of T max (C max), AUC from time 0 (baseline) to t hours (AUC0- t ), and AUC from baseline to infinity (AUC0-∞), blood samples were obtained at intervals over the 24-hour period after studying drug administration."( Pharmacokinetics and bioavailability study of two ondansetron oral soluble film formulations in fasting healthy male Chinese volunteers.
Wan, M; Zhang, Q; Zhao, Z; Zhu, J; Zhu, Y; Zou, J, 2015
)
0.67
" Ondansetron treatment caused a statistically significantly higher Cmax of metformin compared with placebo (18."( Effect of Ondansetron on Metformin Pharmacokinetics and Response in Healthy Subjects.
Guo, D; Li, Q; Polli, JE; Shu, Y; Yang, H; Zhang, T; Zhou, H, 2016
)
1.75
"The pharmacokinetic parameter estimates were V1 (l) = 5."( Population pharmacokinetics and prophylactic anti-emetic efficacy of ramosetron in surgical patients.
Choi, BM; Jeong, SW; Lee, EK; Lee, YH; Lim, YJ; Min, KT; Noh, GJ; Seo, JH, 2016
)
0.43
"Physiologically based pharmacokinetic modeling is considered a valuable tool for predicting pharmacokinetic changes in pregnancy to subsequently guide in-vivo pharmacokinetic trials in pregnant women."( A Physiologically Based Pharmacokinetic Model for Pregnant Women to Predict the Pharmacokinetics of Drugs Metabolized Via Several Enzymatic Pathways.
Coboeken, K; Dallmann, A; Eissing, T; Hempel, G; Ince, I, 2018
)
0.48
"Quantitative information on gestation-specific changes in enzyme activity available in the literature was incorporated in a pregnancy physiologically based pharmacokinetic model and the pharmacokinetics of eight drugs metabolized via one or multiple cytochrome P450 enzymes was predicted."( A Physiologically Based Pharmacokinetic Model for Pregnant Women to Predict the Pharmacokinetics of Drugs Metabolized Via Several Enzymatic Pathways.
Coboeken, K; Dallmann, A; Eissing, T; Hempel, G; Ince, I, 2018
)
0.48
"The pregnancy physiologically based pharmacokinetic model successfully predicted the pharmacokinetics of all tested drugs."( A Physiologically Based Pharmacokinetic Model for Pregnant Women to Predict the Pharmacokinetics of Drugs Metabolized Via Several Enzymatic Pathways.
Coboeken, K; Dallmann, A; Eissing, T; Hempel, G; Ince, I, 2018
)
0.48
"The presented pregnancy physiologically based pharmacokinetic model can quantitatively predict the pharmacokinetics of drugs that are metabolized via one or multiple cytochrome P450 enzymes by integrating prior knowledge of the pregnancy-related effect on these enzymes."( A Physiologically Based Pharmacokinetic Model for Pregnant Women to Predict the Pharmacokinetics of Drugs Metabolized Via Several Enzymatic Pathways.
Coboeken, K; Dallmann, A; Eissing, T; Hempel, G; Ince, I, 2018
)
0.48
"The accuracy of physiologically based pharmacokinetic (PBPK) model prediction in children, especially those younger than 2 years old, has not been systematically evaluated."( Predictive Performance of Physiologically Based Pharmacokinetic (PBPK) Modeling of Drugs Extensively Metabolized by Major Cytochrome P450s in Children.
Al-Huniti, N; Bui, KH; Cheung, SYA; Johnson, TN; Li, J; Xu, H; Zhou, D; Zhou, W, 2018
)
0.48
"This study aimed to incorporate ondansetron hydrochloride (ODS), a water-soluble drug into nanostructured lipid carriers (NLCs) to improve the pharmacokinetic properties of the drug."( Preparation of Ondansetron Hydrochloride-Loaded Nanostructured Lipid Carriers Using Solvent Injection Method for Enhancement of Pharmacokinetic Properties.
Chi, SC; Duong, VA; Maeng, HJ; Nguyen, TT, 2019
)
1.15
" Physicochemical analyses, in vitro drug release, and pharmacokinetic studies were performed."( Preparation of Ondansetron Hydrochloride-Loaded Nanostructured Lipid Carriers Using Solvent Injection Method for Enhancement of Pharmacokinetic Properties.
Chi, SC; Duong, VA; Maeng, HJ; Nguyen, TT, 2019
)
0.87
" Population pharmacokinetic (PK) modelling was implemented to describe the average and individual plasma and CSF profiles of ondansetron."( Plasma and cerebrospinal fluid pharmacokinetics of ondansetron in humans.
Back, H; Blood, J; Chiang, MD; Frey, K; Haroutounian, S; Kagan, L; Kharasch, ED; Lee, C; Sawyer, C; Tallchief, D, 2021
)
1.08
" Mechanistic pharmacokinetic model that included two systemic disposition and three CNS compartments (with intercompartmental exchange) was developed."( Pharmacokinetic Modeling of the Impact of P-glycoprotein on Ondansetron Disposition in the Central Nervous System.
Back, HM; Chiang, M; Girgis, S; Guo, T; Haroutounian, S; Kagan, L; Lee, JB; Oh, S; Park, C, 2020
)
0.8
" We developed a generic physiologically-based pharmacokinetic lactation model for small molecule drugs and applied this model to predict ondansetron transfer into breast milk and characterize infant exposure."( Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk.
Balevic, S; Berens, P; Chen, JY; Dallmann, A; Fu, C; Haas, DM; Hornik, C; Hughes, B; Humphrey, K; Job, KM; Parry, S; Saade, G; Watt, K; Zimmerman, K, 2022
)
1.13

Compound-Compound Interactions

Ondansetron, sometimes combined with acustimulation at PC6 (Neiguan), is commonly used for preventing postoperative nausea and vomiting. Meclizine, a long-acting drug with a low side-effect profile, may be ideal in combination with ondansetrons for at-risk patients.

ExcerptReferenceRelevance
"To define the activity of an individually escalated dacarbazine (DTIC) dose combined with interferon-alpha-2a (IFN), granulocyte-colony stimulating-factor (G-CSF) and ondansetron, 20 patients (pts) with metastatic melanoma were treated with DTIC, ondansetron 8 mg iv, G-CSF 300 micrograms sc and IFN 9 MU sc."( Dose escalation of dacarbazine combined with interferon alpha-2a, G-CSF and ondansetron in patients with metastatic melanoma.
Buter, J; de Vries, EG; Mulder, NH; Schraffordt Koops, H; Sleijfer, DT; van der Graaf, WT; Willemse, PH,
)
0.56
"15 mg/kg for three doses every 4 hours beginning 30 minutes before cisplatin administration either alone or in combination with dexamethasone 20 mg administered 45 minutes before cisplatin."( A randomized, double-blind comparison of intravenous ondansetron alone and in combination with intravenous dexamethasone in the prevention of high-dose cisplatin-induced emesis.
Beck, TM; Bricker, LJ; Hainsworth, JD; Haley, B; Harker, WG; Harvey, WH; Hesketh, PJ; Kish, JA; Murphy, WK; Ryan, T, 1994
)
0.54
"IV ondansetron in combination with dexamethasone is safe and more effective than ondansetron alone in the prevention of emesis induced by high-dose cisplatin."( A randomized, double-blind comparison of intravenous ondansetron alone and in combination with intravenous dexamethasone in the prevention of high-dose cisplatin-induced emesis.
Beck, TM; Bricker, LJ; Hainsworth, JD; Haley, B; Harker, WG; Harvey, WH; Hesketh, PJ; Kish, JA; Murphy, WK; Ryan, T, 1994
)
1.16
" Prior trials have further shown improved antiemetic effects and fewer adverse effects of cisplatin treatment when neurotransmitter receptor blockers are combined with dexamethasone."( Randomized phase II trial comparing two versus three doses of ondansetron when used in combination with dexamethasone in patients receiving cisplatin > or = 100 mg/m2.
Baltzer, L; Clark, RA; Kris, MG; Pisters, KM; Rigas, JR; Tyson, LB, 1994
)
0.53
"Ondansetron 8mg and granisetron 3 mg, both combined with dexamethasone, showed similar efficacy and tolerability in the prevention of cisplatin-induced emesis."( Ondansetron versus granisetron, both combined with dexamethasone, in the prevention of cisplatin-induced emesis. Italian Group of Antiemetic Research.
, 1995
)
3.18
"The aim of the present study was to compare the antiemetic efficacy of ondansetron (OND) with metoclopramide (MCP), both combined with corticosteroid (CS) in patients with malignant lymphoma."( Antiemetic efficacy of ondansetron and metoclopramide, both combined with corticosteroid, in malignant lymphoma patients receiving non-cisplatin chemotherapy.
Jørgensen, M; Victor, MA, 1996
)
0.84
"The anti-emetic efficacy of prophylactic ondansetron and tropisetron in combination with a low dose of droperidol in patients with high probability for post-operative nausea and vomiting undergoing gynaecological laparoscopy was compared."( Comparison of ondansetron and tropisetron combined with droperidol for the prevention of emesis in women with a history of post-operative nausea and vomiting.
Ala-Kokko, TI; Jokela, R; Koivuranta, M; Ranta, P, 1999
)
0.93
" All the patients received ondansetron combined with dexamethasone for prophylaxis against emesis that might occur within 24 hours after the start of chemotherapy (acute emesis)."( Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy.
, 2000
)
0.87
"8 percent of those who received ondansetron combined with dexamethasone, 87."( Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy.
, 2000
)
0.85
" The antiemetic efficacy of NK1 receptor antagonists against chemotherapy-induced emesis is, however, enhanced when combined with a 5-HT3 receptor antagonist."( Comparison of the neurokinin-1 antagonist GR205171, alone and in combination with the 5-HT3 antagonist ondansetron, hyoscine and placebo in the prevention of motion-induced nausea in man.
Clemes, SA; House, F; Palmer, JL; Reid, K; Somal, HS; Stott, JR; Troakes, C; Wright, RJ, 2000
)
0.52
"The enhancement of NK1 receptor antagonist antiemetic activity through combination with a 5-HT3 receptor antagonist is not replicated in motion-induced nausea."( Comparison of the neurokinin-1 antagonist GR205171, alone and in combination with the 5-HT3 antagonist ondansetron, hyoscine and placebo in the prevention of motion-induced nausea in man.
Clemes, SA; House, F; Palmer, JL; Reid, K; Somal, HS; Stott, JR; Troakes, C; Wright, RJ, 2000
)
0.52
"Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 vs."( Comparative efficacy of acustimulation (ReliefBand) versus ondansetron (Zofran) in combination with droperidol for preventing nausea and vomiting.
Coleman, JE; Coloma, M; Hu, J; Ing, CH; Issioui, T; Jones, SB; Macaluso, AR; Markowitz, SD; Waddle, JP; White, PF, 2002
)
0.82
" The aim of this randomized double blind, dose-ranging study was to determine the minimum single effective dose of dexamethasone combined with ondansetron for the prevention of PONV in patients undergoing laparoscopic cholecystectomy."( Dexamethasone 8 mg in combination with ondansetron 4 mg appears to be the optimal dose for the prevention of nausea and vomiting after laparoscopic cholecystectomy.
Atef, A; Elhakim, M; Mahmoud, K; Nafie, M, 2002
)
0.78
"Our results suggest that 8 mg is the minimum dose of dexamethasone that, combined with ondansetron 4 mg will effectively prevent PONV in patients undergoing laparoscopic cholecystectomy."( Dexamethasone 8 mg in combination with ondansetron 4 mg appears to be the optimal dose for the prevention of nausea and vomiting after laparoscopic cholecystectomy.
Atef, A; Elhakim, M; Mahmoud, K; Nafie, M, 2002
)
0.81
" Meclizine, a long-acting drug with a low side-effect profile, may be ideal in combination with ondansetron for at-risk patients."( Meclizine in combination with ondansetron for prevention of postoperative nausea and vomiting in a high-risk population.
Benfield, DA; Forrester, CM; Kelly, JA; Matern, CE; Pellegrini, JE, 2007
)
0.85
" We investigated the analgesic effect of pregabalin and dexamethasone in combination with paracetamol after abdominal hysterectomy."( Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy. A randomized clinical trial.
Dahl, JB; Dierking, G; Fomsgaard, JS; Hilsted, KL; Lech, K; Lose, G; Mathiesen, O; Rasmussen, ML, 2009
)
0.35
"The purpose of this study was to compare the effects of ondansetron combined with dexamethasone on Post-Operative Nausea and Vomiting (PONV) and pain with ondansetron alone in patients with laparoscopy assisted vaginal hysterectomy under general anesthesia."( [Effect of ondansetron combined with dexamethasone on postoperative nausea & vomiting and pain of patients with laparoscopic hysterectomy].
Nam, M; Yoon, H, 2009
)
0.99
"The experimental group that received ondansetron combined with dexamethasone had less PONV (p=."( [Effect of ondansetron combined with dexamethasone on postoperative nausea & vomiting and pain of patients with laparoscopic hysterectomy].
Nam, M; Yoon, H, 2009
)
1.02
"We conclude that the administration of ondansetron combined with dexamethasone is more effective than the administration of ondansetron alone to reduce PONV in patients with laparoscopic hysterectomy."( [Effect of ondansetron combined with dexamethasone on postoperative nausea & vomiting and pain of patients with laparoscopic hysterectomy].
Nam, M; Yoon, H, 2009
)
1.01
"This randomized, double-blind, dose-ranging, placebo-controlled, phase 2 trial evaluated the neurokinin-1 receptor antagonist casopitant mesylate in combination with ondansetron/dexamethasone (ond/dex) for the prevention of chemotherapy-induced nausea and vomiting (CINV) related to moderately emetogenic chemotherapy (MEC)."( Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemothera
Albert, I; Arpornwirat, W; Bandekar, RR; Grunberg, SM; Hansen, VL; Levin, J, 2009
)
0.76
"The hepatic organic anion transporting polypeptides (OATPs) influence the pharmacokinetics of several drug classes and are involved in many clinical drug-drug interactions."( Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
Artursson, P; Haglund, U; Karlgren, M; Kimoto, E; Lai, Y; Norinder, U; Vildhede, A; Wisniewski, JR, 2012
)
0.38
" The participants were randomized into three prophylactic treatment groups: dexamethasone (n = 43), ondansetron in combination with dexamethasone (n = 44), and placebo (n = 42)."( Dexamethasone versus ondansetron in combination with dexamethasone for the prophylaxis of postoperative vomiting in pediatric outpatients: a double-blind, randomized, placebo-controlled clinical trial.
Borges, PS; de Orange, FA; Flores, M; Marques, J, 2012
)
0.91
"8% in the group receiving ondansetron combined with dexamethasone, 14."( Dexamethasone versus ondansetron in combination with dexamethasone for the prophylaxis of postoperative vomiting in pediatric outpatients: a double-blind, randomized, placebo-controlled clinical trial.
Borges, PS; de Orange, FA; Flores, M; Marques, J, 2012
)
1
"To determine the most common drug-drug interaction (DDI) pairs contributing to QTc prolongation in cardiac intensive care units (ICUs)."( Drug-drug interactions contributing to QT prolongation in cardiac intensive care units.
Armahizer, MJ; Kane-Gill, SL; Seybert, AL; Smithburger, PL, 2013
)
0.39
"Ondansetron, sometimes combined with acustimulation at PC6 (Neiguan), is commonly used for preventing postoperative nausea and vomiting, but PC6 is not the only point that can be used for this purpose."( Ondansetron combined with ST36 (Zusanli) acupuncture point injection for postoperative vomiting.
Chen, ZY; Guo, QL; Huang, YL; Lin, L; Wang, HH; Yan, JQ; Zhou, Y, 2014
)
3.29
"CYP2D6 drug-drug interactions appear to change effectiveness of commonly prescribed drugs in the ED."( The effect of CYP2D6 drug-drug interactions on hydrocodone effectiveness.
Campbell, J; Hamamura, D; Heard, KJ; Monte, AA; Vasiliou, V; Weinshilboum, RM, 2014
)
0.4
"The objective of this study is to compare the effectiveness of olanzapine combined with ondansetron or ondansetron alone in preventing chemotherapy-induced nausea and vomiting (CINV) of non-small cell lung cancer (NSCLC)."( Effectiveness of Olanzapine Combined with Ondansetron in Prevention of Chemotherapy-Induced Nausea and Vomiting of Non-small Cell Lung Cancer.
Wang, H; Wang, L; Wang, X; Zhang, H, 2015
)
0.9
"Background Two pivotal Phase III trials compared the efficacy of palonosetron, ondansetron and granisetron, combined with dexamethasone, for the prevention of nausea and vomiting following highly emetogenic chemotherapy."( Economic evaluation of 5-HT3 receptor antagonists in combination with dexamethasone for the prevention of 'overall' nausea and vomiting following highly emetogenic chemotherapy in Chinese adult patients.
Du, Q; Xu, XL; Yu, B; Zhai, Q; Zhu, B, 2017
)
0.68
"A systematic review and meta-analysis of published randomized controlled trials was performed to update the present evidence about the safety and efficacy of dexamethasone combined with other antiemetics versus single antiemetics for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy."( Dexamethasone combined with other antiemetics versus single antiemetics for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: An updated systematic review and meta-analysis.
Abushouk, AI; Ahmed, H; Al Nahrawi, S; Attia, A; Awad, K; Elsherbeny, MY; Mustafa, SM, 2016
)
0.43
"Pooled data from 14 RCTs (1542 patients) favored dexamethasone combined with other antiemetics over single antiemetics as a prophylaxis against postoperative nausea and vomiting after laparoscopic cholecystectomy in the early postoperative period (OR = 0."( Dexamethasone combined with other antiemetics versus single antiemetics for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: An updated systematic review and meta-analysis.
Abushouk, AI; Ahmed, H; Al Nahrawi, S; Attia, A; Awad, K; Elsherbeny, MY; Mustafa, SM, 2016
)
0.43
"Dexamethasone combined with other antiemetics provided better prophylaxis than single antiemetics against postoperative nausea and vomiting after laparoscopic cholecystectomy."( Dexamethasone combined with other antiemetics versus single antiemetics for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: An updated systematic review and meta-analysis.
Abushouk, AI; Ahmed, H; Al Nahrawi, S; Attia, A; Awad, K; Elsherbeny, MY; Mustafa, SM, 2016
)
0.43
" Physicians and pharmacists should be cautious for drug-drug interactions when pipamperon is prescribed, especially in combination with other QT-prolongating agents."( Drug-drug interaction related to the use of pipamperon and ondansetron in a child treated for leukemia.
Bauters, T; Bordon, V; Buts, S; Laureys, G, 2018
)
0.72
"Acupuncture combined with ondansetron as a multimodal prophylaxis approach is more effective than ondansetron alone in preventing postoperative nausea in high-risk patients."( Acupuncture combined with ondansetron for prevention of postoperative nausea and vomiting in high-risk patients undergoing laparoscopic gynaecological surgery: A randomised controlled trial.
Cao, W; Li, H; Liu, C; Xiong, Z; Xu, M; Yan, S; Yang, J; Zhu, Z; Zou, X, 2023
)
1.51

Bioavailability

The thermosensitive-mucoadhesive ondansetron liquid suppository (tmOLS) was developed to enhance patient compliance and bioavailability in high-risk patients receiving highly emetogenic therapy and having difficulty in swallowing. The bases were formulated using poloxamers (P407 and P188) and hydroxypropylmethyl cellulose (HPMC) Plasma concentrations of ondannetron peak 1 hour after an oral dose, and the tablet has an absolute bioavailability of 59%.

ExcerptReferenceRelevance
"9 h) with an absolute bioavailability of around 60%."( Clinical pharmacology of ondansetron in postoperative nausea and vomiting.
Baber, N; Frazer, NM; Palmer, JL; Pritchard, JF, 1992
)
0.59
"4 hours) and mean absolute bioavailability (young, 57%; elderly, 61%; aged, 69%) with increasing age."( Age and gender effects on ondansetron pharmacokinetics: evaluation of healthy aged volunteers.
Benedetti, TL; Bryson, JC; Kernodle, AE; Powell, JR; Pritchard, JF, 1992
)
0.58
" Although ondansetron is moderately well absorbed after oral administration, only a parenteral formulation will initially be available."( Ondansetron: a serotonin receptor (5-HT3) antagonist for antineoplastic chemotherapy-induced nausea and vomiting.
Goldspiel, BR; Kohler, DR, 1991
)
2.13
" The absolute oral bioavailability of ondansetron was 59%."( The clinical pharmacology of ondansetron.
Blackwell, CP; Harding, SM, 1989
)
0.84
" Satisfactory bioavailability has been demonstrated."( Pharmaceutical development of ondansetron tablets.
Leak, RE; Woodford, JD, 1989
)
0.57
" In laboratory animals absorption of the compound across the gastrointestinal tract is rapid and extensive, but due to high first-pass metabolism, the oral systemic bioavailability is low (less than 10%)."( The metabolism of ondansetron.
Dixon, CM; Saynor, DA, 1989
)
0.61
" Owing to hepatic first-pass metabolism, its bioavailability is only about 60% compared with ondansetron administered by infusion over 15 minutes."( Ondansetron clinical pharmacokinetics.
Del Favero, A; Roila, F, 1995
)
1.95
" Absolute bioavailability after the oral dosing on day 1 was 87."( Oral ondansetron pharmacokinetics: the effect of chemotherapy.
Bjurstrom, T; Bozigian, HP; Gooding, AE; Griffin, RH; Hansen, LA; Hsyu, PH; Huang, AT; Mitchell, R; Panella, TL; Pritchard, JF, 1994
)
0.8
" In a randomized, open-label, crossover study in 24 healthy male subjects, the relative bioavailability of a single 8-mg tablet was compared with that of an 8-mg solution using the two one-sided t-tests."( Ondansetron absorption in adults: effect of dosage form, food, and antacids.
Bozigian, HP; Gooding, AE; Pakes, GE; Pritchard, JF, 1994
)
1.73
" Absolute bioavailability after the oral dosing, colonic infusion, and rectal administration averaged 71 +/- 14, 74 +/- 26, and 58 +/- 18%, respectively."( Comparison of the pharmacokinetics of an ondansetron solution (8 mg) when administered intravenously, orally, to the colon, and to the rectum.
Barr, WH; Bozigian, HP; Griffin, RH; Hsyu, PH; Krishna, G; Lloyd, TL; Pritchard, JF; Shamburek, R, 1994
)
0.55
" Plasma concentrations of ondansetron peak 1 hour after an oral dose, and the tablet has an absolute bioavailability of 59%."( Ondansetron: a novel antiemetic agent.
Dukes, GE; Figg, WD; Graham, CL; Hak, LJ, 1993
)
2.03
" After a single, oral dose of ondansetron, mean absolute bioavailability increased markedly with increased hepatic insufficiency (approaching 100% in the group with severe hepatic impairment versus 66% for control subjects)."( Pharmacokinetics of ondansetron in patients with hepatic insufficiency.
Carson, SW; Dukes, GE; Figg, WD; Hak, LJ; Hermann, DJ; Lesesne, HR; Powell, JR; Pritchard, JF; Songer, SS, 1996
)
0.91
" Experimental investigations show that orally it is rapidly absorbed (about 90 min), is highly bioavailable (greater than 90%), has a long half-life (about 12 h) and is more potent (about 10 times) in animal models than ondansetron, currently standard therapy for the prophylactic control of chemotherapy induced nausea and vomiting."( Comparison of oral itasetron with oral ondansetron: results of a double-blind, active-controlled phase II study in chemotherapy-naive patients receiving moderately emetogenic chemotherapy.
Egerer, G; Goldschmidt, H; Kempe, R; Salwender, H; Voigt, T, 1997
)
0.75
"To compare the relative bioavailability of two 16-mg extemporaneously prepared suppository formulations with that of an 8-mg commercially available oral tablet."( Relative bioavailability of ondansetron 8-mg oral tablets versus two extemporaneous 16-mg suppositories: formulation and gender differences.
Jann, MW; Tenjarla, SN; Ward, ES; Weidler, DJ; ZumBrunnen, TL,
)
0.43
"Prospective, crossover bioavailability study."( Relative bioavailability of ondansetron 8-mg oral tablets versus two extemporaneous 16-mg suppositories: formulation and gender differences.
Jann, MW; Tenjarla, SN; Ward, ES; Weidler, DJ; ZumBrunnen, TL,
)
0.43
"Ondansetron was well absorbed by both routes of administration."( Relative bioavailability of ondansetron 8-mg oral tablets versus two extemporaneous 16-mg suppositories: formulation and gender differences.
Jann, MW; Tenjarla, SN; Ward, ES; Weidler, DJ; ZumBrunnen, TL,
)
1.87
" The bioavailability of oral ondansetron was reduced from 60% to 40% (P < ."( The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron.
Kivistö, KT; Neuvonen, PJ; Villikka, K, 1999
)
0.83
"The absolute bioavailability and pharmacokinetics of three formulations of ondansetron hydrochloride 24 mg--an oral tablet, an intravenous solution, and an extemporaneous rectal suppository--were studied."( Pharmacokinetics of three formulations of ondansetron hydrochloride in healthy volunteers: 24-mg oral tablet, rectal suppository, and i.v. infusion.
Jann, MW; Kazmi, Y; Stewart, J; Tenjarla, SN; VanDenBerg, CM; Ward, ES; Weidler, DJ, 2000
)
0.8
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
"To compare the relative bioavailability of an extemporaneous ondansetron capsule formulation with that of an identical dose of the commercially available solution formulation."( Relative bioavailability of an extemporaneous ondansetron 4-mg capsule formulation versus solution.
Ait-Daoud, N; Javors, MA; Johnson, BA; Lam, YW; Roache, JD, 2004
)
0.82
"Ondansetron was well absorbed after administration of both formulations, with the solution achieving a faster rate of drug absorption over the first hour of dosing."( Relative bioavailability of an extemporaneous ondansetron 4-mg capsule formulation versus solution.
Ait-Daoud, N; Javors, MA; Johnson, BA; Lam, YW; Roache, JD, 2004
)
2.02
" While studies have revealed the bioavailability of enteric promethazine to be 25%, current dosing references suggest identical dosing regardless of the route of administration."( No more than necessary: safety and efficacy of low-dose promethazine.
Caldwell, JB; Moser, JD; Rhule, FJ, 2006
)
0.33
" Thus, buccal adhesive tablet of ondansetron could be an alternative route to bypass the hepatic first-pass metabolism and to improve the bioavailability of (OH)."( Development and evaluation of buccal bioadhesive tablet of an anti-emetic agent ondansetron.
Ali, J; Ali, M; Hassan, N; Khar, RK, 2009
)
0.86
"Gellan gum-based mucoadhesive microspheres of ondansetron hydrochloride for intranasal systemic delivery were prepared to avoid first pass effect, an alternative route of administration to injection and to enhance systemic bioavailability of ondansetron hydrochloride."( Nasal administration of ondansetron using a novel microspheres delivery system Part II: ex vivo and in vivo studies.
Gattani, SG; Mahajan, HS, 2010
)
0.93
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" The analytical method was applied to evaluate the relative bioavailability of two pharmaceutical formulations containing 8 mg of ondansetron each in 25 healthy volunteers using a randomized, two-period crossover design."( Development and validation of a rapid and sensitive LC-ESI-MS/MS method for ondansetron quantification in human plasma and its application in comparative bioavailability study.
Azevedo, CP; Borges, DC; Borges, NC; Moreira, RF; Moreno, RA; Oliveira-Silva, D; Salvadori, MC; Sverdloff, CE, 2010
)
0.8
" The film showed enhanced bioavailability and prolonged efficacy compared to the oral solution."( Development of chitosan-based ondansetron buccal delivery system for the treatment of emesis.
Jee, JP; Kim, CK; Kim, HT; Park, DM; Song, YK, 2012
)
0.67
"The mucoadhesive ondansetron buccal film may be a potential alternative to the marketed oral formulation, parenterals and solid suppositories with better patient compliance and higher bioavailability for the treatment of emesis."( Development of chitosan-based ondansetron buccal delivery system for the treatment of emesis.
Jee, JP; Kim, CK; Kim, HT; Park, DM; Song, YK, 2012
)
1.01
" Finally, the bioavailability study in rabbits revealed that the absolute bioavailability of ondansetron hydrochloride was significantly increased from 28."( Thermally reversible xyloglucan gels as vehicles for nasal drug delivery.
Lohiya, G; Mahajan, HS; Nerkar, P; Tyagi, V,
)
0.35
"The current work aims to prepare the solid self-nanoemulsifying granules (SSNEGs) of ondansetron hydrochloride (ONH) to enhance its oral bioavailability by improving its aqueous solubility and facilitating its absorption though lymphatic pathways."( Development of solid self-nanoemulsifying granules (SSNEGs) of ondansetron hydrochloride with enhanced bioavailability potential.
Beg, S; Jena, SS; Patra, ChN; Rao, ME; Rizwan, M; Singh, B; Sruti, J; Swain, S, 2013
)
0.85
"The thermosensitive-mucoadhesive ondansetron liquid suppository (tmOLS) was developed to enhance patient compliance and bioavailability in high-risk patients receiving highly emetogenic therapy and having difficulty in swallowing, The thermosensitive-mucoadhesive liquid suppository bases were formulated using poloxamers (P407 and P188) and hydroxypropylmethyl cellulose (HPMC)."( Design and evaluation of ondansetron liquid suppository for the treatment of emesis.
Ban, E; Kim, CK, 2013
)
0.97
" In-vivo study showed that microspheres based on mucoadhesive polymer were able to promote quick drug absorption as well as enhanced bioavailability of drug."( Bioavailability enhancement of ondansetron after nasal administration of Caesalpinia pulcherrima-based microspheres.
More, DP; Suryawanshi, SR; Thakare, NP; Thombre, NA, 2015
)
0.7
" Developed mucoadhesive microspheres by nasal route showed enhancement of bioavailability as compared to oral route in rabbits."( Bioavailability enhancement of ondansetron after nasal administration of Caesalpinia pulcherrima-based microspheres.
More, DP; Suryawanshi, SR; Thakare, NP; Thombre, NA, 2015
)
0.7
"CPG-based mucoadhesive microspheres can successfully deliver ondansetron intranasally, sustain its effect, avoid first pass effect, an alternative route of administration to injection and thus enhance systemic bioavailability of ondansetron hydrochloride."( Bioavailability enhancement of ondansetron after nasal administration of Caesalpinia pulcherrima-based microspheres.
More, DP; Suryawanshi, SR; Thakare, NP; Thombre, NA, 2015
)
0.94
" Bioavailability of ondansetron was 32% (oral) and 75% (subcutaneous)."( Oral, subcutaneous, and intravenous pharmacokinetics of ondansetron in healthy cats.
Gustafson, DL; Hansen, RJ; Lake, RC; Lunghofer, PJ; Quimby, JM, 2014
)
0.97
"This study was conducted to compare the bioavailability of two 8 mg ondansetron oral soluble film formulations."( Pharmacokinetics and bioavailability study of two ondansetron oral soluble film formulations in fasting healthy male Chinese volunteers.
Wan, M; Zhang, Q; Zhao, Z; Zhu, J; Zhu, Y; Zou, J, 2015
)
0.91
"The mean (standard derivation [SD]) relative bioavailability was 96."( Pharmacokinetics and bioavailability study of two ondansetron oral soluble film formulations in fasting healthy male Chinese volunteers.
Wan, M; Zhang, Q; Zhao, Z; Zhu, J; Zhu, Y; Zou, J, 2015
)
0.67
" The nasal delivery showed improved bioavailability as compared to oral delivery."( Nasal inserts containing ondansetron hydrochloride based on Chitosan-gellan gum polyelectrolyte complex: In vitro-in vivo studies.
Mahajan, HS; Sonje, AG, 2016
)
0.74
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" Following subcutaneous administration in rats, the optimized formulation could prolong the drug release until 72 h with the enhanced bioavailability in comparison with the ODS solution."( Preparation of an oil suspension containing ondansetron hydrochloride as a sustained release parenteral formulation.
Chi, SC; Duong, VA; Maeng, HJ; Nguyen, TT, 2020
)
0.82
" In elderly subjects, bioavailability may be somewhat higher (65%) and lower clearance, presumably due to reduced hepatic first-pass metabolism."( Sustained release formulation of Ondansetron HCl using osmotic drug delivery approach.
Gundu, R; Kulkarni, D; Pekamwar, S; Shelke, S; Shep, S, 2020
)
0.84
"Ondansetron which is used to manage vertigo, nausea and vomiting suffer from the major limitations of low oral bioavailability (60 %) and short half-life (3-4 h), which affects the routine life style of patients (noncompliance due to multiple dosing)."( Pluronic® F127 stabilized reduced graphene oxide hydrogel for transdermal delivery of ondansetron: Ex vivo and animal studies.
Jia, Y; Li, H; Liu, C, 2020
)
2.22
" Preanesthetic oral ketamine is generally used in children but has less bioavailability due to the first-pass effect."( Preanesthetic nebulized ketamine vs preanesthetic oral ketamine for sedation and postoperative pain management in children for elective surgery: A retrospective analysis for effectiveness and safety.
Chen, C; Cheng, X; Fu, F; Lin, L, 2021
)
0.62
"Ondansetron (ODS) is an effective antiemetic drug which suffers from limited solubility and bioavailability during oral administration due to first-pass metabolism."( Ondansetron/Cyclodextrin inclusion complex nanofibrous webs for potential orally fast-disintegrating antiemetic drug delivery.
Celebioglu, A; Durgun, E; Emin Kilic, M; Hsiung, E; Uyar, T, 2022
)
3.61

Dosage Studied

Repeat ondansetron dosing was not more effective than placebo in controlling either postoperative emesis or the severity/duration of postoperative nausea. Dose-response testing revealed that suppression of food intake by 263 mM Polycose was equally attenuated by ondANSetron administered at 1.

ExcerptRelevanceReference
" Our data suggest that in comparison to ondansetron, granisetron is a more potent, longer acting and pharmacologically "cleaner" compound with a more conventional dose-response profile."( Are all 5-HT3 receptor antagonists the same?
Andrews, PL; Bhandari, P; Bingham, S; Blower, PR; Davey, PT; Marr, HE, 1992
)
0.55
"01 mg/kg IP, twice daily for 14 days) produced a significant anxiolytic profile which was not a result of handling during the chronic dosing schedule, an effect was not measureable 24 h after treatment ended."( Comparison of acute and chronic treatment of various serotonergic agents with those of diazepam and idazoxan in the rat elevated X-maze.
Heaton, M; Marsden, CA; Upton, N; Wright, IK, 1992
)
0.28
"This study measured the concentrations of ondansetron in plasma and cerebrospinal fluid (CSF) in six volunteers after oral dosing to steady state."( Concentration of ondansetron in cerebrospinal fluid following oral dosing in volunteers.
Colthup, PV; Murphy, P; Simpson, KH; Whelan, P, 1992
)
0.89
" Because of large intersubject variability in clearance and the relative safety of ondansetron, adjustments in ondansetron dosing based on age or gender alone are not recommended."( Ondansetron metabolism and pharmacokinetics.
Pritchard, JF, 1992
)
1.95
"We examined the anti-emetic effect, safety and usefulness of ondansetron hydrochloride, a selective 5-HT3 receptor antagonist, given orally once daily at the dosage of 4 mg, for 3 to 5 consecutive days to patients with nausea and emesis induced by non-platinum anti-cancer drugs such as cyclophosphamide, doxorubicin and carboplatin."( [Examination of inhibitory effect, safety and usefulness of SN-307 (ondansetron) administered orally once daily for 3-5 consecutive days on nausea and emesis associated with non-platinum anti-cancer drugs].
Akasaka, Y; Ariyoshi, Y; Furue, H; Ikeda, M; Niitani, H; Ohta, J; Ota, K; Suminaga, M; Taguchi, T; Tsukagoshi, S, 1992
)
0.76
" Patients received an intravenous dose of 16 mg dexamethasone with either 8 mg ondansetron or 60 mg metoclopramide before chemotherapy, followed by oral dosing with 8 mg ondansetron or 20 mg metoclopramide 3 times daily for 5 days."( Ondansetron compared with metoclopramide in the control of emesis and quality of life during repeated chemotherapy for breast cancer.
Cassidy, J; Coleman, R; Hunter, E; Kaye, S; Kerr, D; Khanna, S; McQuade, B; Smyth, J; Soukop, M; Stewart, A, 1992
)
1.95
" Several clinical observations suggested that ondansetron may be effective when given in a single dose: (1) demonstration of efficacy over a wide dose range, (2) similar efficacy with dosing intervals of 2, 4, 6, and 8 hours, and (3) efficacy of single-dose regimens with high-dose metoclopramide and other 5-hydroxytryptamine3 antagonists."( Single-dose ondansetron for the prevention of cisplatin-induced emesis: efficacy results.
Hainsworth, JD; Hesketh, PJ, 1992
)
0.92
" Ondansetron, 1 mg and 8 mg, and placebo were given as twice daily dosing for 2 1/2 days."( A study to evaluate the effect of ondansetron on psychomotor performance after repeated oral dosing in healthy subjects.
Ceuppens, PR; Hall, ST, 1991
)
1.47
"The chemistry, pharmacokinetics, adverse effects, stability, compatibility, and dosage of ondansetron hydrochloride are described, and clinical studies of the use of ondansetron for the prophylaxis of nausea and vomiting induced by antineoplastic therapy are reviewed."( Ondansetron--the first of a new class of antiemetic agents.
Chaffee, BJ; Tankanow, RM, 1991
)
1.95
"15 mg/kg) given intravenously every 6 hours (first dose 30 minutes prior to cisplatin administration); 11 additional patients received an identical dosage and schedule except that a fourth daily dose was added 17."( Ondansetron (GR 38032F): a novel antiemetic effective in patients receiving a multiple-day regimen of cisplatin chemotherapy.
Bryson, JC; Finn, AL; Hainsworth, JD; Khojasteh, A; Omura, GA, 1991
)
1.72
" before chemotherapy followed by twice-daily (12-hourly) oral dosing has good efficacy in the control of emesis in oncology outpatients."( Oral treatment with ondansetron in an outpatient setting.
Dicato, MA, 1991
)
0.6
"5 mg/kg/infusion), and shifted the dose-response curve for cocaine self-administration to the right."( GR38032F, a serotonin 5-HT3 antagonist, fails to alter cocaine self-administration in rats.
Peltier, R; Schenk, S, 1991
)
0.28
" GR38032F (10 micrograms/kg) caused a significant rightward shift in the 2-methyl-5-HT dose-response curve."( Effect of 5-hydroxytryptamine on external carotid nerve activity and its blockade by GR38032F in anesthetized rats.
Abe, M; Ikeda, T; Saito, H; Togashi, H; Yoshioka, M, 1991
)
0.28
" These data support recent claims that GR38032F attenuates benzodiazepine withdrawal, and they indicate that this effect shows an inverted U-shaped dose-response curve."( Effects of the 5-HT3 antagonist GR38032F (ondansetron) on benzodiazepine withdrawal in rats.
Goudie, AJ; Leathley, MJ, 1990
)
0.54
"To determine a dose-response relationship of ondansetron for the prevention of emesis induced by high-dose cisplatin and to study the efficacy of the extended dosing schedule of ondansetron during 20 hours after cisplatin administration, 36 patients with malignant neoplasms who had not previously received chemotherapy but who were currently receiving cisplatin were treated."( Ondansetron for the prevention of emesis induced by high-dose cisplatin. A multi-center dose-response study.
Bernard, S; Finn, A; Gandara, D; Khojasteh, A; Lester, E; Sartiano, G; Tapazoglou, E, 1990
)
1.98
") had no effects on duodenal intraluminal pressure, but reduced the responses to distension with a bell-shaped dose-response relationship."( The effects of granisetron, ICS 205-930 and ondansetron on the visceral pain reflex induced by duodenal distension.
Moss, HE; Sanger, GJ, 1990
)
0.54
" Pretreatment with a selective 5-HT3 antagonist, GR38032F (3 x 10(-8) mol/kg), caused a parallel shift to the right in the dose-response curve."( Effect of a novel 5-hydroxytryptamine3-antagonist, GR38032F, on the 5-hydroxytryptamine-induced increase in carotid sinus nerve activity in rats.
Yoshioka, M, 1989
)
0.28
" The pharmacokinetics of ondansetron have been defined in volunteers using intravenous and oral dosage regimens proposed for the clinic."( The clinical pharmacology of ondansetron.
Blackwell, CP; Harding, SM, 1989
)
0.87
" Early clinical studies therefore examined ondansetron treatment to establish an optimal dosing schedule for acute emesis."( Ondansetron in the prophylaxis of acute cisplatin-induced nausea and vomiting.
Marty, M, 1989
)
1.98
" The pharmacokinetic profile of ondansetron has been established following single and multiple oral dosing and intravenous infusions."( The determination in plasma and pharmacokinetics of ondansetron.
Colthup, PV; Palmer, JL, 1989
)
0.81
" Although aging is associated with decreased clearance and increased bioavailability, dosage adjustments are not required for the elderly, and may be necessary only in patients with severe hepatic impairment."( Ondansetron clinical pharmacokinetics.
Del Favero, A; Roila, F, 1995
)
1.73
" After a 4- to 5-day recovery, piglets were hydrated, then dosed with cisplatin (5."( The piglet as a suitable animal model for studying the delayed phase of cisplatin-induced emesis.
Blower, P; Grélot, L; Milano, S; Romain, D, 1995
)
0.29
"One hundred sixteen cases of leukemia patients received supra-high single dose TBI for bone marrow transplantation (BMT) with total a radiation dosage of 700-770 Gy at about 5cGy/min."( [Ondansetron in the prophylaxis of acute emesis induced by supra-high single dose total body irradiation (TBI)].
Fan, Y; Guo, N; Huang, X, 1995
)
1.2
"This is the first double-blind clinical trial in a homogenous group of patients to compare the recommended dosing schedules of ondansetron and granisetron in the control of prolonged emesis after cyclophosphamide-containing chemotherapy (48% CMF, 35% EC) for breast cancer."( Ondansetron compared with granisetron in the prophylaxis of cyclophosphamide-induced emesis in out-patients: a multicentre, double-blind, double-dummy, randomised, parallel-group study. Emesis Study Group for Ondansetron and Granisetron in Breast Cancer P
Corette, L; Cronje, JD; Froger, X; Goedhals, L; Gudgeon, A; Laplaige, P; McQuade, B; Roberts, JT; Stewart, A; Tubiana-Hulin, M,
)
1.78
"It is the purpose of this article to discuss ondansetron hydrochloride (Zofran Glaxo, Research Triangle Park, NJ) and its mechanisms of action, indications for use, dosage and administration, side effects, and nursing implications."( Practical points in the use of ondansetron.
Litwack, K, 1994
)
0.83
" Optimal dose, frequency of dosing and route of administration have not been established."( The clinical use of ondansetron. New South Wales Therapeutic Assessment Group.
Currow, DC; Noble, PD; Stuart-Harris, RC, 1995
)
0.61
" These results indicate that distinct and contrasting dose-response profiles exist for these classical and atypical drugs in an animal model of anxiety based on electric shock."( Differential profile of the CCKB receptor antagonist CI-988 and diazepam in the four-plate test.
Dooley, DJ; Klamt, I, 1993
)
0.29
" Prospective studies designed to generate comparative clinical and economic data are needed in which outcomes are assessed by a common scale and in which previously established optimal doses and dosing schedules of each compound (either alone or in combination therapy) are used."( Impact of ondansetron and granisetron on chemotherapy-induced emesis in adults: the need for comparative pharmacoeconomic data.
Hedayati, S; Moatti, JP; Seitz, JF,
)
0.53
" Absolute bioavailability after the oral dosing on day 1 was 87."( Oral ondansetron pharmacokinetics: the effect of chemotherapy.
Bjurstrom, T; Bozigian, HP; Gooding, AE; Griffin, RH; Hansen, LA; Hsyu, PH; Huang, AT; Mitchell, R; Panella, TL; Pritchard, JF, 1994
)
0.8
"The survey queried patient demographics, type of antineoplastic therapy administered, indications and dosing regimen(s) for ondansetron, additional antiemetic agents administered, and clinical response."( Multicenter postmarketing surveillance of ondansetron therapy in pediatric patients.
McQueen, KD; Milton, JD, 1994
)
0.76
" Ondansetron dosing was off-label in 15 percent and 73 percent prior to and after an emetogenic exposure, respectively."( Multicenter postmarketing surveillance of ondansetron therapy in pediatric patients.
McQueen, KD; Milton, JD, 1994
)
1.46
" Additional evaluation into the most cost-effective dosing of ondansetron would also be valuable."( Multicenter postmarketing surveillance of ondansetron therapy in pediatric patients.
McQueen, KD; Milton, JD, 1994
)
0.79
" Thus, an efficient anti-emetic drug with less frequent dosing, using a simplified dosage regimen and producing a reduction in anticipatory nausea and vomiting and in nursing time, may result in an overall reduction in cost."( Clinical studies to assess the economic impact of new therapies: pragmatic approaches to measuring costs.
Kirchner, V, 1993
)
0.29
" Serial plasma samples were obtained for up to 24 hr after dosing in each treatment period."( Comparison of the pharmacokinetics of an ondansetron solution (8 mg) when administered intravenously, orally, to the colon, and to the rectum.
Barr, WH; Bozigian, HP; Griffin, RH; Hsyu, PH; Krishna, G; Lloyd, TL; Pritchard, JF; Shamburek, R, 1994
)
0.55
" To compare the efficacy and tolerability of standard dosage of tropisetron and ondansetron in controlling emesis induced by chemotherapeutic regimen not containing cisplatin."( [Tropisetron versus ondansetron in the prevention and control of emesis in patients undergoing chemotherapy with FAC/FEC for metastatic or surgically treated breast carcinoma].
Campora, E; Rosso, R; Simoni, C,
)
0.68
"05 mg/kg at 3-minute intervals to establish approximately 95% twitch inhibition so as to construct a dose-response curve."( The effect of ondansetron on atracurium-induced neuromuscular blockade.
Embree, PB; Gadalla, F; Kudlak, TT; Lien, CA; Savarese, JJ; Sharp, GJ,
)
0.49
"Log dose-response curves were determined for the study groups and compared using analysis of variance (ANOVA)."( The effect of ondansetron on atracurium-induced neuromuscular blockade.
Embree, PB; Gadalla, F; Kudlak, TT; Lien, CA; Savarese, JJ; Sharp, GJ,
)
0.49
" On 85 days the dosage was lower than recommended (the lowest 2 mg/m2/day)."( Ondansetron as an effective drug in prophylaxis of chemotherapy--induced emesis in children.
Beshari, SE; Kołecki, P; Wachowiak, J, 1993
)
1.73
" In each experiment, order of dosing conditions was determined by a Latin square design."( Effects of 5-hydroxytryptamine3 antagonist, ondansetron, on cigarette smoking, smoke exposure, and mood in humans.
Apfelbaum, JL; Lichtor, JL; Zacny, JP; Zaragoza, JG, 1993
)
0.55
" Patients received an intravenous dose of 16 mg dexamethasone with either 8 mg ondansetron or 60 mg metoclopramide intravenously before chemotherapy followed by oral dosing with 8 mg ondansetron or 20 mg metoclopramide 3 times daily for 5 days."( Ondansetron: a cost-effective advance in anti-emetic therapy.
Cox, F; Hirsch, J,
)
1.8
" Criteria for dosage and administration were met by 76% of the inpatient orders and 83% of the outpatient orders."( Ondansetron use in a major university teaching hospital.
Chapman, SM; Pruemer, JM, 1993
)
1.73
" It is recommended that the dosing frequency of ondansetron be limited to once daily in patients with severe hepatic impairment."( The pharmacokinetics of intravenous ondansetron in patients with hepatic impairment.
Blake, JC; Burroughs, AK; Minton, NA; Palmer, JL, 1993
)
0.82
" Data were collected on patient demographics, medical history, dosage of ondansetron, outcome, adverse effects, and concurrent medications."( Multicenter evaluation of ondansetron use in hospitalized oncology patients.
Emhart, GC; Jessen, LM; Long, KS; Patel, HS; Peters, MD; Reitz, JA, 1993
)
0.82
" There was little evidence of a dose-response relationship for either compound, and a loss of efficacy for ondansetron was seen at 3 mg/kg."( Ondansetron improves cognitive performance in the Morris water maze spatial navigation task.
Daniels, SE; Eglen, RM; Fontana, DJ; Henderson, C; Wong, EH, 1995
)
1.95
" These experimental conditions are also suitable for analysis of the considered compounds in pharmaceutical dosage forms or in biological fluids."( Retention behaviour of anti-emetic serotonin antagonists in reversed phase high performance liquid chromatography.
Barbato, F; La Rotonda, MI; Quaglia, F, 1995
)
0.29
" Fifty patients received ondansetron therapy in accordance with all indication and dosage aspects of the guidelines."( Compliance with guidelines results in appropriate ondansetron prescribing at Christchurch Hospital.
Allen, B; Begg, EJ; Busch, AF; Pearce, MJ, 1996
)
0.85
" In conclusion, ondansetron given prior to anaesthesia in a dosage of 4 mg did not prevent postoperative nausea and vomiting after laparoscopic cholecystectomy."( Antiemetic efficacy of prophylactic ondansetron in laparoscopic cholecystectomy. A randomised, double-blind, placebo-controlled trial.
Koivuranta, MK; Läärä, E; Ryhänen, PT, 1996
)
0.91
" In addition, ondansetron had a similar dose-response curve in both menstruating and nonmenstruating women."( The effects of the menstrual cycle on the incidence of emesis and efficacy of ondansetron.
Afshar, M; Allen, E; Buxbaum, J; Gratz, I; Joslyn, AF; Prilliman, B, 1996
)
0.88
" In addition, a brief battery of psychomotor tests was administered 1 h prior to dosing and 1 and 4 h after dosing."( The effect of ondansetron on the pharmacokinetics and pharmacodynamics of temazepam.
Keene, ON; Palmer, JL; Preston, GC, 1996
)
0.65
" As animal studies and early clinical studies with ondansetron have suggested nonlinear dose-response relationships, three subjects also underwent pilot studies with three doses of ondansetron (0."( Biological and behavioral responses to D-amphetamine, alone and in combination with the serotonin3 receptor antagonist ondansetron, in healthy volunteers.
Broocks, A; Canter, SK; Dubbert, B; Grady, TA; Hill, JL; Murphy, DL; Pigott, TA, 1996
)
0.75
"001) linear dose-response relationship was observed over the entire dolasetron dosage range for all efficacy parameters."( Therapeutic equivalence of single oral doses of dolasetron mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy. European Dolasetron Comparative Study Group.
Chemaissani, A; Cognetti, F; Conte, PF; Cortes-Funes, H; Del Favero, A; Diaz-Rubio, E; Dressler, H; Duclos, B; Fauser, AA, 1996
)
0.52
" Paclitaxel dosage was escalated in 10 mg/m2/wk increments in subsequent patients, to a maximum dosage of 90 mg/m2/wk."( Schedule- and dose-intensified paclitaxel as weekly 1-hour infusion in pretreated solid tumors: results of a phase I/II trial.
Freund, W; Hausamen, TU; Lipke, J; Löffler, TM, 1996
)
0.29
"6% acetic acid) in conscious rats with a bell-shaped dose-response curve."( Response heterogeneity of 5-HT3 receptor antagonists in a rat visceral hypersensitivity model.
Dahl, SG; Junien, JL; Langlois, A; Pascaud, X; Rivière, PJ, 1996
)
0.29
" In contrast, daily injections of ondansetron with cocaine significantly blocked the development of sensitization with an inverted U-shape dose-response curve."( Blockade of cocaine sensitization and tolerance by the co-administration of ondansetron, a 5-HT3 receptor antagonist, and cocaine.
Ellinwood, EH; King, GR; Xiong, Z, 1997
)
0.81
"To test the evidence for a dose-response with ondansetron for treatment of postoperative nausea and vomiting and to establish whether differences in efficacy between doses are of clinical relevance."( A quantitative systematic review of ondansetron in treatment of established postoperative nausea and vomiting.
McQuay, HJ; Moore, RA; Reynolds, DJ; Tramèr, MR, 1997
)
0.83
" There was no evidence of a clinically relevant dose-response between 1 mg and 8 mg or a difference between ondansetron and either droperidol or metoclopramide in a limited dataset."( A quantitative systematic review of ondansetron in treatment of established postoperative nausea and vomiting.
McQuay, HJ; Moore, RA; Reynolds, DJ; Tramèr, MR, 1997
)
0.78
"The inhibitory effects of GG032X tablets, a new dosage form (fast dispersing tablet) of ondansetron, 5-HT2 receptor antagonist, on nausea and emesis induced by cisplatin (CDDP), were investigated along with safety and usefulness."( [Clinical efficacy of GG032X tablets, a new dosage form of ondansetron (fast dispersing tablet), on cisplatin-induced nausea and emesis].
Akasaka, Y; Ariyoshi, Y; Ikeda, M; Nukariya, N; Ota, J; Suminaga, M; Taguchi, T, 1997
)
0.76
" This study is the first large-scale, double-blind trial to demonstrate that ondansetron 8 mg BID for 3 days, a dosing regimen that may enhance patient convenience and compliance, is as effective as ondansetron 8 mg TID for 3 days in the prevention of nausea and vomiting associated with cyclophosphamide-based chemotherapy."( Oral ondansetron 8 mg twice daily is as effective as 8 mg three times daily in the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. S3A-376 Study Group.
Beck, TM; Chang, A; Griffin, D; Harvey, WH; Meshad, M; Navari, R; Wentz, A; York, M, 1997
)
1.04
"To establish a dose-response relationship for ondansetron, and to evaluate any effects of oral premedication with metoclopramide in pediatric patients undergoing tonsillectomy and adenoidectomy and strabismus surgery."( Ondansetron dose response curve in high-risk pediatric patients.
Kymer, PJ; Lawhorn, CD; Shirey, R; Stewart, FC; Stoner, JM; Volpe, P, 1997
)
2
" The IC consisted of methotrexate, hydrocortisone and cytarabine, dosed according to patient age."( Assessment of the emetogenic potential of intrathecal chemotherapy and response to prophylactic treatment with ondansetron.
Chavez, CM; Holdsworth, MT; Raisch, DW; Winter, SS, 1998
)
0.51
" The percentage of reduction of benzodiazepine daily dosage at all time points in the treatment trial was similar for the ondansetron and placebo groups."( A controlled trial of ondansetron, a 5-HT3 antagonist, in benzodiazepine discontinuation.
Busto, UE; Kaplan, HL; Romach, MK; Sellers, EM; Somer, G, 1998
)
0.82
"To determine the dose-response relationship of ondansetron in preventing postoperative nausea and vomiting (PONV) in women undergoing elective surgery."( A randomized, double-blind, dose-response study of ondansetron in the prevention of postoperative nausea and vomiting.
Chang, Y; Conant, JA; Connors, PM; Dershwitz, M; Rosow, CE, 1998
)
0.81
" dosing regimen over a 24 h period, administered to patients prior to receiving cisplatin (50 mg/m2 or greater) chemotherapy."( A multicenter, double-blind comparison of i.v. and oral administration of ondansetron plus dexamethasone for acute cisplatin-induced emesis. Ondansetron Acute Emesis Study Group.
Goedhals, L; Graham, E; Joly, F; Krzakowski, M; Lees, J; McQuade, B; Pawlicki, M; Rapoport, B; Yelle, L, 1998
)
0.53
" Preloading with the total 24-hour dose of OND 32 mg exhibits a more potent antiemetic activity during the initial 18 h, becoming weaker over the last 5 h of the first day, whereas the every-6-hour schedule leaves periods of poor emesis control between dosing intervals."( A randomized comparative study of antiemetic prophylaxis with ondansentron in a single 32-mg loading dose versus 8 mg every 6 h in patients undergoing cisplatin-based chemotherapy.
Athanassiadis, A; Bacoyiannis, C; Fountzilas, G; Karakousis, C; Kosmas, C; Kosmidis, P; Mylonakis, N; Tsavaris, N,
)
0.13
" Dose-response relationships show that higher doses of ibuprofen may be particularly effective."( Postoperative analgesia and vomiting, with special reference to day-case surgery: a systematic review.
McQuay, HJ; Moore, RA, 1998
)
0.3
" Emesis induced by RS14203 exhibited a dose-response relationship but no such relationship was seen for R-rolipram or CT-2450."( Emesis induced by inhibitors of type IV cyclic nucleotide phosphodiesterase (PDE IV) in the ferret.
Choudhury, I; Robichaud, A; Rodger, IW; Tattersall, FD, 1999
)
0.3
" No dose-response inhibition was observed."( Involvement of 5-HT3 receptors in the prolactin release induced by immobilization stress in rats.
Nonaka, KO, 1999
)
0.3
" Repeat ondansetron dosing was not more effective than placebo in controlling either postoperative emesis or the severity/duration of postoperative nausea."( Efficacy of repeat intravenous dosing of ondansetron in controlling postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled multicenter trial.
Angel, JJ; Baughman, VL; Campbell, C; Creed, MR; Edmondson, D; Jense, HG; Kekoler, LJ; Kovac, AL; Mingus, M; O'Connor, TA; Pearman, MH; Shahvari, MB, 1999
)
1
" The maximal ondansetron dosage (8-16 mg per day) was given for 3 weeks."( Ondansetron treatment in patients with Tourette's syndrome.
Cohen, DJ; Laor, N; Toren, P; Weizman, A; Wolmer, L, 1999
)
2.12
" For prevention of delayed N&V, patients receiving TTS-F for acute N&V were given TTS-F at the same dosage (75 micrograms/h) on days 2-5, whereas patients receiving OND for acute N&V were treated with M 20 mg orally every 6 h on days 2-5, starting 24 h after CDDP."( Prevention of nausea and vomiting (N&V) in cancer patients receiving high-dose cisplatin. Assessment of the potential antiemetic activity of transdermal fentanyl (TTS-F) compared to standard antiemetic treatment in acute and delayed N&V: first clinical re
Contu, P; Curreli, L; Macciò, A; Mantovani, G; Massa, D; Massa, E; Mulas, C; Succu, G,
)
0.13
" dosing for all patients would have resulted in >/=28% savings."( Balancing efficacy with cost: antiemetic control in the pediatric stem cell transplant (SCT) population.
Eichelberger, WJ; Guinan, EC; Hoorntje, LE; Levine, KJ; Mayer, DK; Parsons, SK, 2000
)
0.31
" Serial plasma and pleural or ascitic fluid samples were collected during each dosing and analyzed by high-performance liquid chromatography for both the intact lactone form of topotecan and its ring-opened carboxylate form."( Topotecan lacks third space sequestration.
de Jonge, MJ; Gelderblom, H; Loos, WJ; Sparreboom, A; Verweij, J, 2000
)
0.31
" There is a need for nasal drug delivery in specific patient populations where the use of commercially available intravenous and oral dosage forms may be inconvenient and/or unfeasible."( Nasal absorption of ondansetron in rats: an alternative route of drug delivery.
Dakkuri, A; Hussain, AA; Itoh, S, 2000
)
0.63
" The carboplatin AUC dosing level was 4, 5, or 6 in 6, 5, and 16 individuals, respectively."( The antiemetic efficacy of oral ondansetron plus intravenous dexamethasone in patients with gynecologic malignancies receiving carboplatin-based chemotherapy.
Belinson, J; Kennedy, A; Kulp, B; Markman, M; Peterson, G; Webster, K, 2000
)
0.59
" All subjects received each dosage form on the same day in the following order: oral tablet, rectal suppository, and intravenous infusion."( Pharmacokinetics of three formulations of ondansetron hydrochloride in healthy volunteers: 24-mg oral tablet, rectal suppository, and i.v. infusion.
Jann, MW; Kazmi, Y; Stewart, J; Tenjarla, SN; VanDenBerg, CM; Ward, ES; Weidler, DJ, 2000
)
0.57
"To introduce a computerized data collection system used for an outcomes-based approach to antiemetic therapy in children, and to present data collected with this system in support of a new antiemetic dosing regimen."( Computerized system for outcomes-based antiemetic therapy in children.
Adams, VR; Holdsworth, MT; Raisch, DW; Winter, SS; Wood, JG, 2000
)
0.31
" Hence, we examined the effects of intravenous ondansetron at dosage of 4 and 8 mg in comparison with intravenous prochlorperazine at 5 mg and placebo."( Failure of prevention against postoperative vomiting by ondansetron or prochlorperazine in patients undergoing gynecological laparoscopy.
Buerkle, H; Hsu, TY; Lee, TC; Lee, TH; Lin, CR; Mao, CC; Yang, LC, 2000
)
0.81
"We conclude that at the dosage level studied ondansetron is about twice as effective as metoclopramide in the symptomatic relief of uremia-induced nausea and vomiting."( Comparison of ondansetron with metoclopramide in the symptomatic relief of uremia-induced nausea and vomiting.
Bagatin, J; Hozo, I; Ljutić, D; Perković, D; Pivac, N; Rumboldt, Z, 2002
)
0.94
" Further detailed pharmacokinetic studies of irinotecan in patients receiving concomitant therapy with enzyme-inducing anticonvulsants are required so that rational dosing recommendations can be provided for this patient population."( Influence of phenytoin on the disposition of irinotecan: a case report.
Berg, S; Bernstein, M; Blaney, SM; Cherrick, I; Kuttesch, N; Murry, DJ; Salama, V, 2002
)
0.31
" Continued dosing with MK-869 may enhance control of other measures of delayed emesis, such as the use of rescue medication, although confirmation is required before a definitive conclusion may be drawn."( Prevention of cisplatin-induced acute and delayed emesis by the selective neurokinin-1 antagonists, L-758,298 and MK-869.
Brestan, E; Bui, B; Carides, AD; De Smet, M; Decramer, ML; Eldridge, K; Evans, JK; Garin, AM; Gertz, BJ; Lichinitser, MR; Michiels, N; Navari, RM; Reinhardt, RR; Riviere, A; Thant, M; Van Belle, S, 2002
)
0.31
") either during the second dosing regimen (3."( Ondansetron given in the acute withdrawal from a repeated cocaine sensitization dosing regimen reverses the expression of sensitization and inhibits self-administration.
Davidson, C; Ellinwood, EH; Lee, TH; Xiong, Z, 2002
)
1.76
"5% European American; 20 EOAs; 20 LOAs) received an oral solution of ondansetron at a dosage of 4 microg/kg twice daily for 8 weeks, together with weekly relapse-prevention therapy."( Effects of ondansetron in early- versus late-onset alcoholics: a prospective, open-label study.
Feinn, R; Hernandez-Avila, C; Kranzler, HR; Pierucci-Lagha, A, 2003
)
0.94
"An oral solution of ondansetron seems suitable for the treatment of alcohol dependence, yielding findings consistent with evidence from a placebo-controlled trial that ondansetron, at a dosage of 4 microg/kg twice daily, is of value in the treatment of EOAs."( Effects of ondansetron in early- versus late-onset alcoholics: a prospective, open-label study.
Feinn, R; Hernandez-Avila, C; Kranzler, HR; Pierucci-Lagha, A, 2003
)
1.03
" The lethal toxicity was statistically significantly dosing time-dependent (chi2 = 21."( Circadian rhythms in toxic effects of the serotonin antagonist ondansetron in mice.
Ben Attia, M; Boughattas, NA; Bouzouita, K; Chouchane, L; Gadacha, W; Khedhaier, A; Mechkouri, M; Reinberg, A; Sani, M, 2003
)
0.56
" However, the dosage used in the control group was effective and less expensive."( Ondansetron for the prevention of postoperative nausea and vomiting: which is the best dosage for aesthetic plastic surgery?
Barbosa, MV; Bariani, RL; Farah, AB; Ferreira, LM; João, BB; Nahas, FX,
)
1.57
"15 mg/kg followed by 1 dose of the same dosage orally."( Single-dose oral granisetron versus multidose intravenous ondansetron for moderately emetogenic cyclophosphamide-based chemotherapy in pediatric outpatients with acute lymphoblastic leukemia.
Hu, WY; Hung, IJ; Jaing, TH; Tsay, PK; Yang, CP,
)
0.38
" DPIVM may allow significant financial savings in centers and hospital departments using high-cost pharmaceuticals susceptible of customized dosing --e."( [Financial assessment of device for the preparation of intravenous mixtures in hospital pharmacy].
Bonafont Pujol, X; Casado Collado, A; Clemente Bautista, S; Herdman, M; Jódar Masanés, R; Luengo Pascual, L; Napal Lecumberri, V; Serrano Padilla, G,
)
0.13
" Dose-response curves were also obtained with tramadol combined with ondansetron or droperidol at 1:1 fixed ratios."( Interaction between tramadol and two anti-emetics on nociception and gastrointestinal transit in mice.
Dürsteler, C; Fernandez, V; Mases, A; Pol, O; Puig, MM, 2006
)
0.57
" However, this drug has significant sedative effects with its standard dosage of 25 mg, especially when used in conjunction with narcotic analgesics."( No more than necessary: safety and efficacy of low-dose promethazine.
Caldwell, JB; Moser, JD; Rhule, FJ, 2006
)
0.33
" Factorial design was a powerful tool, allowing simultaneous determination of dose-response relationships for three drugs and identifying a previously unreported negative interaction between OND and MET."( A factorial study of ondansetron, metoclopramide, and dexamethasone for emesis prophylaxis after adenotonsillectomy in children.
Beckman, EC; Gunter, JB; McAuliffe, JJ; Spaeth, JP; Varughese, AM; Wittkugel, EP, 2006
)
0.65
" Ablation of NK-1 receptor expressing cells prevented (a) morphine-induced thermal and mechanical hypersensitivity, (b) increased touch-evoked spinal FOS expression, (c) upregulation of spinal dynorphin content and (d) the rightward displacement of the spinal morphine antinociceptive dose-response curve (i."( Spinal NK-1 receptor expressing neurons mediate opioid-induced hyperalgesia and antinociceptive tolerance via activation of descending pathways.
King, T; Lai, J; Ossipov, MH; Porreca, F; Vanderah, TW; Vera-Portocarrero, LP; Zhang, ET, 2007
)
0.34
" Some differences were noted in dosing subanalyses."( A meta-analysis comparing the efficacy of four 5-HT3-receptor antagonists for acute chemotherapy-induced emesis.
Arnold, D; Grothey, A; Hinke, A; Jordan, K; Schmoll, HJ; Voigt, W; Wolf, HH, 2007
)
0.34
"Unlike patients with chemotherapy-induced nausea and vomiting, perioperative patients who failed ondansetron prophylaxis did not have a significant response to cross-over dosing with granisetron."( Granisetron versus ondansetron treatment for breakthrough postoperative nausea and vomiting after prophylactic ondansetron failure: a pilot study.
Arheart, KL; Birnbach, DJ; Candiotti, KA; Deepika, K; Kamat, A; Lubarsky, DA; Nhuch, F, 2007
)
0.89
"The objectives of this study were to determine the effect of single and repeat dosing with oral ondansetron, a 5-HT3-specific receptor blocker, on the degree and duration of bronchodilation induced by inhaled ipratropium bromide in patients with COPD."( Bronchodilating effect of combined therapy with ipratropium bromide and ondansetron in patients with COPD.
Faiferman, I; Fogarty, C; Hirschberg, S; Joos, GF; Pauwels, R; Vessey, R; Wouters, EF, 2008
)
0.8
" During a 1 yr span (2005), four 24 h studies were performed with a single dosing time at 1, 7, 13, and 19 hours after light onset (HALO), respectively."( Seasonal modulation of the 8-and 24-hour rhythms of ondansetron tolerance in mice.
Ben-Attia, M; Boughattas, NA; Gadacha, W; Khedhaier, A; Reinberg, A; Sani, M, 2007
)
0.59
"This study examined whether different ondansetron dosing schedules plus dexamethasone influenced antiemetic efficacy during multiple cycles of cisplatin-based chemotherapy (CT)."( Intravenous ondansetron plus intravenous dexamethasone with different ondansetron dosing schedules during multiple cycles of cisplatin-based chemotherapy.
Chen, PT; Liaw, CC,
)
0.78
" Pharmacokinetics suggest that the adult dosing regimen is appropriate for adolescents."( Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability.
Carides, AD; Chawla, S; Chua, V; Devandry, S; Evans, JK; Gore, L; Hemenway, M; Oxenius, B; Petrilli, A; Schissel, D; Taylor, A; Valentine, J, 2009
)
0.35
" These results allow Rapidfilm to claim the same panel of indications of the conventional immediate release oral solid dosage forms, but offering several advantages also over the ODT: it can result in higher patient convenience for several applications."( Rapidfilm: an innovative pharmaceutical form designed to improve patient compliance.
Breitenbach, A; Giarratana, N; Klaffenbach, P; Monti, NC; Reiner, V, 2010
)
0.36
" These results should allow a better individualization of etoposide dosing in children."( Developmental pharmacokinetics of etoposide in 67 children: lack of dexamethasone effect.
Auvrignon, A; Chastagner, P; Corradini, N; Doz, F; Gentet, JC; Giraud, C; Leblond, P; Rey, E; Rubie, H; Treluyer, JM; Urien, S; Vassal, G, 2011
)
0.37
" Due to the variation in concurrent therapies and dosing regimens, it is difficult to establish an optimal dose from the reviewed trials."( The role of ondansetron in the treatment of schizophrenia.
Bennett, AC; Vila, TM,
)
0.51
" The exact dosing regimen for ondansetron and dexamethasone was different in each study."( Differential time course of action of 5-HT3 and NK1 receptor antagonists when used with highly and moderately emetogenic chemotherapy (HEC and MEC).
Carides, AD; Hesketh, PJ; Street, JC; Warr, DG, 2011
)
0.66
"The in vivo assessment of percutaneous absorption of molecules is a very important step in the evaluation of any transdermal drug delivery system and a key goal in the design and optimization of transdermal dosage forms lies in understanding the factors that determine a good in vivo performance."( Preclinical evaluation of drug in adhesive type ondansetron loaded transdermal therapeutic systems.
Mallick, S; Pattnaik, S; Swain, K; Yeasmin, N, 2011
)
0.62
"We enrolled 202 chemotherapy naïve patients treated with cisplatin at a dosage of ≥50 mg/m(2) as monotherapy or as combined chemotherapy."( Association of ABCB1, 5-HT3B receptor and CYP2D6 genetic polymorphisms with ondansetron and metoclopramide antiemetic response in Indonesian cancer patients treated with highly emetogenic chemotherapy.
Baak-Pablo, RF; Gelderblom, H; Guchelaar, HJ; Hakimi, M; Mustofa, M; Nortier, JW; Perwitasari, DA; van der Straaten, RJ; Wessels, JA, 2011
)
0.6
" This requirement may reflect a necessary dosing regimen towards normalizing underlying dysfunctional neural circuits and "addiction memory" states."( Pharmacologically-mediated reactivation and reconsolidation blockade of the psychostimulant-abuse circuit: a novel treatment strategy.
Beyer, WF; Fowler, JC; Lee, TH; Mangum, OB; Mannelli, P; Patkar, A; Szabo, ST; Wetsel, WC, 2012
)
0.38
" During cycle 1 and cycle 2, subjects received dinaciclib with aprepitant in one cycle and dinaciclib without aprepitant in the other cycle; aprepitant was administered at a dose of 125 mg orally on day 1 and 80 mg orally on days 2 and 3, along with standard dosing regimens of ondansetron and dexamethasone."( Effect of aprepitant on the pharmacokinetics of the cyclin-dependent kinase inhibitor dinaciclib in patients with advanced malignancies.
Bannerji, R; Kantesaria, B; Mita, M; Poon, J; Shapiro, GI; Small, K; Statkevich, P; Tzontcheva, A; Zhang, D; Zhu, Y, 2012
)
0.56
" This research primarily aimed to evaluate the efficacy and safety of ondansetron at a 16mg/day dosage to treat alcohol-dependent outpatients."( A pilot study of full-dose ondansetron to treat heavy-drinking men withdrawing from alcohol in Brazil.
Baltieri, DA; Corrêa Filho, JM, 2013
)
0.92
" Therefore it was concluded that the proposed developed HPTLC method can be applied for identification and quantitative determination of ondansetron in bulk drug and dosage forms."( Development of HPTLC method for the estimation of ondansetron hydrochloride in bulk drug and sublingual tablets.
Ali, J; Baboota, S; Kohli, K; Mujtaba, A, 2013
)
0.85
" Thus, tmOLS could be administered to patients who have difficulty in swallowing; however, adjustments in dosing interval may be needed."( Design and evaluation of ondansetron liquid suppository for the treatment of emesis.
Ban, E; Kim, CK, 2013
)
0.69
" Complications include frequent nausea and vomiting, anaphylactoid reactions and dosing errors."( Scottish and Newcastle antiemetic pre-treatment for paracetamol poisoning study (SNAP).
Bateman, DN; Coyle, J; Dear, JW; Eddleston, M; Gray, A; Lewis, S; Sandilands, EA; Thanacoody, HK; Thomas, SH; Webb, DJ, 2013
)
0.39
" Although probiotics appear to be an effective option for the treatment of AGE amongst hospitalized children, outpatient data is lacking and more studies are urgently needed to determine the optimal organism, dosing and duration of treatment."( Treatment of acute gastroenteritis in children: an overview of systematic reviews of interventions commonly used in developed countries.
Ali, S; Freedman, SB; Gouin, S; Hartling, L; Oleszczuk, M, 2013
)
0.39
" Subcutaneous dosing resulted in an extent of systemic exposure similar to that with intramuscular or intravenous dosing and greater than that with oral administration, and may be an option for clinical administration of ondansetron."( Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers.
Bahn, JD; DeNoia, E; Dychter, SS; Fellows, D; Harrigan, R; Haughey, DB; Maneval, DC; Printz, MA; Sugarman, BJ, 2014
)
0.84
" Statistical analysis of dose-response showed the maximum mean difference in QTcF, compared to placebo and corrected for baseline (ddQTcF), was less than 10 milliseconds (ms) after an 8 mg IV dose and approximately 20 ms after the 32 mg dose, each infused over 15 minutes."( Integration of modeling and simulation to support changes to ondansetron dosing following a randomized, double-blind, placebo-, and active-controlled thorough QT study.
Fang, L; Haberer, LJ; Hunt, TL; Ridgway, D; Russo, MW; Zuo, P, 2014
)
0.64
" Each dosing period was followed by a 3- or 7-day washout period."( Bioequivalence of ondansetron oral soluble film 8 mg (ZUPLENZ) and ondansetron orally disintegrating tablets 8 mg (ZOFRAN) in healthy adults.
Dadey, E,
)
0.47
" A dosing regimen for prevention of NAS was designed based on the model."( Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome.
Carvalho, B; Clavijo, C; Drover, DR; Elkomy, MH; Galinkin, JL; Peltz, G; Sultan, P; Wu, M, 2015
)
1.86
" Together with these new biomarkers of hepatotoxicity, a 12-hour acetylcysteine protocol offers clinicians and patients the possibility for better targeting of therapy, fewer adverse effects, a simpler dosing regimen, and shorter hospital stay."( Changing the Management of Paracetamol Poisoning.
Bateman, DN, 2015
)
0.42
" There are numerous limitations in the current literature on ondansetron safety including exposure to the medication is not limited to sensitive windows of organogenesis, there is a lack of information on dosing and compliance, self-reports of exposure are commonly used, an inadequate accounting exists for other factors that may explain the relationship between ondansetron exposure and the adverse outcome, and there exists a lack of biologic plausibility by which ondansetron might cause harm."( Ondansetron Use in Pregnancy.
Bodnar, LM; Caritis, SN; Siminerio, LL; Venkataramanan, R, 2016
)
2.12
"In the process of implementation and innovation of paediatric dosage forms, buccal films for transmucosal administration of drug represent one of the most interesting approach."( Design and evaluation of buccal films as paediatric dosage form for transmucosal delivery of ondansetron.
Abruzzo, A; Bigucci, F; Cerchiara, T; Gallucci, MC; Luppi, B; Saladini, B; Trastullo, R, 2016
)
0.65
" Serial plasma samples were collected from the subject over one 8-hour dosing interval at 14, 24, and 35 weeks' gestation (representing early-, mid-, and late-pregnancy time points, respectively)."( Ondansetron Exposure Changes in a Pregnant Woman.
Caritis, SN; Haas, DM; Hankins, GD; Hebert, MF; Lemon, LS; Venkataramanan, R; Zhang, H, 2016
)
1.88
" Aprepitant and ondansetron as dosed in this trial was not superior to standard ondansetron monotherapy."( Effectiveness of aprepitant in addition to ondansetron in the prevention of nausea and vomiting caused by fractionated radiotherapy to the upper abdomen (AVERT).
Ades, S; Ashikaga, T; Blackstock, W; Halyard, M; Heimann, R; Kumar, S; Wilson, K, 2017
)
1.06
"A prospective, randomized, double-blind, parallel controlled study was conducted in 0-18 years old cancer patients administered highly emetogenic chemotherapy, with different dosage of palonosetron or ondansetron, both followed by dexamethasone."( Palonosetron is nonsuperior to ondansetron in acute phase but provides superior antiemetic control in delayed phase for pediatric patients administered highly emetogenic chemotherapy.
Deng, X; Kong, XR; Li, CC; Liang, X; Peng, L; Tan, J; Wang, S; Yang, C; Zhang, J; Zhao, Z, 2018
)
0.96
" Orodispersible films (ODF) have increasingly been evaluated as a suitable dosage form for extemporaneous oral preparations."( Application of miniaturized near-infrared spectroscopy for quality control of extemporaneous orodispersible films.
Chan, SY; Foo, WC; Gokhale, R; Khong, YM; Widjaja, E, 2018
)
0.48
"The weight-based dosing of ondansetron to reduce hypotension has never been investigated."( Minimal effective weight-based dosing of ondansetron to reduce hypotension in cesarean section under spinal anesthesia: a randomized controlled superiority trial.
Dilokrattanaphijit, N; Karnjanawanichkul, O; Kunapaisal, T; Leeratiwong, J; Oofuvong, M, 2018
)
1.04
" The results revealed a highly significant relationship between dosage and activation in bilateral insula, somatosensory and premotor regions, cingulate cortex, and temporal cortex for control but not body-focused videos."( High-dose ondansetron reduces activation of interoceptive and sensorimotor brain regions.
Burdick, KE; Coffey, BJ; Fleysher, L; Goodman, WK; Grimaldi, SJ; Leibu, E; Murrough, JW; Parides, MK; Shahab, R; Stern, ER, 2019
)
0.92
"Literature data pertaining to the physicochemical, pharmaceutical, and pharmacokinetic properties of ondansetron hydrochloride dihydrate are reviewed to arrive at a decision on whether a marketing authorization of an immediate release (IR) solid oral dosage form can be approved based on a Biopharmaceutics Classification System (BCS)-based biowaiver."( Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.
Abrahamsson, B; Belubbi, T; Cristofoletti, R; Dressman, J; Groot, DW; Langguth, P; Mehta, M; Nagarsenker, MS; Parr, A; Polli, JE; Rajawat, GS; Shah, VP; Tajiri, T, 2019
)
0.97
"The ODS-loaded NLCs appear potential for prolongation of drug action and reduction in dosing frequency."( Preparation of Ondansetron Hydrochloride-Loaded Nanostructured Lipid Carriers Using Solvent Injection Method for Enhancement of Pharmacokinetic Properties.
Chi, SC; Duong, VA; Maeng, HJ; Nguyen, TT, 2019
)
0.87
" To reduce dosing frequency and side effects and improve patient compliance, a sustained release parenteral formulation of ODS was developed."( Preparation of an oil suspension containing ondansetron hydrochloride as a sustained release parenteral formulation.
Chi, SC; Duong, VA; Maeng, HJ; Nguyen, TT, 2020
)
0.82
" Moreover, chitosan based film allowed to obtain the highest amount of permeated drug and could represent a novel child-appropriate dosage form able to combine the advantages of solid dosage form with the possibility to avoid the swallowing."( Ondansetron buccal administration for paediatric use: A comparison between films and wafers.
Abruzzo, A; Bigucci, F; Cerchiara, T; Dalena, F; Giordani, B; Luppi, B; Nicoletta, FP; Prata, C, 2020
)
2
"The oral control drug delivery is the most acceptable delivery system for patient acceptance, industrial application and economical but still it has several challenges to design a dosage form."( Design and development of ondansetron hydrochloride pH independent control released matrix tablets.
Anilkumar, A; Krishna Murthy, TEG; Rani, AP, 2020
)
0.86
" Moreover, repeat dosing may increase the frequency of diarrhea."( A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan.
Beer, D; Dixon, A; Freedman, SB; Gouin, S; Heath, A; Hopkin, G; Joubert, G; Klassen, TP; McCabe, C; Offringa, M; Pechlivanoglou, P; Plint, AC; Rios, JD; Williamson-Urquhart, S, 2020
)
0.8
"Our results suggest that routine administration of ODS in a dosage of 8 mg does not effectively attenuate postspinal change in maternal blood pressure during CS in our setting."( 5-HT3 blockade does not attenuate postspinal blood pressure change in cesarean section: A case-control study.
Heik-Guth, C; Hilbert, T; Klaschik, S; Neumann, C; Strizek, B; Velten, M; Wittmann, M, 2020
)
0.56
" Ondansetron is an effective antiemetic drug widely used to prevent CINV; however, the effective administrative dosing strategies among pediatrics remain unclear."( Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial.
Lertvivatpong, N; Monsereenusorn, C; Photia, A; Rujkijyanont, P; Ruktrirong, J; Traivaree, C, 2021
)
1.78
"In all, 194 children undergoing chemotherapy were randomized to receive either single daily dosing (0."( Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial.
Lertvivatpong, N; Monsereenusorn, C; Photia, A; Rujkijyanont, P; Ruktrirong, J; Traivaree, C, 2021
)
0.87
"No significant differences were found between the two dosing strategies concerning number of emesis episodes and parent's satisfaction."( Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial.
Lertvivatpong, N; Monsereenusorn, C; Photia, A; Rujkijyanont, P; Ruktrirong, J; Traivaree, C, 2021
)
0.87
"Ondansetron administered as divided dosing should be considered among children aged under 7 years to prevent chemotherapy-induced nausea and among patients receiving low emetogenic chemotherapy to maintain their appetite."( Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial.
Lertvivatpong, N; Monsereenusorn, C; Photia, A; Rujkijyanont, P; Ruktrirong, J; Traivaree, C, 2021
)
2.31
" Participants in the olanzapine group received olanzapine once daily on days 1 and 2, while those in the control group received a placebo in the same dosage and schedule."( Efficacy and Safety of Olanzapine in Children Receiving Highly Emetogenic Chemotherapy: A Randomized, Double-blind Placebo-controlled Phase 3 Trial.
Gupta, AK; Meena, JP; Moothedath, AW; Pandey, RM; Seth, R; Velpandian, T, 2022
)
0.72
"The scoping review identified 57 studies with most data available on their tolerability (68% local, 54% systemic), clinical effects (82%), details on dosage (96%) and routes of application (100%)."( Subcutaneous Drugs and Off-label Use in Hospice and Palliative Care: A Scoping Review.
Dürr, F; Jean-Petit-Matile, S; Kobleder, A; Meyer-Massetti, C; Wernli, U, 2022
)
0.72
" PONV incidence, complete response, 80 mg aprepitant combined with dexamethasone and ondansetron, vomiting, nausea, and analgesic dose-response were the main outcomes measured."( The efficacy of aprepitant for the prevention of postoperative nausea and vomiting: A meta-analysis.
Chen, X; He, H; Hu, W; Liao, Y; Liu, W; Liu, Y; Pan, Z; Wang, X; Zheng, F; Zhong, H, 2023
)
1.13
" No statistically significant difference between the dose-response of analgesics was identified (mean difference: -1."( The efficacy of aprepitant for the prevention of postoperative nausea and vomiting: A meta-analysis.
Chen, X; He, H; Hu, W; Liao, Y; Liu, W; Liu, Y; Pan, Z; Wang, X; Zheng, F; Zhong, H, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
carbazoles
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (104)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
acetylcholinesteraseHomo sapiens (human)Potency27.19440.002541.796015,848.9004AID1347395; AID1347398
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency24.80440.01237.983543.2770AID1645841
EWS/FLI fusion proteinHomo sapiens (human)Potency16.16250.001310.157742.8575AID1259252; AID1259253; AID1259256
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency21.50680.001530.607315,848.9004AID1224848; AID1259401; AID1259403
cytochrome P450 2D6Homo sapiens (human)Potency12.20720.00108.379861.1304AID1645840
thyroid stimulating hormone receptorHomo sapiens (human)Potency0.47310.001628.015177.1139AID1259385
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
5-hydroxytryptamine receptor 3EHomo sapiens (human)Ki0.01050.00100.88359.9000AID5980; AID6344
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Ki10.00000.00020.656110.0000AID40505; AID72139
Solute carrier family 22 member 2Homo sapiens (human)IC50 (µMol)1.29500.40003.10009.7000AID692192; AID721751
Solute carrier family 22 member 1 Homo sapiens (human)IC50 (µMol)140.13330.21005.553710.0000AID386625; AID692194; AID721750
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Solute carrier family 22 member 3Homo sapiens (human)IC50 (µMol)17.40000.09003.72779.5000AID721749
5-hydroxytryptamine receptor 3BHomo sapiens (human)Ki0.01050.00100.87119.9000AID5980; AID6344
Bile salt export pumpHomo sapiens (human)IC50 (µMol)134.00000.11007.190310.0000AID1443980; AID1473738
Integrin beta-3Homo sapiens (human)Ki10.00000.00100.98459.1400AID221935
Muscarinic acetylcholine receptor M1Rattus norvegicus (Norway rat)Ki10.00000.00010.579710.0000AID104027
Muscarinic acetylcholine receptor M3Rattus norvegicus (Norway rat)Ki10.00000.00011.48339.1400AID225226
Integrin alpha-IIbHomo sapiens (human)Ki10.00000.00202.33529.1400AID221935
Cytochrome P450 3A4Homo sapiens (human)IC50 (µMol)11.00000.00011.753610.0000AID526453
5-hydroxytryptamine receptor 1AHomo sapiens (human)Ki10.00000.00010.532610.0000AID1889690
5-hydroxytryptamine receptor 2CRattus norvegicus (Norway rat)Ki8.33330.00020.667710.0000AID4767; AID5304; AID6424
Neuronal acetylcholine receptor subunit alpha-4Rattus norvegicus (Norway rat)Ki46.00000.00000.12345.5000AID146640
Beta-2 adrenergic receptorRattus norvegicus (Norway rat)Ki10.00000.00050.35461.6000AID218722
Muscarinic acetylcholine receptor M2Rattus norvegicus (Norway rat)Ki10.00000.00010.58908.2600AID225225
D(2) dopamine receptorHomo sapiens (human)Ki10.00000.00000.651810.0000AID1889688
5-hydroxytryptamine receptor 2ARattus norvegicus (Norway rat)Ki10.00000.00010.601710.0000AID5304; AID6424
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Ki10.00000.00020.656110.0000AID40505; AID72139
Alpha-1B adrenergic receptorRattus norvegicus (Norway rat)Ki10.00000.00010.949010.0000AID218722
Neuronal acetylcholine receptor subunit beta-2Homo sapiens (human)IC50 (µMol)66.00000.00110.539010.0000AID146308
Neuronal acetylcholine receptor subunit beta-2Homo sapiens (human)Ki46.00000.00000.11173.5400AID146640
Beta-1 adrenergic receptorRattus norvegicus (Norway rat)Ki10.00000.00000.667310.0000AID218722
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Ki10.00000.00020.656110.0000AID40505; AID72139
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.505710.0000AID71989
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Ki10.00000.00020.561410.0000AID40505; AID72139
DRattus norvegicus (Norway rat)Ki10.00000.00010.610010.0000AID218722; AID61649
D(3) dopamine receptorRattus norvegicus (Norway rat)Ki10.00000.00010.25675.8000AID218722; AID65752
5-hydroxytryptamine receptor 1ARattus norvegicus (Norway rat)Ki10.00000.00010.739610.0000AID4352; AID6424
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.497310.0000AID71989
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Ki10.00000.00020.635210.0000AID40505; AID72139
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Ki10.00000.00020.621710.0000AID40505; AID72139
Voltage-dependent L-type calcium channel subunit alpha-1CRattus norvegicus (Norway rat)Ki10.00000.00080.57965.4000AID47563; AID47564
Alpha-2A adrenergic receptorRattus norvegicus (Norway rat)Ki10.00000.00000.937510.0000AID219805
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.498810.0000AID71989
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Ki10.00000.00020.675810.0000AID40505; AID72139
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.504610.0000AID71989
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Ki10.00000.00020.646910.0000AID40505; AID72139
Alpha-1D adrenergic receptorRattus norvegicus (Norway rat)Ki10.00000.00000.575110.0000AID218722
5-hydroxytryptamine receptor 3AMus musculus (house mouse)Ki0.01200.00130.23781.4300AID6008
D(1B) dopamine receptorRattus norvegicus (Norway rat)Ki10.00000.00020.24622.0000AID218722
Beta-3 adrenergic receptorRattus norvegicus (Norway rat)Ki10.00000.00050.33671.6000AID218722
Voltage-dependent L-type calcium channel subunit alpha-1DRattus norvegicus (Norway rat)Ki10.00000.00080.74105.4000AID47563; AID47564
5-hydroxytryptamine receptor 2AHomo sapiens (human)Ki10.00000.00000.385510.0000AID1889689
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Ki10.00000.00020.656110.0000AID40505; AID72139
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Ki10.00000.00020.656110.0000AID40505; AID72139
5-hydroxytryptamine receptor 1BRattus norvegicus (Norway rat)Ki6.85000.00031.29679.2440AID4703; AID6424
5-hydroxytryptamine receptor 1DRattus norvegicus (Norway rat)Ki15.00000.00101.67479.2000AID4876; AID6424
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Ki10.00000.00020.671210.0000AID40505; AID72139
Cholecystokinin receptor type ARattus norvegicus (Norway rat)Ki10.00000.00010.27892.8900AID50508
Gastrin/cholecystokinin type B receptorRattus norvegicus (Norway rat)Ki0.68000.00060.11960.6800AID51469
D(4) dopamine receptorRattus norvegicus (Norway rat)Ki10.00000.00020.18872.0000AID218722
Neuronal acetylcholine receptor subunit beta-4Homo sapiens (human)IC50 (µMol)27.00000.00181.67796.5000AID146148
5-hydroxytryptamine receptor 1FRattus norvegicus (Norway rat)Ki10.00000.00101.67479.2000AID6424
5-hydroxytryptamine receptor 2BRattus norvegicus (Norway rat)Ki10.00000.00020.590910.0000AID5304; AID6424
5-hydroxytryptamine receptor 6Rattus norvegicus (Norway rat)Ki10.00000.00020.42542.1000AID6424
Histamine H1 receptorRattus norvegicus (Norway rat)Ki10.00000.00071.54406.5000AID87533
Neuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)IC50 (µMol)27.00000.00181.31326.5000AID146148
5-hydroxytryptamine receptor 7 Rattus norvegicus (Norway rat)Ki10.00000.00000.14803.1800AID6424
Delta-type opioid receptorRattus norvegicus (Norway rat)Ki10.00000.00000.60689.2330AID220521
Mu-type opioid receptorRattus norvegicus (Norway rat)Ki2.90000.00000.38458.6000AID224719
5-hydroxytryptamine receptor 7Homo sapiens (human)Ki1.00000.00030.380610.0000AID1889691
Kappa-type opioid receptorRattus norvegicus (Norway rat)Ki10.00000.00000.18683.9500AID223592
5-hydroxytryptamine receptor 5ARattus norvegicus (Norway rat)Ki10.00000.30101.30032.1000AID6424
5-hydroxytryptamine receptor 5BRattus norvegicus (Norway rat)Ki10.00000.30101.30032.1000AID228446; AID6424
5-hydroxytryptamine receptor 3ARattus norvegicus (Norway rat)IC50 (µMol)0.01360.00021.13514.6000AID6063; AID6077; AID6080; AID712498
5-hydroxytryptamine receptor 3ARattus norvegicus (Norway rat)Ki0.72010.00020.484110.0000AID5886; AID5890; AID5896; AID5899; AID5908; AID5911; AID6041; AID6136; AID6284; AID6297; AID6298; AID6424
5-hydroxytryptamine receptor 2BHomo sapiens (human)IC50 (µMol)0.71700.00011.18738.9125AID625217
5-hydroxytryptamine receptor 2BHomo sapiens (human)Ki0.45600.00030.769310.0000AID625217
Alpha-1A adrenergic receptorRattus norvegicus (Norway rat)Ki10.00000.00000.965010.0000AID218722
Neuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)IC50 (µMol)66.00000.00110.491110.0000AID146308
Neuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)Ki46.00000.00000.11573.5400AID146640
5-hydroxytryptamine receptor 3AHomo sapiens (human)IC50 (µMol)0.00010.00011.07899.0000AID712501
5-hydroxytryptamine receptor 3AHomo sapiens (human)Ki0.01000.00000.74119.9000AID526452; AID5980; AID6344; AID6364; AID6369; AID712522
Neuronal acetylcholine receptor subunit alpha-7Mus musculus (house mouse)Ki3.00000.00120.12230.4800AID146789
5-hydroxytryptamine receptor 7Cavia porcellus (domestic guinea pig)IC50 (µMol)20.40002.03005.53139.9000AID386625
D(2) dopamine receptorRattus norvegicus (Norway rat)Ki6.25610.00000.437510.0000AID218722; AID6364; AID6424; AID65903
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.506510.0000AID71989
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Ki10.00000.00020.557710.0000AID40505; AID72139
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.505710.0000AID71989
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Ki10.00000.00020.640310.0000AID40505; AID72139
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Ki10.00000.00020.570810.0000AID40505; AID72139
Glutamate receptor ionotropic, NMDA 2CRattus norvegicus (Norway rat)Ki10.00000.00030.81966.6900AID143098
Thyrotropin-releasing hormone receptorRattus norvegicus (Norway rat)Ki10.00000.02000.03120.0423AID210172
Voltage-dependent L-type calcium channel subunit alpha-1SRattus norvegicus (Norway rat)Ki10.00000.00080.66735.4000AID47563; AID47564
Neuronal acetylcholine receptor subunit alpha-7Rattus norvegicus (Norway rat)IC50 (µMol)25.00000.00301.69437.0795AID146925
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)IC50 (µMol)0.73030.00091.901410.0000AID161281; AID243151; AID408340; AID526455; AID576612
5-hydroxytryptamine receptor 4 Rattus norvegicus (Norway rat)Ki5.60000.00161.02535.0119AID3202; AID6424
5-hydroxytryptamine receptor 3DHomo sapiens (human)Ki0.01050.00100.88359.9000AID5980; AID6344
Multidrug and toxin extrusion protein 2Homo sapiens (human)IC50 (µMol)2.45330.16003.95718.6000AID692196; AID721748; AID721752
5-hydroxytryptamine receptor 3CHomo sapiens (human)Ki0.01050.00100.88359.9000AID5980; AID6344
GABA theta subunitRattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
GABA theta subunitRattus norvegicus (Norway rat)Ki10.00000.00020.656110.0000AID40505; AID72139
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
Multidrug and toxin extrusion protein 1Homo sapiens (human)IC50 (µMol)0.08750.01002.765610.0000AID692195; AID721746; AID721747; AID721754
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)IC50 (µMol)10.00000.00010.507510.0000AID71989
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Ki10.00000.00020.656110.0000AID40505; AID72139
5-hydroxytryptamine receptor 3BMus musculus (house mouse)Ki0.01200.00130.26351.4300AID6008
5-hydroxytryptamine receptor 3BRattus norvegicus (Norway rat)IC50 (µMol)0.01810.00041.17424.6000AID6063; AID6077; AID6080
5-hydroxytryptamine receptor 3BRattus norvegicus (Norway rat)Ki0.72010.00020.502310.0000AID5886; AID5890; AID5896; AID5899; AID5908; AID5911; AID6041; AID6136; AID6284; AID6297; AID6298; AID6424
Histamine H3 receptorRattus norvegicus (Norway rat)Ki10.00000.00010.29638.5110AID89720
Sigma non-opioid intracellular receptor 1Rattus norvegicus (Norway rat)Ki0.68000.00030.26715.0700AID229206
NischarinHomo sapiens (human)Ki10.00000.00420.21923.8019AID91719
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
5-hydroxytryptamine receptor 3EHomo sapiens (human)Kd0.00020.00000.02840.1060AID6026; AID6027
5-hydroxytryptamine receptor 3ACavia porcellus (domestic guinea pig)Kd0.07760.05013.28198.0000AID1784759
5-hydroxytryptamine receptor 3BHomo sapiens (human)Kd0.00020.00000.01370.1060AID6026; AID6027
5-hydroxytryptamine receptor 3ARattus norvegicus (Norway rat)Kd0.00200.00082.62148.5114AID7229
5-hydroxytryptamine receptor 3AHomo sapiens (human)Kd0.00020.00000.00980.1060AID6026; AID6027
5-hydroxytryptamine receptor 3DHomo sapiens (human)Kd0.00020.00000.02840.1060AID6026; AID6027
5-hydroxytryptamine receptor 3CHomo sapiens (human)Kd0.00020.00000.02840.1060AID6026; AID6027
5-hydroxytryptamine receptor 3BRattus norvegicus (Norway rat)Kd0.00200.00082.62148.5114AID7229
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
5-hydroxytryptamine receptor 3EHomo sapiens (human)Kb0.01940.00930.01390.0194AID5963
5-hydroxytryptamine receptor 3BHomo sapiens (human)Kb0.01940.00930.01390.0194AID5963
5-hydroxytryptamine receptor 3AHomo sapiens (human)Kb0.01940.00930.01390.0194AID5963
5-hydroxytryptamine receptor 6Homo sapiens (human)Kb10.00000.00030.00430.0300AID1784760
5-hydroxytryptamine receptor 3DHomo sapiens (human)Kb0.01940.00930.01390.0194AID5963
5-hydroxytryptamine receptor 3CHomo sapiens (human)Kb0.01940.00930.01390.0194AID5963
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (399)

Processvia Protein(s)Taxonomy
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3EHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3EHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3EHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3EHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3EHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3EHomo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic processSolute carrier family 22 member 2Homo sapiens (human)
positive regulation of gene expressionSolute carrier family 22 member 2Homo sapiens (human)
organic cation transportSolute carrier family 22 member 2Homo sapiens (human)
monoatomic cation transportSolute carrier family 22 member 2Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 2Homo sapiens (human)
serotonin transportSolute carrier family 22 member 2Homo sapiens (human)
body fluid secretionSolute carrier family 22 member 2Homo sapiens (human)
organic cation transportSolute carrier family 22 member 2Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 2Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 2Homo sapiens (human)
amine transportSolute carrier family 22 member 2Homo sapiens (human)
putrescine transportSolute carrier family 22 member 2Homo sapiens (human)
spermidine transportSolute carrier family 22 member 2Homo sapiens (human)
acetylcholine transportSolute carrier family 22 member 2Homo sapiens (human)
choline transportSolute carrier family 22 member 2Homo sapiens (human)
dopamine transportSolute carrier family 22 member 2Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 2Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 2Homo sapiens (human)
histamine transportSolute carrier family 22 member 2Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 2Homo sapiens (human)
histamine uptakeSolute carrier family 22 member 2Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 2Homo sapiens (human)
thiamine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
amino acid import across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 2Homo sapiens (human)
L-arginine import across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
export across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 2Homo sapiens (human)
L-alpha-amino acid transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
L-arginine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transport across blood-brain barrierSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic metabolic processSolute carrier family 22 member 1 Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 1 Homo sapiens (human)
serotonin transportSolute carrier family 22 member 1 Homo sapiens (human)
establishment or maintenance of transmembrane electrochemical gradientSolute carrier family 22 member 1 Homo sapiens (human)
organic cation transportSolute carrier family 22 member 1 Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 1 Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 1 Homo sapiens (human)
monoamine transportSolute carrier family 22 member 1 Homo sapiens (human)
putrescine transportSolute carrier family 22 member 1 Homo sapiens (human)
spermidine transportSolute carrier family 22 member 1 Homo sapiens (human)
acetylcholine transportSolute carrier family 22 member 1 Homo sapiens (human)
dopamine transportSolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 1 Homo sapiens (human)
thiamine transportSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 1 Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 1 Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 1 Homo sapiens (human)
thiamine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
metanephric proximal tubule developmentSolute carrier family 22 member 1 Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 1 Homo sapiens (human)
monoatomic cation transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 1 Homo sapiens (human)
(R)-carnitine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
acyl carnitine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transport across blood-brain barrierSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
histamine metabolic processSolute carrier family 22 member 3Homo sapiens (human)
organic cation transportSolute carrier family 22 member 3Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 3Homo sapiens (human)
monoatomic ion transportSolute carrier family 22 member 3Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 3Homo sapiens (human)
serotonin transportSolute carrier family 22 member 3Homo sapiens (human)
organic cation transportSolute carrier family 22 member 3Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 3Homo sapiens (human)
organic anion transportSolute carrier family 22 member 3Homo sapiens (human)
monocarboxylic acid transportSolute carrier family 22 member 3Homo sapiens (human)
monoamine transportSolute carrier family 22 member 3Homo sapiens (human)
spermidine transportSolute carrier family 22 member 3Homo sapiens (human)
dopamine transportSolute carrier family 22 member 3Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 3Homo sapiens (human)
regulation of appetiteSolute carrier family 22 member 3Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 3Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 3Homo sapiens (human)
histamine transportSolute carrier family 22 member 3Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 3Homo sapiens (human)
histamine uptakeSolute carrier family 22 member 3Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 3Homo sapiens (human)
epinephrine uptakeSolute carrier family 22 member 3Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 3Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 3Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 3Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 3Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 3Homo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3BHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3BHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3BHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3BHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3BHomo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
negative regulation of low-density lipoprotein receptor activityIntegrin beta-3Homo sapiens (human)
positive regulation of protein phosphorylationIntegrin beta-3Homo sapiens (human)
positive regulation of endothelial cell proliferationIntegrin beta-3Homo sapiens (human)
positive regulation of cell-matrix adhesionIntegrin beta-3Homo sapiens (human)
cell-substrate junction assemblyIntegrin beta-3Homo sapiens (human)
cell adhesionIntegrin beta-3Homo sapiens (human)
cell-matrix adhesionIntegrin beta-3Homo sapiens (human)
integrin-mediated signaling pathwayIntegrin beta-3Homo sapiens (human)
embryo implantationIntegrin beta-3Homo sapiens (human)
blood coagulationIntegrin beta-3Homo sapiens (human)
positive regulation of endothelial cell migrationIntegrin beta-3Homo sapiens (human)
positive regulation of gene expressionIntegrin beta-3Homo sapiens (human)
negative regulation of macrophage derived foam cell differentiationIntegrin beta-3Homo sapiens (human)
positive regulation of fibroblast migrationIntegrin beta-3Homo sapiens (human)
negative regulation of lipid storageIntegrin beta-3Homo sapiens (human)
response to activityIntegrin beta-3Homo sapiens (human)
smooth muscle cell migrationIntegrin beta-3Homo sapiens (human)
positive regulation of smooth muscle cell migrationIntegrin beta-3Homo sapiens (human)
platelet activationIntegrin beta-3Homo sapiens (human)
positive regulation of vascular endothelial growth factor receptor signaling pathwayIntegrin beta-3Homo sapiens (human)
cell-substrate adhesionIntegrin beta-3Homo sapiens (human)
activation of protein kinase activityIntegrin beta-3Homo sapiens (human)
negative regulation of lipid transportIntegrin beta-3Homo sapiens (human)
regulation of protein localizationIntegrin beta-3Homo sapiens (human)
regulation of actin cytoskeleton organizationIntegrin beta-3Homo sapiens (human)
cell adhesion mediated by integrinIntegrin beta-3Homo sapiens (human)
positive regulation of cell adhesion mediated by integrinIntegrin beta-3Homo sapiens (human)
positive regulation of osteoblast proliferationIntegrin beta-3Homo sapiens (human)
heterotypic cell-cell adhesionIntegrin beta-3Homo sapiens (human)
substrate adhesion-dependent cell spreadingIntegrin beta-3Homo sapiens (human)
tube developmentIntegrin beta-3Homo sapiens (human)
wound healing, spreading of epidermal cellsIntegrin beta-3Homo sapiens (human)
cellular response to platelet-derived growth factor stimulusIntegrin beta-3Homo sapiens (human)
apolipoprotein A-I-mediated signaling pathwayIntegrin beta-3Homo sapiens (human)
wound healingIntegrin beta-3Homo sapiens (human)
apoptotic cell clearanceIntegrin beta-3Homo sapiens (human)
regulation of bone resorptionIntegrin beta-3Homo sapiens (human)
positive regulation of angiogenesisIntegrin beta-3Homo sapiens (human)
positive regulation of bone resorptionIntegrin beta-3Homo sapiens (human)
symbiont entry into host cellIntegrin beta-3Homo sapiens (human)
platelet-derived growth factor receptor signaling pathwayIntegrin beta-3Homo sapiens (human)
positive regulation of fibroblast proliferationIntegrin beta-3Homo sapiens (human)
mesodermal cell differentiationIntegrin beta-3Homo sapiens (human)
positive regulation of smooth muscle cell proliferationIntegrin beta-3Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationIntegrin beta-3Homo sapiens (human)
negative regulation of lipoprotein metabolic processIntegrin beta-3Homo sapiens (human)
negative chemotaxisIntegrin beta-3Homo sapiens (human)
regulation of release of sequestered calcium ion into cytosolIntegrin beta-3Homo sapiens (human)
regulation of serotonin uptakeIntegrin beta-3Homo sapiens (human)
angiogenesis involved in wound healingIntegrin beta-3Homo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeIntegrin beta-3Homo sapiens (human)
platelet aggregationIntegrin beta-3Homo sapiens (human)
cellular response to mechanical stimulusIntegrin beta-3Homo sapiens (human)
cellular response to xenobiotic stimulusIntegrin beta-3Homo sapiens (human)
positive regulation of glomerular mesangial cell proliferationIntegrin beta-3Homo sapiens (human)
blood coagulation, fibrin clot formationIntegrin beta-3Homo sapiens (human)
maintenance of postsynaptic specialization structureIntegrin beta-3Homo sapiens (human)
regulation of postsynaptic neurotransmitter receptor internalizationIntegrin beta-3Homo sapiens (human)
regulation of postsynaptic neurotransmitter receptor diffusion trappingIntegrin beta-3Homo sapiens (human)
positive regulation of substrate adhesion-dependent cell spreadingIntegrin beta-3Homo sapiens (human)
positive regulation of adenylate cyclase-inhibiting opioid receptor signaling pathwayIntegrin beta-3Homo sapiens (human)
regulation of trophoblast cell migrationIntegrin beta-3Homo sapiens (human)
regulation of extracellular matrix organizationIntegrin beta-3Homo sapiens (human)
cellular response to insulin-like growth factor stimulusIntegrin beta-3Homo sapiens (human)
negative regulation of endothelial cell apoptotic processIntegrin beta-3Homo sapiens (human)
positive regulation of T cell migrationIntegrin beta-3Homo sapiens (human)
cell migrationIntegrin beta-3Homo sapiens (human)
positive regulation of leukocyte migrationIntegrin alpha-IIbHomo sapiens (human)
cell-matrix adhesionIntegrin alpha-IIbHomo sapiens (human)
integrin-mediated signaling pathwayIntegrin alpha-IIbHomo sapiens (human)
angiogenesisIntegrin alpha-IIbHomo sapiens (human)
cell-cell adhesionIntegrin alpha-IIbHomo sapiens (human)
cell adhesion mediated by integrinIntegrin alpha-IIbHomo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
gamma-aminobutyric acid signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of serotonin secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of vasoconstriction5-hydroxytryptamine receptor 1AHomo sapiens (human)
exploration behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of dopamine metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of hormone secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1AHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
temperature homeostasisD(2) dopamine receptorHomo sapiens (human)
response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein phosphorylationD(2) dopamine receptorHomo sapiens (human)
response to amphetamineD(2) dopamine receptorHomo sapiens (human)
nervous system process involved in regulation of systemic arterial blood pressureD(2) dopamine receptorHomo sapiens (human)
regulation of heart rateD(2) dopamine receptorHomo sapiens (human)
regulation of sodium ion transportD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(2) dopamine receptorHomo sapiens (human)
positive regulation of neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
positive regulation of receptor internalizationD(2) dopamine receptorHomo sapiens (human)
autophagyD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
neuron-neuron synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
axonogenesisD(2) dopamine receptorHomo sapiens (human)
synapse assemblyD(2) dopamine receptorHomo sapiens (human)
sensory perception of smellD(2) dopamine receptorHomo sapiens (human)
long-term memoryD(2) dopamine receptorHomo sapiens (human)
grooming behaviorD(2) dopamine receptorHomo sapiens (human)
locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
adult walking behaviorD(2) dopamine receptorHomo sapiens (human)
protein localizationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell population proliferationD(2) dopamine receptorHomo sapiens (human)
associative learningD(2) dopamine receptorHomo sapiens (human)
visual learningD(2) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(2) dopamine receptorHomo sapiens (human)
response to light stimulusD(2) dopamine receptorHomo sapiens (human)
response to toxic substanceD(2) dopamine receptorHomo sapiens (human)
response to iron ionD(2) dopamine receptorHomo sapiens (human)
response to inactivityD(2) dopamine receptorHomo sapiens (human)
Wnt signaling pathwayD(2) dopamine receptorHomo sapiens (human)
striatum developmentD(2) dopamine receptorHomo sapiens (human)
orbitofrontal cortex developmentD(2) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(2) dopamine receptorHomo sapiens (human)
adenohypophysis developmentD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell migrationD(2) dopamine receptorHomo sapiens (human)
peristalsisD(2) dopamine receptorHomo sapiens (human)
auditory behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of synaptic transmission, GABAergicD(2) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(2) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
response to histamineD(2) dopamine receptorHomo sapiens (human)
response to nicotineD(2) dopamine receptorHomo sapiens (human)
positive regulation of urine volumeD(2) dopamine receptorHomo sapiens (human)
positive regulation of renal sodium excretionD(2) dopamine receptorHomo sapiens (human)
positive regulation of multicellular organism growthD(2) dopamine receptorHomo sapiens (human)
response to cocaineD(2) dopamine receptorHomo sapiens (human)
negative regulation of circadian sleep/wake cycle, sleepD(2) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(2) dopamine receptorHomo sapiens (human)
drinking behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(2) dopamine receptorHomo sapiens (human)
response to morphineD(2) dopamine receptorHomo sapiens (human)
pigmentationD(2) dopamine receptorHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
positive regulation of G protein-coupled receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(2) dopamine receptorHomo sapiens (human)
negative regulation of innate immune responseD(2) dopamine receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IID(2) dopamine receptorHomo sapiens (human)
negative regulation of insulin secretionD(2) dopamine receptorHomo sapiens (human)
acid secretionD(2) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(2) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(2) dopamine receptorHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityD(2) dopamine receptorHomo sapiens (human)
response to axon injuryD(2) dopamine receptorHomo sapiens (human)
branching morphogenesis of a nerveD(2) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(2) dopamine receptorHomo sapiens (human)
epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(2) dopamine receptorHomo sapiens (human)
release of sequestered calcium ion into cytosolD(2) dopamine receptorHomo sapiens (human)
dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of synapse structural plasticityD(2) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(2) dopamine receptorHomo sapiens (human)
excitatory postsynaptic potentialD(2) dopamine receptorHomo sapiens (human)
positive regulation of growth hormone secretionD(2) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeD(2) dopamine receptorHomo sapiens (human)
regulation of locomotion involved in locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
negative regulation of cellular response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
positive regulation of glial cell-derived neurotrophic factor productionD(2) dopamine receptorHomo sapiens (human)
positive regulation of long-term synaptic potentiationD(2) dopamine receptorHomo sapiens (human)
hyaloid vascular plexus regressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of neuron migrationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(2) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(2) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
response to hypoxiaNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
monoatomic ion transportNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
calcium ion transportNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
smooth muscle contractionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
signal transductionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
synaptic transmission, cholinergicNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
visual perceptionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
sensory perception of soundNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
learningNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
memoryNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
locomotory behaviorNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
associative learningNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
visual learningNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
regulation of dopamine secretionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
sensory perception of painNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
vestibulocochlear nerve developmentNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
optic nerve morphogenesisNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
lateral geniculate nucleus developmentNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
central nervous system projection neuron axonogenesisNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
positive regulation of B cell proliferationNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
regulation of synaptic transmission, dopaminergicNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
positive regulation of dopamine secretionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
monoatomic ion transmembrane transportNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
response to nicotineNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
behavioral response to nicotineNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
social behaviorNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
regulation of dopamine metabolic processNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
B cell activationNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
response to cocaineNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
regulation of circadian sleep/wake cycle, REM sleepNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
response to ethanolNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
negative regulation of action potentialNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
regulation of dendrite morphogenesisNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
nervous system processNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
cognitionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
membrane depolarizationNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
regulation of synapse assemblyNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
excitatory postsynaptic potentialNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
synaptic transmission involved in micturitionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
acetylcholine receptor signaling pathwayNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
response to acetylcholineNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
chemical synaptic transmissionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
temperature homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytokine production involved in immune response5-hydroxytryptamine receptor 2AHomo sapiens (human)
glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytosolic calcium ion concentration5-hydroxytryptamine receptor 2AHomo sapiens (human)
memory5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2AHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
regulation of dopamine secretion5-hydroxytryptamine receptor 2AHomo sapiens (human)
artery smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
urinary bladder smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of heat generation5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of potassium ion transport5-hydroxytryptamine receptor 2AHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of neuron apoptotic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein localization to cytoskeleton5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of vasoconstriction5-hydroxytryptamine receptor 2AHomo sapiens (human)
symbiont entry into host cell5-hydroxytryptamine receptor 2AHomo sapiens (human)
sensitization5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral response to cocaine5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of inflammatory response5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylation5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of temperature stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergic5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic modulation of chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of execution phase of apoptosis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of platelet aggregation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of DNA biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2AHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
monoatomic ion transportNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
smooth muscle contractionNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
regulation of smooth muscle contractionNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
signal transductionNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
synaptic transmission, cholinergicNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
locomotory behaviorNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
neuronal action potentialNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
monoatomic ion transmembrane transportNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
behavioral response to nicotineNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
regulation of neurotransmitter secretionNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
positive regulation of transmission of nerve impulseNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
excitatory postsynaptic potentialNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
synaptic transmission involved in micturitionNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
chemical synaptic transmissionNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
acetylcholine receptor signaling pathwayNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
membrane depolarizationNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
monoatomic ion transportNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
regulation of smooth muscle contractionNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
signal transductionNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
activation of transmembrane receptor protein tyrosine kinase activityNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
synaptic transmission, cholinergicNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
nervous system developmentNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
locomotory behaviorNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
regulation of acetylcholine secretion, neurotransmissionNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
monoatomic ion transmembrane transportNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
behavioral response to nicotineNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
regulation of membrane potentialNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
regulation of dendrite morphogenesisNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
excitatory postsynaptic potentialNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
synaptic transmission involved in micturitionNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
acetylcholine receptor signaling pathwayNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
response to acetylcholineNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
response to nicotineNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
membrane depolarizationNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
smooth muscle contraction5-hydroxytryptamine receptor 7Homo sapiens (human)
circadian rhythm5-hydroxytryptamine receptor 7Homo sapiens (human)
blood circulation5-hydroxytryptamine receptor 7Homo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 7Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 7Homo sapiens (human)
neural crest cell migration5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cytokine production5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of endothelial cell proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor internalization5-hydroxytryptamine receptor 2BHomo sapiens (human)
heart morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
cardiac muscle hypertrophy5-hydroxytryptamine receptor 2BHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
neural crest cell differentiation5-hydroxytryptamine receptor 2BHomo sapiens (human)
intestine smooth muscle contraction5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphorylation5-hydroxytryptamine receptor 2BHomo sapiens (human)
calcium-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 2BHomo sapiens (human)
negative regulation of apoptotic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of canonical NF-kappaB signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of MAP kinase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
embryonic morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of nitric-oxide synthase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell division5-hydroxytryptamine receptor 2BHomo sapiens (human)
ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cellular response to temperature stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2BHomo sapiens (human)
action potentialNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
response to hypoxiaNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
DNA repairNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
monoatomic ion transportNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
calcium ion transportNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
response to oxidative stressNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
signal transductionNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
chemical synaptic transmissionNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
synaptic transmission, cholinergicNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
regulation of dopamine secretionNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
sensory perception of painNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
monoatomic ion transmembrane transportNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
response to nicotineNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
behavioral response to nicotineNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
B cell activationNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
regulation of membrane potentialNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
nervous system processNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
cognitionNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
membrane depolarizationNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
excitatory postsynaptic potentialNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
inhibitory postsynaptic potentialNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
acetylcholine receptor signaling pathwayNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3AHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3AHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3AHomo sapiens (human)
regulation of presynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3AHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
cerebral cortex cell migration5-hydroxytryptamine receptor 6Homo sapiens (human)
positive regulation of TOR signaling5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 6Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 6Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by hormonePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of DNA-templated transcriptionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion homeostasisPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cardiac muscle contractionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of ventricular cardiac muscle cell membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cellular response to xenobiotic stimulusPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane depolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion import across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3DHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3DHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3DHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3DHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3DHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3DHomo sapiens (human)
organic cation transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
transmembrane transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
proton transmembrane transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3CHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3CHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3CHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3CHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3CHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3CHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
organic cation transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
putrescine transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
thiamine transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
amino acid import across plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine import across plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-alpha-amino acid transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
proton transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
apoptotic processNischarinHomo sapiens (human)
Rac protein signal transductionNischarinHomo sapiens (human)
actin cytoskeleton organizationNischarinHomo sapiens (human)
negative regulation of cell migrationNischarinHomo sapiens (human)
outer dynein arm assemblyNischarinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (125)

Processvia Protein(s)Taxonomy
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3EHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3EHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3EHomo sapiens (human)
amine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
acetylcholine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
L-amino acid transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
pyrimidine nucleoside transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
choline transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
thiamine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
putrescine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
efflux transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
L-arginine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
acetylcholine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
dopamine:sodium symporter activitySolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine:sodium symporter activitySolute carrier family 22 member 1 Homo sapiens (human)
protein bindingSolute carrier family 22 member 1 Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
secondary active organic cation transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
pyrimidine nucleoside transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
thiamine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
putrescine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
identical protein bindingSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
(R)-carnitine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
protein bindingSolute carrier family 22 member 3Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3BHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3BHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3BHomo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
fibroblast growth factor bindingIntegrin beta-3Homo sapiens (human)
C-X3-C chemokine bindingIntegrin beta-3Homo sapiens (human)
insulin-like growth factor I bindingIntegrin beta-3Homo sapiens (human)
neuregulin bindingIntegrin beta-3Homo sapiens (human)
virus receptor activityIntegrin beta-3Homo sapiens (human)
fibronectin bindingIntegrin beta-3Homo sapiens (human)
protease bindingIntegrin beta-3Homo sapiens (human)
protein disulfide isomerase activityIntegrin beta-3Homo sapiens (human)
protein kinase C bindingIntegrin beta-3Homo sapiens (human)
platelet-derived growth factor receptor bindingIntegrin beta-3Homo sapiens (human)
integrin bindingIntegrin beta-3Homo sapiens (human)
protein bindingIntegrin beta-3Homo sapiens (human)
coreceptor activityIntegrin beta-3Homo sapiens (human)
enzyme bindingIntegrin beta-3Homo sapiens (human)
identical protein bindingIntegrin beta-3Homo sapiens (human)
vascular endothelial growth factor receptor 2 bindingIntegrin beta-3Homo sapiens (human)
metal ion bindingIntegrin beta-3Homo sapiens (human)
cell adhesion molecule bindingIntegrin beta-3Homo sapiens (human)
extracellular matrix bindingIntegrin beta-3Homo sapiens (human)
fibrinogen bindingIntegrin beta-3Homo sapiens (human)
protein bindingIntegrin alpha-IIbHomo sapiens (human)
identical protein bindingIntegrin alpha-IIbHomo sapiens (human)
metal ion bindingIntegrin alpha-IIbHomo sapiens (human)
extracellular matrix bindingIntegrin alpha-IIbHomo sapiens (human)
molecular adaptor activityIntegrin alpha-IIbHomo sapiens (human)
fibrinogen bindingIntegrin alpha-IIbHomo sapiens (human)
integrin bindingIntegrin alpha-IIbHomo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
receptor-receptor interaction5-hydroxytryptamine receptor 1AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(2) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(2) dopamine receptorHomo sapiens (human)
protein bindingD(2) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(2) dopamine receptorHomo sapiens (human)
dopamine bindingD(2) dopamine receptorHomo sapiens (human)
ionotropic glutamate receptor bindingD(2) dopamine receptorHomo sapiens (human)
identical protein bindingD(2) dopamine receptorHomo sapiens (human)
heterocyclic compound bindingD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(2) dopamine receptorHomo sapiens (human)
protein bindingNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
ligand-gated monoatomic ion channel activityNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
acetylcholine receptor activityNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
acetylcholine-gated monoatomic cation-selective channel activityNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
acetylcholine bindingNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
protein-containing complex bindingNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
quaternary ammonium group bindingNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
heterocyclic compound bindingNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
virus receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein tyrosine kinase activator activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein-containing complex binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein bindingNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
ligand-gated monoatomic ion channel activityNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
acetylcholine receptor activityNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
acetylcholine-gated monoatomic cation-selective channel activityNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
protein bindingNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
ligand-gated monoatomic ion channel activityNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
acetylcholine receptor activityNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
acetylcholine-gated monoatomic cation-selective channel activityNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
acetylcholine bindingNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
G-protein alpha-subunit binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
GTPase activator activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein bindingNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
ligand-gated monoatomic ion channel activityNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
acetylcholine receptor activityNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
acetylcholine-gated monoatomic cation-selective channel activityNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
acetylcholine bindingNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3AHomo sapiens (human)
histamine receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 6Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
transcription cis-regulatory region bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
delayed rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ubiquitin protein ligase bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
identical protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein homodimerization activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
C3HC4-type RING finger domain bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
scaffold protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in ventricular cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 3DHomo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3DHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3DHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3DHomo sapiens (human)
organic cation transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
antiporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
polyspecific organic cation:proton antiporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 3CHomo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3CHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3CHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3CHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
protein bindingMultidrug and toxin extrusion protein 1Homo sapiens (human)
organic cation transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-amino acid transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
thiamine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
antiporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
putrescine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
polyspecific organic cation:proton antiporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
integrin bindingNischarinHomo sapiens (human)
protein bindingNischarinHomo sapiens (human)
phosphatidylinositol bindingNischarinHomo sapiens (human)
identical protein bindingNischarinHomo sapiens (human)
dynein heavy chain bindingNischarinHomo sapiens (human)
alpha-tubulin bindingNischarinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (96)

Processvia Protein(s)Taxonomy
plasma membrane5-hydroxytryptamine receptor 3EHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3EHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3EHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3EHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3EHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3EHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3EHomo sapiens (human)
plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
membraneSolute carrier family 22 member 2Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
extracellular exosomeSolute carrier family 22 member 2Homo sapiens (human)
presynapseSolute carrier family 22 member 2Homo sapiens (human)
plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
membraneSolute carrier family 22 member 1 Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
lateral plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
presynapseSolute carrier family 22 member 1 Homo sapiens (human)
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
nuclear outer membraneSolute carrier family 22 member 3Homo sapiens (human)
plasma membraneSolute carrier family 22 member 3Homo sapiens (human)
endomembrane systemSolute carrier family 22 member 3Homo sapiens (human)
membraneSolute carrier family 22 member 3Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 3Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 3Homo sapiens (human)
mitochondrial membraneSolute carrier family 22 member 3Homo sapiens (human)
neuronal cell bodySolute carrier family 22 member 3Homo sapiens (human)
presynapseSolute carrier family 22 member 3Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3BHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3BHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3BHomo sapiens (human)
cell surface5-hydroxytryptamine receptor 3BHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3BHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3BHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3BHomo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
glutamatergic synapseIntegrin beta-3Homo sapiens (human)
nucleusIntegrin beta-3Homo sapiens (human)
nucleoplasmIntegrin beta-3Homo sapiens (human)
plasma membraneIntegrin beta-3Homo sapiens (human)
cell-cell junctionIntegrin beta-3Homo sapiens (human)
focal adhesionIntegrin beta-3Homo sapiens (human)
external side of plasma membraneIntegrin beta-3Homo sapiens (human)
cell surfaceIntegrin beta-3Homo sapiens (human)
apical plasma membraneIntegrin beta-3Homo sapiens (human)
platelet alpha granule membraneIntegrin beta-3Homo sapiens (human)
lamellipodium membraneIntegrin beta-3Homo sapiens (human)
filopodium membraneIntegrin beta-3Homo sapiens (human)
microvillus membraneIntegrin beta-3Homo sapiens (human)
ruffle membraneIntegrin beta-3Homo sapiens (human)
integrin alphav-beta3 complexIntegrin beta-3Homo sapiens (human)
melanosomeIntegrin beta-3Homo sapiens (human)
synapseIntegrin beta-3Homo sapiens (human)
postsynaptic membraneIntegrin beta-3Homo sapiens (human)
extracellular exosomeIntegrin beta-3Homo sapiens (human)
integrin alphaIIb-beta3 complexIntegrin beta-3Homo sapiens (human)
glycinergic synapseIntegrin beta-3Homo sapiens (human)
integrin complexIntegrin beta-3Homo sapiens (human)
protein-containing complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-PKCalpha complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-IGF-1-IGF1R complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-HMGB1 complexIntegrin beta-3Homo sapiens (human)
receptor complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-vitronectin complexIntegrin beta-3Homo sapiens (human)
alpha9-beta1 integrin-ADAM8 complexIntegrin beta-3Homo sapiens (human)
focal adhesionIntegrin beta-3Homo sapiens (human)
cell surfaceIntegrin beta-3Homo sapiens (human)
synapseIntegrin beta-3Homo sapiens (human)
plasma membraneIntegrin alpha-IIbHomo sapiens (human)
focal adhesionIntegrin alpha-IIbHomo sapiens (human)
cell surfaceIntegrin alpha-IIbHomo sapiens (human)
platelet alpha granule membraneIntegrin alpha-IIbHomo sapiens (human)
extracellular exosomeIntegrin alpha-IIbHomo sapiens (human)
integrin alphaIIb-beta3 complexIntegrin alpha-IIbHomo sapiens (human)
blood microparticleIntegrin alpha-IIbHomo sapiens (human)
integrin complexIntegrin alpha-IIbHomo sapiens (human)
external side of plasma membraneIntegrin alpha-IIbHomo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 1AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1AHomo sapiens (human)
Golgi membraneD(2) dopamine receptorHomo sapiens (human)
acrosomal vesicleD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
ciliumD(2) dopamine receptorHomo sapiens (human)
lateral plasma membraneD(2) dopamine receptorHomo sapiens (human)
endocytic vesicleD(2) dopamine receptorHomo sapiens (human)
axonD(2) dopamine receptorHomo sapiens (human)
dendriteD(2) dopamine receptorHomo sapiens (human)
synaptic vesicle membraneD(2) dopamine receptorHomo sapiens (human)
sperm flagellumD(2) dopamine receptorHomo sapiens (human)
dendritic spineD(2) dopamine receptorHomo sapiens (human)
perikaryonD(2) dopamine receptorHomo sapiens (human)
axon terminusD(2) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(2) dopamine receptorHomo sapiens (human)
ciliary membraneD(2) dopamine receptorHomo sapiens (human)
non-motile ciliumD(2) dopamine receptorHomo sapiens (human)
dopaminergic synapseD(2) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(2) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(2) dopamine receptorHomo sapiens (human)
presynaptic membraneD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
external side of plasma membraneNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
membraneNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
presynaptic membraneNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
plasma membrane raftNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
cholinergic synapseNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
postsynaptic specialization membraneNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
acetylcholine-gated channel complexNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
neuron projectionNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
synapseNeuronal acetylcholine receptor subunit beta-2Homo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
neurofilament5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
caveola5-hydroxytryptamine receptor 2AHomo sapiens (human)
axon5-hydroxytryptamine receptor 2AHomo sapiens (human)
cytoplasmic vesicle5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
neuronal cell body5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendritic shaft5-hydroxytryptamine receptor 2AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
cell body fiber5-hydroxytryptamine receptor 2AHomo sapiens (human)
glutamatergic synapse5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
membraneNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
specific granule membraneNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
postsynaptic membraneNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
tertiary granule membraneNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
cholinergic synapseNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
acetylcholine-gated channel complexNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
neuron projectionNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
synapseNeuronal acetylcholine receptor subunit beta-4Homo sapiens (human)
endoplasmic reticulumNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
Golgi apparatusNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
postsynaptic densityNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
membraneNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
nuclear speckNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
dendriteNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
neuronal cell bodyNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
plasma membrane raftNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
postsynaptic membraneNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
acetylcholine-gated channel complexNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
neuron projectionNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
synapseNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit alpha-3Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
trans-Golgi network membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
synapse5-hydroxytryptamine receptor 7Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 7Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
nucleoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
cytoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2BHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
external side of plasma membraneNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
membraneNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
dendriteNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
neuronal cell bodyNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
postsynaptic membraneNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
acetylcholine-gated channel complexNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
synapseNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
neuron projectionNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
plasma membraneNeuronal acetylcholine receptor subunit alpha-4Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
cleavage furrow5-hydroxytryptamine receptor 3AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3AHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
cilium5-hydroxytryptamine receptor 6Homo sapiens (human)
synapse5-hydroxytryptamine receptor 6Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 6Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
endoplasmic reticulum membraneGlutamate receptor ionotropic, NMDA 2CRattus norvegicus (Norway rat)
plasma membraneGlutamate receptor ionotropic, NMDA 2CRattus norvegicus (Norway rat)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cell surfacePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
perinuclear region of cytoplasmPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3DHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3DHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3DHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3DHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3DHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3DHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3DHomo sapiens (human)
plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
apical plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3CHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3CHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3CHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3CHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3CHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3CHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3CHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
basolateral plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
apical plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
nucleoplasmNischarinHomo sapiens (human)
early endosomeNischarinHomo sapiens (human)
cytosolNischarinHomo sapiens (human)
plasma membraneNischarinHomo sapiens (human)
microtubule cytoskeletonNischarinHomo sapiens (human)
membraneNischarinHomo sapiens (human)
intracellular membrane-bounded organelleNischarinHomo sapiens (human)
intercellular bridgeNischarinHomo sapiens (human)
recycling endosomeNischarinHomo sapiens (human)
cytoplasmNischarinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (372)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID526453Inhibition of human CYP3A42010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Discovery of 2-substituted benzoxazole carboxamides as 5-HT3 receptor antagonists.
AID145994In vitro Binding affinity towards alpha-3 (PC12) nAChR; not done2001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
The 5-HT3 antagonist tropisetron (ICS 205-930) is a potent and selective alpha7 nicotinic receptor partial agonist.
AID3202The binding affinity was measured on 5-hydroxytryptamine 4 receptor using [3H]- GR-113808 as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID60995-hydroxytryptamine 3 receptor antagonistic activity was measured by the inhibition of 5H+ T-induced bradycardia after po administration of 1000 ug/kg dose in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID91719The binding affinity was measured on imidazoline I2 receptor using [3H]- indazoxan as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID61940Mean percentage increase emetic latency in dog after an intravenous administration of 1 mg/kg of drug (when dogs did not vomit, 360 min)1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID47563Inhibition of [3H]nitrendipine binding to L-type calcium channel dihydropyridine site of rat brain1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID152095The binding affinity was measured on substance P as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID72710Compound was evaluated for number of emetic episodes in ferrets administered intravenously at 1.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID5911Binding affinity for 5-hydroxytryptamine 3 receptor from rat cortex using [3H]BRL-43694 as radioligand1995Journal of medicinal chemistry, Jul-07, Volume: 38, Issue:14
Novel, potent, and selective 5-HT3 receptor antagonists based on the arylpiperazine skeleton: synthesis, structure, biological activity, and comparative molecular field analysis studies.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID568196Antagonist activity at 5-HT3 receptor in guinea pig ileum muscle2011Bioorganic & medicinal chemistry letters, Feb-15, Volume: 21, Issue:4
Discovery of new anti-depressants from structurally novel 5-HT3 receptor antagonists: design, synthesis and pharmacological evaluation of 3-ethoxyquinoxalin-2-carboxamides.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID568202Antipsychotic activity in Swiss Albino mouse assessed as spontaneous locomotor score at 2 mg/kg, ip measured for 10 mins by actophotometer2011Bioorganic & medicinal chemistry letters, Feb-15, Volume: 21, Issue:4
Discovery of new anti-depressants from structurally novel 5-HT3 receptor antagonists: design, synthesis and pharmacological evaluation of 3-ethoxyquinoxalin-2-carboxamides.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID79380The compound was evaluated for the pA2 value that was estimated using 2-methyl-5-HT in five to seven different tissues in guinea pig ileum1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis of 2-piperazinylbenzothiazole and 2-piperazinylbenzoxazole derivatives with 5-HT3 antagonist and 5-HT4 agonist properties.
AID183121Inhibitory dose causing inhibition of restraint stress induced defecation by oral administration1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.
AID692195Inhibition of human MATE1 expressed in HEK-293-Flp-In cells incubated for 3 mins by ASP+ substrate uptake assay2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID712501Antagonist activity at human 5HT3A receptor expressed in xenopus oocytes assessed as inhibition of 5HT-induced effect by electrophysiological method2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder.
AID386625Inhibition of 4-(4-(dimethylamino)styryl)-N-methylpyridinium uptake at human OCT1 expressed in HEK293 cells by confocal microscopy2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Structural requirements for drug inhibition of the liver specific human organic cation transport protein 1.
AID72053Antiemetic potency against cisplatin-induced emetic latency period in ferret after intravenous administration1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 2. Two novel tricyclic benzamides.
AID692193Inhibition of human OCT2 A270S mutant expressed in HEK-293-Flp-In cells incubated for 3 mins by ASP+ substrate uptake assay2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID192537Percent inhibition of serotonin-induced B-J reflex (Bezold-Jarisch reflex)in the right femoral vein of rat at a dose of 20 ug/kg1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Aromatic thiazole derivatives: structurally novel and selective serotonin-3 receptor antagonists.
AID60119Inhibition of emesis induced by intravenous administration of cisplatin in 6 dogs at 0.1 mg/kg (p<0.01)1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID72058Antiemetic activity (oral administration) against cisplatin-induced emesis in ferret, as the dose required to reduce emetic episodes to 50% of control value1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 1. Initial structure-activity relationship of novel benzamides.
AID5908The binding affinity was measured on 5-hydroxytryptamine 3 receptor using [3H]GR-65630 as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID692188Therapeutic index, ratio of Cmax in human to IC50 for human OCT22011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID526456Bioavailability in rat at 10 mg/kg, po or 1 mg/kg, iv2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Discovery of 2-substituted benzoxazole carboxamides as 5-HT3 receptor antagonists.
AID72843Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in ferrets administered perorally at 1.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID60124Inhibition of emesis induced by peroral administration of cisplatin in 6 dogs at 0.01 mg/kg1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID183120Inhibitory dose causing inhibition of increase in thyrotropin-releasing hormone (TRH) induced defecation by sc administration at 1 mg/kg1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID243151Inhibitory concentration against potassium channel HERG2005Bioorganic & medicinal chemistry letters, Jun-02, Volume: 15, Issue:11
A discriminant model constructed by the support vector machine method for HERG potassium channel inhibitors.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID5902Displacement of [3H]GR-65630 binding to 5-hydroxytryptamine 3 receptor in rat brain cortical membranes1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID712520Inhibition of SERT-mediated [3H]5HT uptake in rat synaptosomes by scintillation counting2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder.
AID40505Displacement of [3H]- Diazepam from rat GABA-A benzodiazepine receptor1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID219805The binding affinity was measured on alpha-2-adrenergic receptor using [3H]- clonidine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID692184Therapeutic index, ratio of Cmax in human to IC50 for human MATE2-K2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID6284Binding affinity to 5-hydroxytryptamine 3 receptor using [3H]GR-65630 as radioligand in rat cortex1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Conformation-activity relationship study of 5-HT3 receptor antagonists and a definition of a model for this receptor site.
AID65903The binding affinity was measured on dopamine receptor D2 using [3H]- spiperone as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID221936The binding affinity was measured on glycine strych. ins receptor using [3H]- 5,7-diClkyn.acid as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID526462Cardioprotective effect in po dosed mouse assessed as inhibition of 5-HT-induced bradycardia administered 1 hr prior to 5-HT challenge2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Discovery of 2-substituted benzoxazole carboxamides as 5-HT3 receptor antagonists.
AID721746Inhibition of human MATE1-mediated [14]-metformin uptake expressed in polarized MDCK2 cells after 5 mins by liquid scintillation counting analysis2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID1784822Antipsychotic activity in Sprague-Dawley rat assessed as inhibition of PCP-induced hyperactivity at 0.5 mg/kg, po measured after 2 hrs
AID146148Antagonism of ACh-evoked responses at human Nicotinic acetylcholine receptor alpha3-beta4 expressed in xenopus oocytes2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID146008Antagonism of ACh response at Nicotinic acetylcholine receptor alpha-3-beta-2-alpha-5 receptor expressed in xenopus oocytes up to 1 mM2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID692189Therapeutic index, ratio of Cmax in human to IC50 for human OCT2 A270S mutant2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID224719The binding affinity was measured on mu-opiate receptor using [3H]- naloxone as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID5968In vitro binding affinity was measured for 5-hydroxytryptamine 3 receptor in the guinea pig ileum.1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID4876The binding affinity was measured on 5-hydroxytryptamine 1D receptor using [3H]- serotonin as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID229206The binding affinity was measured on sigma receptor using [3H]- (+)-3-PPP as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID72832Compound was evaluated for number of emetic episodes in ferrets administered intravenously at 0.1 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID61938Mean percentage increase emetic latency in dog after an intravenous administration of 0.1 mg/kg of drug1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID1443980Inhibition of human BSEP expressed in fall armyworm sf9 cell plasma membrane vesicles assessed as reduction in vesicle-associated [3H]-taurocholate transport preincubated for 10 mins prior to ATP addition measured after 15 mins in presence of [3H]-tauroch2010Toxicological sciences : an official journal of the Society of Toxicology, Dec, Volume: 118, Issue:2
Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development.
AID79521Single-point analysis using 5(10e-9) M concentration of the antagonist (pA2= -log([B]/concentration ratio-1); [B] =concentration of the antagonist).1999Journal of medicinal chemistry, Dec-02, Volume: 42, Issue:24
Benzimidazole derivatives. 2. Synthesis and structure-activity relationships of new azabicyclic benzimidazole-4-carboxylic acid derivatives with affinity for serotoninergic 5-HT(3) receptors.
AID50508The binding affinity was measured on cholecystokinin type A receptor using [3H]- CCK-8 as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID5976Concentration required to produce 50% of maximal contraction induced by 5-HT through 5-HT3 receptors in the presence of the compound, in isolated guinea pig ileum.1999Journal of medicinal chemistry, Dec-02, Volume: 42, Issue:24
Benzimidazole derivatives. 2. Synthesis and structure-activity relationships of new azabicyclic benzimidazole-4-carboxylic acid derivatives with affinity for serotoninergic 5-HT(3) receptors.
AID61325Binding affinity against dopamine D2 receptor in rat brain synaptic membrane using [3H]-spiperone as radioligand1998Bioorganic & medicinal chemistry letters, Mar-17, Volume: 8, Issue:6
A novel series of N-(hexahydro-1,4-diazepin-6-yl) and N-(hexahydroazepin- 3-yl)benzamides with high affinity for 5-HT3 and dopamine D2 receptors.
AID5891Compound was evaluated for its binding affinity for 5-hydroxytryptamine 3 receptor by measuring displacement [3H]GR-65630 in rat cerebral cortex1998Journal of medicinal chemistry, Jan-29, Volume: 41, Issue:3
5-HT3 antagonists derived from aminopyridazine-type muscarinic M1 agonists.
AID679120TP_TRANSPORTER: transepithelial transport (basal to apical) in mdr1a-expressing LLC-PK1 cell1996The Journal of clinical investigation, Jun-01, Volume: 97, Issue:11
P-glycoprotein in the blood-brain barrier of mice influences the brain penetration and pharmacological activity of many drugs.
AID183599Tested in vivo for antagonistic activity to bradycardic effect of 5-HT in anesthetized rats1993Journal of medicinal chemistry, Sep-17, Volume: 36, Issue:19
Novel antagonists of 5-HT3 receptors. Synthesis and biological evaluation of piperazinylquinoxaline derivatives.
AID143098The binding affinity was measured on NMDA receptor using [3H]- CGS-19755 as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID5932Compound was tested for the inhibition of 5-HT-induced bradycardia after peroral administration of 1 mg/kg at 1 hour in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID692196Inhibition of human MATE2-K expressed in HEK-293-Flp-In cells incubated for 3 mins by ASP+ substrate uptake assay2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID183118Inhibitory dose causing inhibition of increase in 5-HT induced defecation by sc administration at 1 to 10 mg/kg1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1784762Antagonist activity at human 5-HT6 receptor expressed in 1321N1 cells assessed as inhibition of 5-CT induced cAMP production incubated for 30 mins relative to control
AID552110Partial agonist activity at human 5HT3A receptor expressed in HEK293 cells at 3 uM relative to 5HT2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Novel serotonin type 3 receptor partial agonists for the potential treatment of irritable bowel syndrome.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID60121Inhibition of emesis induced by intravenous administration of cisplatin in 6 dogs at 1 mg/kg (p<0.01)1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID5304The binding affinity was measured on 5-hydroxytryptamine 2 receptor using [3H]- spiperone as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID526728Antidepressant-like activity in mouse assessed as immobility time at 2 mg/kg, ip by forced swimming test2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Design, synthesis and structure-activity relationship of novel quinoxalin-2-carboxamides as 5-HT3 receptor antagonists for the management of depression.
AID72139Displacement of [3H]DH-muscimol from rat GABA-A receptor1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID128846Acute lethal toxicity in mouse at 8.4 mg/kg when administered intravenously; value = 5/101992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID51469The binding affinity was measured on cholecystokinin type B receptor using [3H]- CCK-8 as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID71989Non-competitive antagonist activity against Gamma-aminobutyric acid A (GABA-A) receptor2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
GABA-Activated ligand gated ion channels: medicinal chemistry and molecular biology.
AID72833Compound was evaluated for number of emetic episodes in ferrets administered intravenously at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID62973Mean percentage reduction due to cisplatin-induced emetic episodes in dog after an intravenous administration of 1 mg/kg of drug1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID721749Inhibition of human OCT3-mediated ASP+ uptake expressed in HEK293 cells after 3 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID5929Compound was tested for the inhibition of 5-HT-induced bradycardia after peroral administration of 1 mg/kg at 3 hours in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID29359Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID62855Mean percentage reduction due to cisplatin-induced emetic episodes in dog after an intravenous administration of 0.3 mg/kg of drug1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID146925Inhibition of the response to ACh when coapplied with Nicotinic acetylcholine receptor alpha72004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID721752Inhibition of human MATE2K-mediated ASP+ uptake expressed in HEK293 cells after 1.5 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID60120Inhibition of emesis induced by intravenous administration of cisplatin in 6 dogs at 0.3 mg/kg (p<0.01)1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID721743Ratio of Cmax unbound to IC50 for human MATE1-mediated [14]-metformin uptake expressed in HEK293 cells2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID62534Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in dogs administered intravenously at 0.03 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID1129361Unbound fraction in HEK293 cell homogenate at 0.1 uM by equilibrium dialysis based UPLC-MS/MS analysis2014Journal of medicinal chemistry, Apr-10, Volume: 57, Issue:7
A high-throughput cell-based method to predict the unbound drug fraction in the brain.
AID62426Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in dogs administered perorally at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID89720The binding affinity was measured on histamine H3 receptor using [3H]- N-Me-histam as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID78016Blockade of isolated longitudinal muscle myenteric plexus contraction from guinea-pig ileum2003Bioorganic & medicinal chemistry letters, Oct-06, Volume: 13, Issue:19
Design and synthesis of new benzimidazole-arylpiperazine derivatives acting as mixed 5-HT1A/5-HT3 ligands.
AID526730Toxicity in mouse assessed as induction of spontaneous locomotor activity at 0.5 mg/kg, ip after 10 mins by actophotometry2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Design, synthesis and structure-activity relationship of novel quinoxalin-2-carboxamides as 5-HT3 receptor antagonists for the management of depression.
AID5886Displacement of the 5-hydroxytryptamine 3 receptor ligand [3H]GR-65630 from rat brain cortical membranes.1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 1. Initial structure-activity relationship of novel benzamides.
AID568197Antidepressant activity in mouse assessed as immobility time at 1 mg/kg, ip by forced swimming test2011Bioorganic & medicinal chemistry letters, Feb-15, Volume: 21, Issue:4
Discovery of new anti-depressants from structurally novel 5-HT3 receptor antagonists: design, synthesis and pharmacological evaluation of 3-ethoxyquinoxalin-2-carboxamides.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID576612Inhibition of human ERG2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Predicting hERG activities of compounds from their 3D structures: development and evaluation of a global descriptors based QSAR model.
AID6298pKi value for inhibition of [3H]LY-278584 binding to 5-hydroxytryptamine 3 receptor1990Journal of medicinal chemistry, Dec, Volume: 33, Issue:12
Synthesis and biochemical evaluation of tritium-labeled 1-methyl-N-(8-methyl-8-azabicyclo[3.2.1]oct-3-yl)-1H-indazole-3-carboxa mide, a useful radioligand for 5HT3 receptors.
AID72708Compound was evaluated for number of emetic episodes in ferrets administered intravenously at 0.1 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID72839Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in ferrets administered perorally at 0.1 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID72059Antiemetic potency against cisplatin-induced emetic episodes in ferret after intravenous administration1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 2. Two novel tricyclic benzamides.
AID146146Responses to that evoked by Nicotinic acetylcholine receptor alpha3-beta4 expressed in xenopus oocytes up to 1 mM2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID228446The binding affinity was measured on tryptamine receptor using [3H]- tryptamine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID6136Binding affinity against radioligand [3H]quipazine labeled 5-hydroxytryptamine 3 receptor sites in neuroblastoma-glioma (NG108-15) cells.1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID6424The binding affinity was measured on 5-hydroxytryptamine receptor uptake receptor using [3H]- paroxetine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID60115Inhibition of emesis induced by intravenous administration of cisplatin in 6 dogs at 0.01 mg/kg1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID373867Hepatic clearance in human hepatocytes in absence of fetal calf serum2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
First-principle, structure-based prediction of hepatic metabolic clearance values in human.
AID5963Antagonistic potency against serotonin 5-hydroxytryptamine 3 receptor in GPI assay1997Journal of medicinal chemistry, Oct-10, Volume: 40, Issue:21
Phenylimidazolidin-2-one derivatives as selective 5-HT3 receptor antagonists and refinement of the pharmacophore model for 5-HT3 receptor binding.
AID526731Toxicity in mouse assessed as induction of spontaneous locomotor activity at 2 mg/kg, ip after 10 mins by actophotometry2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Design, synthesis and structure-activity relationship of novel quinoxalin-2-carboxamides as 5-HT3 receptor antagonists for the management of depression.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID221171The binding affinity was measured on leukotriene-D4 receptor using [3H]- LTD4 as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID526455Inhibition of human ERG expressed in HEK cells by patch clamp technique2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Discovery of 2-substituted benzoxazole carboxamides as 5-HT3 receptor antagonists.
AID146640In vitro Binding affinity towards Nicotinic acetylcholine receptor alpha4-beta2 was determined2001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
The 5-HT3 antagonist tropisetron (ICS 205-930) is a potent and selective alpha7 nicotinic receptor partial agonist.
AID72060Antiemetic potency was tested against cisplatin-induced emetic episodes in ferret after oral administration1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 2. Two novel tricyclic benzamides.
AID5980Binding affinity towards [3H]quipazine labeled 5-hydroxytryptamine 3 receptor sites in HG108-151993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.
AID5896In vitro affinity for 5-hydroxytryptamine 3 (5-HT3) receptor by displacement of [3H]BRL-43694 from rat entorhinal cortex1997Journal of medicinal chemistry, Oct-10, Volume: 40, Issue:21
Phenylimidazolidin-2-one derivatives as selective 5-HT3 receptor antagonists and refinement of the pharmacophore model for 5-HT3 receptor binding.
AID106806Inhibition of malate dehydrogenase (MDH) at 400 uM2003Journal of medicinal chemistry, Oct-09, Volume: 46, Issue:21
Identification and prediction of promiscuous aggregating inhibitors among known drugs.
AID221935The binding affinity was measured on glycine receptor using [3H]- strychnine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID6123Serotonin receptor antagonist activity was measured as ability to block the serotonin-induced Bezold-Jarisch reflex in rats after iv administration of 2 ug/Kg1990Journal of medicinal chemistry, Oct, Volume: 33, Issue:10
Thiazole as a carbonyl bioisostere. A novel class of highly potent and selective 5-HT3 receptor antagonists.
AID79370The compound was evaluated for the percentage inhibition in guinea pig ileum stimulated with 10 uM 5-HT and tested at fixed concentration of 10 uM1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis of 2-piperazinylbenzothiazole and 2-piperazinylbenzoxazole derivatives with 5-HT3 antagonist and 5-HT4 agonist properties.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID592681Apparent permeability across human Caco2 cell membrane after 2 hrs by LC-MS/MS analysis2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
QSAR-based permeability model for drug-like compounds.
AID64277Inhibition of the binding of radioligand [3H]spiperone to dopamine receptor D2 in rat brain synaptic membrane2003Journal of medicinal chemistry, Feb-27, Volume: 46, Issue:5
Synthesis and structure-affinity relationships of novel N-(1-ethyl-4-methylhexahydro-1,4-diazepin-6-yl)pyridine-3-carboxamides with potent serotonin 5-HT3 and dopamine D2 receptor antagonistic activity.
AID145998Responses to that evoked by Nicotinic acetylcholine receptor alpha3-beta2 expressed in xenopus oocytes up to 1 mM2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID6011Binding affinity towards 5-hydroxytryptamine 3 receptor was determined by using [3H]-ICS 205-930 as radioligand in mouse N1E 115 cells1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Conformation-activity relationship study of 5-HT3 receptor antagonists and a definition of a model for this receptor site.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID178008Effective dose causing reduction of serotonin effect at 5 min administered iv in Bezold-Jarisch reflex test1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.
AID6066Concentration required to inhibit the binding of radioligand [3H]GR-65630 to serotonin 5-hydroxytryptamine-3 receptor (5-HT 3 receptor)in rat brain cortical membrane2003Journal of medicinal chemistry, Feb-27, Volume: 46, Issue:5
Synthesis and structure-affinity relationships of novel N-(1-ethyl-4-methylhexahydro-1,4-diazepin-6-yl)pyridine-3-carboxamides with potent serotonin 5-HT3 and dopamine D2 receptor antagonistic activity.
AID5890Compound was evaluated for its ability to displace [3H]quipazine binding to 5-hydroxytryptamine 3 receptor sites in NG 108-15. 1992Journal of medicinal chemistry, Dec-25, Volume: 35, Issue:26
5-HT3 receptor antagonists. 1. New quinoline derivatives.
AID177426Compound was evaluated for the inhibition of 5-HT induced bradycardia [Bezold-Jarisch (BJ) reflex test] in rats at 5 min1992Journal of medicinal chemistry, Dec-25, Volume: 35, Issue:26
5-HT3 receptor antagonists. 1. New quinoline derivatives.
AID62413Compound was evaluated for protection against cisplatin-induced emesis by measuring number of emetic episodes in dogs administered intravenously at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID6297The compound was tested for the binding affinity against 5-hydroxytryptamine 3 receptor using [3H]zacopride as radioligand.1999Journal of medicinal chemistry, Oct-21, Volume: 42, Issue:21
Pyrroloquinoxaline derivatives as high-affinity and selective 5-HT(3) receptor agonists: synthesis, further structure-activity relationships, and biological studies.
AID146306Responses to that evoked by ACh at human Nicotinic acetylcholine receptor alpha4-beta2 expressed in xenopus oocytes up to 1 mM2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID87533The binding affinity was measured on histamine H1 receptor using [3H]- mepyramine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID72573Compound was evaluated for number of emetic episodes in ferrets administered perorally at 1.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID61939Mean percentage increase emetic latency in dog after an intravenous administration of 0.3 mg/kg of drug1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID6027Potency at neuronal 5-hydroxytryptamine 3 receptor in the rabbit heart1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Conformation-activity relationship study of 5-HT3 receptor antagonists and a definition of a model for this receptor site.
AID60126Inhibition of emesis induced by peroral administration of cisplatin in 6 dogs at 0.03 mg/kg1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID22293Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID5977Tested for the antagonistic activity against 5-hydroxytryptamine 3 receptor from guinea pig ileum1993Journal of medicinal chemistry, Sep-17, Volume: 36, Issue:19
Novel antagonists of 5-HT3 receptors. Synthesis and biological evaluation of piperazinylquinoxaline derivatives.
AID721751Inhibition of human OCT2-mediated ASP+ uptake expressed in HEK293 cells after 3 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID1784818Sedative activity in Sprague-Dawley rat assessed as effect on spontaneous locomotor activity at 0.5 mg/kg, po
AID1889694Competitive binding affinity towards 5-HT3 receptor (unknown origin)2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID146922Activation responses to that evoked by ACh at human Nicotinic acetylcholine receptor alpha-7 expressed in xenopus oocytes at 100 uM2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID526726Antidepressant-like activity in mouse assessed as immobility time at 1 mg/kg, ip by forced swimming test2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Design, synthesis and structure-activity relationship of novel quinoxalin-2-carboxamides as 5-HT3 receptor antagonists for the management of depression.
AID6278Compound was evaluated for the displacement of [3H]-Q-ICS 205-930 binding to 5-hydroxytryptamine 3 recognition sites in rat brain membranes1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Novel 5-HT3 antagonists. Indole oxadiazoles.
AID183110Inhibition of wrap-restraint stress-induced colonic propulsion measured by the time required to expel a teflon ball inserted 3 cm into the rat colon1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.
AID62416Compound was evaluated for protection against cisplatin-induced emesis by measuring number of emetic episodes in dogs administered perorally at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID60242Inhibition of emesis induced by peroral administration of cisplatin in 6 dogs at 0.3 mg/kg (p<0.01)1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID721754Inhibition of human MATE1-mediated ASP+ uptake expressed in HEK293 cells after 1.5 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID72376Inhibition of emesis induced by peroral administration of cisplatin in 5 ferrets at 0.1 mg/kg (p<0.01)1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID1889689Displacement of [3H]-ketanserin from human 5-HT2A receptor expressed in CHO-K1 cells measured after 1.5 hrs by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID6063Binding affinity against 5-hydroxytryptamine 3 receptor in rat cortical membrane using [3H]GR-65630 as radioligand1998Bioorganic & medicinal chemistry letters, Mar-17, Volume: 8, Issue:6
A novel series of N-(hexahydro-1,4-diazepin-6-yl) and N-(hexahydroazepin- 3-yl)benzamides with high affinity for 5-HT3 and dopamine D2 receptors.
AID72841Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in ferrets administered perorally at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID6364Binding affinity towards 5-hydroxytryptamine 3 receptor by displacement of [3H]2 in Neuroblastoma-Glioma NG-108-15 cells1990Journal of medicinal chemistry, Oct, Volume: 33, Issue:10
Thiazole as a carbonyl bioisostere. A novel class of highly potent and selective 5-HT3 receptor antagonists.
AID712498Antagonist activity at rat 5HT3A receptor expressed in xenopus oocytes assessed as inhibition of 5HT-induced effect by electrophysiological method2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder.
AID61015-hydroxytryptamine 3 receptor antagonistic activity was measured by the inhibition of 5H+ T-induced bradycardia after po administration of 300 ug/kg dose in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID60243Inhibition of emesis induced by peroral administration of cisplatin in 6 dogs at 1.0 mg/kg (p<0.01)1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID6054Compound was tested for the inhibition of 5-HT-induced bradycardia after peroral administration of 1000 ug/kg dose in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID72373Inhibition of emesis induced by peroral administration of cisplatin in 5 ferrets at 0.03 mg/kg1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID183147Potency to inhibit bradycardiac effect measured by Von Bezold-Jarisch assay in 9 anesthetized rats1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID1784759Antagonist activity at 5-HT3 receptor in guinea-pig ileum assessed as inhibition of 5HT-induced contraction incubated for 15 mins
AID43581Inhibition of beta-lactamase at 100 uM2003Journal of medicinal chemistry, Oct-09, Volume: 46, Issue:21
Identification and prediction of promiscuous aggregating inhibitors among known drugs.
AID5928Compound was tested for the inhibition of 5-HT-induced bradycardia after peroral administration of 1 mg/kg at 0.5 hours in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID552297Partial agonist activity at human 5HT3A receptor expressed in HEK293 cells assessed as decrease in 100 uM 5-chloroindole-induced increase in intracellular calcium release at 3 uM relative to 5-HT2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Novel serotonin type 3 receptor partial agonists for the potential treatment of irritable bowel syndrome.
AID7229In vitro antagonism of the 5-HT-3 receptor determined by inhibition of 5-HT-induced depolarization of the isolated rat vagus nerve.1992Journal of medicinal chemistry, May-01, Volume: 35, Issue:9
Novel antagonists of the 5-HT3 receptor. Synthesis and structure-activity relationships of (2-alkoxybenzoyl)ureas.
AID62411Compound was evaluated for protection against cisplatin-induced emesis by measuring number of emetic episodes in dogs administered intravenously at 0.1 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID6126Tested for inhibition of Bezold-Jarisch (B-J) reflex mediated by 5-hydroxytryptamine 3 receptor in rats after intravenous administration (2.0 ug/kg)1990Journal of medicinal chemistry, Oct, Volume: 33, Issue:10
An initial three-component pharmacophore for specific serotonin-3 receptor ligands.
AID408340Inhibition of human ERG expressed in CHO cells by whole cell patch clamp technique2008Bioorganic & medicinal chemistry, Jun-01, Volume: 16, Issue:11
Support vector machines classification of hERG liabilities based on atom types.
AID62420No. of emetic episodes in dogs when administered perorally at 3.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID5884Compound was evaluated for its in vitro affinity at serotonergic 5-hydroxytryptamine 3 receptor by radioligand binding assay, using [3H]-LY 278584 in rat cerebral cortex membranes.1999Journal of medicinal chemistry, Dec-02, Volume: 42, Issue:24
Benzimidazole derivatives. 2. Synthesis and structure-activity relationships of new azabicyclic benzimidazole-4-carboxylic acid derivatives with affinity for serotoninergic 5-HT(3) receptors.
AID72057Antiemetic activity (oral administration) against cisplatin-induced emesis in ferret, as the dose required to increase latency to first emetic bout by 50%1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 1. Initial structure-activity relationship of novel benzamides.
AID61005-hydroxytryptamine 3 receptor antagonistic activity was measured by the inhibition of 5H+ T-induced bradycardia after po administration of 30 ug/kg dose in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID721750Inhibition of human OCT1-mediated ASP+ uptake expressed in HEK293 cells after 3 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID210172The binding affinity was measured on TRH receptor using [3H]- MeTRH as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID191058Percent response to 100 ug/kg serotonin was determined as blockade of serotonin-induced bradycardia in anesthetized rat1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Aromatic thiazole derivatives: structurally novel and selective serotonin-3 receptor antagonists.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID62427Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in dogs administered perorally at 1.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID184262The compound was evaluated for the percentage increase in gastric emptying for a dose of 1 mg/kg perorally in rat1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis of 2-piperazinylbenzothiazole and 2-piperazinylbenzoxazole derivatives with 5-HT3 antagonist and 5-HT4 agonist properties.
AID692186Therapeutic index, ratio of Cmax in human to IC50 for human OCT12011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID65752The binding affinity was measured on dopamine receptor D3 using [3H]- dopamine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID568201Antipsychotic activity in Swiss Albino mouse assessed as spontaneous locomotor score at 0.5 mg/kg, ip measured for 10 mins by actophotometer2011Bioorganic & medicinal chemistry letters, Feb-15, Volume: 21, Issue:4
Discovery of new anti-depressants from structurally novel 5-HT3 receptor antagonists: design, synthesis and pharmacological evaluation of 3-ethoxyquinoxalin-2-carboxamides.
AID197155The pA2 is the negative logarithm of the molar concentration of an antagonist which necessitates the doubling of the agonist dose to couteract the effect of that antagonist and restore the original response was measured in guinea pig isolated ileu m test.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID3693Displacement of binding of [3H]5-HT to 5-hydroxytryptamine 1 receptor in rat cerebral cortex1993Journal of medicinal chemistry, Sep-17, Volume: 36, Issue:19
Novel antagonists of 5-HT3 receptors. Synthesis and biological evaluation of piperazinylquinoxaline derivatives.
AID62536Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in dogs administered intravenously at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID62429Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in dogs administered perorally at 3.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID192536Percent inhibition of serotonin-induced B-J reflex (Bezold-Jarisch reflex)in the right femoral vein of rat at a dose of 2 ug/kg1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Aromatic thiazole derivatives: structurally novel and selective serotonin-3 receptor antagonists.
AID6026Binding affinity to 5-hydroxytryptamine 3 receptor of neuronal in the afferent rabbit vagus1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Conformation-activity relationship study of 5-HT3 receptor antagonists and a definition of a model for this receptor site.
AID5964Binding affinity to 5-hydroxytryptamine 3 receptor entirely in guinea pig ileum1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Conformation-activity relationship study of 5-HT3 receptor antagonists and a definition of a model for this receptor site.
AID773790Displacement of [3H]LY 278584 from 5-HT3 receptor in Sprague-Dawley rat cerebral cortex after 30 mins2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
New serotonin 5-HT1A receptor agonists endowed with antinociceptive activity in vivo.
AID183155Antagonist activity (100 mg/Kg) for the Bezold Jarisch reflex evoked by 30(mg/Kg) of 5-HT in ethylurethane anesthetized rats (i.v.)1997Journal of medicinal chemistry, Oct-10, Volume: 40, Issue:21
Phenylimidazolidin-2-one derivatives as selective 5-HT3 receptor antagonists and refinement of the pharmacophore model for 5-HT3 receptor binding.
AID5899Inhibitory activity against 5-hydroxytryptamine 3 receptor in rat cortical membranes using [3H]-1-Methyl-1H-indazole-3-carboxylic acid (8-methyl-8-aza-bicyclo[3.2.1]oct-3-yl)-amide as a radioligand1990Journal of medicinal chemistry, Dec, Volume: 33, Issue:12
Synthesis and biochemical evaluation of tritium-labeled 1-methyl-N-(8-methyl-8-azabicyclo[3.2.1]oct-3-yl)-1H-indazole-3-carboxa mide, a useful radioligand for 5HT3 receptors.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID692183Protein binding in human plasma2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID146872The binding affinity was measured on Na+2(BTX)brain receptor using [3H]- batrachotox as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID6080Binding affinity against 5-hydroxytryptamine 3 (5-HT3) receptor from rat cortical homogenate using [3H]zacopride as radioligand1999Journal of medicinal chemistry, Oct-21, Volume: 42, Issue:21
Pyrroloquinoxaline derivatives as high-affinity and selective 5-HT(3) receptor agonists: synthesis, further structure-activity relationships, and biological studies.
AID60985-hydroxytryptamine 3 receptor antagonistic activity was measured by the inhibition of 5H+ T-induced bradycardia after po administration of 100 ug/kg dose in urethane-anesthetized rats1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID692185Cmax in human2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID62409Compound was evaluated for protection against cisplatin-induced emesis by measuring number of emetic episodes in dogs administered intravenously at 0.03 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID526454Intrinsic clearance in human liver microsomes2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Discovery of 2-substituted benzoxazole carboxamides as 5-HT3 receptor antagonists.
AID62854Mean percentage reduction due to cisplatin-induced emetic episodes in dog after an intravenous administration of 0.1 mg/kg of drug1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID61649The binding affinity was measured on dopamine receptor D1 using [3H]- dopamine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID146789In vitro Binding affinity towards alpha-7 nAChR was determined2001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
The 5-HT3 antagonist tropisetron (ICS 205-930) is a potent and selective alpha7 nicotinic receptor partial agonist.
AID721748Inhibition of human MATE2K-mediated ASP+ uptake expressed in HEK293 cells up to 500 uM after 1.5 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID60117Inhibition of emesis induced by intravenous administration of cisplatin in 6 dogs at 0.03 mg/kg1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID6041In vitro displacement of [3H]ICS-205-930 from 5-hydroxytryptamine 3 receptor in cultured NG-108-15 rat glioma cells1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Aromatic thiazole derivatives: structurally novel and selective serotonin-3 receptor antagonists.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID220521The binding affinity was measured on delta-opiate receptor using [3H]- dadle as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID62535Compound was evaluated for protection against cisplatin-induced emesis by measuring number of retches in dogs administered intravenously at 0.1 mg/kg.1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID47564Inhibition of [3H]D-888 binding to L-type calcium channel verapamil site of rat brain1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID526727Antidepressant-like activity in mouse assessed as immobility time at 0.5 mg/kg, ip by forced swimming test2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Design, synthesis and structure-activity relationship of novel quinoxalin-2-carboxamides as 5-HT3 receptor antagonists for the management of depression.
AID5909The compound was evaluated for the binding affinity towards 5-hydroxytryptamine 3 receptor by displacement of radioligand [3H]GR-656301992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 2. Two novel tricyclic benzamides.
AID721745Ratio of Cmax unbound to IC50 for human MATE1-mediated ASP+ uptake expressed in HEK293 cells2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID4703The binding affinity was measured on 5-hydroxytryptamine 1B receptor using [3H]- serotonin as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID526725Antagonist activity at 5HT3 receptor in guinea pig ileum longitudinal muscle myenteric plexus assessed as inhibition of 2-methyl-5-HT-induced contraction2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Design, synthesis and structure-activity relationship of novel quinoxalin-2-carboxamides as 5-HT3 receptor antagonists for the management of depression.
AID225225The binding affinity was measured on muscarine M2 receptor using [3H]- N-Me-SCOPOL as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID184452Acute lethal toxicity for rat after intravenous administration1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID218722The binding affinity was measured on beta-1,2-adrenergic receptor using [3H]- DHA as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID26304Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID29811Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID721747Inhibition of human MATE1-mediated [14]-metformin uptake expressed in HEK293 cells after 1.5 mins by scintillation counting analysis2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID62419Compound was evaluated for protection against cisplatin-induced emesis by measuring number of emetic episodes in dogs administered perorally at 1.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID59353Percent inhibition of apomorphine (0.3 mg/kg) induced emesis in dogs when 1 mg/kg of compound administered perorally2003Journal of medicinal chemistry, Feb-27, Volume: 46, Issue:5
Synthesis and structure-affinity relationships of novel N-(1-ethyl-4-methylhexahydro-1,4-diazepin-6-yl)pyridine-3-carboxamides with potent serotonin 5-HT3 and dopamine D2 receptor antagonistic activity.
AID699539Inhibition of human liver OATP1B1 expressed in HEK293 Flp-In cells assessed as reduction in E17-betaG uptake at 20 uM by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID4767The binding affinity was measured on 5-hydroxytryptamine 1C receptor using [3H]- serotonin as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID6008The binding affinity was measured for 5-hydroxytryptamine 3 receptor on NG 108-15 cell line of mouse neuroblastoma-glioma cells in presence of [3H]5 radioligand (in vitro)1990Journal of medicinal chemistry, Nov, Volume: 33, Issue:11
Synthesis, in vitro binding profile, and central nervous system penetrability of the highly potent 5-HT3 receptor antagonist [3H]-4-(2-methoxyphenyl)-2-[4(5)-methyl-5(4)-imidazolylmethyl]thiazole.
AID72377Inhibition of emesis induced by peroral administration of cisplatin in 5 ferrets at 0.3 mg/kg (p<0.01)1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID173594Dose of antagonist which inhibits the by the 2-Me-5-HT induced slowing of the heart rate by 10 beats/5 s.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID4352The binding affinity was measured on 5-hydroxytryptamine 1A receptor using [3H]- 8-OH-DPAT as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID568198Antidepressant activity in Swiss Albino mouse assessed as immobility time at 0.5 mg/kg, ip by forced swimming test (Rvb = 165.6 +/- 03.2 sec)2011Bioorganic & medicinal chemistry letters, Feb-15, Volume: 21, Issue:4
Discovery of new anti-depressants from structurally novel 5-HT3 receptor antagonists: design, synthesis and pharmacological evaluation of 3-ethoxyquinoxalin-2-carboxamides.
AID225226The binding affinity was measured on muscarine M3 receptor using [3H]- N-Me-SCOPOL as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID4846Tested for antagonistic activity against 5-hydroxytryptamine 2 receptor from rat thoracic aorta1993Journal of medicinal chemistry, Sep-17, Volume: 36, Issue:19
Novel antagonists of 5-HT3 receptors. Synthesis and biological evaluation of piperazinylquinoxaline derivatives.
AID5895Displacement of binding of [3H]-BRL 43694 to 5-hydroxytryptamine 3 receptor in rat cerebral cortex1993Journal of medicinal chemistry, Sep-17, Volume: 36, Issue:19
Novel antagonists of 5-HT3 receptors. Synthesis and biological evaluation of piperazinylquinoxaline derivatives.
AID6344In vitro Binding affinity towards 5-hydroxytryptamine 3 receptor was determined2001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
The 5-HT3 antagonist tropisetron (ICS 205-930) is a potent and selective alpha7 nicotinic receptor partial agonist.
AID1784760Antagonist activity at human 5-HT6 receptor expressed in 1321N1 cells assessed as inhibition of 5-CT induced cAMP production incubated for 30 mins
AID526452Binding affinity to human HT3A receptor2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Discovery of 2-substituted benzoxazole carboxamides as 5-HT3 receptor antagonists.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID197156The pA2 is the negative logarithm of the molar concentration of an antagonist which necessitates the doubling of the agonist dose to couteract the effect of that antagonist and restore the original response was measured in rat isolated vagus nerve test.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID6310Binding affinity against 5-hydroxytryptamine 3 (5-HT3) receptor in rat brain cortical membranes using radioligand [3H]quipazine1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID239870Antagonism of 2-methyl-5-HT effect on 5-hydroxytryptamine 3 receptor in isolated guinea pig ileum2004Bioorganic & medicinal chemistry letters, Oct-18, Volume: 14, Issue:20
Microwave assisted synthesis of 2-(4-substituted piperazin-1-yl)-1,8-naphthyridine-3-carbonitrile as a new class of serotonin 5-HT3 receptor antagonists.
AID680106TP_TRANSPORTER: increase in brain concentration in mdr1a(-/-) mouse1996The Journal of clinical investigation, Jun-01, Volume: 97, Issue:11
P-glycoprotein in the blood-brain barrier of mice influences the brain penetration and pharmacological activity of many drugs.
AID1889690Displacement of [3H]-8-OH-DPAT from human 5-HT1A receptor expressed in HEK293 cells measured after 1 hr by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1889688Displacement of [3H]-raclopride from human D2L receptor expressed in HEK293 cells measured after 1 hr by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID79328Antagonism to 2-methyl-5-HT induced contractions in guinea pig ileum1993Journal of medicinal chemistry, Sep-17, Volume: 36, Issue:19
Novel antagonists of 5-HT3 receptors. Synthesis and biological evaluation of piperazinylquinoxaline derivatives.
AID183111Inhibitory activity against Bezold-jarisch functional assay, inducing a transient bradycardia upon intravenous administration of 5-hydroxytryptamine-(10 ug/kg) in anesthetized rats.1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID568200Antipsychotic activity in Swiss Albino mouse assessed as spontaneous locomotor score at 1 mg/kg, ip measured for 10 mins by actophotometer2011Bioorganic & medicinal chemistry letters, Feb-15, Volume: 21, Issue:4
Discovery of new anti-depressants from structurally novel 5-HT3 receptor antagonists: design, synthesis and pharmacological evaluation of 3-ethoxyquinoxalin-2-carboxamides.
AID6244In vitro affinity at serotonergic 5-hydroxytryptamine 4 receptor by radioligand binding assay using [3H]GR-113808 in rat striatum membranes.1999Journal of medicinal chemistry, Dec-02, Volume: 42, Issue:24
Benzimidazole derivatives. 2. Synthesis and structure-activity relationships of new azabicyclic benzimidazole-4-carboxylic acid derivatives with affinity for serotoninergic 5-HT(3) receptors.
AID223425The binding affinity was measured on leukotriene-6 receptor using [3H]- IL-6 as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID386623Inhibition of 4-(4-(dimethylamino)styryl)-N-methylpyridinium uptake at human OCT1 expressed in HEK293 cells at 100 uM by confocal microscopy2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Structural requirements for drug inhibition of the liver specific human organic cation transport protein 1.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID52790Inhibition of chymotrypsin at 250 uM2003Journal of medicinal chemistry, Oct-09, Volume: 46, Issue:21
Identification and prediction of promiscuous aggregating inhibitors among known drugs.
AID222169The binding affinity was measured on melatonin receptor using [3H]- 2-iodo-melat as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID692194Inhibition of human OCT1 expressed in HEK-293-Flp-In cells incubated for 3 mins by ASP+ substrate uptake assay2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID183119Inhibitory dose causing inhibition of increase in castor oil induced diarrhea by oral administration at 1 ml/rat1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.
AID6279Compound was evaluated for the displacement of [3H]Q-ICS-205-930 from 5-HT3 recognition sites in rat brain membranes1992Journal of medicinal chemistry, Mar-20, Volume: 35, Issue:6
Novel 5-HT3 antagonists: indol-3-ylspiro(azabicycloalkane-3,5'(4'H)-oxazoles).
AID145857In vitro Binding affinity towards alpha-1-beta-1-gamma-delta nAChR; not done2001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
The 5-HT3 antagonist tropisetron (ICS 205-930) is a potent and selective alpha7 nicotinic receptor partial agonist.
AID72056Antiemetic activity (intravenous administration) against cisplatin-induced emesis in ferret, as the dose required to reduce emetic episodes to 50% of control value1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 1. Initial structure-activity relationship of novel benzamides.
AID699541Inhibition of human liver OATP2B1 expressed in HEK293 Flp-In cells assessed as reduction in [3H]E3S uptake at 20 uM incubated for 5 mins by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID72834Compound was evaluated for number of emetic episodes in ferrets administered intravenously at 1.0 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID72054Antiemetic potency was tested against cisplatin-induced emetic latency period in ferret after oral administration1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 2. Two novel tricyclic benzamides.
AID6055Inhibition of 5-HT-induced bradycardia by 5-hydroxytryptamine 3+1992Journal of medicinal chemistry, Jan-24, Volume: 35, Issue:2
Zatosetron, a potent, selective, and long-acting 5HT3 receptor antagonist: synthesis and structure-activity relationships.
AID59346Effective dose for inhibition of apomorphine (0.3 mg/kg) induced emesis in dogs when 1 mg/kg of compound administered perorally2003Journal of medicinal chemistry, Feb-27, Volume: 46, Issue:5
Synthesis and structure-affinity relationships of novel N-(1-ethyl-4-methylhexahydro-1,4-diazepin-6-yl)pyridine-3-carboxamides with potent serotonin 5-HT3 and dopamine D2 receptor antagonistic activity.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID146308Antagonism of ACh response at Nicotinic acetylcholine receptor alpha4-beta2 expressed in xenopus oocytes2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
Activity of alpha7-selective agonists at nicotinic and serotonin 5HT3 receptors expressed in Xenopus oocytes.
AID72572Compound was evaluated for number of emetic episodes in ferrets administered perorally at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID721742Ratio of Cmax unbound to IC50 for human MATE1-mediated [14]-metformin uptake expressed in polarized MDCK2 cells2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID71931Antiemetic activity (intravenous administration) against cisplatin-induced emesis in ferret, as the dose required to increase latency to first emetic bout by 100%1992Journal of medicinal chemistry, Mar-06, Volume: 35, Issue:5
Development of high-affinity 5-HT3 receptor antagonists. 1. Initial structure-activity relationship of novel benzamides.
AID179597Inhibition of the Bezold Jarisch reflex evoked by 30 ug/Kg of 5-HT.1997Journal of medicinal chemistry, Oct-10, Volume: 40, Issue:21
Phenylimidazolidin-2-one derivatives as selective 5-HT3 receptor antagonists and refinement of the pharmacophore model for 5-HT3 receptor binding.
AID6369In vitro binding affinity for the 5-hydroxytryptamine 3 receptor was determined with NG-108-15 mouse neuroblastoma-glioma cells1990Journal of medicinal chemistry, Oct, Volume: 33, Issue:10
An initial three-component pharmacophore for specific serotonin-3 receptor ligands.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID699540Inhibition of human liver OATP1B3 expressed in HEK293 Flp-In cells assessed as reduction in [3H]E17-betaG uptake at 20 uM incubated for 5 mins by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID526729Toxicity in mouse assessed as induction of spontaneous locomotor activity at 1 mg/kg, ip after 10 mins by actophotometry2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Design, synthesis and structure-activity relationship of novel quinoxalin-2-carboxamides as 5-HT3 receptor antagonists for the management of depression.
AID72571Compound was evaluated for number of emetic episodes in ferrets administered perorally at 0.1 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID1889691Displacement of [3H]-5-CT from human 5-HT7b receptor expressed in HEK293 cells measured after 1 hr by Microbeta plate reader method2022European journal of medicinal chemistry, Mar-15, Volume: 232Novel D
AID104027The binding affinity was measured on muscarine M1 receptor using [3H]- pirenzepine as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID60128Inhibition of emesis induced by peroral administration of cisplatin in 6 dogs at 0.1 mg/kg1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
2-(Quinuclidin-3-yl)pyrido[4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists.
AID6089Inhibition of 5-HT evoked reflex bradycardia in rat.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
5-Hydroxytryptamine (5-HT3) receptor antagonists. 1. Indazole and indolizine-3-carboxylic acid derivatives.
AID72709Compound was evaluated for number of emetic episodes in ferrets administered intravenously at 0.3 mg/kg1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Novel 5-HT3 antagonists. Isoquinolinones and 3-aryl-2-pyridones.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID712522Displacement of [3H]granisetron from human 5HT3A receptor expressed in HEK293 cells by filter binding assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder.
AID692187Therapeutic index, ratio of Cmax in human to IC50 for human MATE12011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID692192Inhibition of human OCT2 expressed in HEK-293-Flp-In cells incubated for 3 mins by ASP+ substrate uptake assay2011Journal of medicinal chemistry, Jul-14, Volume: 54, Issue:13
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
AID184810Lowest effective dose affecting behavioral parameter in at least half of the animals.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID712521Displacement of [3H]5-carboxamidotryptamine to human 5HT1A expressed in HEK293 cells by filter binding assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder.
AID568199Antidepressant activity in Swiss Albino mouse assessed as immobility time at 2 mg/kg, ip by forced swimming test2011Bioorganic & medicinal chemistry letters, Feb-15, Volume: 21, Issue:4
Discovery of new anti-depressants from structurally novel 5-HT3 receptor antagonists: design, synthesis and pharmacological evaluation of 3-ethoxyquinoxalin-2-carboxamides.
AID223592The binding affinity was measured on kappa-opiate receptor using [3H]- EKC as radioligand.1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Development of high-affinity 5-HT3 receptor antagonists. Structure-affinity relationships of novel 1,7-annelated indole derivatives.
AID6124Serotonin receptor antagonist activity was measured as ability to block the serotonin-induced Bezold-Jarisch reflex in rats after iv administration of 20 ug/Kg1990Journal of medicinal chemistry, Oct, Volume: 33, Issue:10
Thiazole as a carbonyl bioisostere. A novel class of highly potent and selective 5-HT3 receptor antagonists.
AID6077Inhibition of [3H]BRL-43694 binding to rat 5-hydroxytryptamine 3 receptor1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis of 2-piperazinylbenzothiazole and 2-piperazinylbenzoxazole derivatives with 5-HT3 antagonist and 5-HT4 agonist properties.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID161281Inhibition of human Potassium channel HERG expressed in mammalian cells2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Prediction of hERG potassium channel affinity by traditional and hologram qSAR methods.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID6056In vivo inhibitory concentration after 5 minutes against 5-hydroxytryptamine 3 receptor induced bradycardia [bezold-jarisch (B-J) reflex test] in rat by intravenous administration1993Journal of medicinal chemistry, Mar-05, Volume: 36, Issue:5
5-HT3 receptor antagonists. 2. 4-Hydroxy-3-quinolinecarboxylic acid derivatives.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID91481Binding constant against human serum albumin (HSA)2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Cheminformatic models to predict binding affinities to human serum albumin.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (3,155)

TimeframeStudies, This Drug (%)All Drugs %
pre-199045 (1.43)18.7374
1990's1241 (39.33)18.2507
2000's777 (24.63)29.6817
2010's846 (26.81)24.3611
2020's246 (7.80)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 142.59

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index142.59 (24.57)
Research Supply Index8.43 (2.92)
Research Growth Index6.28 (4.65)
Search Engine Demand Index272.32 (26.88)
Search Engine Supply Index2.03 (0.95)

This Compound (142.59)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,216 (35.98%)5.53%
Reviews331 (9.79%)6.00%
Case Studies226 (6.69%)4.05%
Observational23 (0.68%)0.25%
Other1,584 (46.86%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (359)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Matching Genotypes and Serotonergic Medications for Alcoholism [NCT01113164]Phase 179 participants (Actual)Interventional2008-09-30Completed
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetoge [NCT00337727]Phase 3848 participants (Actual)Interventional2007-01-01Completed
Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia [NCT01121042]Phase 385 participants (Actual)Interventional2010-07-31Completed
Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial [NCT03578081]Phase 3690 participants (Actual)Interventional2018-10-15Completed
Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial [NCT01257672]Phase 3356 participants (Actual)Interventional2011-07-31Completed
Ondansetron Vs Metoclopramide in the Treatment of Vomiting in Gastroenteritis Patients: A Randomized Controlled Trial [NCT01165866]Phase 4170 participants (Actual)Interventional2008-06-30Completed
Phase Ia/Ib Study of Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation [NCT01290276]Phase 16 participants (Actual)Interventional2010-12-31Completed
Ondansetron Augmentation in Treatment-resistant OCD [NCT01303536]Phase 421 participants (Actual)Interventional2009-12-31Completed
Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial [NCT03435692]42 participants (Actual)Interventional2011-07-15Terminated(stopped due to Funding was exhausted prior to enrolling intended number of patients.)
The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section [NCT03931863]Phase 3180 participants (Anticipated)Interventional2019-05-22Recruiting
Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery [NCT01169805]105 participants (Actual)Interventional2010-08-31Completed
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy [NCT03435003]Phase 4104 participants (Actual)Interventional2017-08-28Completed
Comparative Electrocardiographic Effects of Intravenous Ondansetron and Granisetron in Patients Undergoing Surgery for Carcinoma Breast: A Prospective Single Blind Randomised Trial [NCT01352130]Phase 470 participants (Actual)Interventional2007-03-31Completed
Role of Dexamethasone or Ondansetron in the Quality of Recovery After Intrathecal Morphine Administration in Patients Undergoing Lower Limb Surgery. [NCT03035942]Phase 4135 participants (Actual)Interventional2017-01-02Completed
A Study Examining the Pharmacodynamics Interaction Between Buprenorphine and Fentanyl [NCT03747341]Phase 122 participants (Actual)Interventional2018-03-22Completed
[NCT02408146]80 participants (Anticipated)Interventional2014-01-31Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder [NCT02354703]Phase 2293 participants (Actual)Interventional2015-08-31Completed
Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery: A Randomized Controlled Study [NCT03685032]54 participants (Actual)Interventional2014-08-07Completed
Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery [NCT03653520]651 participants (Actual)Interventional2017-06-28Completed
Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron [NCT02901054]19 participants (Actual)Interventional2016-08-25Completed
A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome [NCT05065567]Phase 238 participants (Actual)Interventional2021-08-30Terminated(stopped due to Lost too many patients to follow up, unable to enroll enough patients)
A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy [NCT01370408]Phase 285 participants (Actual)Interventional2012-02-29Completed
Dexamethasone vs Ondansetron as the First-line Antiemetic to Prevent Postoperative Nausea and Vomiting After Cesarean Delivery [NCT05692245]Phase 4100 participants (Anticipated)Interventional2023-03-31Not yet recruiting
Feasibility of Delivering Enhanced Recovery After Cardiac Surgery [NCT03859102]80 participants (Anticipated)Interventional2018-12-17Recruiting
Nasally Inhaled Isopropyl Alcohol Versus Oral Ondansetron for the Treatment of Nausea in the Emergency Department: A Double-Blind Randomized Controlled Trial [NCT02760069]Phase 4122 participants (Actual)Interventional2016-01-31Completed
Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy [NCT05620641]Phase 3100 participants (Anticipated)Interventional2022-10-01Recruiting
Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP) [NCT04606264]Phase 32,500 participants (Anticipated)Interventional2023-05-15Recruiting
Evaluation of an Enhanced Recovery Pathway for Endoscopy Patients Receiving Moderate Sedation [NCT04983498]Phase 40 participants (Actual)Interventional2021-09-01Withdrawn(stopped due to Investigator left organization before study initiated.)
An Open Label Phase II Study of Aprepitant for Multi-day Moderately-high to Highly Emetogenic Chemotherapy Regimens [NCT00711555]Phase 222 participants (Actual)Interventional2005-11-30Completed
A Randomized, Double-Blind, Double-Dummy, Dose-Ranging, Active- and Placebo-Controlled Study of Single-Dose Oral Rolapitant Monotherapy for the Prevention of Postoperative Nausea and Vomiting (PONV) [NCT00539721]Phase 2619 participants (Actual)Interventional2007-10-31Completed
Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section [NCT03530007]Phase 2/Phase 3120 participants (Anticipated)Interventional2018-05-15Not yet recruiting
Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer [NCT02441894]Phase 421 participants (Actual)Interventional2015-04-30Completed
The Use of Propofol/Ketamine Anesthesia With Bispectral Monitoring (PKA-BIS) Versus Inhalational Anesthetics in Rhytidoplasty - A Prospective, Double-blinded, Randomized Comparison Study [NCT02410460]30 participants (Actual)Interventional2013-09-30Completed
Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis [NCT03478605]Phase 2130 participants (Anticipated)Interventional2018-05-25Recruiting
A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery [NCT02382146]Phase 460 participants (Actual)Interventional2012-04-30Completed
A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0517/Fosaprepitant and Ondansetron Versus Ondansetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Subjects Receiving E [NCT02519842]Phase 375 participants (Actual)Interventional2015-09-14Terminated(stopped due to Further data are no longer required to support an application for use in pediatric patients. The decision to terminate was not based on any new safety findings)
Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity: A Randomized Controlled Trial In Poison Control Center Of Ain Shams University Hospitals [NCT05006638]Phase 462 participants (Anticipated)Interventional2022-12-31Recruiting
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants [NCT03511118]1,600 participants (Anticipated)Observational2018-10-04Recruiting
Optimization of Post-Operative Therapy for Nausea or Vomiting [NCT03075163]Phase 4300 participants (Actual)Interventional2016-10-18Terminated(stopped due to recruitment futility)
Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection [NCT03134612]Phase 2104 participants (Actual)Interventional2016-07-31Completed
Intrathecal Atropine Versus Preoperative Intravenous Ondasetron for Prevention of Postoperative Nausea and Vomiting Due to Intrathecal Morphine in Perineal Surgery [NCT05137288]100 participants (Anticipated)Interventional2021-12-01Not yet recruiting
A Single Center, Randomized Controlled Prospective Double-blinded Trial Comparing Haloperidol to Standard Ondansetron Therapy for Control of Nausea and Vomiting in the Emergency Department [NCT04764344]Phase 460 participants (Actual)Interventional2021-04-01Completed
The Effects of Intravenous Fosaprepitant and Ondansetron for the Prevention of Postoperative Nausea and Vomiting in Thoracicsurgery Patients: A Single-center, Randomized, Double-Blinded Clinical Study [NCT05881486]234 participants (Anticipated)Interventional2023-06-30Not yet recruiting
Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer. [NCT03606369]Phase 2/Phase 3560 participants (Anticipated)Interventional2015-11-05Recruiting
Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study [NCT03182179]48 participants (Actual)Interventional2016-11-01Completed
A Prospective, Open-label, Single-arm Study for Efficacy and Safety of Three-drug Antiemetic Regimen to Prevent the Emesis During Radiotherapy With Concurrent Chemoradiotherapy in Locally Advanced HNSCC [NCT03572829]Phase 244 participants (Actual)Interventional2018-03-01Completed
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone. Can This Modality Improve the Antiemetic Effect [NCT05872893]Phase 340 participants (Anticipated)Interventional2023-06-27Recruiting
Trial of Ondansetron as a Parkinson's HAllucinations Treatment [NCT04167813]Phase 2306 participants (Anticipated)Interventional2021-10-01Recruiting
Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized Controlled Trial [NCT03056482]Phase 433 participants (Actual)Interventional2017-05-21Completed
Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED) [NCT03125811]Early Phase 1121 participants (Actual)Interventional2017-07-17Completed
The Use of Preoperative Oral Dexamethasone to Improve Quality of Recovery After Breast Surgery [NCT02234466]Phase 280 participants (Anticipated)Interventional2014-08-31Enrolling by invitation
Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial [NCT02194192]168 participants (Actual)Interventional2014-07-31Completed
A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Fasting Conditions [NCT00934180]Phase 124 participants (Actual)Interventional2002-12-31Completed
Phase II Trial Testing the Antiemetic Efficacy of a Single-day Low Dose Aprepitant (or Fosaprepitant) Added to a 5-HT3 Receptor Antagonist Plus Dexamethasone in Patients Receiving Carboplatin [NCT03237611]Phase 215 participants (Actual)Interventional2018-10-30Terminated(stopped due to Expired IRB approval on 2/11/21)
The Effect of Ondansetron on the Efficacy of Tramadol [NCT04745273]Phase 460 participants (Actual)Interventional2020-09-02Completed
A Comparison of Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients [NCT00738621]Phase 4100 participants (Actual)Interventional2008-07-31Completed
Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting [NCT03297021]Phase 4141 participants (Actual)Interventional2017-10-23Completed
Effects on Ondansetron on Maternal Hemodynamics After Cesarean Section Under Spinal Anesthesia: a Randomized Controlled Trial [NCT03629522]Phase 4100 participants (Actual)Interventional2017-08-01Completed
A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine [NCT03262038]Phase 446 participants (Actual)Interventional2017-12-07Terminated(stopped due to Interim analysis showed no difference between groups)
Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia [NCT05583214]Phase 490 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery [NCT02473042]188 participants (Actual)Interventional2016-02-29Active, not recruiting
Pharmacotherapy for HIV+ Stimulant Dependent Individuals [NCT00599573]12 participants (Anticipated)Interventional2007-10-31Recruiting
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects [NCT00972595]Phase 145 participants (Actual)Interventional2004-06-30Completed
Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better [NCT00918190]75 participants (Anticipated)Interventional2009-06-30Completed
1) The Effect of Xenon and Sevoflurane on Hypnosis Monitors. 2) Prevention of Postoperative Nausea and Vomiting. 3) Rescue Treatment of Established Postoperative Nausea and Vomiting. Sevoflurane. [NCT00793663]Phase 4220 participants (Anticipated)Interventional2008-11-30Completed
Comparison of Efficacy of Ondansetron Versus Metoclopramide for Vomiting in Children With Acute Gastroenteritis: Randomized Controlled Clinical Trial [NCT02619201]Phase 3250 participants (Anticipated)Interventional2015-11-30Not yet recruiting
A Multi-Center, Open-Label, 2-Arm, Randomized, Stratified, Parallel, Pilot Study to Assess Palonosetron vs. Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU) [NCT00967499]Phase 2239 participants (Actual)Interventional2009-07-13Completed
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults [NCT00890149]Phase 274 participants (Actual)Interventional2015-09-30Terminated(stopped due to Difficulty recruiting target sample)
A Multicenter, Open-Label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy [NCT00818259]Phase 192 participants (Actual)Interventional2009-02-05Terminated(stopped due to Study terminated early prior to completing targeted enrollment of participants <6 months of age due to recruitment challenges.)
A Randomised, Placebo Controlled Trial to Determine the Efficacy and Mode of Action of Ondansetron in the Treatment of Irritable Bowel Syndrome With Diarrhoea [NCT03555188]Phase 380 participants (Actual)Interventional2018-03-29Completed
Comparative Study of Antiemetic Effect of Ramosetron With Combination of Ondansetron and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy [NCT02803788]Phase 4100 participants (Anticipated)Interventional2015-07-31Recruiting
Comparative Trial Ondansetron Alone Versus Combination of Ondansetron Plus Aprepitant for Prevention of Nausea and Vomiting With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine [NCT00954941]Phase 2100 participants (Actual)Interventional2009-11-30Completed
A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Non-Fasting Conditions [NCT00934921]Phase 124 participants (Actual)Interventional2003-02-28Completed
A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia [NCT02386059]Phase 41,200 participants (Anticipated)Interventional2015-03-31Not yet recruiting
A Comparison of Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting in High Risk Patients Undergoing Laparoscopic Surgeries [NCT03603119]120 participants (Actual)Interventional2018-05-01Completed
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Ped [NCT01362530]Phase 3307 participants (Actual)Interventional2011-09-13Completed
Efficacy of the Anterior Quadratus Lumborum Block Versus the Transversus Abdominis Plane Block for Elective Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial [NCT03023462]60 participants (Actual)Interventional2019-09-05Completed
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting [NCT02473887]Phase 140 participants (Actual)Interventional2014-09-30Completed
The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients [NCT02085577]Phase 4147 participants (Actual)Interventional2014-05-31Completed
A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline [NCT02456662]319 participants (Actual)Interventional2015-10-07Completed
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial [NCT02143531]Phase 4120 participants (Actual)Interventional2008-09-30Completed
Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair [NCT03041948]88 participants (Anticipated)Interventional2015-09-01Recruiting
Drug Disposition and Nephrotoxicity [NCT03817970]Phase 372 participants (Anticipated)Interventional2019-11-15Recruiting
Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma [NCT00651755]23 participants (Actual)Interventional2008-03-31Completed
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy [NCT02541019]Phase 480 participants (Actual)Interventional2015-10-31Completed
A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions [NCT00946387]Phase 126 participants (Actual)Interventional2004-09-30Completed
Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 16 mg ODT With That of GlaxoSmithKine's Zofran 16 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions [NCT00659685]Phase 124 participants (Actual)Interventional2003-11-30Completed
Single-Dose Food In Vivo Bioequivalence Study of Ondansetron Orally Disintegrating Tablets (8 mg; Mylan) to Zofran ODT® Tablets (8 mg; GlaxoSmithKline) in Healthy Volunteers [NCT00648804]Phase 128 participants (Actual)Interventional2005-07-31Completed
A Prospective,Open-label, Dose Escalation Phase 1 Study to Investigate the Safety, and Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of a HLX07, in Patients With Advanced Solid Cancers. [NCT02648490]Phase 119 participants (Actual)Interventional2016-09-30Completed
Effect of Dexmedetomidine Infusion on Desflurane Consumption and Hemodynamics During BIS Guided Laparoscopic Surgery: A Randomized Controlled Study [NCT02652312]40 participants (Actual)Interventional2016-02-29Completed
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Efficacy Study of Oral Dronabinol Alone and in Combination With Ondansetron Versus Ondansetron Alone in Subjects With Delayed Chemotherapy-Induced Nausea and Vomiting [NCT00642512]Phase 364 participants (Actual)Interventional2003-07-31Completed
Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis [NCT00691275]0 participants (Actual)Interventional2008-09-30Withdrawn
Efficacy of Preoperative Melatonin Versus Pregabalin on Intraoperative Anxiolysis and Sedation During Hip Arthroplasty Under Regional Anesthesia [NCT05221151]Phase 478 participants (Actual)Interventional2022-01-30Completed
Single-Dose Crossover Comparative Bioavailability Study to Assess the Effect of Food on the Pharmacokinetics of Ondansetron Modified-Release Capsules (EUR-1025) in Healthy Male and Female Volunteers [NCT00981487]Phase 122 participants (Actual)Interventional2009-02-28Completed
A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Oxaliplatin Induced Nausea and Vomiting. [NCT00601172]Phase 3710 participants (Actual)Interventional2008-03-10Completed
Single-Dose Fasting In Vivo Bioequivalence Study of Ondansetron Tablets (24 mg; Mylan) and Zofran® Tablets (24 mg; GSK) in Healthy Volunteers [NCT00649532]Phase 128 participants (Actual)Interventional2003-07-31Completed
Phase III, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Ondansetron in the Control of Chronic Nausea and Vomiting Not Due to Antineoplastic Therapy in Patients With Advanced Cancer [NCT00006348]Phase 3100 participants (Actual)Interventional2000-10-31Completed
Optimizing Anesthesia Antiemetic Measures Versus Combination With Dexamethasone or Ondansetron in the Prevention of Postoperative Nausea and Vomiting. [NCT00825071]Phase 4180 participants (Actual)Interventional2007-11-30Completed
The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section. A Prospective, Observational and Non-inferiority Study Against Epidural Analgesia. [NCT05879536]312 participants (Anticipated)Observational2023-05-23Recruiting
Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia [NCT03865290]Phase 2150 participants (Anticipated)Interventional2019-04-02Recruiting
A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Cisplatin-Induced Nausea and Vomiting [NCT00891761]Phase 30 participants (Actual)Interventional2009-09-30Withdrawn(stopped due to This study has been cancelled prior to enrollment.)
Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer [NCT00971399]Phase 3172 participants (Anticipated)Interventional2009-09-30Completed
Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy [NCT04503668]Phase 3170 participants (Anticipated)Interventional2020-12-28Recruiting
A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery [NCT00819039]Phase 198 participants (Actual)Interventional2009-01-26Completed
A Comparison Between Palonosetron And Ondansetron As Prophylaxis Against Postoperative Nausea and Vomiting In Idiopathic Scoliosis Surgery: A Randomised Trial [NCT05956899]Phase 474 participants (Anticipated)Interventional2023-06-01Recruiting
Combined Pharmacotherapies for Alcoholism [NCT00768508]Phase 3300 participants (Actual)Interventional2008-09-30Completed
Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy [NCT04403191]240 participants (Actual)Observational [Patient Registry]2019-03-10Completed
Open-label Randomized, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip 8mg With Zofran Orally Disintegrating Tablets 8 mg in 48 Healthy, Adult, Participants Under Fed Conditions. [NCT01217801]Phase 148 participants (Actual)Interventional2008-10-31Completed
Ondansetron 4 mg vs. 2 mg vs. Metoclopramide 10 mg for Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial [NCT00778011]Phase 4137 participants (Actual)Interventional2005-11-30Completed
Single-Dose Food In Vivo Bioequivalence Study of Ondansetron Tablets (24 mg; Mylan) and Zofran® Tablets (24 mg; GSK) in Healthy Volunteers [NCT00648583]Phase 128 participants (Actual)Interventional2003-07-31Completed
Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study [NCT00796497]Phase 414 participants (Actual)Interventional2008-03-31Completed
Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 8 mg ODT With That of GlaxoSmithKine's Zofran 8 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions [NCT00654277]Phase 132 participants (Actual)Interventional2002-08-31Completed
The Effect of Preventive Use of Ondansetron on the Blood Pressure and Vasopressor Consumption in the Cesarean Section Under Spinal Anesthesia [NCT02883192]100 participants (Anticipated)Interventional2016-02-29Recruiting
Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial [NCT02830906]Phase 399 participants (Actual)Interventional2014-04-30Completed
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial [NCT00678457]Phase 240 participants (Actual)Interventional2007-01-31Completed
A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Indu [NCT00619359]Phase 32,322 participants (Actual)Interventional2008-02-29Completed
A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions [NCT00947128]Phase 126 participants (Actual)Interventional2004-09-30Completed
A Randomized Double-Blind, Sponsor-Open, Double-Dummy, Proof of Concept Phase 2 Study to Evaluate the Efficacy and Safety of TAK-951 Versus Ondansetron in the Prophylaxis of Postoperative Nausea and Vomiting in High-Risk Subjects [NCT04557189]Phase 289 participants (Actual)Interventional2020-10-20Completed
Effect of Ondansetron for Withdrawal Symptoms [NCT00695864]31 participants (Actual)Interventional2008-05-31Completed
Developing Individualized Strategies to Prevent Nausea and Vomiting [NCT01393288]0 participants (Actual)Interventional2013-11-30Withdrawn
Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors [NCT00609765]Phase 21 participants (Actual)Interventional2007-08-31Terminated(stopped due to Development of new chemotherapy standard of care for treatment rendered the trial obsolete.)
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of AD04 (Ondansetron) in Adults With Alcohol Use Disorder (AUD) and Selected Polymorphisms in the Serotonin Transporter and Receptor Genes [NCT04101227]Phase 3302 participants (Actual)Interventional2020-02-01Completed
Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia [NCT00929955]Phase 136 participants (Actual)Interventional2009-06-30Completed
"Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D): Identifying the Responder" [NCT00745004]Phase 4150 participants (Actual)Interventional2009-01-31Completed
A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section [NCT02793843]194 participants (Actual)Interventional2016-06-30Completed
[NCT01007500]Phase 4123 participants (Actual)Interventional2009-09-30Completed
Rescue Emetic Therapy for Children Having Elective Therapy [NCT01067677]0 participants (Actual)Interventional2010-02-28Withdrawn(stopped due to We do not have the funding or resources to complete the study at this time)
A Phase III, Randomized, Open-label, Active-controlled, Two-arm, Parallel-design, Interventional Clinical Trial Evaluating the Efficacy and Safety of Ondansetron 8 mg IV/ IM Injection Compared to Metoclopramide 10 mg in the Management of Nausea and Vomiti [NCT05876585]Phase 3126 participants (Anticipated)Interventional2023-06-30Not yet recruiting
Patient Information and Antiemetic Drug Efficacy [NCT00005994]0 participants Interventional2000-08-31Completed
Effectiveness of Aprepitant in Addition to Ondansetron in the Prevention of Nausea and Vomiting Caused by Fractionated Radiotherapy to the Upper Abdomen [NCT00970905]Phase 252 participants (Actual)Interventional2009-10-31Completed
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vo [NCT00090207]Phase 4477 participants (Actual)Interventional2004-01-13Completed
See Detailed Description [NCT00169572]Phase 2492 participants Interventional2005-02-28Completed
Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia? [NCT02928601]Phase 4108 participants (Actual)Interventional2016-11-30Completed
Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT03973411]Phase 4100 participants (Anticipated)Interventional2019-03-01Recruiting
Alcohol Research Center Grant. Component #1. COMBINING MEDICATIONS: ALCOHOL REACTIVITY AND CONSUMPTION [NCT00183222]Phase 2160 participants Interventional2005-05-31Completed
Parallel, Group, Laboratory-Blinded, Single and Multiple-dose Pharmacokinetic Study of Ondansetron Administered as the Immediate-Release (Zofran) and Modified-Release (EUR1025) Formulations [NCT01036854]Phase 1128 participants (Actual)Interventional2009-02-28Completed
A Randomised Trial to Assess the Effectiveness of Pre-treatment With Ondansetron at Reducing Nausea and Vomiting in Patients Treated With Either the Conventional Regimen or a Modified Regimen of Acetylcysteine for Paracetamol Poisoning [NCT01050270]Phase 4222 participants (Actual)Interventional2010-09-30Completed
A Phase 1, Randomized Study to Evaluate the Rate of Nausea in Healthy Premenopausal Female Subjects Treated With a Single Dose of Bremelanotide Alone or With Zofran [NCT03973047]Phase 1228 participants (Actual)Interventional2019-06-17Completed
A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety and Tolerability of IV MK0517 for the Prevention of Postoperative Nausea and Vomiting (PONV) [NCT00231777]Phase 3216 participants (Actual)Interventional2005-07-31Completed
Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery? [NCT01876290]Phase 4122 participants (Actual)Interventional2013-05-31Completed
A Randomized, Phase IV Trial of Individualized Care Versus Standard Care, in the Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. The EPIC Study [NCT01913990]Phase 4323 participants (Anticipated)Interventional2011-09-30Active, not recruiting
Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron [NCT01952626]80 participants (Actual)Interventional2013-04-30Completed
Phase II Randomized Cross-over Study to Evaluate Patient Satisfaction, Efficacy and Compliance of Granisetron Patch vs. Ondansetron in Malignant Glioma Patients Receiving Standard Radiotherapy (RT) and Concomitant Temozolomide (TMZ) [NCT01952886]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to Lack of approval and funding from company)
Examining the Effect of Ondansetron on Bowel Prep Success [NCT05439772]Phase 441 participants (Actual)Interventional2021-01-01Completed
A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery [NCT04144933]Phase 360 participants (Anticipated)Interventional2021-05-15Recruiting
THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY [NCT02021851]Phase 467 participants (Actual)Interventional2011-07-31Completed
[NCT02026778]168 participants (Actual)Interventional2013-12-31Completed
Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter [NCT02028910]Phase 320 participants (Actual)Interventional2014-01-31Terminated
Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department [NCT00387556]268 participants (Actual)Interventional2002-12-31Completed
Combining Medications Treatment for Alcoholism [NCT00006205]Phase 2320 participants (Anticipated)Interventional2005-03-31Recruiting
Intravenous Granisetron Provides Less Ephedrine Requirement Than Ondansetron in Patients Undergoing Cesarean Section With Spinal Anesthesia: A Randomised Placebo-controlled Trial [NCT04613726]Phase 3120 participants (Actual)Interventional2018-12-03Completed
MK0869 and MK0517 Time-on-Target PET Study [NCT01111851]Phase 116 participants (Actual)Interventional2010-04-30Completed
Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery [NCT04533867]100 participants (Actual)Observational [Patient Registry]2020-08-15Completed
Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department: A Open Label, Randomized Controlled Clinical Trial [NCT05418244]Phase 2/Phase 384 participants (Anticipated)Interventional2022-04-20Recruiting
Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade:an Randomized Clinical Trial [NCT06080880]98 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days [NCT05819619]Early Phase 1168 participants (Anticipated)Interventional2023-07-20Recruiting
Single Dose Crossover Comparative Bioavailability Study To Assess the Effect of Food on the Pharmacokinetics of Ondansetron Modified-Release Capsules (EUR1025) in Healthy Male and Female Volunteers [NCT00905190]Phase 122 participants (Actual)Interventional2009-02-28Completed
Comparison of Aprepitant PO and Ondansetron IV for Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Orthognathic Surgery and General Anesthesia. [NCT00699894]0 participants (Actual)Interventional2008-06-30Withdrawn(stopped due to Logistical difficulties running the study)
Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial [NCT04318847]Phase 4220 participants (Anticipated)Interventional2021-10-10Not yet recruiting
fMRI Imaging of Opioid Withdrawal in Healthy Human Volunteers [NCT01006707]15 participants (Actual)Interventional2010-11-30Completed
Iinterest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section: Double-blind Randomized Controlled Single-centre Study [NCT02862873]7 participants (Actual)Interventional2015-03-31Terminated
Single-Dose Fasting In Vivo Bioequivalence Study of Ondansetron Orally Disintegrating Tablets (8 mg; Mylan) to Zofran ODT® Tablets (8 mg; GlaxoSmithKline) in Healthy Volunteers [NCT00649363]Phase 128 participants (Actual)Interventional2005-07-31Completed
Effects of Addition of Systemic Tramadol or Adjunct Tramadol to Lidocaine Used for Intravenous Regional Anesthesia in Patients Undergoing Hand Surgery [NCT02658721]Phase 360 participants (Actual)Interventional2013-01-31Completed
[NCT00674713]Phase 4140 participants (Actual)Interventional2006-01-31Completed
Granisteron Versus Ondansetron for Prophylaxis Against Post-Spinal Anesthesia Shivering: a Randomized Controlled Study [NCT04294992]180 participants (Anticipated)Interventional2020-04-01Not yet recruiting
Comparative, Randomized, Single-Dose, Cross Over Bioavailability Study of Kali's Ondansetron ODT 8 mg With That of GlaxoSmithKine's Zofran ODT 8 mg in Healthy Adult Subjects Under Fed Conditions [NCT00653458]Phase 118 participants (Actual)Interventional2002-08-31Completed
Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 24 mg ODT With That of GlaxoSmithKine's Zofran 24 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions [NCT00659074]Phase 124 participants (Actual)Interventional2003-10-31Completed
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department [NCT00590317]Phase 264 participants (Actual)Interventional2005-03-31Completed
A PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED STUDY OF THE EFFECT OF A STANDARD DOSE OF INTRAVENOUS ONDANSETRON ON THE EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAR [NCT04703088]Phase 360 participants (Anticipated)Interventional2021-06-30Not yet recruiting
An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects [NCT00437229]Phase 137 participants (Actual)Interventional2007-02-19Completed
Effect Of Dexmedetomidine, Dexamethasone And Ondansetron On Postoperative Nausea And Vomiting In Children Undergoing Dental Rehabilitation [NCT05124067]Phase 14 participants (Actual)Interventional2021-10-27Completed
The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis [NCT04169828]176 participants (Anticipated)Interventional2019-08-02Recruiting
Ondansetron for Bipolar Disorder and Alcohol Use Disorders [NCT02082678]Phase 470 participants (Actual)Interventional2014-02-28Completed
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Every 3 Weeks in Subjects With Advanced Malignancies [NCT00871910]Phase 181 participants (Actual)Interventional2006-10-11Completed
A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy [NCT00734929]Phase 4115 participants (Actual)Interventional2007-09-30Completed
Prevention of Nausea and Vomitting Associated With Stem Cell Transplant: Results of a Prospective, Randomized Trial of Aprepitant Used With Highly Emetogenic Preparative Regimens [NCT00781768]Phase 4181 participants (Actual)Interventional2003-08-31Completed
Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography ERCP: A Prospective Randomized Controlled Study [NCT04576390]Phase 490 participants (Anticipated)Interventional2020-10-24Not yet recruiting
Comparative Randomized Controlled Trial Study of General Balanced Anesthesia Based on Opioid and Opioid Sparing Balanced Anesthesia for Cholecystectomy Surgery Via Laparoscopy: Intraoperative and Postoperative Outcomes [NCT02953210]Phase 440 participants (Anticipated)Interventional2016-11-30Enrolling by invitation
Effects of Inhaled Ondansetron on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction [NCT01851993]Early Phase 130 participants (Actual)Interventional2013-06-30Completed
Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in Emergency Departments in Pakistan [NCT01870635]Phase 4625 participants (Actual)Interventional2014-05-31Completed
Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in Emergency Departments in Pakistan [NCT01870648]Phase 4918 participants (Actual)Interventional2014-05-31Completed
A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11) [NCT05755737]Phase 270 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Using Pharmacogenomics (PGx) Results to Guide Post-operative Nausea and Vomiting (PONV) Treatment Practices: A Pilot Study [NCT03503292]Phase 492 participants (Actual)Interventional2018-05-02Completed
Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department [NCT02985840]Phase 4127 participants (Actual)Interventional2014-01-28Terminated(stopped due to Unable to access EMR for patients enrolled prior to 8/2015 for data collection)
A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist Casopitant (GW679769) in Combination With Ondansetron a [NCT00366834]Phase 31,840 participants (Actual)Interventional2006-07-31Completed
The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children [NCT01477242]266 participants (Anticipated)Interventional2011-11-30Recruiting
A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting [NCT00499668]0 participants (Actual)Interventional2007-08-31Withdrawn(stopped due to slow accrual)
Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: A Randomized Controlled Study [NCT05317611]Early Phase 163 participants (Anticipated)Interventional2022-04-01Not yet recruiting
An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects [NCT00971633]Phase 112 participants (Actual)Interventional2003-11-30Completed
Study to Evaluate the Anti-emetic Effect of Aprepitant as an add-on Therapy in Children and Adolescents Receiving AML Remission Induction Chemotherapy: An Investigator-initiated, Randomized, Open Label Trial [NCT02979548]Phase 3116 participants (Anticipated)Interventional2016-11-30Recruiting
Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study [NCT02913768]Phase 4160 participants (Actual)Interventional2016-10-31Completed
Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting [NCT05590936]190 participants (Actual)Interventional2018-01-01Completed
The Effects of Droperidol and Ondansetron on Dispersion of Myocardial Repolarization in Children [NCT00624208]80 participants (Actual)Interventional2008-02-29Completed
Inhibition of Small Conductance Calcium-Activated Potassium Current: A New Therapeutic Approach for Atrial Fibrillation [NCT05844501]Phase 480 participants (Anticipated)Interventional2023-11-01Recruiting
MyRisk: Efficacy and Safety Evaluation of Oral Akynzeo® in Patients Receiving MEC at High Risk of Developing CINV Based on a Prediction Tool: A Multinational and Multicenter Study [NCT04817189]Phase 4530 participants (Anticipated)Interventional2021-02-01Recruiting
Open-label, Randomized, Three-way Crossover Bioavailability Study Comparing Ondansetron Orally Dissolving Filmstrip (ODFS) With and Without Water to Zofran Orally Dissolving Tablets (ODT) Without Water in Healthy Adult Study Participants [NCT01220167]Phase 118 participants (Actual)Interventional2008-08-31Completed
Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study [NCT05265507]Phase 4480 participants (Anticipated)Interventional2022-03-21Recruiting
A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination With Ondansetron Hydrochloride and Dexamethasone for [NCT00104403]Phase 2722 participants (Actual)Interventional2004-12-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated W [NCT00080444]Phase 350 participants (Actual)Interventional2004-04-30Completed
Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department [NCT00120744]0 participants Interventional2004-01-31Completed
A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomitin [NCT00090246]Phase 3922 participants (Actual)Interventional2004-05-13Completed
A Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation [NCT00314743]Early Phase 148 participants (Actual)Interventional2005-10-31Completed
An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs) [NCT02592707]Phase 1/Phase 240 participants (Actual)Interventional2017-03-06Terminated(stopped due to Terminated (Due to small number of ongoing patients. Patients ongoing at time of termination could choose to join study D-FR-01072-004 for long term follow-up.)
A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomitin [NCT00090155]Phase 3805 participants (Actual)Interventional2003-09-26Completed
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Che [NCT00092183]Phase 4866 participants (Actual)Interventional2002-10-10Completed
A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department [NCT00429832]Phase 4120 participants Interventional2003-10-31Completed
A Phase III Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Efficacy and Safety of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant, Administered in Combination With ZOFRAN and [NCT00431236]Phase 3810 participants (Actual)Interventional2006-11-06Completed
A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing [NCT00137202]36 participants (Actual)Interventional2005-06-30Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered With Intravenous Ondan [NCT00108095]Phase 2701 participants (Actual)Interventional2004-10-31Completed
Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy [NCT00429702]Phase 27 participants (Actual)Interventional2007-10-31Terminated(stopped due to Closed due to poor accrual and lack of feasibility to finish study per DSMB)
1/2 - Pharmacogenetic Treatments for Alcoholism [NCT01591291]Phase 2/Phase 30 participants (Actual)Interventional2012-06-30Withdrawn(stopped due to Grant was transferred to University of Maryland and results were reported under NCT02354703.)
The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section [NCT01216410]306 participants (Actual)Interventional2008-12-31Completed
Ondansetron for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled Trial [NCT05475873]120 participants (Actual)Interventional2023-06-18Completed
Phase II Randomized Study to Evaluate Efficacy, Patient Satisfaction, and Compliance of the Oral Combination of Rolapitant (Varubi®) Plus Ondansetron vs. Ondansetron Monotherapy in Malignant Glioma Patients Receiving Radiotherapy (RT) and Concomitant Temo [NCT02991456]Phase 248 participants (Actual)Interventional2017-10-09Completed
[NCT00199329]160 participants (Actual)Interventional2005-01-31Completed
A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE). [NCT00588835]Phase 420 participants (Anticipated)Interventional2008-03-31Terminated
Open-Label Randomized, Single Oral Dose, Two-Way Crossover Bioequivalence Study Comparing Ondansetron Orally Dissolving Film Strip 8 mg With Zofran Orally Disintegrating Tablets (ODT) (Containing Ondansetron 8 mg) in Healthy Adults [NCT01217190]Phase 1/Phase 248 participants (Actual)Interventional2008-09-16Completed
Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Ondansetron Hydrochloride Tablets 8 mg With Zofran® (Containing Ondansetron Hydrochloride Dihydrate) Tablets 8 mg in Healthy, A [NCT01511705]Phase 126 participants (Actual)Interventional2006-10-31Completed
Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Ondansetron Hydrochloride Tablets 8 mg With Zofran® (Containing Ondansetron Hydrochloride Dihydrate) Tablets 8 mg in Healthy, A [NCT01511718]Phase 126 participants (Actual)Interventional2006-10-31Completed
Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair [NCT03041935]90 participants (Actual)Interventional2015-09-01Completed
An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Ondansetron 8 mg Orally Disintegrating Tablets of OHM Laboratories Inc (A Subsidiary of Ranbaxy Pharmaceuticals Inc,) With [NCT01523093]32 participants (Actual)Interventional2006-07-31Completed
To Assess the Efficacy and Safety of Ramosetron, Aprepitant and Dexamethasone Therapy vs Ondansetron, Aprepitant and Dexamethasone Therapy for Preventing of Nausea and Vomiting in Highly Emetogenic Chemotherapy (ROAD Study) [NCT01536691]Phase 3338 participants (Anticipated)Interventional2011-06-30Recruiting
[NCT01543945]Phase 2340 participants (Actual)Interventional2008-03-31Completed
5HT3 Antagonism and Auditory Gating in Schizophrenia [NCT00018850]0 participants Interventional1998-06-30Completed
[NCT00027079]Phase 2360 participants Interventional2001-09-30Completed
An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Ondansetron 8 mg Orally Disintegrating Tablets of Ohm Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Zofr [NCT01523119]35 participants (Actual)Interventional2006-07-31Completed
Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence [NCT00033085]Phase 260 participants Interventional2001-05-31Completed
A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis [NCT00016380]Phase 3211 participants (Actual)Interventional2001-02-28Completed
A Double-blinded, Randomized Control Trial of Prophylactic Ondansetron in a Post-operative Cardiac Surgery Population for Post-operative Nausea and Vomiting [NCT02966041]186 participants (Actual)Interventional2018-03-06Completed
The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock [NCT05402553]Phase 1/Phase 240 participants (Anticipated)Interventional2022-04-24Recruiting
The Effect of an Ondansetron on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry [NCT04499274]12 participants (Anticipated)Interventional2020-09-16Recruiting
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial [NCT04785118]Phase 4165 participants (Actual)Interventional2021-10-01Completed
Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence. [NCT00040053]Phase 2154 participants Interventional2002-06-30Completed
Treatment of Delayed Nausea: What Works Best? [NCT00020657]Phase 30 participants Interventional2001-07-31Completed
An Open-label, Randomised Study Comparing the Uptake of rIL-2 in HIV-1 Infected Individuals Receiving Different Combinations of Antiemetics and Analgesic Agents During rIL-2 Dosing in ESPRIT: Toxicity Substudy of ESPRIT: TOXIL-2 Substudy [NCT00147355]Phase 328 participants (Actual)Interventional2005-11-30Terminated(stopped due to 28 of 168 patients only were enrolled, numbers too low to be conclusive)
A Randomized Phase II Trial of Acupressure and Acustimulation Wrist Bands for the Prevention of Chemotherapy-Induced Nausea and Vomiting [NCT00003817]Phase 2700 participants (Anticipated)Interventional1999-10-31Completed
A Randomized Trial to Evaluate Resolution of Symptoms Using Vestibular Rehab Versus Conventional Therapy in Patients Presenting to the Emergency Department (ED) With Diagnosis of Benign Paroxysmal Positional Vertigo (BPPV) [NCT00641797]26 participants (Actual)Interventional2006-11-30Completed
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study [NCT02987985]Phase 350 participants (Actual)Interventional2017-10-15Completed
Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells [NCT00795769]Phase 249 participants (Actual)Interventional2008-08-08Completed
Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron [NCT05342818]Phase 290 participants (Actual)Interventional2022-04-15Completed
Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC). [NCT01640340]40 participants (Actual)Interventional2011-01-31Completed
Efficacy of Pre-operative Aprepitant Plus Ondansetron vs Ondansetron Plus Placebo in Patients at Moderate-to-High Risk Post-operative Nausea (PONV) Undergoing Ambulatory Plastic Surgery [NCT00659945]Phase 4150 participants (Actual)Interventional2008-06-30Completed
Study to Compare the Safety and Efficacy of 2 Different Doses of Inhaled D8-THC to Standard Therapy With Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy [NCT00285051]Phase 26 participants (Actual)Interventional2005-11-30Terminated(stopped due to Study drug expiry date not extended)
Atypical Antipsychotics and P50 Sensory Gating [NCT00149734]Phase 38 participants (Actual)Interventional2005-01-31Completed
A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Group, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of a Single Intravenous (6 mg, 12 mg, 18 mg, 24 mg or 36 mg) Dose of the Neurokinin-1 Receptor Antagonist, Vestip [NCT01507194]Phase 2131 participants (Actual)Interventional2012-02-29Completed
Pharmacologic MRI in Cocaine-addiction [NCT01652378]12 participants (Actual)Observational2012-08-31Completed
A Multicenter, Randomized, Open-label, Paralleled-group, Active-controlled, Phase IV Study to Evaluate the Efficacy and Safety of Sancuso Patch (Granisetron) in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly E [NCT01659775]Phase 4389 participants (Actual)Interventional2011-08-31Completed
Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy [NCT01661335]Phase 319 participants (Actual)Interventional2012-06-01Completed
Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy [NCT01668069]36 participants (Actual)Interventional2012-10-31Completed
Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia [NCT01669213]100 participants (Anticipated)Interventional2012-08-31Active, not recruiting
Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia. [NCT01679093]Phase 366 participants (Actual)Interventional2009-06-30Completed
Randomized, Prospective, Placebo-Controlled, Crossover Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9) [NCT05657925]Phase 324 participants (Anticipated)Interventional2023-12-01Not yet recruiting
IRB-HSR# 14583: Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients [NCT01414777]Phase 2/Phase 368 participants (Actual)Interventional2009-11-30Completed
Improving Tolerance of Treatment of Pulmonary Mycobacterium Avium Complex Infections [NCT01719042]Phase 20 participants (Actual)Interventional2013-01-31Withdrawn(stopped due to No recruitment was achievable)
Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis [NCT01739985]322 participants (Actual)Interventional2010-12-31Completed
Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial [NCT06175806]160 participants (Actual)Interventional2023-09-10Completed
Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy. [NCT01759706]123 participants (Actual)Interventional2010-10-31Completed
Clinical Predictors and Epigenetic Markers for Liver Fibrosis in Alpha-1 Antitrypsin Deficiency [NCT01810458]109 participants (Actual)Observational2013-10-31Completed
Ondansetron for Pediatric Mild Traumatic Brain Injury; a Pilot Randomized Controlled Trial. [NCT01815125]Phase 116 participants (Actual)Interventional2013-03-31Completed
The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study. [NCT01819857]Phase 475 participants (Anticipated)Interventional2011-06-30Completed
A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP. [NCT01843868]130 participants (Anticipated)Interventional2013-05-31Not yet recruiting
Prevention of Neonatal Abstinence Syndrome [NCT01801475]Phase 1/Phase 2100 participants (Actual)Interventional2013-01-31Completed
Efficacy, Safety and Feasibility of Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients With Solid Tumors Receiving Moderately and Highly Emetogenic Chemotherapy [NCT04508400]Phase 2108 participants (Anticipated)Interventional2021-09-01Not yet recruiting
A Randomized Control Equivalence Study of Emergency Medical Services Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron for Treatment of Pre-hospital Nausea [NCT02618343]51 participants (Actual)Interventional2016-10-04Completed
Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block With Intravenous Antiemetic Drugs Dexamethasone and Ondansetron and Incidence of Post-operative Nausea Vomiting for Inner Ear Surgery [NCT02724033]Phase 437 participants (Actual)Interventional2014-05-31Terminated(stopped due to PI has left Riley Anesthesia. Lack of staff for continued recruitment)
Randomized, Double-blind, Placebo-controlled, Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) [NCT02757105]Phase 2127 participants (Actual)Interventional2016-05-19Completed
A Randomized Open Label Phase II Trial of Aprepitant (Emend) in Combination With Ondansetron Compared to Standard 5HT3 Serotonin Antagonist (Ondansetron) in the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Glioma Pati [NCT01450826]Phase 2136 participants (Actual)Interventional2014-06-24Completed
Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy [NCT06017167]Phase 270 participants (Anticipated)Interventional2022-09-15Recruiting
Analgesic Effect of Single Dose Intravenous Acetaminophen in Pediatric Patients Undergoing Tonsillectomy [NCT01691690]Phase 2250 participants (Actual)Interventional2012-10-31Completed
Effects of Pgp Transporter Inhibition on CNS Biodistribution of Ondansetron in Healthy Volunteers [NCT03809234]Phase 114 participants (Actual)Interventional2019-05-20Terminated(stopped due to Adverse effects related to study procedure (not study drug))
The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries Under Spinal Anesthesia: A Randomized Controlled Trial [NCT01841606]Phase 257 participants (Actual)Interventional2013-03-31Completed
Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery: a Randomized Clinical Trial [NCT05087615]Phase 3130 participants (Actual)Interventional2021-03-01Completed
Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children [NCT01432977]Phase 372 participants (Actual)Interventional2011-09-30Completed
Comparison of Three Different Prophylactic Treatments of PONV in Children [NCT01434017]Phase 4300 participants (Actual)Interventional2008-11-30Completed
A Randomized, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous Ondansetron, a 5-HT3 Antagonist, on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects [NCT01449188]Phase 160 participants (Actual)Interventional2011-08-16Completed
Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial [NCT05378113]Phase 2120 participants (Anticipated)Interventional2023-05-18Recruiting
Does Higher Operation Theatre Ambient Temperature and Intravenous Ondansetron Prophylaxis Reduce Incidence of Post-spinal Shivering in Obstetric Population? A Double-blind, Randomised, Factorial Study. [NCT04654429]Phase 4628 participants (Anticipated)Interventional2020-10-13Recruiting
Is Intra-operative Acupuncture Point P6 Stimulation as Effective as Traditional Pharmacotherapy in Reducing Nausea and Vomiting During Cesarean Section With Regional Anesthesia? [NCT02959840]Phase 4180 participants (Actual)Interventional2015-07-31Completed
The Effect of Intravenous Ondansetron on Reducing Hypotension Due to Bone Cement Syndrome in Total Knee Prosthesis Surgery [NCT05405608]1 participants (Anticipated)Observational2022-06-30Not yet recruiting
The Effects of Ondansetron on Myocardial Repolarization in Children Receiving Chemotherapy [NCT01896440]Phase 40 participants (Actual)Interventional2013-10-31Withdrawn(stopped due to FDA did not approve)
Pharmacological Treatment for Alcoholism [NCT00382642]Phase 3283 participants (Actual)Interventional2006-06-30Completed
Ondansetron Pharmacotherapy for Hazardous Drinking in HIV+, African-American Women [NCT01254877]Phase 2357 participants (Actual)Interventional2010-12-31Completed
Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial [NCT03052361]Phase 2/Phase 381 participants (Actual)Interventional2017-07-15Terminated(stopped due to The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.)
Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence. [NCT03117894]200 participants (Actual)Interventional2017-05-23Completed
5-HT3 Antagonists (Antiemetics) and Cardiac Safety Using an Active Surveillance Approach [NCT02436798]266 participants (Actual)Observational2014-06-30Completed
Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation [NCT05098067]Phase 230 participants (Anticipated)Interventional2022-05-24Recruiting
Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea [NCT03833999]Phase 416 participants (Actual)Interventional2018-10-16Completed
Noninvasive Markers of Functional Nausea in Children [NCT03593811]130 participants (Anticipated)Interventional2018-08-03Enrolling by invitation
Phase 1 Open-Label Randomized 4 Period Crossover Study Comparing Safety, Tolerability and PK of Ondansetron Given Subcutaneously With Hylenex Recombinant and Given Alone Intramuscularly, Intravenously and Orally in Healthy Volunteers [NCT01572012]Phase 112 participants (Actual)Interventional2012-02-29Completed
A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Ondansetron Tablets USP 8 mg With Zofran® 8 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition. [NCT01578252]Phase 148 participants (Actual)Interventional2011-05-31Completed
A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Ondansetron Tablets USP 8 mg With Zofran® 8 mg in Normal, Healthy, Adult, Human Subjects Under Fed Condition. [NCT01578265]Phase 148 participants (Actual)Interventional2011-05-31Completed
Comparison of the Effects of Palonosetron + Dexamethazone, Ondansetron + Dexamethazone and Dexametazone Alone Against Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Laparoscopic Surgery [NCT05439798]Phase 366 participants (Anticipated)Interventional2022-06-01Enrolling by invitation
Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial [NCT03785691]Phase 258 participants (Actual)Interventional2019-03-01Terminated(stopped due to Recruiting difficulties)
Randomized Double Blind Placebo Controlled Study of Ondansetron and Simvastatis Added to Treatment as Usual in Patients With Schizophrenia [NCT01602029]Phase 2303 participants (Actual)Interventional2010-08-31Completed
Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results [NCT00324467]Phase 2150 participants (Actual)Interventional2006-08-31Active, not recruiting
Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia for Cesarian Section [NCT03421860]Phase 4120 participants (Actual)Interventional2017-02-23Completed
Role of Metabolites in Nicotine Dependence (3) [NCT00000289]Phase 20 participants Interventional1998-05-31Completed
A Korean Multicenter, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies (MEC, Non-AC R [NCT01636947]Phase 4494 participants (Actual)Interventional2012-12-12Completed
Efficacy and Safety Addition of Low Dose Olanzapine to the Standard Prophylaxis of Nausea and Vomiting Induced by Highly-emetogenic Chemotherapy in Children and Adolescents (OZONE-V) [NCT05346731]Phase 3210 participants (Anticipated)Interventional2022-04-01Recruiting
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial [NCT02116530]Phase 3401 participants (Actual)Interventional2014-08-31Completed
Pharmacological Treatment for Alcoholism [NCT00000443]Phase 20 participants InterventionalCompleted
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis [NCT02625181]27,034 participants (Actual)Interventional2016-07-31Completed
A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of TAK-058 and Ondansetron on P50 Auditory Gating in Subjects With Stable Schizophrenia [NCT02614586]Phase 111 participants (Actual)Interventional2015-12-31Terminated
A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT) [NCT00248547]40 participants (Actual)Interventional2004-05-31Completed
Efficacy of Palonosetron in the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Following Dose Dense Adriamycin-Cyclophosphamide Chemotherapy in Early Stage Breast Cancer Patients [NCT00343863]41 participants (Actual)Interventional2006-01-31Completed
Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering [NCT04682743]Early Phase 1120 participants (Actual)Interventional2021-01-06Completed
The Effects of Ondansetron on Brain Function [NCT02460341]Phase 154 participants (Actual)Interventional2015-08-31Completed
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention [NCT01594749]Phase 31,015 participants (Actual)Interventional2012-09-24Completed
A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction [NCT02601027]Phase 3120 participants (Actual)Interventional2015-11-30Completed
Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting [NCT05076461]300 participants (Actual)Interventional2020-07-01Completed
BMT-08: A Comparative Effectiveness Study of the Efficacy and Safety of Transdermal Granisetron to Ondansetron in the Prevention of Nausea and Vomiting in Patients Undergoing Preparative Chemotherapy and Hematopoietic Stem Cell Transplantation [NCT04150614]Phase 490 participants (Anticipated)Interventional2020-05-14Recruiting
Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy: a Randomized Clinical Trial [NCT02327923]Phase 490 participants (Actual)Interventional2015-01-31Completed
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation [NCT01536392]Phase 376 participants (Actual)Interventional2012-03-31Completed
5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence [NCT01549652]133 participants (Actual)Interventional2011-04-30Completed
A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Ped [NCT01395901]Phase 3670 participants (Actual)Interventional2011-06-30Completed
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting [NCT01474915]Phase 4122 participants (Actual)Interventional2007-06-30Completed
A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexameth [NCT02106494]Phase 3942 participants (Actual)Interventional2014-03-31Completed
"Olanzapine for Prevention of Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC): An Investigator Initiated, Randomized, Open-label Trial (PRaCTiCE Trial: PRevention of ChemoTherapy Induced Emesis in Children)" [NCT03219710]Phase 3240 participants (Actual)Interventional2017-07-01Completed
Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy [NCT01837394]Phase 460 participants (Actual)Interventional2012-08-31Completed
[NCT03017222]80 participants (Actual)Interventional2015-09-07Completed
Phase II, Open, Randomized Comparative Trial of Two Different Schedules of Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting in Patients With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine [NCT01031498]Phase 2150 participants (Actual)Interventional2005-09-30Completed
Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial [NCT04191694]284 participants (Anticipated)Interventional2019-10-28Recruiting
Neurobiological, Cognitive-affective and Behavioral Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children Undergoing MRI [NCT03022240]Phase 350 participants (Actual)Interventional2017-01-31Completed
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section, a Prospective, Randomized Double Blind Study [NCT04140058]Phase 3151 participants (Actual)Interventional2016-01-02Completed
Effects of Ondansetron in Obsessive-compulsive and Tic Disorders [NCT03239210]Phase 4110 participants (Actual)Interventional2017-06-16Completed
Effect of a 5-HT3 Receptor Antagonist on Respiratory Drive in Spontaneously Breathing Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS): a Pilot Proof-of-concept Crossover Non-randomized Controlled Trial [NCT05514483]Phase 410 participants (Anticipated)Interventional2022-11-10Recruiting
New Medication Treatment for Stimulant Dependence [NCT00689572]Phase 2108 participants (Actual)Interventional2008-07-31Completed
A Randomized, Double Blind, and Placebo-Controlled Trial Comparing Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult Emergency Department. [NCT00655642]171 participants (Actual)Interventional2007-03-31Terminated(stopped due to Conditional analysis showed observed differences were significantly less than power calculations)
Prevention of Postoperative Nausea and Vomiting in Surgical Patients [NCT00757822]216 participants (Actual)Interventional2009-12-31Completed
Efficacy and Safety of Multimodal Analgesia Used in Patients With Microvascular Decompression [NCT03152955]Phase 490 participants (Anticipated)Interventional2017-05-15Active, not recruiting
A Prospective Evaluation of an Anesthesia Protocol to Reduce Post-operative and Post-discharge Nausea and Vomiting in a High Risk Orthognathic Surgery Population [NCT01592708]233 participants (Actual)Interventional2012-06-30Completed
Comparative Study Between Nefopam and Ondansteron for Prevention of Post Spinal Shivering. A Randomized Controlled Trial. [NCT04870541]Phase 4150 participants (Anticipated)Interventional2020-12-01Recruiting
A Randomized Study to Determine the Efficacy and Tolerability of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients [NCT03079219]Phase 3120 participants (Actual)Interventional2017-03-23Completed
Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial [NCT05127876]Phase 4168 participants (Actual)Interventional2022-01-10Completed
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder Who Have Not Adequately Responded To [NCT01275248]Phase 2130 participants (Actual)Interventional2011-01-31Terminated(stopped due to lack of efficacy)
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy [NCT00878228]Phase 498 participants (Actual)Interventional2009-04-30Completed
Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial [NCT01510379]100 participants (Actual)Interventional2011-08-31Completed
AIM 2- Prevention of Neonatal Abstinence Syndrome [NCT01965704]Phase 2196 participants (Actual)Interventional2014-09-09Completed
Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial [NCT01912807]300 participants (Actual)Interventional2013-12-31Completed
Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial [NCT04509258]Phase 4100 participants (Anticipated)Interventional2020-10-31Not yet recruiting
Randomised, Double-blind, Dose-finding Phase II Study to Assess the Efficacy of APD403 in the Prevention of Nausea and Vomiting Caused by Cisplatin- or Anthracycline/Cyclophosphamide (AC)-Based Chemotherapy [NCT01857232]Phase 2342 participants (Actual)Interventional2013-10-31Completed
The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial. [NCT02657031]Phase 454 participants (Actual)Interventional2016-03-17Completed
Prospective Study of Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting - a Phase II Study [NCT02006056]Phase 230 participants (Actual)Interventional2013-11-30Completed
A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post Operative Nausea and Vomiting [NCT01732458]Phase 2229 participants (Actual)Interventional2013-02-12Completed
A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC o [NCT01442376]Phase 3502 participants (Actual)Interventional2011-09-30Completed
Double Blinded Study Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen [NCT02296333]Phase 480 participants (Actual)Interventional2014-05-31Completed
Comparison of Preoperative Intravenous Fluid Loading and Ondansetron in Reduction of Incidence Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study [NCT03141645]171 participants (Actual)Interventional2017-06-20Completed
A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents [NCT03475693]Early Phase 117 participants (Actual)Interventional2017-09-01Completed
Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy [NCT04468685]Phase 250 participants (Actual)Interventional2020-07-15Completed
Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI) [NCT02732015]Phase 237 participants (Actual)Interventional2016-10-12Terminated(stopped due to Terminated per PI's request)
Administration of Ondansetron With P-glycoprotein Inhibitor Tariquidar in Patients With Neuropathic Pain [NCT04603066]Phase 1/Phase 223 participants (Actual)Interventional2021-01-31Completed
A Randomised, Double-blind, Placebo-controlled, Crossover Study in Healthy Adult Subjects to Investigate the Effect of Intravenous APD421, With and Without Ondansetron, on Cardiac Conduction [NCT03583489]Phase 130 participants (Actual)Interventional2018-07-17Completed
Hepatic Cytochrome Drug Interactions in Emergency Department Patients [NCT01859715]502 participants (Actual)Interventional2012-06-30Completed
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled [NCT02468323]Phase 4150 participants (Actual)Interventional2015-10-31Completed
Randomized Controlled Trial Examining Effect Of Endotracheal Tube Intubation On Dysphagia In Children Presenting For Upper GI Endoscopy [NCT02460055]0 participants (Actual)Interventional2016-03-31Withdrawn(stopped due to no subject met enrollment criteria)
Multi-dose Oral Ondansetron For Pediatric Gastroenteritis: A Pragmatic Randomized Controlled Trial [NCT03851835]Phase 31,030 participants (Anticipated)Interventional2019-09-04Recruiting
A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomitin [NCT01697579]Phase 2240 participants (Actual)Interventional2012-12-13Completed
Effect of Ondansetron on Spinal-induced Hypotension by Using Bupivacaine -Dexmedetomidine Mixture Intrathecally for Percutaneous Nephrolithotomy [NCT04891484]Early Phase 190 participants (Actual)Interventional2021-04-01Completed
Ondansetron and the QT Interval In Adult Emergency Department Patients [NCT01759420]28 participants (Actual)Observational2012-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00149734 (1) [back to overview]P50 Sensory Gating
NCT00231777 (4) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs)
NCT00231777 (4) [back to overview]Number of Patients With Serious CAEs
NCT00231777 (4) [back to overview]Number of Patients With Drug-related CAEs
NCT00231777 (4) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs)
NCT00248547 (1) [back to overview]Number of Emesis Free Participants During the Study Period.
NCT00337727 (2) [back to overview]Number of Patients Who Reported No Vomiting
NCT00337727 (2) [back to overview]Number of Patients Who Reported Complete Response
NCT00343863 (8) [back to overview]Quality of Life
NCT00343863 (8) [back to overview]Number of Participants That Had Emesis Within 48 Hours of Chemotherapy
NCT00343863 (8) [back to overview]Number of Participants That Had First Administration of Rescue Medication Within 48 Hours
NCT00343863 (8) [back to overview]Severity of Nausea
NCT00343863 (8) [back to overview]Number of Days With Emetic Episodes and Rescue Medicines
NCT00343863 (8) [back to overview]Side Effects of Antiemetic Medications Used
NCT00343863 (8) [back to overview]Count of Patients Achieving a Complete Response
NCT00343863 (8) [back to overview]Count of Patients Achieving Complete Response
NCT00429702 (2) [back to overview]Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy
NCT00429702 (2) [back to overview]Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy
NCT00590317 (3) [back to overview]Vomiting at 0 to 120 Min.
NCT00590317 (3) [back to overview]Nausea at 0 to 120 Min
NCT00590317 (3) [back to overview]Akithisia at 0 to 120 Min
NCT00601172 (25) [back to overview]Percentage of Participants Who Received Rescue Medication
NCT00601172 (25) [back to overview]Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VAS
NCT00601172 (25) [back to overview]Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VAS
NCT00601172 (25) [back to overview]Percentage of Participants Who Vomited and/or Retched
NCT00601172 (25) [back to overview]Percentage of Participants Whose Daily Life Activities Were Impacted in the Overall Phase of Cycle 1, Assessed by Functional Living Index-Emesis (FLIE) Questionnaire
NCT00601172 (25) [back to overview]Single-dose Pharmacokinetic (PK) Parameters: Area Under the Curve (AUC) 0 to Infinity (0-∞), AUC 0 to t (0-t) and AUC 0 to 24 Hours (0-24) for Casopitant; AUC (0-t) and AUC (0-24) for Metabolites GSK525060, GSK517142 and GSK631832
NCT00601172 (25) [back to overview]Single-dose Pharmacokinetic Parameters: Maximum Observed Drug Concentration (Cmax) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832
NCT00601172 (25) [back to overview]Single-dose Pharmacokinetic Parameters: Time to Maximum Observed Drug Concentration (Tmax) and Observed Elimination Half-life (t1/2) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832
NCT00601172 (25) [back to overview]Severity of Nausea in the Overall, Acute, and Delayed Phases of Cycle 1 Assessed by a Categorical Scale
NCT00601172 (25) [back to overview]Single-dose Pharmacokinetic Parameters: Clearance (CL) for Casopitant
NCT00601172 (25) [back to overview]Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1
NCT00601172 (25) [back to overview]Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1
NCT00601172 (25) [back to overview]Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen
NCT00601172 (25) [back to overview]Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2
NCT00601172 (25) [back to overview]Single-dose Pharmacokinetic Parameters: Volume of Distribution (Vdss) for Casopitant
NCT00601172 (25) [back to overview]Time to First Anti-emetic Rescue Medication
NCT00601172 (25) [back to overview]Time to First Emetic Event
NCT00601172 (25) [back to overview]Evaluation of Vital Signs: Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
NCT00601172 (25) [back to overview]Evaluation of Vital Signs: Mean Heart Rate
NCT00601172 (25) [back to overview]Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS)
NCT00601172 (25) [back to overview]Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
NCT00601172 (25) [back to overview]Number of Participants With Clinical Chemistry Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4
NCT00601172 (25) [back to overview]Number of Participants With Hematology Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4
NCT00601172 (25) [back to overview]Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant Nausea
NCT00601172 (25) [back to overview]Percentage of Participants Who Achieved Total Control, Defined as Complete Responders Who Had no Nausea
NCT00619359 (3) [back to overview]No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)
NCT00619359 (3) [back to overview]A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).
NCT00619359 (3) [back to overview]A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).
NCT00641797 (1) [back to overview]Likert Scale for Satisfaction
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group
NCT00655642 (1) [back to overview]Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.
NCT00659945 (1) [back to overview]Number of Participants Having Post-operative Emesis and Nausea.
NCT00689572 (2) [back to overview]Cocaine Use by Urine Benzoylecgonine
NCT00689572 (2) [back to overview]Cocaine Use by Self-report
NCT00695864 (1) [back to overview]Change in Withdrawal Symptoms With Placebo and With Ondansetron
NCT00711555 (5) [back to overview]no Emesis
NCT00711555 (5) [back to overview]no Nausea
NCT00711555 (5) [back to overview]no Significant Nausea
NCT00711555 (5) [back to overview]Complete Response (Percentage of Patients)
NCT00711555 (5) [back to overview]Complete Protection
NCT00734929 (12) [back to overview]Average Nausea Score
NCT00734929 (12) [back to overview]Use of Rescue Antiemetics (24 Hours)
NCT00734929 (12) [back to overview]Use of Rescue Antiemetics (48 Hours)
NCT00734929 (12) [back to overview]Use of Rescue Antiemetics (Post OP)
NCT00734929 (12) [back to overview]Incidence of Nausea
NCT00734929 (12) [back to overview]Number of Participants With a Complete Response Rate
NCT00734929 (12) [back to overview]Time to First Vomiting
NCT00734929 (12) [back to overview]"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"
NCT00734929 (12) [back to overview]Cumulative Incidence of Emesis
NCT00734929 (12) [back to overview]Incidence of Vomiting (24 Hours)
NCT00734929 (12) [back to overview]Incidence of Vomiting (Post OP)
NCT00734929 (12) [back to overview]Number of Vomiting Episodes
NCT00757822 (8) [back to overview]Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication
NCT00757822 (8) [back to overview]Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting
NCT00757822 (8) [back to overview]Post-operative Antiemetic Use
NCT00757822 (8) [back to overview]Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure
NCT00757822 (8) [back to overview]Incidence of Postoperative Nausea and Vomiting
NCT00757822 (8) [back to overview]Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery
NCT00757822 (8) [back to overview]Post-Operative Care Unit Length of Stay (Min)
NCT00757822 (8) [back to overview]Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale
NCT00795769 (1) [back to overview]Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
NCT00818259 (8) [back to overview]Tmax for Fosaprepitant
NCT00818259 (8) [back to overview]Cmax for Fosaprepitant
NCT00818259 (8) [back to overview]Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
NCT00818259 (8) [back to overview]Apparent Terminal Half-life (t1/2) for Aprepitant
NCT00818259 (8) [back to overview]Number of Participants Experiencing Adverse Events (AEs)
NCT00818259 (8) [back to overview]Time to Cmax (Tmax) for Aprepitant
NCT00818259 (8) [back to overview]Maximum Plasma Concentration (Cmax) for Aprepitant
NCT00818259 (8) [back to overview]Number of Participants Discontinuing Study Drug Due to an AE
NCT00819039 (12) [back to overview]Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2
NCT00819039 (12) [back to overview]Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2
NCT00819039 (12) [back to overview]Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
NCT00819039 (12) [back to overview]Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
NCT00819039 (12) [back to overview]Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
NCT00819039 (12) [back to overview]Number of Participants With Vomiting Frequency in Study Part 2
NCT00819039 (12) [back to overview]Number of Participants Experiencing Adverse Events (AEs)
NCT00819039 (12) [back to overview]Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
NCT00819039 (12) [back to overview]Number of Participants Discontinuing Study Treatment Due to AEs
NCT00819039 (12) [back to overview]Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2
NCT00819039 (12) [back to overview]Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2
NCT00819039 (12) [back to overview]Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
NCT00878228 (3) [back to overview]Severity of Nausea
NCT00878228 (3) [back to overview]Incidence of Nausea
NCT00878228 (3) [back to overview]Impact of Nausea and Vomiting on Quality of Life
NCT00934180 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00934180 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00934180 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00934921 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00934921 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00934921 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00954941 (2) [back to overview]Treatment Success Rate
NCT00954941 (2) [back to overview]Participant Responses
NCT00967499 (6) [back to overview]Change From Baseline in Nausea Severity Score
NCT00967499 (6) [back to overview]Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure
NCT00967499 (6) [back to overview]Percentage of Participants With Complete Response
NCT00967499 (6) [back to overview]Percentage of Participants With Complete Control
NCT00967499 (6) [back to overview]Percentage of Participants Who Did Not Experience Any Episode of Emesis
NCT00967499 (6) [back to overview]Modified Osoba Nausea and Emesis Module Questionnaire Score
NCT00971633 (2) [back to overview]Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
NCT00971633 (2) [back to overview]Maximum Plasma Concentration (Cmax) of Ondansetron
NCT00972595 (2) [back to overview]Peak Plasma Concentration (Cmax) for Ondansetron
NCT00972595 (2) [back to overview]Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron
NCT01006707 (4) [back to overview]Brain Regions With Increases or Decreases in Amplitude of Low Frequency Fluctuations (ALFF) Associated With Ondansetron Administration
NCT01006707 (4) [back to overview]Objective Opioid Withdrawal Scale Score 15 Minutes Following Ondansetron or Placebo Administration
NCT01006707 (4) [back to overview]Subjective Opioid Withdrawal Scale (SOWS) Score 20 Minutes Following Ondansetron or Placebo Administration
NCT01006707 (4) [back to overview]Objective Opioid Withdrawal Scale Score 5 Minutes Following Ondansetron or Placebo Administration
NCT01031498 (1) [back to overview]Number of Patients With Complete Response
NCT01111851 (4) [back to overview]Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)
NCT01111851 (4) [back to overview]Brain NK1-receptor Occupancy at 120 Hours Post Dose
NCT01111851 (4) [back to overview]Brain NK1-receptor Occupancy at 24 Hours Post Dose
NCT01111851 (4) [back to overview]Brain NK1-receptor Occupancy at 48 Hours Post Dose
NCT01216410 (5) [back to overview]Intraoperative Nausea and Vomiting
NCT01216410 (5) [back to overview]Maternal Hemodynamics
NCT01216410 (5) [back to overview]Pruritus
NCT01216410 (5) [back to overview]Satisfaction
NCT01216410 (5) [back to overview]Postoperative Nausea and Vomiting (PONV)
NCT01217190 (3) [back to overview]Cmax
NCT01217190 (3) [back to overview]AUCt
NCT01217190 (3) [back to overview]AUCinf
NCT01217801 (1) [back to overview]Area Under Plasma Concentration
NCT01220167 (3) [back to overview]AUCt
NCT01220167 (3) [back to overview]Cmax
NCT01220167 (3) [back to overview]AUCinf
NCT01254877 (6) [back to overview]Alcohol-related Problems
NCT01254877 (6) [back to overview]Number of Subjects Who Discontinue Due to Side Effects
NCT01254877 (6) [back to overview]Number of Days/Week Abstinent From Alcohol
NCT01254877 (6) [back to overview]Number of Alcoholic Containing Drinks Per Drinking Day
NCT01254877 (6) [back to overview]Medication Safety
NCT01254877 (6) [back to overview]HIV Medication Adherence
NCT01362530 (4) [back to overview]Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1
NCT01362530 (4) [back to overview]Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1
NCT01362530 (4) [back to overview]Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1
NCT01362530 (4) [back to overview]Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1
NCT01370408 (8) [back to overview]Patients Who Experience First Emetic Episode Within 24 Hours
NCT01370408 (8) [back to overview]Number of Patients That Required First Administration of Rescue Medication Within 24 Hours
NCT01370408 (8) [back to overview]Number of Patients That Experience Treatment Failure Within the First 24 Hours
NCT01370408 (8) [back to overview]Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting
NCT01370408 (8) [back to overview]Complete Remission During Overall Chemotherapy Time Period
NCT01370408 (8) [back to overview]Complete Remission During Acute Phase Post-chemotherapy
NCT01370408 (8) [back to overview]Complete Control Rate for Nausea & Vomiting
NCT01370408 (8) [back to overview]Emetic Episodes
NCT01395901 (5) [back to overview]Proportion of Patients With no Vomiting
NCT01395901 (5) [back to overview]Proportion of Patients Without Emetic Episodes
NCT01395901 (5) [back to overview]Proportion of Patients Without Antiemetic Rescue Medication
NCT01395901 (5) [back to overview]Proportion of Patients With Complete Response
NCT01395901 (5) [back to overview]Proportion of Patients Without Nausea (Patient Aged > 6 Years)
NCT01442376 (2) [back to overview]Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1
NCT01442376 (2) [back to overview]Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1
NCT01450826 (4) [back to overview]Patient's Global Satisfaction With the Antiemetic Regimen
NCT01450826 (4) [back to overview]Proportion of Patients Achieving an Acute and Delayed Complete Response (CR)
NCT01450826 (4) [back to overview]Proportion of Patients Achieving Complete Control (CC)
NCT01450826 (4) [back to overview]Time to Treatment Failure
NCT01474915 (2) [back to overview]Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale
NCT01474915 (2) [back to overview]Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia
NCT01510379 (2) [back to overview]Quantify the Amounts of Phenergan Used Between the Two Groups.
NCT01510379 (2) [back to overview]Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.
NCT01536392 (2) [back to overview]Percentage of Participants With Response Rate to Anti Emetic Therapy 0-24 Hours Each Chemotherapy Cycle
NCT01536392 (2) [back to overview]Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle
NCT01549652 (12) [back to overview]Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal)
NCT01549652 (12) [back to overview]Change in Objective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)
NCT01549652 (12) [back to overview]Change in Roland-Morris Disability (RMDI) Index From Baseline (Prevention of Physical Dependence)
NCT01549652 (12) [back to overview]Change in Subjective Opioid Withdrawal Score (SOWS) From Baseline (Prevention of Opioid Withdrawal)
NCT01549652 (12) [back to overview]Change in Subjective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)
NCT01549652 (12) [back to overview]Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Opioid Withdrawal)
NCT01549652 (12) [back to overview]Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Physical Dependence)
NCT01549652 (12) [back to overview]Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Physical Dependence)
NCT01549652 (12) [back to overview]Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Physical Dependence)
NCT01549652 (12) [back to overview]Change in Roland-Morris Disability Index (RMDI) From Baseline (Prevention of Opioid Withdrawal)
NCT01549652 (12) [back to overview]Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Opioid Withdrawal)
NCT01549652 (12) [back to overview]Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Opioid Withdrawal)
NCT01592708 (5) [back to overview]Hospital Length of Stay
NCT01592708 (5) [back to overview]Post-discharge Nausea
NCT01592708 (5) [back to overview]Post-discharge Vomiting
NCT01592708 (5) [back to overview]Post-operative Nausea
NCT01592708 (5) [back to overview]Post-operative Vomiting
NCT01594749 (6) [back to overview]Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC
NCT01594749 (6) [back to overview]Percentage of Participants With Severe Infusion-site Reactions
NCT01594749 (6) [back to overview]Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC
NCT01594749 (6) [back to overview]Percentage of Participants With Infusion-site Thrombophlebitis
NCT01594749 (6) [back to overview]Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)
NCT01594749 (6) [back to overview]Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC
NCT01636947 (8) [back to overview]Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage
NCT01636947 (8) [back to overview]Percentage of Participants With No Vomiting - Acute and Delayed Stages
NCT01636947 (8) [back to overview]Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages
NCT01636947 (8) [back to overview]Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages
NCT01636947 (8) [back to overview]The Percentage of Participants With No Vomiting - Overall Stage
NCT01636947 (8) [back to overview]Percentage of Participants With One or More Clinical Adverse Event
NCT01636947 (8) [back to overview]Percentage of Participants With No Impact on Daily Life - Overall Stage
NCT01636947 (8) [back to overview]Number of Emetic Events - Overall Stage
NCT01640340 (6) [back to overview]Acute CR (Complete Response)
NCT01640340 (6) [back to overview]Use of Rescue Medication for Each Treatment Arm
NCT01640340 (6) [back to overview]Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours
NCT01640340 (6) [back to overview]Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours
NCT01640340 (6) [back to overview]Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication
NCT01640340 (6) [back to overview]Delayed CR (Complete Response)
NCT01691690 (3) [back to overview]Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
NCT01691690 (3) [back to overview]FLACC Pain Score Greater Than or Equal to 4
NCT01691690 (3) [back to overview]Time of First Opioid Analgesia in PACU
NCT01697579 (33) [back to overview]Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age
NCT01697579 (33) [back to overview]C24hr of Aprepitant in Participants 12 to 17 Years of Age
NCT01697579 (33) [back to overview]AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age
NCT01697579 (33) [back to overview]AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age
NCT01697579 (33) [back to overview]AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]C24hr of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age
NCT01697579 (33) [back to overview]Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]C24hr of Aprepitant in Participants 6 to <12 Years of Age
NCT01697579 (33) [back to overview]C48hr of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]C48hr of Aprepitant in Participants 6 to <12 Years of Age
NCT01697579 (33) [back to overview]CL/F of Aprepitant in Participants 12 to 17 Years of Age
NCT01697579 (33) [back to overview]CL/F of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]CL/F of Aprepitant in Participants 6 to <12 Years of Age
NCT01697579 (33) [back to overview]Cmax of Aprepitant in Participants 12 to 17 Years of Age
NCT01697579 (33) [back to overview]Cmax of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]Cmax of Aprepitant in Participants 6 to <12 Years of Age
NCT01697579 (33) [back to overview]Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1
NCT01697579 (33) [back to overview]Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6
NCT01697579 (33) [back to overview]t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours
NCT01697579 (33) [back to overview]t1/2 of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]t1/2 of Aprepitant in Participants 6 to <12 Years of Age
NCT01697579 (33) [back to overview]Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age
NCT01697579 (33) [back to overview]Tmax of Aprepitant in Participants 12 to 17 Years of Age
NCT01697579 (33) [back to overview]Tmax of Aprepitant in Participants 2 to <6 Years of Age
NCT01697579 (33) [back to overview]Tmax of Aprepitant in Participants 6 to <12 Years of Age
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]Percentage of Participants Discontinuing Study Due to an AE
NCT01732458 (38) [back to overview]Percentage of Participants Experiencing at Least One Adverse Event (AE)
NCT01732458 (38) [back to overview]Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group
NCT01732458 (38) [back to overview]Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group
NCT01759420 (2) [back to overview]Number of Adverse Events
NCT01759420 (2) [back to overview]Change in QTc Interval With Ondansetron Administration
NCT01801475 (2) [back to overview]Metabolic Clearance of Ondasetron
NCT01801475 (2) [back to overview]Volume of Distribution Estimated Pharmacokinetic Parameter
NCT01841606 (1) [back to overview]Change in Cardiac Output From Baseline to 20 Minutes Post-spinal
NCT01857232 (2) [back to overview]Number of Participants With CR in the Overall Phase.
NCT01857232 (2) [back to overview]Number of Participants With Delayed Phase Complete Response(CR)
NCT01859715 (2) [back to overview]Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
NCT01859715 (2) [back to overview]Adverse Drug Events
NCT01912807 (4) [back to overview]Number of Participants With Postoperative Vomiting Between 0 to 2 Hours
NCT01912807 (4) [back to overview]Number of Participants Receiving Rescue Antiemetic Medications
NCT01912807 (4) [back to overview]Number of Participants Having Delayed Home Discharge
NCT01912807 (4) [back to overview]Blood Glucose Level
NCT01965704 (4) [back to overview]Total Dose of Narcotic Required to Treat the Symptoms of NAS
NCT01965704 (4) [back to overview]Number of Participants With Neonatal Abstinence Syndrome
NCT01965704 (4) [back to overview]Length of Hospital Stay
NCT01965704 (4) [back to overview]Number of Participants Requiring Adjunctive Medication to Treat NOWS
NCT02006056 (5) [back to overview]The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
NCT02006056 (5) [back to overview]Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
NCT02006056 (5) [back to overview]Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
NCT02006056 (5) [back to overview]The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
NCT02006056 (5) [back to overview]Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
NCT02082678 (3) [back to overview]Number of Standard Drinks Per Assessment Period on Timeline Followback (TLFB)
NCT02082678 (3) [back to overview]Number of Heavy Drinking Days Per Assessment Period on Timeline Followback (TLFB)
NCT02082678 (3) [back to overview]Hamilton Rating Scale for Depression (HAMD)
NCT02106494 (5) [back to overview]Overall Complete Control Rate
NCT02106494 (5) [back to overview]Overall Complete Response Rate
NCT02106494 (5) [back to overview]Rate of No Emetic Episodes
NCT02106494 (5) [back to overview]Delayed Complete Control (CC) Rate
NCT02106494 (5) [back to overview]Delayed Phase Complete Response (CR) Rate
NCT02116530 (5) [back to overview]Frequency of Rescue Medication
NCT02116530 (5) [back to overview]Proportion of Patients With Complete Response
NCT02116530 (5) [back to overview]Median Nausea Scores
NCT02116530 (5) [back to overview]Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
NCT02116530 (5) [back to overview]Proportion of Patients With no Nausea
NCT02354703 (3) [back to overview]Drinks Per Drinking Day
NCT02354703 (3) [back to overview]Percent Drinking Days
NCT02354703 (3) [back to overview]Percent Heavy Drinking Days
NCT02456662 (1) [back to overview]Number of Participants Experiencing Symptoms
NCT02519842 (6) [back to overview]Percentage of Participants Who Experienced No Vomiting, Regardless of Rescue Medication Use, During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1
NCT02519842 (6) [back to overview]Percentage of Participants Who Experienced a Complete Response During the Acute Phase (0 to 24 Hours Post Initiation of Chemotherapy) in Cycle 1
NCT02519842 (6) [back to overview]Percentage of Participants Who Experienced One or More Adverse Events
NCT02519842 (6) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT02519842 (6) [back to overview]Percentage of Participants Who Experienced a Complete Response During the Delayed Phase (>24 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1
NCT02519842 (6) [back to overview]Percentage of Participants Who Experienced a Complete Response During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1
NCT02592707 (30) [back to overview]Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1
NCT02592707 (30) [back to overview]Maximal Uptake (%) of 177Lu-IPN01072 in Blood in Cycle 1
NCT02592707 (30) [back to overview]Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1
NCT02592707 (30) [back to overview]Disease Control Rate (DCR)
NCT02592707 (30) [back to overview]Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1
NCT02592707 (30) [back to overview]AUC of 177Lu-IPN01072 in Blood in Cycle 1
NCT02592707 (30) [back to overview]AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1
NCT02592707 (30) [back to overview]Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1
NCT02592707 (30) [back to overview]Ae (0-48h) of IPN01072 in Cycle 1
NCT02592707 (30) [back to overview]Overall Response Rate (ORR)
NCT02592707 (30) [back to overview]Progression Free Survival (PFS)
NCT02592707 (30) [back to overview]T1/2 of IPN01072 in Cycle 1
NCT02592707 (30) [back to overview]Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1
NCT02592707 (30) [back to overview]Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1
NCT02592707 (30) [back to overview]Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1
NCT02592707 (30) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
NCT02592707 (30) [back to overview]Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1
NCT02592707 (30) [back to overview]Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1
NCT02592707 (30) [back to overview]Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1
NCT02592707 (30) [back to overview]Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1
NCT02592707 (30) [back to overview]Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
NCT02592707 (30) [back to overview]Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
NCT02592707 (30) [back to overview]Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
NCT02592707 (30) [back to overview]Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit
NCT02592707 (30) [back to overview]Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit
NCT02592707 (30) [back to overview]Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1
NCT02592707 (30) [back to overview]Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1
NCT02592707 (30) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1
NCT02592707 (30) [back to overview]Number of Participants With Dose Limiting Toxicities (DLT)
NCT02592707 (30) [back to overview]Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1
NCT02601027 (6) [back to overview]Time to First Bowel Movement
NCT02601027 (6) [back to overview]Time to Ambulation
NCT02601027 (6) [back to overview]Post-operative Pain Score
NCT02601027 (6) [back to overview]Post-operative Anti-emetic Usage
NCT02601027 (6) [back to overview]Post-operative Narcotic Usage
NCT02601027 (6) [back to overview]Quality of Life Measurement
NCT02618343 (2) [back to overview]Time to Nausea Reduction by 50% by Visual Analog Scale.
NCT02618343 (2) [back to overview]Number of Subjects That Required Rescue Ondansetron
NCT02625181 (4) [back to overview]Adherence to PONV Guidelines
NCT02625181 (4) [back to overview]Time to Discharge From the Postanesthesia Care Unit (PACU)
NCT02625181 (4) [back to overview]The Number of Prophylactic Interventions for PONV
NCT02625181 (4) [back to overview]PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
NCT02657031 (5) [back to overview]Nausea
NCT02657031 (5) [back to overview]Headache Following Intervention
NCT02657031 (5) [back to overview]The Number of Participants Experiencing Vomiting
NCT02657031 (5) [back to overview]The Number of Patients Experiencing Restlessness
NCT02657031 (5) [back to overview]Anxiety
NCT02732015 (1) [back to overview]Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose
NCT02760069 (2) [back to overview]Number of Participants Who Required Rescue Anti-emetics
NCT02760069 (2) [back to overview]Nausea 100 mm Visual Analogue Scale (VAS)
NCT02901054 (1) [back to overview]CSF to Plasma Concentration Ratio
NCT02959840 (12) [back to overview]Vomiting
NCT02959840 (12) [back to overview]Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
NCT02959840 (12) [back to overview]Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
NCT02959840 (12) [back to overview]Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)
NCT02959840 (12) [back to overview]Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
NCT02959840 (12) [back to overview]Nausea
NCT02959840 (12) [back to overview]Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
NCT02959840 (12) [back to overview]Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
NCT02959840 (12) [back to overview]Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)
NCT02959840 (12) [back to overview]Overall Anesthetic Care Satisfaction
NCT02959840 (12) [back to overview]Satisfaction of Anti-emetic Treatment
NCT02959840 (12) [back to overview]Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
NCT02991456 (17) [back to overview]Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes
NCT02991456 (17) [back to overview]Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)
NCT02991456 (17) [back to overview]Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes
NCT02991456 (17) [back to overview]Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks
NCT02991456 (17) [back to overview]Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks
NCT02991456 (17) [back to overview]Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes
NCT02991456 (17) [back to overview]Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks
NCT02991456 (17) [back to overview]Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks
NCT02991456 (17) [back to overview]Week 6 Patient Satisfaction: Convenience
NCT02991456 (17) [back to overview]Week 3 Patient Satisfaction: Overall Satisfaction
NCT02991456 (17) [back to overview]Ondansetron Medication Compliance Weeks 1-3
NCT02991456 (17) [back to overview]Week 3 Patient Satisfaction: Effectiveness
NCT02991456 (17) [back to overview]Ondansetron Medication Compliance Weeks 4-6
NCT02991456 (17) [back to overview]Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events
NCT02991456 (17) [back to overview]Week 3 Patient Satisfaction: Convenience
NCT02991456 (17) [back to overview]Week 6 Patient Satisfaction: Overall Satisfaction
NCT02991456 (17) [back to overview]Week 6 Patient Satisfaction: Effectiveness
NCT03035942 (4) [back to overview]Nausea and Vomiting During PACU Staying
NCT03035942 (4) [back to overview]Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)
NCT03035942 (4) [back to overview]Number of Participants With Pruritus
NCT03035942 (4) [back to overview]Quality of Recovery
NCT03075163 (1) [back to overview]Change in Nausea Score
NCT03237611 (4) [back to overview]Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy
NCT03237611 (4) [back to overview]Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy
NCT03237611 (4) [back to overview]Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy
NCT03237611 (4) [back to overview]Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy
NCT03239210 (5) [back to overview]Change in Sensory Phenomena Scale (SPS) Score
NCT03239210 (5) [back to overview]Change in Brain Activation - Somatosensory Cortex
NCT03239210 (5) [back to overview]Change in Brain Activation - Insula Cortex
NCT03239210 (5) [back to overview]Change in Yale Global Tic Severity Scale (YGTSS) Score
NCT03239210 (5) [back to overview]Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score
NCT03262038 (4) [back to overview]Incidence of Post Operative Nausea or Vomiting
NCT03262038 (4) [back to overview]Incidence of Pruritus
NCT03262038 (4) [back to overview]Severity of Post Operative Nausea or Vomiting
NCT03262038 (4) [back to overview]Severity of Pruritus
NCT03297021 (5) [back to overview]Nausea Scale
NCT03297021 (5) [back to overview]Number of Participants With Symptoms on POD 1
NCT03297021 (5) [back to overview]Total Anesthesia Time
NCT03297021 (5) [back to overview]Number of Participants Who Needed Rescue Anti-emetics
NCT03297021 (5) [back to overview]Number of Participants With Episodes of Vomiting in the PACU
NCT03435692 (6) [back to overview]Nausea
NCT03435692 (6) [back to overview]Muscle Spasm
NCT03435692 (6) [back to overview]Maximum Pain Score
NCT03435692 (6) [back to overview]Itching
NCT03435692 (6) [back to overview]Hospital Length of Stay
NCT03435692 (6) [back to overview]Total Perioperative Morphine Equivalents
NCT03503292 (2) [back to overview]Episodes of Postoperative Nausea
NCT03503292 (2) [back to overview]Episodes of Postoperative Vomiting
NCT03578081 (5) [back to overview]Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
NCT03578081 (5) [back to overview]Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
NCT03578081 (5) [back to overview]No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
NCT03578081 (5) [back to overview]Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
NCT03578081 (5) [back to overview]Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire
NCT04557189 (17) [back to overview]Percentage of Participants With Emesis Within 24 Hours Post-Surgery
NCT04557189 (17) [back to overview]Percentage of Participants With Total Response
NCT04557189 (17) [back to overview]Percentage of Participants With Complete Response Within 24 Hours Post-Surgery
NCT04557189 (17) [back to overview]Peak Nausea Verbal Rating Scale (VRS) Score
NCT04557189 (17) [back to overview]Percentage of Participants With Markedly Abnormal Clinical Laboratory Values
NCT04557189 (17) [back to overview]Percentage of Participants With Markedly Abnormal Vital Signs
NCT04557189 (17) [back to overview]Percentage of Participants With TAK-951 Antidrug Antibodies (ADA)
NCT04557189 (17) [back to overview]TAK-951 Plasma Concentrations
NCT04557189 (17) [back to overview]TAK-951 Plasma Concentrations
NCT04557189 (17) [back to overview]Percentage of Participants With Complete Response in the Immediate Postoperative Period
NCT04557189 (17) [back to overview]Percentage of Participants With Emesis in the First 6 Hours Post-Surgery
NCT04557189 (17) [back to overview]Percentage of Participants With Clinically Significant Electrocardiogram (ECG)
NCT04557189 (17) [back to overview]Percentage of Participants With Any Treatment Emergent Adverse Event (TEAE)
NCT04557189 (17) [back to overview]Percentage of Participants With Absence of Nausea in the First 6 Hours Post-Surgery
NCT04557189 (17) [back to overview]Percentage of Participants With Absence of Nausea in the First 24 Hours Post-Surgery
NCT04557189 (17) [back to overview]Percentage of Participants Requiring Rescue Therapy for Breakthrough PONV Within 24 Hours Post-Surgery
NCT04557189 (17) [back to overview]Time From End of Surgery to First Emetic Event

P50 Sensory Gating

P50 Sensory Gating as measured by evoked potentials (response to stimuli, in this case, clicking sounds).The P50 potential was identified and measured using a computer algorithm. The amplitude of the P50 test wave was divided by the amplitude of the P50 conditioning wave, expressed as a percentage: the P50 ratio. Lower P50 ratios represent better outcomes. (NCT00149734)
Timeframe: Up to 3 hours

Interventionpercentage (Mean)
Ondansetron41.4
Placebo80.2

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Number of Patients With Laboratory Adverse Experiences (LAEs)

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. (NCT00231777)
Timeframe: Baseline and 24 hours

InterventionParticipants (Number)
MK0517 Intravenous (IV) 40 mg9
Ondansetron IV 4 mg2

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Number of Patients With Serious CAEs

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00231777)
Timeframe: Baseline and 24 hours

InterventionParticipants (Number)
MK0517 Intravenous (IV) 40 mg15
Ondansetron IV 4 mg3

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Number of Patients With Clinical Adverse Experiences (CAEs)

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00231777)
Timeframe: Baseline and 24 hours

InterventionParticipants (Number)
MK0517 Intravenous (IV) 40 mg125
Ondansetron IV 4 mg32

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Number of Emesis Free Participants During the Study Period.

To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period (NCT00248547)
Timeframe: Up to three weeks

InterventionParticipants (Number)
Aprepitant13
Placebo (Sugar Pill)5

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Number of Patients Who Reported No Vomiting

"The number of patients who reported No Vomiting in the overall phase in Cycle~1" (NCT00337727)
Timeframe: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.

InterventionParticipants (Number)
Aprepitant Regimen324
Standard Regimen252

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Number of Patients Who Reported Complete Response

The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1. (NCT00337727)
Timeframe: Overall phase (0-120 hours post initiation of MEC) in Cycle 1

InterventionParticipants (Number)
Aprepitant Regimen292
Standard Regimen229

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Quality of Life

(NCT00343863)
Timeframe: Up to 3 months

InterventionFLIE questionnaires (Count of Units)
FLIE Nausea72045916FLIE Nausea72045917FLIE Vomiting72045916FLIE Vomiting72045917
High impact (<36)Medium impact (36-54)No impact of daily life (>54)
Dexamethasone + Ondansetron IV4
Dexamethasone + Palonosetron IV44
Dexamethasone + Ondansetron IV5
Dexamethasone + Palonosetron IV74
Dexamethasone + Ondansetron IV26
Dexamethasone + Palonosetron IV248
Dexamethasone + Ondansetron IV1
Dexamethasone + Palonosetron IV10
Dexamethasone + Ondansetron IV3
Dexamethasone + Palonosetron IV9
Dexamethasone + Ondansetron IV31
Dexamethasone + Palonosetron IV347

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Number of Participants That Had Emesis Within 48 Hours of Chemotherapy

Count of patients that had emesis within 48 hours of chemotherapy (NCT00343863)
Timeframe: Up to 48 hours of chemotherapy

InterventionParticipants (Count of Participants)
Dexamethasone + Ondansetron IV0
Dexamethasone + Palonosetron IV1

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Number of Participants That Had First Administration of Rescue Medication Within 48 Hours

Count of patients that had first administration of rescue medication within 48 Hours (NCT00343863)
Timeframe: up to 48 hours of chemotherapy

InterventionParticipants (Count of Participants)
Dexamethasone + Ondansetron IV1
Dexamethasone + Palonosetron IV4

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Severity of Nausea

Count of participants with severe nausea (NCT00343863)
Timeframe: Up to 3 months

InterventionParticipants (Count of Participants)
Dexamethasone + Ondansetron IV1
Dexamethasone + Palonosetron IV4

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Number of Days With Emetic Episodes and Rescue Medicines

(NCT00343863)
Timeframe: Up to 3 months

,
Interventiondays (Median)
Vomiting during neoadjuvant chemotherapyTook rescue medicines
Dexamethasone + Ondansetron IV02
Dexamethasone + Palonosetron IV09.5

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Side Effects of Antiemetic Medications Used

(NCT00343863)
Timeframe: Up to 3 months

,
InterventionParticipants (Count of Participants)
ConstipationHeadaches
Dexamethasone + Ondansetron IV20
Dexamethasone + Palonosetron IV152

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Count of Patients Achieving a Complete Response

(NCT00343863)
Timeframe: At 0-24 hours after weekly intravenous doxorubin

InterventionParticipants (Count of Participants)
Dexamethasone + Ondansetron IV3
Dexamethasone + Palonosetron IV15

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Count of Patients Achieving Complete Response

(NCT00343863)
Timeframe: At 24-120 hours after weekly intravenous doxorubicin

InterventionParticipants (Count of Participants)
Dexamethasone + Ondansetron IV3
Dexamethasone + Palonosetron IV15

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Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy

Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference. (NCT00429702)
Timeframe: during in-patient cycle of chemotherapy, up to 4 days

Interventionparticipants (Number)
Benadryl® Ativan® Decadron® (BAD) Pump1
Control Arm Saline3

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Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy

CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference. (NCT00429702)
Timeframe: 3 days of following completion of first chemotherapy cycle

Interventionparticipants (Number)
Benadryl® Ativan® Decadron® (BAD) Pump3
Control Arm Saline4

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Vomiting at 0 to 120 Min.

(NCT00590317)
Timeframe: 0 to 120 minutes after receiving medication

Interventionnumber of participants exp vomiting (Number)
Prochlorperazine1
Ondansetron4

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Nausea at 0 to 120 Min

100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea (NCT00590317)
Timeframe: 0 to 120 minutes after receiving medication

Interventionunits on a scale (Geometric Mean)
Prochlorperazine16.8
Ondansetron34.3

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Akithisia at 0 to 120 Min

(NCT00590317)
Timeframe: 0 to 120 min after receiving medication

Interventionno. participants exp akathisia (Number)
Prochlorperazine3
Ondansetron1

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Percentage of Participants Who Received Rescue Medication

Anti-emetic rescue medication was defined as medication that was administered specifically for the treatment of nausea and/or emesis during Days 1-6 of each cycle. The choice of rescue anti-emetic medication was left to the discretion of the investigator. Participants who required antiemetic rescue medication(s) during the 120-hour assessment period were considered treatment failures for that cycle. Percentage of participants who received rescue medication are presented. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

,
InterventionPercentage of participants (Number)
0-120 hours0-24 hours24-120 hours
Casopitant 90 mg818
Placebo929

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Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VAS

VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported nausea, defined as a maximum score of >= 5 mm on the VAS are presented. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

,
InterventionPercentage of participants (Number)
0-120 hours0-24 hours24-120 hours
Casopitant 90 mg451545
Placebo371237

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Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VAS

VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported significant nausea, defined as a maximum score >= 25 mm on the VAS are presented. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

,
InterventionPercentage of participants (Number)
0-120 hours0-24 hours24-120 hours
Casopitant 90 mg21521
Placebo19419

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Percentage of Participants Who Vomited and/or Retched

Vomiting was defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit, that is not productive of gastrointestinal contents (also known as dry heaves). If a participant took rescue medication but there was no evidence of vomiting or retching, then the participant was considered as not having vomited. Percentage of participants who vomited and/or retched during the first 120 hours of the first cycle of chemotherapy are presented. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

,
InterventionPercentage of participants (Number)
0-120 hours0-24 hours24-120 hours
Casopitant 90 mg10210
Placebo11311

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Percentage of Participants Whose Daily Life Activities Were Impacted in the Overall Phase of Cycle 1, Assessed by Functional Living Index-Emesis (FLIE) Questionnaire

FLIE questionnaire specifically addresses the impact of nausea and vomiting on daily activities (physical, social and emotional function, ability to enjoy meals). It consists of 18 items with questions divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). Each item is scored on a VAS with 7 hatch marks. The scale is anchored at 1 (Not at all) and 7 (A great deal). For questions 1,2,4,5,7,8-10,12-14,16 and 17 the final score was calculated by subtracting the initial score from 100 for questions 3,6,11,15 and 18 the final score was the one provided in the dataset. The score for the nausea domain: ([sum of nausea item scores] ÷ [Number of items answered] x 9) and for vomiting domain: ([sum of vomiting item scores] ÷ [Number of items answered] x 9). The total score was the sum of the nausea and vomiting domain scores. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. (NCT00601172)
Timeframe: 0 to 120 hours in the first cycle of chemotherapy

,
InterventionPercentage of participants (Number)
Nausea impactVomiting impact
Casopitant 90 mg23.711.5
Placebo21.312.5

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Single-dose Pharmacokinetic (PK) Parameters: Area Under the Curve (AUC) 0 to Infinity (0-∞), AUC 0 to t (0-t) and AUC 0 to 24 Hours (0-24) for Casopitant; AUC (0-t) and AUC (0-24) for Metabolites GSK525060, GSK517142 and GSK631832

Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the electronic case report form (eCRF). Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. AUC(0-∞), AUC(0-t), AUC(0-24) for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented. (NCT00601172)
Timeframe: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion

InterventionHour*nanogram/milliliter (hr*ng/mL) (Geometric Mean)
Casopitant: AUC(0-24)Casopitant: AUC(0-inf)Casopitant: AUC(0-t)GSK525060: AUC(0-24)GSK525060: AUC(0-t)GSK517142: AUC(0-24)GSK517142: AUC(0-t)GSK631832: AUC(0-24)GSK631832: AUC(0-t)
Casopitant 90 mg6913.6268607.0497688.5622247.2902796.73449.96440.997165.550231.018

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Single-dose Pharmacokinetic Parameters: Maximum Observed Drug Concentration (Cmax) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832

Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the electronic case report form (eCRF). Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. (Cmax) for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented. (NCT00601172)
Timeframe: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion

InterventionNanogram/milliliter (ng/mL) (Geometric Mean)
CasopitantGSK525060GSK517142GSK631832
Casopitant 90 mg2078.776143.0383.4269.853

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Single-dose Pharmacokinetic Parameters: Time to Maximum Observed Drug Concentration (Tmax) and Observed Elimination Half-life (t1/2) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832

Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. Tmax and t1/2 for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented. (NCT00601172)
Timeframe: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion

InterventionHour (Median)
Casopitant: TmaxCasopitant: t1/2GSK525060: TmaxGSK517142: TmaxGSK631832: Tmax
Casopitant 90 mg0.52012.3473.5801.5005.500

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Severity of Nausea in the Overall, Acute, and Delayed Phases of Cycle 1 Assessed by a Categorical Scale

Participants were asked to rate the level of nausea he/she experienced over the previous (24 hours for a period of 120 hours following the administration of MEC), by placing a vertical mark on a VAS. The severity of nausea and was calculated by using a 0 - 100 VAS where 0 = No Nausea and 100 = Nausea as bad as it can be. The categorical scale assessed the participants severity of his/her nausea using the following: mild: Queasiness/upset stomach that is manageable and minimally (if at all) affects daily activities, moderate: increased queasiness, sometimes with the feeling of having to vomit/throw up (but not vomiting), that has significant negative effect on the daily activities (for example, being unable to work, eat and drink, prepare food, care for children or others) and severe: feeling sick and vomiting or feeling like you are going to vomit, and unable to perform most daily activities. Higher scores indicated worst outcome. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

InterventionParticipants (Count of Participants)
0-120 hours723799890-120 hours723799900-24 hours723799890-24 hours7237999024-120 hours7237999024-120 hours72379989
MildModerateSevereNone
Placebo218
Placebo73
Casopitant 90 mg97
Placebo49
Casopitant 90 mg54
Placebo12
Casopitant 90 mg12
Placebo313
Casopitant 90 mg299
Placebo23
Casopitant 90 mg40
Placebo13
Casopitant 90 mg15
Placebo3
Casopitant 90 mg1
Casopitant 90 mg192

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Single-dose Pharmacokinetic Parameters: Clearance (CL) for Casopitant

Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. CL for casopitant is presented. (NCT00601172)
Timeframe: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion

InterventionLiter/hour (Geometric Mean)
Casopitant 90 mg10.457

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Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1

Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the acute phase of Cycle 1 are presented. (NCT00601172)
Timeframe: 0 to 24 hours in the first cycle of chemotherapy

InterventionPercentage of participants (Number)
Placebo96
Casopitant 90 mg97

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Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1

Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the delayed phase of Cycle 1 are presented. (NCT00601172)
Timeframe: 24 to 120 hours (delayed phase) in the first cycle of chemotherapy

InterventionPercentage of participants (Number)
Placebo85
Casopitant 90 mg86

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Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen

Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase (0-120 hours) are presented. (NCT00601172)
Timeframe: 0 to 120 hours in the first cycle of chemotherapy

InterventionPercentage of participants (Number)
Placebo85
Casopitant 90 mg86

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Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2

Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase of Cycle 2 are presented. (NCT00601172)
Timeframe: 0 to 120 hours in the second cycle of chemotherapy

InterventionPercentage of participants (Number)
Placebo84
Casopitant 90 mg90

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Single-dose Pharmacokinetic Parameters: Volume of Distribution (Vdss) for Casopitant

Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. Vdss for casopitant is presented. (NCT00601172)
Timeframe: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion

InterventionLiter (Geometric Mean)
Casopitant 90 mg126.776

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Time to First Anti-emetic Rescue Medication

Time to first rescue medication was defined as the length of time from initiation of oxaliplatin till the first reported use of a rescue medication. Participants withdrawing prematurely during the 120 hour assessment period without having received a rescue medication were assumed to have done so and the time of rescue medication was set to 0 hours. The first quartile for time to use of anti-emetic rescue medication was evaluated when 25th percentile of participants of MITT population reported use of anti-emetic rescue medication. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 25th percentile of participants reported use of anti-emetic rescue medication at the end of the 120 hour time period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA). (NCT00601172)
Timeframe: 0 to 120 hours in the first cycle of chemotherapy

InterventionHours (Median)
PlaceboNA
Casopitant 90 mgNA

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Time to First Emetic Event

Time to first emetic event was defined as the length of time from initiation of oxaliplatin until the time of first emetic event. Participants withdrawing prematurely from the study without having experienced an emetic event were assumed to have done so and the time of emetic event was set to 0 hours. The first quartile for time to emetic event was evaluated when 25th percentile of participants of MITT population reported emetic event. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 25th percentile of participants reported emetic event at the end of the 120 hour time period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA). (NCT00601172)
Timeframe: 0 to 120 hours in the first cycle of chemotherapy

InterventionHours (Median)
PlaceboNA
Casopitant 90 mgNA

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Evaluation of Vital Signs: Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Vital signs assessment included DBP and SBP. SBP and DBP were recorded at Screening, on Day 1 of each cycle immediately before start of the investigational product infusion, at the completion of the infusion, and immediately after the end of the oxaliplatin infusion, then again at each end of cycle visit. Mean SBP and DBP are presented. (NCT00601172)
Timeframe: Up to End of Cycle for 6 cycles, an average of 24 days per cycle

,
InterventionMillimeters of mercury (mmHg) (Mean)
DBP: Cycle 1, post-oxaliplatinDBP: Cycle 1, End of cycleDBP: Cycle 2, post-oxaliplatinDBP: Cycle 2, End of cycleDBP: Cycle 3, post-oxaliplatinDBP: Cycle 3, End of cycleDBP: Cycle 4, post-oxaliplatinDBP: Cycle 4, End of cycleDBP: Cycle 5, post-oxaliplatinDBP: Cycle 5, End of cycleDBP: Cycle 6, post-oxaliplatinDBP: Cycle 6, End of cycleSBP: Cycle 1, post-oxaliplatinSBP: Cycle 1, End of cycleSBP: Cycle 2, post-oxaliplatinSBP: Cycle 2, End of cycleSBP: Cycle 3, post-oxaliplatinSBP: Cycle 3, End of cycleSBP: Cycle 4, post-oxaliplatinSBP: Cycle 4, End of cycleSBP: Cycle 5, post-oxaliplatinSBP: Cycle 5, End of cycleSBP: Cycle 6, post-oxaliplatinSBP: Cycle 6, End of cycle
Casopitant 90 mg76.576.576.877.176.677.276.976.477.777.777.677.5126.8126.7129.3127.8128.7127.7129.0128.3129.7128.8131.5129.1
Placebo77.276.977.776.878.077.378.276.877.477.177.977.9130.6128.7130.1128.9131.0128.8131.8128.0131.3128.6132.2129.7

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Evaluation of Vital Signs: Mean Heart Rate

Vital sign included heart rate which was recorded at Screening, on Day 1 of each cycle immediately before start of the investigational product infusion, at the completion of the infusion, and immediately after the end of the oxaliplatin infusion, then again at each end of cycle visit. Mean heart rate is presented. (NCT00601172)
Timeframe: Up to End of Cycle for 6 cycles, an average of 24 days per cycle

,
InterventionBeats/minute (Mean)
Cycle 1, post-oxaliplatinCycle 1, End of cycleCycle 2, post-oxaliplatinCycle 2, End of cycleCycle 3, post-oxaliplatinCycle 3, End of cycleCycle 4, post-oxaliplatinCycle 4, End of cycleCycle 5, post-oxaliplatinCycle 5, End of cycleCycle 6, post-oxaliplatinCycle 6, End of cycle
Casopitant 90 mg73.775.373.774.772.275.472.274.772.975.073.475.6
Placebo73.175.173.074.873.274.972.675.072.874.773.574.7

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Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS)

VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

,
InterventionScores on a Scale (Mean)
0-120 hours0-24 hours24-120 hours
Casopitant 90 mg16.05.315.3
Placebo13.54.313.0

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Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact. (NCT00601172)
Timeframe: Up to 35 days

,
InterventionParticipants (Count of Participants)
AESAE
Casopitant 90 mg17126
Placebo17623

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Number of Participants With Clinical Chemistry Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4

Grade shifts from Baseline were assessed as shift from any Grade to Grade 3 or Grade 4 in any cycle. Toxicities were graded according to the NCI-CTCAE, version 3.0. Grade refers to the severity of the toxicity. The NCI-CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. It was assessed on Baseline (Day 1), during Day 6-10 and end of cycle. Clinical chemistry parameters assessed were alanine amino transferase (ALT), aspartate amino transferase (AST), chloride, glucose, potassium, sodium and total bilirubin. Data has been presented for the number of participants with chemistry toxicity grade shifts from Baseline to toxicity grade 3 and 4 for all cycles in a consolidated format. (NCT00601172)
Timeframe: Up to Day 24

,
InterventionParticipants (Count of Participants)
ALT: All cycles, Grade 0 to 3ALT: All cycles, Grade 2 to 3AST: All cycles, Grade 0 to 3High chloride: All cycles, Grade 1 to 3Low chloride: All cycles, Grade 0 to 3Hyperglycemia: Al cycles, Grade 0 to 3Hyperglycemia: All cycles, Grade 1 to 3Hyperglycemia: All cycles, Grade 2 to 3Hyperglycemia: All cycles, Grade 3 to 3Hypoglycemia: All cycles, Grade 0 to 4Hyperkalemia: All cycles, Grade 2 to 3Hyperkalemia: All cycles, Grade 4 to 3Hyperkalemia: All cycles, Grade 0 to 3Hyperkalemia: All cycles, Grade 0 to 4Hypokalemia: All cycles, Grade 0 to 3Hyponatremia: All cycles, Grade 1 to 3Total Bilirubin: All cycles, Grade 0 to 3Total Bilirubin: All cycles, Grade 0 to 4
Casopitant 90 mg201013253100228810
Placebo110201193111006611

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Number of Participants With Hematology Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4

Grade shifts from Baseline were assessed as shift from any Grade to Grade 3 or Grade 4 in any cycle. Toxicities were graded according to the National Cancer Institute common toxicity criteria for adverse events (NCI-CTCAE), version 3.0. Grade refers to the severity of the toxicity. The NCI-CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. It was assessed on Baseline (Day 1), during Day 6-10 and end of cycle. Hematology parameters assessed were hematocrit, hemoglobin, platelet count, total neutrophils and white blood cell count. Data has been presented for the number of participants with hematology toxicity grade shifts from Baseline to toxicity grade 3 and 4 for all cycles in a consolidated format. (NCT00601172)
Timeframe: Baseline (Day 1) to Day 24

,
InterventionParticipants (Count of Participants)
Hematocrit: All cycles, Grade 2 to Grade 3Hemoglobin: All cycles, Grade 1 to Grade 3Hemoglobin: All cycles, Grade 2 to Grade 3Hemoglobin: All cycles, Grade 3 to Grade 3Platelet count: All cycles, Grade 0 to 3Total Neutrophils: All cycles, Grade 0 to 3Total Neutrophils: All cycles, Grade 1 to 3Total Neutrophils: All cycles, Grade 2 to 3White Blood Cell count: All cycles, Grade 0 to 3White Blood Cell count: All cycles, Grade 1 to 3White Blood Cell count: All cycles, Grade 2 to 3
Casopitant 90 mg101213710512
Placebo0230124011001

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Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant Nausea

Complete protection was defined as no vomiting/retching, no use of rescue medication and no significant nausea. Percentage of participants who achieved complete protection or complete responders with no significant nausea are presented. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

,
InterventionPercentage of participants (Number)
0-120 hours0-24 hours24-120 hours
Casopitant 90 mg749374
Placebo759375

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Percentage of Participants Who Achieved Total Control, Defined as Complete Responders Who Had no Nausea

Total control was defined as no vomiting/retching, no use of rescue medication and no nausea. Percentage of participants who achieved total control or complete responders with no nausea are presented. (NCT00601172)
Timeframe: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy

,
InterventionPercentage of participants (Number)
0-120 hours0-24 hours24-120 hours
Casopitant 90 mg548354
Placebo618861

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No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)

The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy. (NCT00619359)
Timeframe: Overall (the 120 hours following initiation of cisplatin chemotherapy)

InterventionParticipants (Number)
Fosaprepitant806
Aprepitant844

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A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy. (NCT00619359)
Timeframe: Overall (in the 120 hours following initiation of cisplatin chemotherapy).

InterventionParticipants (Number)
Fosaprepitant795
Aprepitant820

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A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy. (NCT00619359)
Timeframe: Delayed phase (25 to 120 hours following initiation of cisplatin).

InterventionParticipants (Number)
Fosaprepitant822
Aprepitant841

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Likert Scale for Satisfaction

The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied). (NCT00641797)
Timeframe: 0 days

Interventionunits on a scale (Mean)
Arm 1, Conventional Therapy9
Arm 2, Epley Maneuver9

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Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionug/mL*hr (Geometric Mean)
Aprepitant4.5
Control6.0

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Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionug/mL*hr (Geometric Mean)
Aprepitant3.9
Control4.0

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Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionug/mL*hr (Geometric Mean)
Aprepitant300
Control Group250

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Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionng/mL*hr (Geometric Mean)
Aprepitant4416
Control3817

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Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionng/mL*hr (Geometric Mean)
Aprepitant41
Control39

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Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionng/mL*hr (Geometric Mean)
Aprepitant287
Control265

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Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.

"Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words Least Severe on the left and Most Severe on the right. The possible values range from 0 to 100mm with 0 at the Least Severe extreme and 100 at the Most Severe extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes)." (NCT00655642)
Timeframe: Baseline and 30 minute assessments

Interventionmillimeter (Median)
Ondansetron-22.0
Metoclopramide-30.0
Promethazine-29.0
Placebo-16.0

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Number of Participants Having Post-operative Emesis and Nausea.

Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups. (NCT00659945)
Timeframe: 48 hours post surgery

Interventionparticipants (Number)
Group A(Oral Aprepitant+iv Ondansetron)7
Group B(Oral Placebo+iv Ondansetron)22

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Cocaine Use by Urine Benzoylecgonine

Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine (NCT00689572)
Timeframe: up to 9 weeks

InterventionPercent of cocaine-free urines (Mean)
Ondansetron16
Placebo26

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Cocaine Use by Self-report

Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report (NCT00689572)
Timeframe: up to 9 weeks

InterventionPercent of cocaine-free (abstinent)days (Mean)
Ondansetron67
Placebo67

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Change in Withdrawal Symptoms With Placebo and With Ondansetron

Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity. (NCT00695864)
Timeframe: Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron

InterventionPercent change (Mean)
Placebo - Sugar Pill-22.08
Ondansetron-42.71

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no Emesis

(NCT00711555)
Timeframe: cycle 1, day 1

Interventionpercentage of participants (Number)
Aprepitant, Dexamethasone, Ondansetron, Multiple Days100

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no Nausea

defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea) (NCT00711555)
Timeframe: cycle 1, day 1

Interventionpercentage of participants (Number)
Aprepitant, Dexamethasone, Ondansetron, Multiple Days74

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no Significant Nausea

defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea) (NCT00711555)
Timeframe: cycle 1, day 1

Interventionpercentage of participants (Number)
Aprepitant, Dexamethasone, Ondansetron, Multiple Days79

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Complete Response (Percentage of Patients)

defined as a no emetic episodes and no use of rescue therapy (NCT00711555)
Timeframe: cycle 1, day 1

Interventionpercentage of participants (Number)
Aprepitant, Dexamethasone, Ondansetron, Multiple Days84

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Complete Protection

defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea) (NCT00711555)
Timeframe: cycle 1, day 1

Interventionpercentage of participants (Number)
Aprepitant, Dexamethasone, Ondansetron, Multiple Days74

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Average Nausea Score

Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable (NCT00734929)
Timeframe: Post OP hours 0-2, 24 h, 48 h

,
Interventionunits on a scale (Mean)
0-2 hours post op24 hours post op48 hours post op
Aprepitant0.40.80.9
Ondansetron0.61.31.1

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Use of Rescue Antiemetics (24 Hours)

(NCT00734929)
Timeframe: 24 h

Interventionparticipants (Number)
Aprepitant31
Ondansetron30

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Use of Rescue Antiemetics (48 Hours)

(NCT00734929)
Timeframe: 48 hour

Interventionparticipants (Number)
Aprepitant33
Ondansetron32

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Use of Rescue Antiemetics (Post OP)

(NCT00734929)
Timeframe: Post OP (0 - 2 hours)

Interventionparticipants (Number)
Aprepitant20
Ondansetron24

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Incidence of Nausea

operative procedure (NCT00734929)
Timeframe: Post operative procedure (OP) hours (0-2, 24, 48)

,
Interventionparticipants (Number)
0-2 hours Post OP24 Hours Post Op48 Hours Post Op
Aprepitant273335
Ondansetron273032

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Number of Participants With a Complete Response Rate

complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics. (NCT00734929)
Timeframe: 24 hours Post OP, 48 hours Post OP

,
Interventionparticipants (Number)
24 Hours Post OP48 Hours Post OP
Aprepitant1411
Ondansetron2119

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Time to First Vomiting

(NCT00734929)
Timeframe: 48 h

Interventionhours (Median)
Aprepitant + Dexamethasone13.5
Ondansetron + Dexamethasone2

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"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"

Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied) (NCT00734929)
Timeframe: 48 hour

Interventionparticipants (Number)
Aprepitant36
Ondansetron32

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Cumulative Incidence of Emesis

Any vomiting or retching (NCT00734929)
Timeframe: 48 h

Interventionparticipants (Number)
Aprepitant8
Ondansetron20

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Incidence of Vomiting (24 Hours)

Any vomiting or retching (NCT00734929)
Timeframe: 24 h

Interventionparticipants (Number)
Aprepitant7
Ondansetron19

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Incidence of Vomiting (Post OP)

(NCT00734929)
Timeframe: Post OP (0 - 2 hours)

Interventionparticipants (Number)
Aprepitant3
Ondansetron11

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Number of Vomiting Episodes

(NCT00734929)
Timeframe: 48 hours

Interventionvomiting episodes (Mean)
Aprepitant0
Ondansetron0

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Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication

Percent of participants willing to pay extra money for preemptive medication for PONV for subsequent surgical procedures when queried at post-operative 24-48 hr. and at 2-6 wk. follow-up interviews. (NCT00757822)
Timeframe: Post-operative follow-up interviews 24 hr to 6 weeks post surgery

,
Interventionpercent of participants (Number)
24-48 hr. post-op2-6 wk post-op
Arm 1:Dronabinol8073
Arm 2:Ondansetron7068

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Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting

Percent of participants who responded that they would be willing to take preemptive medication for nausea and vomiting for subsequent surgeries when queried during post-operative follow-up interviews at 24-48 hrs or 2-6 weeks. (NCT00757822)
Timeframe: Post operative follow up interviews 24 hrs to 6 wks

,
Interventionpercent of participants (Number)
24-48 hr post-operative interview2-6 week post-operative interview
Arm 1:Dronabinol9287
Arm 2:Ondansetron8975

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Post-operative Antiemetic Use

Percentage of participants requiring post-operative anti-emetic medications.. Anti-emetic medication need was assessed during a) post-operative care unit (PACU) stay and b)during the first 48 hrs. following discharge from PACU to home or if applicable to in-patient unit. (NCT00757822)
Timeframe: End of surgery to 48 hr post surgery

,
Interventionpercentage of participants (Number)
Medication need during PACU stayMedication need for first 48 hrs after discharge t
Arm 1:Dronabinol253
Arm 2: Ondansetron174

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Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure

Number of all-cause hospital admissions on day of elective out-patient surgery . (NCT00757822)
Timeframe: Post-operative Day of Surgery (DOS)

,
Interventionparticipants (Number)
DOS admission-observationDOS admission- urinary retensionDOS admission-pain managementDOS admission- low SpO2DOS admission -intractable nausea/vomitting
Arm 1:Dronabinol34110
Arm 2: Ondnasetron33100

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Incidence of Postoperative Nausea and Vomiting

The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay. (NCT00757822)
Timeframe: Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)

,
Interventionpercentage of participants (Number)
Incidence PACU PONIncidence PACU POV
Arm 1:Dronabinol34.412.5
Arm 2:Ondansetron29.87

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Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery

Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery. (NCT00757822)
Timeframe: 24-48 hrs post surgery

,
Interventionpercentage of participants (Number)
24-48hr PON incidence24-48 hr POV incidence
Arm 1: Dronabinol23.46.3
Arm 2:Ondansetron22.83.5

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Post-Operative Care Unit Length of Stay (Min)

Length of time in PACU (minutes) measured from end of surgery to time of transfer to ambulatory care prior to home discharge or time to hospital admission if applicable. (NCT00757822)
Timeframe: Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)

Interventionminutes (Median)
Arm 1:Dronabinol99.5
Arm 2:Ondansetron97.0

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Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale

"VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting.~VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU." (NCT00757822)
Timeframe: Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit

,
Interventionpercentage of participants (Number)
No nausea (VAS score=0)Mild Nausea (VAS score=1-3)Moderate Nausea (VAS score =4-6)Severe nausea (VAS score=7-9)Extreme nausea (VAS score=10)
Arm 1: Dronabinol59.415.67.87.89.4
Arm 2:Ondansetron70.212.31.87.08.8

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Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)

Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent. (NCT00795769)
Timeframe: Baseline up to 120 minutes

InterventionParticipants (Count of Participants)
MAT score >2 on arrival and pre-ondansetronBaseline MAT score >2 prior to first ASCT infusionMAT score increases >2 by end of infusionNumber of patients that vomited
Ondansetron Therapy239129

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Tmax for Fosaprepitant

Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy. (NCT00818259)
Timeframe: Up to 72 hours post fosaprepitant dose

,
Interventionhr (Mean)
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)2 years to <6 years (n=0, 0, 0, 0, 0, 0, 7)6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)
Part IB-fosaprepitant 150 mgNANANA0.614
Part V-fosaprepitant Regimen1.131.051.04NA

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Cmax for Fosaprepitant

Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy. (NCT00818259)
Timeframe: Up to 72 hours post fosaprepitant dose

,
Interventionng/mL (Mean)
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)2 years to <6 years (n=0, 0, 0, 0, 0, 0, 8)6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)
Part IB-fosaprepitant 150 mgNANANA1310
Part V-fosaprepitant Regimen275630341654NA

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Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant

AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy. (NCT00818259)
Timeframe: Up to 24 hours post fosaprepitant/aprepitant dose

,,,,,
Interventionhr*ng/mL (Mean)
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 6)2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)6 years to <12 years (n=0, 0, 6, 6, 0, 6, 8)12 years to 17 years (n=8, 11, 0, 0, 0, 0, 0)
Part IA-fosaprepitant 115 mg/AprepitantNANANA19500
Part IB-fosaprepitant 150 mgNANANA30800
Part IIA-aprepitant 80 mg Equiv.200001640016000NA
Part IIB-aprepitant 125 mg Equiv.63102300022000NA
Part IV-aprepitant Regimen211001730024400NA
Part V-fosaprepitant Regimen117001830019500NA

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Apparent Terminal Half-life (t1/2) for Aprepitant

t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy. (NCT00818259)
Timeframe: Up to 72 hours post fosaprepitant/aprepitant dose

,,,,,
Interventionhr (Mean)
6 months to <2 years (n=0, 0, 5, 3, 0, 3, 6)2 years to <6 years (n=0, 0, 6, 4, 0, 5, 7)6 years to <12 years (n=0, 0, 5, 6, 0, 4, 8)12 years to 17 years (n=6 11, 0, 0, 0, 0, 0)
Part IA-fosaprepitant 115 mg/AprepitantNANANA11.0
Part IB-fosaprepitant 150 mgNANANA22.2
Part IIA-aprepitant 80 mg Equiv.7.288.279.17NA
Part IIB-aprepitant 125 mg Equiv.8.096.066.89NA
Part IV-aprepitant Regimen6.189.2110.8NA
Part V-fosaprepitant Regimen7.716.448.76NA

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Number of Participants Experiencing Adverse Events (AEs)

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug. (NCT00818259)
Timeframe: Up to 14 days after last dose of study drug (Up to 17 days)

InterventionParticipants (Number)
Part IA-fosaprepitant 115 mg/Aprepitant11
Part IB-fosaprepitant 150 mg6
Part IIA-aprepitant 80 mg Equiv.18
Part IIB-aprepitant 125 mg Equiv.16
Part III-ondansetron15
Part IV-aprepitant Regimen13
Part V-fosaprepitant Regimen17

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Time to Cmax (Tmax) for Aprepitant

Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy. (NCT00818259)
Timeframe: Up to 72 hours post fosaprepitant/aprepitant dose

,,,,,
Interventionhr (Mean)
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)
Part IA-fosaprepitant 115 mg/AprepitantNANANA0.41
Part IB-fosaprepitant 150 mgNANANA0.64
Part IIA-aprepitant 80 mg Equiv.2.333.785.17NA
Part IIB-aprepitant 125 mg Equiv.3.455.283.08NA
Part IV-aprepitant Regimen7.344.926.42NA
Part V-fosaprepitant Regimen1.131.411.07NA

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Maximum Plasma Concentration (Cmax) for Aprepitant

Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy. (NCT00818259)
Timeframe: Up to 72 hours post fosaprepitant/aprepitant dose

,,,,,
Interventionng/mL (Mean)
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)
Part IA-fosaprepitant 115 mg/AprepitantNANANA3240
Part IB-fosaprepitant 150 mgNANANA5870
Part IIA-aprepitant 80 mg Equiv.193013001300NA
Part IIB-aprepitant 125 mg Equiv.65921001930NA
Part IV-aprepitant Regimen181018401800NA
Part V-fosaprepitant Regimen170024302850NA

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Number of Participants Discontinuing Study Drug Due to an AE

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized. (NCT00818259)
Timeframe: Day 1 up to Day 3

InterventionParticipants (Number)
Part IA-fosaprepitant 115 mg/Aprepitant0
Part IB-fosaprepitant 150 mg0
Part IIA-aprepitant 80 mg Equiv.0
Part IIB-aprepitant 125 mg Equiv.0
Part III-ondansetron0
Part IV-aprepitant Regimen0
Part V-fosaprepitant Regimen1

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Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2

Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery. (NCT00819039)
Timeframe: Up to 48 Hours

InterventionParticipants (Number)
Part 2: Oral Aprepitant17
Part 2: Intravenous Ondansetron20

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Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2

Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery. (NCT00819039)
Timeframe: Up to 24 Hours

InterventionParticipants (Number)
Part 2: Oral Aprepitant19
Part 2: Intravenous Ondansetron20

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Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1

Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose. (NCT00819039)
Timeframe: Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose

Interventionhr*ug/ml (Mean)
6 months to <2 years (n=11)2 years to <6 years (n=11)6 years to <12 years (n=11)12 years to 17 years (n=10)
Part 1: Oral Aprepitant5.974.766.166.01

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Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1

Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that >50% of measurements were below the lower level of quantitaion (LLOQ). (NCT00819039)
Timeframe: 24 Hours Post-Dose

Interventionng/mL (Mean)
6 months to <2 years (n=11)2 years to <6 years (n=11)6 years to <12 years (n=11)12 years to 17 years (n=10)
Part 1: Oral Aprepitant31.058.651.181.1

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Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1

Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing. (NCT00819039)
Timeframe: 48 Hours Post-Dose

Interventionng/mL (Mean)
6 months to <2 years (n=11)2 years to <6 years (n=11)6 years to <12 years (n=11)12 years to 17 years (n=10)
Part 1: Oral Aprepitant715586913520

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Number of Participants With Vomiting Frequency in Study Part 2

(NCT00819039)
Timeframe: Up to 24 Hours

,
InterventionParticipants (Number)
No Vomiting1 Vomiting Episode2 Vomiting Episodes3 Vomiting Episodes>3 Vomiting Episodes
Part 2: Intravenous Ondansetron203101
Part 2: Oral Aprepitant205000

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Number of Participants Experiencing Adverse Events (AEs)

(NCT00819039)
Timeframe: Up to 21 Days Post-Surgery

InterventionParticipants (Number)
Part 1: Oral Aprepitant20
Part 2: Oral Aprepitant12
Part 2: Intravenous Ondansetron7

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Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1

Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing. (NCT00819039)
Timeframe: 48 Hours Post-Dose

InterventionHours (Median)
6 months to <2 years (n=11)2 years to <6 years (n=11)6 years to <12 years (n=11)12 years to 17 years (n=10)
Part 1: Oral Aprepitant3.003.002.003.50

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Number of Participants Discontinuing Study Treatment Due to AEs

(NCT00819039)
Timeframe: Day 1

InterventionParticipants (Number)
Part 1: Oral Aprepitant0
Part 2: Oral Aprepitant0
Part 2: Intravenous Ondansetron0

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Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2

(NCT00819039)
Timeframe: Up to 48 Hours

InterventionParticipants (Number)
Part 2: Oral Aprepitant18
Part 2: Intravenous Ondansetron20

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Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2

(NCT00819039)
Timeframe: Up to 24 Hours

InterventionParticipants (Number)
Part 2: Oral Aprepitant20
Part 2: Intravenous Ondansetron20

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Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1

The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose. (NCT00819039)
Timeframe: 48 Hours Post-Dose

Interventionng/mL (Mean)
6 months to <2 years (n=11)2 years to <6 years (n=11)6 years to <12 years (n=11)12 years to 17 years (n=10)
Part 1: Oral AprepitantNANANA7.25

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Severity of Nausea

Percentage of participants reporting moderate or severe nausea in the first 24 hours (NCT00878228)
Timeframe: Postdischarge Day 1

Interventionpercentage of participants (Number)
Study Group23
Control Group32

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Incidence of Nausea

Percentage of participants with nausea (NCT00878228)
Timeframe: Postdischarge Day 1

Interventionpercentage of participants (Number)
Study Group46
Control Group54

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Impact of Nausea and Vomiting on Quality of Life

Percentage of participants whose quality of life was impacted by nausea and vomiting (NCT00878228)
Timeframe: Postdischarge Day 1

Interventionpercentage of participants (Number)
Study Group18
Control Group30

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00934180)
Timeframe: Blood samples collected over 24 hour period

Interventionng/mL (Mean)
Ondansetron32.096
Zofran®31.753

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00934180)
Timeframe: Blood samples collected over 24 hour period

Interventionng*h/mL (Mean)
Ondansetron237.935
Zofran®237.458

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00934180)
Timeframe: Blood samples collected over 24 hour period

Interventionng*h/mL (Mean)
Ondansetron224.155
Zofran®224.692

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00934921)
Timeframe: Blood samples collected over 24 hour period

Interventionng*h/mL (Mean)
Ondansetron270.928
Zofran®276.641

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00934921)
Timeframe: Blood samples collected over 24 hour period

Interventionng/mL (Mean)
Ondansetron30.196
Zofran®30.892

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00934921)
Timeframe: Blood samples collected over 24 hour period

Interventionng*h/mL (Mean)
Ondansetron293.492
Zofran®303.106

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Treatment Success Rate

Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success. (NCT00954941)
Timeframe: First 6 treatment days

Interventionpercentage of participants (Number)
Group 1: Ondansetron48
Group 2: Ondansetron + Aprepitant51

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Participant Responses

Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring. (NCT00954941)
Timeframe: First 6 treatment days

,
Interventionparticipants (Number)
Complete ResponsePartial ResponseNo Response
Group 1: Ondansetron20913
Group 2: Ondansetron + Aprepitant21128

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Change From Baseline in Nausea Severity Score

Severity of nausea was assessed at specific time points using an 11-point NRS scale (ranging from 0-10) for evaluation of nausea severity. On the 0-10 rating scale, 0 means no nausea, 2 or 3 was mild nausea, around 5 was moderate nausea, 7 and higher was severe nausea and 10 means the worst possible nausea. Higher scores were considered as worse outcome. (NCT00967499)
Timeframe: Baseline up to 72 hours postdose

,
Interventionscore on a scale (Mean)
BaselineChange at 72 hours postdose
Ondansetron5.9-5.6
Palonosetron5.7-5.1

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Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure

(NCT00967499)
Timeframe: Up to 72 hours postdose

Interventionpercentage of participants (Number)
Palonosetron37.5
Ondansetron44.0

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Percentage of Participants With Complete Response

Complete response was defined as participants with no emetic episode and no use of rescue medication. An emetic episodic is defined as any number of retches (unproductive emesis) in a single 5-minute period; 1 or a sequence of vomits in a close succession not relieved by a period of relaxation of at least 2 minutes; or retching of less than (<) 5 minutes duration combined with a single vomit. (NCT00967499)
Timeframe: Up to 72 hours postdose

Interventionpercentage of participants (Number)
Palonosetron31.3
Ondansetron26.0

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Percentage of Participants With Complete Control

Complete control was defined as participants with no emetic episode, no rescue medication, and no more than 3 on the nausea numeric rating scale (NRS) severity score. The 11-point NRS scale (ranging from 0-10), where 0 means no nausea, 2 or 3 was mild nausea, around 5 was moderate nausea, 7 and higher was severe nausea and 10 means the worst possible nausea. Higher scores were considered as worse outcome. (NCT00967499)
Timeframe: Up to 72 hours postdose

Interventionpercentage of participants (Number)
Palonosetron25.0
Ondansetron18.0

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Percentage of Participants Who Did Not Experience Any Episode of Emesis

(NCT00967499)
Timeframe: Up to 72 hours postdose

Interventionpercentage of participants (Number)
Palonosetron70.8
Ondansetron52.0

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Modified Osoba Nausea and Emesis Module Questionnaire Score

"Modified Osoba nausea and emesis module questionnaire was used to assess the impact of nausea and emesis on functional interference at 24, 48 and 72 hours postdose. The modified Osoba questionnaire included specific questions regarding the interference of nausea and emesis in daily activities (appetite, sleep, physical activities, social life, and enjoyment of life) with respective choices. The raw score of the modified Osoba questionnaire was the arithmetic mean of the non-missing item scores, using 1 for the answer not at all, 2 for the answer a little, 3 for the answer quite a bit, and 4 for the answer very much. Raw score range from 5-20 and the total score was computed by linearly transformed the raw score to final score range as 0 to 100 by calculating ([RS-1]/range)*100, with RS being the raw score and range being 3 in this case of answers scored from 1 to 4. Lower scores indicate better quality of life." (NCT00967499)
Timeframe: 24, 48 and 72 hours postdose

,
Interventionscore on a scale (Mean)
24 Hours Postdose48 Hours Postdose72 Hours Postdose
Ondansetron12.17.06.2
Palonosetron11.36.56.7

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Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron

(NCT00971633)
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose

InterventionnM*hr (Least Squares Mean)
Treatment OE U.K. Tablet644
Treatment U.K. Tablet712
Treatment U.S. Tablet649

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Maximum Plasma Concentration (Cmax) of Ondansetron

(NCT00971633)
Timeframe: 24 hours post dose

InterventionnM (Least Squares Mean)
Treatment OE U.K. Tablet82
Treatment U.K. Tablet93
Treatment U.S. Tablet86

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Peak Plasma Concentration (Cmax) for Ondansetron

(NCT00972595)
Timeframe: 24 hours post-dose

Interventionng/mL (Least Squares Mean)
OE U.K. Tablet41.3
U.K. Tablet41.8

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Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron

(NCT00972595)
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose

Interventionng*hr/mL (Least Squares Mean)
OE U.K. Tablet257.8
U.K. Tablet262.6

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Brain Regions With Increases or Decreases in Amplitude of Low Frequency Fluctuations (ALFF) Associated With Ondansetron Administration

Changes are reporting using Spearman's correlation coefficient, using within-subject factors of time (pre-naloxone, post-naloxone) and pre-treatment (placebo, ondansetron). Changes in Objective Opioid Withdrawal Scale (OOWS) and Subjective Opioid Withdrawal Scale (SOWS) with correlation coefficient >0.45 are reported. The OOWS consists of 13 observable physical symptoms assessed over a 5-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from 0 to 13; lower scores correspond to fewer symptoms. SOWS consists of 16 physical and emotional symptoms rated by the participant on a scale from 0 (not at all) to 4 (extremely), to indicate the extent to which the symptom describes how they are feeling at the time. The total SOWS score is determined by summing the scores of the 16 items. Scores range from 0 to 64; lower scores correspond to fewer symptoms. (NCT01006707)
Timeframe: 36 minutes

Interventioncorrelation coefficient (Number)
Left inferior frontal gyrus, orbital (OOWS)Right inferior frontal gyrus, orbital (OOWS)Right superior frontal gyrus, medial (SOWS)Right inferior frontal gyrus, orbital (SOWS)Left superior temporal gyrus (OOWS)Left caudate head (SOWS)
All Ondansetron0.5190.5620.4780.486-0.6120.475

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Objective Opioid Withdrawal Scale Score 15 Minutes Following Ondansetron or Placebo Administration

The OOWS consists of 13 observable physical symptoms that are assessed over a five-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from a low of 0 to a high of 13. A score of 0 would suggest that no objective signs of withdrawal were observed while a score of 13 would suggest that every observable sign of withdrawal was observed. (NCT01006707)
Timeframe: 15 Minutes Following Ondansetron or Placebo Administration

Interventionunits on a scale (Mean)
Ondansetron2.7
Placebo2.2

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Subjective Opioid Withdrawal Scale (SOWS) Score 20 Minutes Following Ondansetron or Placebo Administration

The SOWS consists of 16 physical and emotional symptoms that are rated by the participant on a scale from 0 (not at all) to 4 (extremely), to indicate the extent to which the symptom describes how they are feeling at the time. The total SOWS score is determined by summing the scores of the 16 items. Scores range from a low of 0 to a high of 64. A score of 0 would suggest that the individual is experiencing no symptoms of withdrawal while a score of 64 would suggest that the individual is experiencing all 16 symptoms of withdrawal to the fullest extent possible. (NCT01006707)
Timeframe: 20 minutes following Ondansetron or Placebo administration

Interventionunits on a scale (Mean)
Ondansetron5.7
Placebo8.1

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Objective Opioid Withdrawal Scale Score 5 Minutes Following Ondansetron or Placebo Administration

The OOWS consists of 13 observable physical symptoms that are assessed over a five-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from a low of 0 to a high of 13. A score of 0 would suggest that no objective signs of withdrawal were observed while a score of 13 would suggest that every observable sign of withdrawal was observed. (NCT01006707)
Timeframe: 5 Minutes Following Ondansetron or Placebo Administration

Interventionunits on a scale (Mean)
Ondansetron1
Placebo2

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Number of Patients With Complete Response

Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as < or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy. (NCT01031498)
Timeframe: 7 days, starting first day of chemotherapy

Interventionparticipants (Number)
Ondansetron: Standard of Care11
Palonosetron Group 1 (5 Days)15
Palonosetron Group 2 (3 Days)18

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Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)

(NCT01111851)
Timeframe: 30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant

InterventionPercent of occupancy (Geometric Mean)
Fosaprepitant 150 mg100.25
Aprepitant 165 mg99.99

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Brain NK1-receptor Occupancy at 120 Hours Post Dose

(NCT01111851)
Timeframe: 120 hours post dose

InterventionPercent of occupancy (Geometric Mean)
Fosaprepitant 150 mg59.93
Aprepitant 165 mg54.32

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Brain NK1-receptor Occupancy at 24 Hours Post Dose

(NCT01111851)
Timeframe: 24 hours post dose

InterventionPercent of occupancy (Geometric Mean)
Fosaprepitant 150 mg100.40
Aprepitant 165 mg100.20

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Brain NK1-receptor Occupancy at 48 Hours Post Dose

(NCT01111851)
Timeframe: 48 hours post dose

InterventionPercent of occupancy (Geometric Mean)
Fosaprepitant 150 mg98.62
Aprepitant 165 mg98.79

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Intraoperative Nausea and Vomiting

Comparison of intraoperative nausea and vomiting between the 3 groups. (NCT01216410)
Timeframe: Intraoperatively

Interventionparticipants (Number)
Combination Group23
Metoclopramide31
Phenylephrine Infusion49

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Maternal Hemodynamics

The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively (NCT01216410)
Timeframe: Intraoperatively

Interventionparticipants with SBP< 20 % baseline (Number)
Combination Group16
Metoclopramide19
Phenylephrine Infusion16

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Pruritus

(NCT01216410)
Timeframe: 0-24 hrs

Interventionparticipants (Number)
Combination Group95
Metoclopramide93
Phenylephrine Infusion97

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Satisfaction

1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted. (NCT01216410)
Timeframe: 24 h

Interventionparticipants (Number)
Combination Group94
Metoclopramide85
Phenylephrine Infusion87

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Postoperative Nausea and Vomiting (PONV)

(NCT01216410)
Timeframe: 0-2h, 2-6h, 6-24h

,,
Interventionparticipants (Number)
0-2 hrs PONV2-6 hrs PONV6-24 hrs PONV
Combination Group202822
Metoclopramide333526
Phenylephrine Infusion394122

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Cmax

Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration) (NCT01217190)
Timeframe: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours

Interventionng/mL (Mean)
Ondansetron ODFS37.282
Zofran ODT41.108

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AUCt

Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (NCT01217190)
Timeframe: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours

Interventionng*hr/mL (Mean)
Ondansetron ODFS216.269
Zofran ODT239.463

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AUCinf

Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity (NCT01217190)
Timeframe: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours

Interventionnghr/mL (Mean)
Ondansetron ODFS225.032
Zofran ODT250.673

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Area Under Plasma Concentration

Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence. (NCT01217801)
Timeframe: Day 1 and Day 7

Interventionng*hr/ml (Mean)
Film213.7
Tablet225.9

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AUCt

"Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose)" (NCT01220167)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Interventionng*hr/mL (Mean)
ODFS without waterODFS with waterZofran ODT
Ondansetron ODFS With and Without Water and Zofran ODT290.687291.069285.457

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Cmax

Maximum Plasma Concentration (Time to reach maximum concentration) (NCT01220167)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Interventionng/mL (Mean)
ODFS without waterODFS with waterZofran ODT
Ondansetron ODFS With or Without Water and Zofran ODT40.86642.84339.382

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AUCinf

Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity (NCT01220167)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Interventionng*hr/mL (Mean)
ODFS without waterODFS with waterZofran ODT
Ondansetron ODFS With and Without Water and Zofran ODT311.349310.394306.497

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Number of Subjects Who Discontinue Due to Side Effects

The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects. (NCT01254877)
Timeframe: 16 weeks

InterventionParticipants (Count of Participants)
Placebo Ondansetron - Sugar Pill0
Low Dose Ondansetron (0.2 mg Bid)0
Moderate Dose Ondansetron (0.8 mg Bid)0

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Number of Days/Week Abstinent From Alcohol

The Time-line Follow-back (Sobell, Sobell, Leo & Cancilla, 1988) is used to obtain this secondary dependent measure. Alcohol use will be assessed biweekly and quantified over the 16-week medication period. Number of days/week abstinent from alcohol is calculated as the number of abstinent days divided by the number of study medication days (adjusted for days in confinement (e.g., hospitalization; jail)) and multiplied by 7. (NCT01254877)
Timeframe: 16 weeks

Interventiondays/week abstinent from alcohol (Mean)
Placebo Ondansetron - Sugar Pill4.7
Low Dose Ondansetron (0.2 mg Bid)4.9
Moderate Dose Ondansetron (0.8 mg Bid)4.8

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Number of Alcoholic Containing Drinks Per Drinking Day

The Time-line Follow-back (TLFB; Sobell, Sobell, Leo & Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period (NCT01254877)
Timeframe: 16 weeks

InterventionStandard alcohol drinks per drinking day (Mean)
Placebo Ondansetron - Sugar Pill5.9
Low Dose Ondansetron (0.2 mg Bid)6.1
Moderate Dose Ondansetron (0.8 mg Bid)5.9

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Medication Safety

Medication side-effects and adverse events were measured using the Systematic Assessment for Treatment of Emergent Events (SAFTEE). The SAFTEE contains 25 detailed questions that systematically address 29 body systems. A trained interviewer elicits information about onset, duration, pattern, and judgment of attribution. For the present trial outcome, we report number of events. (NCT01254877)
Timeframe: 16 weeks

Interventionnumber of events (Mean)
Placebo Ondansetron - Sugar Pill11.4
Low Dose Ondansetron (0.2 mg Bid)12.4
Moderate Dose Ondansetron (0.8 mg Bid)11.0

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HIV Medication Adherence

The investigators will obtain patient self reports of the number of HIV medication doses taken as a function of the total number of doses prescribed. The adherence measure is expressed as the % of prescribed doses. (NCT01254877)
Timeframe: 16 weeks

Interventionpercentage of prescribed doses (Mean)
Placebo Ondansetron - Sugar Pill92.4
Low Dose Ondansetron (0.2 mg Bid)87.6
Moderate Dose Ondansetron (0.8 mg Bid)85.4

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Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1

Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the overall phase of Cycle 1. (NCT01362530)
Timeframe: 0 to 120 hours after initiation of chemotherapy

InterventionPercentage of participants (Number)
Aprepitant Regimen46.7
Control Regimen21.3

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Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1

Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the overall phase of Cycle 1. (NCT01362530)
Timeframe: 0 to 120 hours after initiation of chemotherapy

InterventionPercentage of participants (Number)
Aprepitant Regimen40.1
Control Regimen20.0

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Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1

Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1. (NCT01362530)
Timeframe: 25 to 120 hours after the start of chemotherapy

InterventionPercentage of participants (Number)
Aprepitant Regimen50.7
Control Regimen26.0

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Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1

Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the acute phase of Cycle 1. (NCT01362530)
Timeframe: 0 to 24 hours after initiation of chemotherapy

InterventionPercentage of participants (Number)
Aprepitant Regimen66.4
Control Regimen52.0

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Patients Who Experience First Emetic Episode Within 24 Hours

Number of patients with first emetic episode experienced within 24 hours (NCT01370408)
Timeframe: 24 hours

Interventionparticipants (Number)
Palonosetron15

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Number of Patients That Required First Administration of Rescue Medication Within 24 Hours

Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours (NCT01370408)
Timeframe: 24 hours

Interventionparticipants (Number)
Palonosetron46

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Number of Patients That Experience Treatment Failure Within the First 24 Hours

Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours (NCT01370408)
Timeframe: 24 hours

Interventionparticipants (Number)
Palonosetron49

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Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting

Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy. (NCT01370408)
Timeframe: 120 hours

Interventionparticipants (Number)
Palonosetron13

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Complete Remission During Overall Chemotherapy Time Period

Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period (NCT01370408)
Timeframe: 120 hours

Interventionparticipants (Number)
Palonosetron10

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Complete Remission During Acute Phase Post-chemotherapy

Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours) (NCT01370408)
Timeframe: 24 hours

Interventionparticipants (Number)
Palonosetron33

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Complete Control Rate for Nausea & Vomiting

Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea) (NCT01370408)
Timeframe: 120 hours

Interventionparticipants (Number)
Palonosetron8

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Emetic Episodes

Number of emetic episodes (NCT01370408)
Timeframe: 120 Hours

Interventionepisodes (Mean)
Palonosetron1.7

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Proportion of Patients With no Vomiting

Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. (NCT01395901)
Timeframe: 0-24 hours after T0

Interventionpercentage of patients (Number)
Palonosetron and Placebo to Ondansetron83.1
Ondansetron and Placebo to Palonosetron87.6

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Proportion of Patients Without Emetic Episodes

An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. (NCT01395901)
Timeframe: 0-24 hours after T0

Interventionpercentage of patients (Number)
Palonosetron and Placebo to Ondansetron80.1
Ondansetron and Placebo to Palonosetron83.9

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Proportion of Patients Without Antiemetic Rescue Medication

Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. (NCT01395901)
Timeframe: 0-24 hours after T0

Interventionpercentage of patients (Number)
Palonosetron and Placebo to Ondansetron93.1
Ondansetron and Placebo to Palonosetron96.4

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Proportion of Patients With Complete Response

Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. (NCT01395901)
Timeframe: 0-24 hours after T0

Interventionpercentage of patients (Number)
Palonosetron and Placebo to Ondansetron78.2
Ondansetron and Placebo to Palonosetron82.7

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Proportion of Patients Without Nausea (Patient Aged > 6 Years)

(NCT01395901)
Timeframe: 0-24 hours after T0

Interventionpercentage of patients (Number)
Palonosetron and Placebo to Ondansetron83.2
Ondansetron and Placebo to Palonosetron82.0

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Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1

Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from >24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. (NCT01442376)
Timeframe: from >24 to 120 hours (delayed phase) after T0

Interventionpercentage of patients (Number)
Palonosetron 10 mcg/kg28.9
Palonosetron 20 mcg/kg38.8
Ondansetron28.4

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Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1

Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy. (NCT01442376)
Timeframe: 0 to 24 hours after T0

Interventionpercentage of patients (Number)
Palonosetron 10 mcg/kg54.2
Palonosetron 20 mcg/kg59.4
Ondansetron58.6

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Patient's Global Satisfaction With the Antiemetic Regimen

"Patients' global satisfaction with the antiemetic regimen is measured using the Osoba survey, which was administered on days 1-7. This survey asks patients In the past 24 hours, did vomiting or dry heaves a) interfere with your appetite, b) affect your sleep, c) interfere with your physical activities, d) interfere with your social life, and e) interfere with your enjoyment of life? Patients responded on a scale of 1-4 ranging from 'Not at all' to 'Very much.' Global satisfaction was defined as responding 'Not at all' for all questions related to vomiting/retching for each study day. The proportion of patients responding 'Not at all' for all Osoba vomiting/retching questions over the study period is reported." (NCT01450826)
Timeframe: 7 days

Interventionproportion of patients (Number)
Aprepitant+Ondansetron0.87
Ondansetron0.81

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Proportion of Patients Achieving an Acute and Delayed Complete Response (CR)

CR is the proportion of patients with no emetic episode and no rescue medication. (1) Assessed from the beginning of study day 1, CR is defined for acute CINV as no emetic episode and no use of rescue anti-nausea medication during the first 24 hours following chemotherapy administration. An emetic episode is defined as one episode of vomiting or a sequence of episodes in very close succession not relieved by a period of relaxation of at least 1 min, any number of unproductive emetic episodes (retches) in any given 5 minute period, or an episode of retching lasting <5 minutes combined with vomiting not relieved by a period of relaxation of at least 1 minute; (2) Complete response (CR) on study days 2-7 (delayed CINV) is defined as the proportion of patients achieving a CR during the delayed time period. The data will be captured by the validated ultinational Association of Supportive Care in Cancer (MASCC) Anti-emesis Tool (MAT)/Osoba survey. (NCT01450826)
Timeframe: 7 days

,
Interventionproportion of patients (Number)
Acute CINV CRDelayed CINV CR
Aprepitant+Ondansetron0.970.59
Ondansetron0.880.58

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Proportion of Patients Achieving Complete Control (CC)

Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4.0). (NCT01450826)
Timeframe: 7 days

Interventionproportion of patients (Number)
Aprepitant+Ondansetron0.59
Ondansetron0.55

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Time to Treatment Failure

Median time in days to first emetic episode or first need of rescue medication, whichever occurred first as measured by the MAT/Osoba survey, among those patients experiencing an emetic episode or need of rescue medication (NCT01450826)
Timeframe: 7 days

Interventiondays (Median)
Aprepitant+Ondansetron5
Ondansetron4

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Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale

"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during a delayed period after neurological surgery under general anesthesia.~- Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.~Nausea is evaluated by a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting is evaluated by the investigator or nursing staff numerically as either 0, no vomiting;, 1, mild vomiting;, 2, moderate vomiting;, or 3, severe vomiting." (NCT01474915)
Timeframe: 24 hours post-operatively

,
Interventionunits on a scale (Mean)
Nausea episodesVomiting episodes
Aprepitant11.5
Ondansetron11.5

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Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia

"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during the first 24 hours after neurological surgery under general anesthesia.~- Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia.~Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia.~Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia." (NCT01474915)
Timeframe: 24 hours post operatively

,
Interventionparticipants (Number)
Complete ControlComplete Response
Aprepitant3830
Ondansetron4130

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Quantify the Amounts of Phenergan Used Between the Two Groups.

(NCT01510379)
Timeframe: one week

Interventionmg (Mean)
Reletex42
Control57.6

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Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.

Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV). (NCT01510379)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Reletex1.81
Control2.03

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Percentage of Participants With Response Rate to Anti Emetic Therapy 0-24 Hours Each Chemotherapy Cycle

The response rates to anti-emetic therapy (no emetic or retching episodes and no rescue medication use) in the acute (0-24 hours) phase. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence. (NCT01536392)
Timeframe: Baseline, up to 24 hours post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks

Interventionpercentage of participants (Number)
Arm 1: Transdermal Granisetron49.8
Arm 2: Oral Ondansetron39.7

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Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle

Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence. (NCT01536392)
Timeframe: Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks

Interventionpercentage of participants (Number)
Arm 1: Transdermal Granisetron49.8
Arm 2: Oral Ondansetron39.7

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Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal)

"Originally developed by Handelsman, the Objective Opioid Withdrawal Scale (OOWS) score is a well-characterized measure of opioid withdrawal in humans, calculated as the sum of a 13-item physician assessment documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. The minimum score of 0 means the patient is not showing any signs of opioid withdrawal. The maximum score of 13 signifies all signs of opioid withdrawal to the largest extent possible.~Immediately prior to ondansetron or placebo administration a baseline OOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an OOWS score was taken. If deemed necessary by the clinician, participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an OOWS score was taken. Change from the baseline OOWS score to the score assessed following the last naloxone dose is reported." (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in OOWS (Ondansetron)Change in OOWS (Placebo)
Prevention of Opioid Withdrawal3.63.6

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Change in Objective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)

"Originally developed by Handelsman, the OOWS score is a well-characterized measure of opioid withdrawal in humans, calculated as the sum of a 13-item physician assessment documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. The maximum score is 13 and suggests the patient is showing all signs of opioid withdrawal to the largest extent possible. The minimum score of 0 suggests the patient is not showing any signs of opioid withdrawal.~Immediately prior to ondansetron or placebo administration a baseline OOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an OOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an OOWS score was taken. Change from the baseline OOWS score to the score assessed following the last naloxone dose is reported." (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in OOWS (Ondansetron)Change in OOWS (Placebo)
Prevention of Physical Dependence4.54.2

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Change in Roland-Morris Disability (RMDI) Index From Baseline (Prevention of Physical Dependence)

The Roland-Morris Disability Index is a 24-question instrument used to assess level of disability from lower back pain. Scores range from 0-24 with lower scores corresponding to fewer symptoms. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Change in RMDI (Ondansetron)Change in RMDI (Placebo)
Prevention of Physical Dependence-4.6-2.0

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Change in Subjective Opioid Withdrawal Score (SOWS) From Baseline (Prevention of Opioid Withdrawal)

The Subjective Opioid Withdrawal Score (SOWS) score is calculated as the sum of 16 subjective patient-reported symptom scores rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. A maximum score of 64 would suggest the patient is experiencing the symptoms of withdrawal to the maximum extent possible while the lowest score of 0 would suggest the patient is not experiencing any of the symptoms of withdrawal. Immediately prior to ondansetron or placebo administration a baseline SOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an SOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an SOWS score was taken. Change from the baseline SOWS score to the score assessed following the last naloxone dose is reported (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in SOWS (Ondansetron)Change in SOWS (Placebo)
Prevention of Opioid Withdrawal12.512.2

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Change in Subjective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)

The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. A maximum score of 64 would suggest the patient is experiencing the symptoms of withdrawal to the maximum extent possible while the lowest score of 0 would suggest the patient is not experiencing any of the symptoms of withdrawal. Immediately prior to ondansetron or placebo administration a baseline SOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an SOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an SOWS score was taken. Change from the baseline SOWS score to the score assessed following the last naloxone dose is reported (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in SOWS (Ondansetron)Change in SOWS (Placebo)
Prevention of Physical Dependence16.412.0

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Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Opioid Withdrawal)

Profile of Mood States (POMS) is a 65-question survey of how participants have been feeling over the past week, assessing tension, depression, anger, fatigue, confusion and vigor. Each question is on a 5-point scale: 0 (not at all) to 4 (extremely). Overall score range: 0 to 200 (lower scores corresponding to fewer symptoms), calculated by adding total scores for tension, depression, anger, fatigue and confusing, and subtracting that total score from the total score for vigor. Immediately prior to ondansetron or placebo administration a baseline POMS score was taken. 30 minutes later participants received naloxone, then 15 minutes later a POMS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an POMS score was taken. Change from the baseline POMS score to the score assessed following the last naloxone dose is reported. (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in POMS Score (Ondansetron)Change in POMS Score (Placebo)
Prevention of Opioid Withdrawal29.328.3

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Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Physical Dependence)

(Profile of Mood States) POMS is a 65-question survey of how participants have been feeling over the past week, assessing tension, depression, anger, fatigue, confusion and vigor. Each question is on a 5-point scale: 0 (not at all) to 4 (extremely). Overall score range: 0 to 200 (lower scores corresponding to fewer symptoms), calculated by adding total scores for tension, depression, anger, fatigue and confusing, and subtracting that total score from the total score for vigor. Immediately prior to ondansetron or placebo administration a baseline POMS score was taken. 30 minutes later participants received naloxone, then 15 minutes later a POMS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an POMS score was taken. Change from the baseline POMS score to the score assessed following the last naloxone dose is reported. (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in POMS (Ondansetron)Change in POMS (Placebo)
Prevention of Physical Dependence36.129.2

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Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Physical Dependence)

The VAS is a 0 to 100 millimeter scale where 0 corresponds to no pain and 100 to extreme pain, used by participants to indicated their level of pain over the last two weeks. Change is from baseline score for average level of pain (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Change in VAS Score (Ondansetron)Change in VAS Score (Placebo)
Prevention of Physical Dependence-2.9-2.8

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Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Physical Dependence)

The Beck Depression Inventory (a 21-item self-report multiple-choice inventory) yields a single summed score between 0 and 63; higher scores indicate more severe depression. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Change in BDIS (Ondansetron)Change in BDIS (Placebo)
Prevention of Physical Dependence-0.60.2

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Change in Roland-Morris Disability Index (RMDI) From Baseline (Prevention of Opioid Withdrawal)

The Roland-Morris Disability Index is a 24-question instrument used to assess level of disability from lower back pain. Scores range from 0-24 with lower scores corresponding to fewer symptoms. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Prevention of Opioid Withdrawal-2.59

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Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Opioid Withdrawal)

The VAS is a 0 to 100 millimeter scale where 0 corresponds to no pain and 100 to extreme pain, used by participants to indicated their level of pain over the last two weeks. Change is from baseline score for average level of pain (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Prevention of Opioid Withdrawal-2.68

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Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Opioid Withdrawal)

The Beck Depression Inventory (a 21-item self-report multiple-choice inventory) yields a single summed score between 0 and 63; higher scores indicate more severe depression. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Prevention of Opioid Withdrawal-0.44

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Hospital Length of Stay

Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge. (NCT01592708)
Timeframe: Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours

Interventionhours (Median)
Intervention Cohort26.4
Comparison Cohort28.2

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Post-discharge Nausea

To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital (NCT01592708)
Timeframe: 1 week from discharge from hospital

Interventionpercentage of subjects with PDN (Number)
Intervention Cohort72
Comparison Cohort60

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Post-discharge Vomiting

(NCT01592708)
Timeframe: 1 week post discharge

Interventionpercentage of subjects with PDV (Number)
Intervention Cohort22
Comparison Cohort29

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Post-operative Nausea

End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted. (NCT01592708)
Timeframe: End of surgery to discharge from hospital

Interventionpercentage of subjects with PON (Number)
Intervention Cohort24
Comparison Cohort70

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Post-operative Vomiting

(NCT01592708)
Timeframe: End of surgery to discharge from hospital

Interventionpercentage of subjects with POV (Number)
Intervention Cohort11
Comparison Cohort28

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Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC

A Complete Response was defined as no vomiting and no use of rescue medication. (NCT01594749)
Timeframe: 0 to 120 hours after initiation of MEC

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen77.1
Control Regimen66.9

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Percentage of Participants With Severe Infusion-site Reactions

The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented. (NCT01594749)
Timeframe: Day 1 through Day 17, inclusive

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen0.0
Control Regimen0.0

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Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC

No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication. (NCT01594749)
Timeframe: 0 to 120 hours after initiation of MEC

InterventionPercentage of participants (Number)
Fosaprepitant Regimen82.7
Control Regimen72.9

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Percentage of Participants With Infusion-site Thrombophlebitis

The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever. (NCT01594749)
Timeframe: Day 1 through Day 17, inclusive

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen0.6
Control Regimen0.0

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Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)

A Complete Response was defined as no vomiting and no use of rescue medication. (NCT01594749)
Timeframe: 25 to 120 hours after initiation of MEC

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen78.9
Control Regimen68.5

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Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC

A Complete Response was defined as no vomiting and no use of rescue medication. (NCT01594749)
Timeframe: 0 to 24 hours after initiation of MEC

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen93.2
Control Regimen91.0

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Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage

"Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: How much nausea have you had over the last 24 hours? The left end of the scale (0 mm) was labeled no nausea, and the right end of the scale (100 mm) is labeled nausea as bad as it could be. In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm." (NCT01636947)
Timeframe: Days 1 to Day 5

InterventionPercentage of Participants (Number)
Aprepitant Regimen76.4
Control Regimen72.4

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Percentage of Participants With No Vomiting - Acute and Delayed Stages

A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Day 1, Day 2 to Day 5

,
InterventionPercentage of Participants (Number)
Acute StageDelayed Stage
Aprepitant Regimen95.878.5
Control Regimen98.872.4

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Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages

A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

,
InterventionPercentage of Participants (Number)
Overall StageAcute StageDelayed Stage
Aprepitant Regimen73.495.874.3
Control Regimen70.497.971.2

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Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages

The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Day 1 to Day 5

,
InterventionPercentage of Participants (Number)
Overall StageAcute StageDelayed Stage
Aprepitant Regimen84.898.784.8
Control Regimen87.799.288.5

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The Percentage of Participants With No Vomiting - Overall Stage

A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC). (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

InterventionPercentage of Participants (Number)
Aprepitant Regimen77.2
Control Regimen72.0

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Percentage of Participants With One or More Clinical Adverse Event

An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event. (NCT01636947)
Timeframe: Day 1 through Day 29 (Up to 28 days after first dose of study drug)

InterventionPercentage of Participants (Number)
Aprepitant Regimen56.2
Control Regimen53.2

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Percentage of Participants With No Impact on Daily Life - Overall Stage

"The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, No Impact on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC." (NCT01636947)
Timeframe: Day 6

InterventionPercentage of Participants (Number)
Aprepitant Regimen76.8
Control Regimen73.8

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Number of Emetic Events - Overall Stage

The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented. (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

InterventionNumber of Emetic Events (Number)
Aprepitant Regimen54
Control Regimen68

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Acute CR (Complete Response)

After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours. (NCT01640340)
Timeframe: 0-24 hours after chemotherapy

Interventionpercentage of particpants (Number)
Arm A (Palonosetron 0.25 mg IV on Day 1)75
Arm B (Ondansetron 24 mg Oral on Day 1)55

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Use of Rescue Medication for Each Treatment Arm

(NCT01640340)
Timeframe: From time 0 to 120 hours

Interventionpercentage of participants (Number)
Arm A (Palonosetron 0.25 mg IV on Day 1)35
Arm B (Ondansetron 24 mg Oral on Day 1)55

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Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours

The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated. (NCT01640340)
Timeframe: From time 0 to 120 hours

Interventionpercentage of participants (Number)
Arm A (Palonosetron 0.25 mg IV on Day 1)5
Arm B (Ondansetron 24 mg Oral on Day 1)15

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Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours

The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated. (NCT01640340)
Timeframe: Time 0 to 120 hours

Interventionpercentage of participants (Number)
Arm A (Palonosetron 0.25 mg IV on Day 1)55
Arm B (Ondansetron 24 mg Oral on Day 1)65

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Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication

We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals. (NCT01640340)
Timeframe: Up to 120 hours after completion of chemotherapy

Interventionpercentage of patients (Number)
Arm A (Palonosetron 0.25 mg IV on Day 1)65
Arm B (Ondansetron 24 mg Oral on Day 1)40

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Delayed CR (Complete Response)

After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours. (NCT01640340)
Timeframe: 24-120 hours after chemotherapy

Interventionpercentage of participants (Number)
Arm A (Palonosetron 0.25 mg IV on Day 1)65
Arm B (Ondansetron 24 mg Oral on Day 1)45

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Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each

Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine. (NCT01691690)
Timeframe: 8-12 hours post-operatively

,
InterventionParticipants (Count of Participants)
hydrocodone/acetaminophenoxycodoneNSAIDSacetaminophenmorphine
IV Acetaminophen68311531
Saline Placebo Infused Intraoperatively57392220

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FLACC Pain Score Greater Than or Equal to 4

The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score >/= 4 at one or more time points. (NCT01691690)
Timeframe: 0-60 mins post-operatively

InterventionParticipants (Count of Participants)
IV Acetaminophen58
Saline Placebo69

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Time of First Opioid Analgesia in PACU

Mean time to first drug administration among patients requiring opioid analgesia in the PACU. (NCT01691690)
Timeframe: 0-90 minutes post-operatively

Interventionminutes (Mean)
IV Acetaminophen56.80
Saline Placebo Infused Intraoperatively60.46

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Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 17.94

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Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 136800

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AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 147400
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 129200
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 112000
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 14260

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C24hr of Aprepitant in Participants 12 to 17 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion. (NCT01697579)
Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Interventionng/mL (Mean)
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1735
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1142
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1101

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AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 155300
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 134300
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 110700
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 12860

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AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 130400
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 19700
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 14820

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AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 145000
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 121800
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 119700
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 11840

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Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

InterventionmL/min (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 124.2

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AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 146400
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 115300
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 116000
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 12070

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C24hr of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion. (NCT01697579)
Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 11060
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1278
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1332
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 19.23

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AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 133800
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 112300
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 13500

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Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhr•ng/mL (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 137200

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C24hr of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion. (NCT01697579)
Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 11210
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1589
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1219
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 170.4

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C48hr of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group. (NCT01697579)
Timeframe: Approximately 48 hours (from 46 to 50 hours) post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1232

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C48hr of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group. (NCT01697579)
Timeframe: Approximately 48 hours (from 46 to 50 hours) post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1164

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CL/F of Aprepitant in Participants 12 to 17 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

InterventionmL/min (Mean)
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 176.2
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 191.7
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1105

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CL/F of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

InterventionmL/min (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 131.8
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 166.2
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 129.6
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 148.5

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CL/F of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

InterventionmL/min (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 142.1
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 169.2
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 178.8
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 189.6

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Cmax of Aprepitant in Participants 12 to 17 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionng/mL (Mean)
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 13500
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 11180
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1582

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Cmax of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 14270
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 12320
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 12030
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1323

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Cmax of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 14400
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 13550
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 11360
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1507

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Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion. (NCT01697579)
Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1691

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Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group. (NCT01697579)
Timeframe: Approximately 48 hours (from 46 to 50 hours) post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1352

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Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionng/mL (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 13550

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Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. (NCT01697579)
Timeframe: Up to 14 days postdose in Cycle 1

InterventionPercentage of participants (Number)
Fosaprepitant 5 mg/Kg-Cycle 187.8
Fosaprepitant 3 mg/Kg-Cycle 183.3
Fosaprepitant 1.2 mg/Kg-Cycle 190.7
Fosaprepitant 0.4 mg/Kg-Cycle 180.0
Placebo Control-Cycle 177.1

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Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. (NCT01697579)
Timeframe: Up to 14 days postdose for each cycle (Cycles 2-6)

InterventionPercentage of participants (Number)
Fosaprepitant 5 mg/Kg-Cycles 2-693.6
Fosaprepitant 3 mg/Kg-Cycles 2-675.5

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t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 110.5
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 17.92
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 18.27

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t1/2 of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 19.27
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 16.55
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 17.27
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 16.18

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t1/2 of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 19.77
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 17.69
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 18.23
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 16.58

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Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 12.01

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Tmax of Aprepitant in Participants 12 to 17 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 10.546
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 10.722
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 10.736

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Tmax of Aprepitant in Participants 2 to <6 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 11.90
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 12.29
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 11.36
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 11.34

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Tmax of Aprepitant in Participants 6 to <12 Years of Age

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion. (NCT01697579)
Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Interventionhours (Mean)
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 12.92
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 11.99
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 12.14
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 11.68

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Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12930

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Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <21570

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Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 171340

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Percentage of Participants Discontinuing Study Due to an AE

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group. (NCT01732458)
Timeframe: From pre-operative phase up to Follow-up (Day 1 to Day 15)

Interventionpercentage of participants (Number)
Aprepitant Dose 1: Equivalent to 125 mg in Adults0
Aprepitant Dose 2: Equivalent to 40 mg in Adults0
Aprepitant Dose 3: Equivalent to 10 mg in Adults0
Ondansetron0

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Percentage of Participants Experiencing at Least One Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group. (NCT01732458)
Timeframe: From pre-operative phase up to Follow-up (Day 1 to Day 15)

Interventionpercentage of participants (Number)
Aprepitant Dose 1: Equivalent to 125 mg in Adults31.6
Aprepitant Dose 2: Equivalent to 40 mg in Adults43.6
Aprepitant Dose 3: Equivalent to 10 mg in Adults35.7
Ondansetron48.1

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Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhour (hr) (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 174.86

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Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 174.17

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Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 173.53

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Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <63.36

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Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <123.75

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Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <24.11

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Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <64.91

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Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <126.82

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Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <24.71

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Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <63.35

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Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <124.22

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Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <24.94

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Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <121870

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Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 177120

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AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17806

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AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 172570

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AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <61580

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AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <121390

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AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <21800

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AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <612000

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AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <1210300

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AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <26410

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AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <66320

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AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <124730

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AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionhr*ng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <27910

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Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17513

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Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17131

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Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6300

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Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12289

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Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2336

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Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <62260

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Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <21280

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Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL. (NCT01732458)
Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Interventionng/mL (Geometric Mean)
Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <61290

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Number of Adverse Events

The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient. All of these outcomes will be recorded for each patient during the emergency department stay which could range from 20 minutes to several hours. (NCT01759420)
Timeframe: 20 minutes to 8 hours

Interventionpercentage of patients (Number)
IV Ondansetron0

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Change in QTc Interval With Ondansetron Administration

The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. A baseline EKG will be obtained and then after drug administration an EKG will be performed every 2 minutes until 20 minutes has passed. The mean maximal QTc change will be calculated. (NCT01759420)
Timeframe: Baseline to 20 minutes

InterventionmS (Mean)
IV Ondansetron19.7

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Metabolic Clearance of Ondasetron

This is a mathematical estimation of the clearance for ondasetron as calculated by NONMEM. (NCT01801475)
Timeframe: 8 hours for women; 48 hours for neonate.

InterventionL/hr (Mean)
Women - Pregnant/Non-pregnant21.8
NeonatesNA

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Volume of Distribution Estimated Pharmacokinetic Parameter

This is an estimated pharmacokinetic parameter as calculated by NONMEM. (NCT01801475)
Timeframe: 8 hours for women; 48 hours for neonate.

InterventionLiters (Mean)
Women - Pregnant/Non-pregnant27.9
NeonatesNA

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Change in Cardiac Output From Baseline to 20 Minutes Post-spinal

Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal) (NCT01841606)
Timeframe: Baseline and 20 minutes

InterventionL/min (Mean)
Ondansetron-2.05
Placebo-1.92

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Number of Participants With CR in the Overall Phase.

CR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy) (NCT01857232)
Timeframe: 0 to 120 hours after the initiation of chemotherapy

InterventionParticipants (Count of Participants)
Control33
Placebo11
APD403 10MG21
APD403 20MG17
ADP403 40MG17

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Number of Participants With Delayed Phase Complete Response(CR)

"Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy.~The primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country." (NCT01857232)
Timeframe: 24-120 hours

InterventionParticipants (Count of Participants)
Control37
PLACEBO13
APD403 10MG27
ADP421 20MG21
APD421 40MG20

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Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users

Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED. (NCT01859715)
Timeframe: Baseline and 90 minutes

Interventionmillimeters (Mean)
Oxycodone Group7.4
Hydrocodone/Acetaminophen Group10.9
Nausea-observational Group-14.0

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Adverse Drug Events

Determine all possible adverse drug events that occurred after the study drugs were administered. (NCT01859715)
Timeframe: Duration of ED stay, <24 hours. (up to 24 hours)

Interventionparticipants (Number)
Oxycodone Group0
Hydrocodone/Acetaminophen Group0
Nausea-observational Group0

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Number of Participants With Postoperative Vomiting Between 0 to 2 Hours

"In the Post Anesthetic Care Unit (PACU) the proper data (intraoperative and recovery period) was recorded at immediate postoperative period, at 2 hours after the procedure and prior to discharge.~Parents were informed during the consent process that postoperative 24 hour follow up was going to be done over the phone by researcher." (NCT01912807)
Timeframe: 0 to 2 hr after the procedure (in PACU)

InterventionParticipants (Count of Participants)
Dextrose (D5NS) - Intervention Group11
Ondansetron - Control Group5

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Number of Participants Receiving Rescue Antiemetic Medications

"Parents were informed during the consent process that postoperative 24 hour follow up was going to be done over the phone by the researcher.~The number of participants (parents / caregivers) who answered the call was recorded, and from those the number of patients who presented the secondary outcome." (NCT01912807)
Timeframe: 2 to 24 hr after procedure

InterventionParticipants (Count of Participants)
Dextrose (D5NS) - Intervention Group15
Ondansetron - Control Group9

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Number of Participants Having Delayed Home Discharge

Data was recorder for number of patients with delays in discharge from PACU due to POV (NCT01912807)
Timeframe: Within 24 hours after the procedure

InterventionParticipants (Count of Participants)
Dextrose (D5NS) - Intervention Group2
Ondansetron - Control Group0

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Blood Glucose Level

Measuring the blood glucose level is important to ensure that administration of IV Dextrose at the dose to be used in our protocol, did not cause hyperglycemia in the participants. This measurement was done while patients were still under general anesthetic during the procedure. (NCT01912807)
Timeframe: Intraoperatively

Interventionmmol/L (Median)
Dextrose (D5NS) - Intervention Group6.3
Ondansetron - Control Group5.5

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Total Dose of Narcotic Required to Treat the Symptoms of NAS

Median dose of morphine required by neonates within 15 days of delivery. (NCT01965704)
Timeframe: 15 days

Interventionmg (Median)
Ondansetron - Neonates9.3
Placebo - Neonates11.1

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Number of Participants With Neonatal Abstinence Syndrome

The incidence of neonatal abstinence syndrome (NAS) measured as the number of neonates who need for morphine treatment for the symptoms of neonatal opioid withdrawal syndrome (NOWS) while the neonates received study medication and for the 30 days after stopping the study medication. (NCT01965704)
Timeframe: 35 days

InterventionParticipants (Count of Participants)
Ondansetron - Neonates22
Placebo - Neonates26

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Length of Hospital Stay

Severity of NAS will be measured by neonates' length of hospital stay (birth to discharge). Length of stay was calculated with 1) no maximum length, and 2) maximum length of stay capped at 15 days. All participants were included in both analyses. (NCT01965704)
Timeframe: At Day 15 and up to 64 days

,
Interventiondays (Mean)
Mean hospital stayMean hospital stay with a 15-day maximum
Ondansetron - Neonates15.59.3
Placebo - Neonates17.411.2

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Number of Participants Requiring Adjunctive Medication to Treat NOWS

Number of neonates requiring treatment with phenobarbital or clonidine. (NCT01965704)
Timeframe: 15 days

InterventionParticipants (Count of Participants)
Ondansetron - Neonates5
Placebo - Neonates5

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The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.

Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning. (NCT02006056)
Timeframe: Day 6-10 of treatment

Interventionunits on a scale (Mean)
PainDyspneaInsomniaAppetite lossConstipationOverall quality of lifePhysical functioningFatigueNausea/vomitingEmotional functioning
C15-PAL Results49.425.944.438.327.147.749.054.85.7569.2

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Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)

"Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life.~Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days.~Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?" (NCT02006056)
Timeframe: Day 3

Interventionunits on a scale (Mean)
Q2 nausea affecting leisure activitiesQ3 nausea affecting ability to do house workQ4 nausea affecting enjoyment of mealsQ5 nausea affecting enjoyment of refreshmentsQ6 nausea affecting spending time with loved onesQ7 nausea affecting daily functioningQ8 nausea imposing personal hardshipQ9 nausea imposing hardship on othersQ11 vomiting affecting leisure activitiesQ12 vomiting affecting ability to do house workQ13 vomiting affecting enjoyment of mealsQ14 vomiting affecting enjoyment of refreshmentsQ15 vomiting affecting spending time with loved onQ16 vomiting affecting daily functioningQ17 vomiting imposing personal hardshipQ18 vomiting imposing hardship on others
C15-PAL Results1.311.211.401.171.101.131.201.131.0311.031.031.031.031.071.03

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Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)

"Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life.~Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days.~Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?" (NCT02006056)
Timeframe: Day 7

Interventionunits on a scale (Mean)
Q2 nausea affecting leisure activitiesQ3 nausea affecting ability to do house workQ4 nausea affecting enjoyment of mealsQ5 nausea affecting enjoyment of refreshmentsQ6 nausea affecting spending time with loved onesQ7 nausea affecting daily functioningQ8 nausea imposing personal hardshipQ9 nausea imposing hardship on othersQ11 vomiting affecting leisure activitiesQ12 vomiting affecting ability to do house workQ13 vomiting affecting enjoyment of mealsQ14 vomiting affecting enjoyment of refreshmentsQ15 vomiting affecting spending time with loved onQ16 vomiting affecting daily functioningQ17 vomiting imposing personal hardshipQ18 vomiting imposing hardship on others
C15-PAL Results1.231.191.371.151.191.191.261.221.191.191.301.301.151.191.191.12

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The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.

Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning. (NCT02006056)
Timeframe: Day 0-5 during treatment

Interventionunits on a scale (Mean)
PainDyspneaInsomniaAppetite lossConstipationOverall quality of lifePhysical functioningFatigueNausea/vomitingEmotional functioning
C15-PAL Results50.624.134.536.827.647.749.054.85.7569.2

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Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.

"The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases.~Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline.~Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy.~Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication." (NCT02006056)
Timeframe: Day 0 - Day 10

InterventionParticipants (Count of Participants)
Acute-Nausea72035347Acute-Nausea72035348Acute-Vomiting72035347Acute-Vomiting72035348Delayed-Nausea72035347Delayed-Nausea72035348Delayed-Vomiting72035347Delayed-Vomiting72035348Combined-Nausea72035347Combined-Nausea72035348Combined-Vomiting72035347Combined-Vomiting72035348
Partial controlUncontrolledComplete control
Primary Prophylaxis21
Secondary Prophylaxis4
Primary Prophylaxis2
Primary Prophylaxis3
Primary Prophylaxis25
Primary Prophylaxis1
Secondary Prophylaxis0
Primary Prophylaxis18
Primary Prophylaxis17
Secondary Prophylaxis2
Primary Prophylaxis8
Secondary Prophylaxis1
Primary Prophylaxis0
Primary Prophylaxis7

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Number of Standard Drinks Per Assessment Period on Timeline Followback (TLFB)

The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB is interviewer-administered and asks participants to retrospectively estimate their alcohol use between each visit. The reported drinks are then converted to standard drinks based on the drink's alcohol by volume (ABV). The higher number is associated with more standard drinks and worse outcome. Values are corrected for the number of days covered in the assessment period. (NCT02082678)
Timeframe: Baseline and Week 12

,
Interventionmean number of standard drinks per week (Mean)
BaselineWeek 12
Ondansetron4.062.50
Placebo4.922.92

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Number of Heavy Drinking Days Per Assessment Period on Timeline Followback (TLFB)

The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB involves asking participants to retrospectively estimate their alcohol between each research visit. The reported drinks are then converted to heavy drinking days based on the drink's alcohol by volume (ABV) and participant's sex (male/female) - 5 drinks per day for males and 4 for females. Each day during which 4-5 drinks are consumed is counted as a heavy drinking day within a given assessment period. The reported values are corrected for days covered (divided by the number of days between each visit). The higher number is associated with more heavy drinking days and worse outcome. (NCT02082678)
Timeframe: Baseline and Week 12

,
Interventionheavy drinking days (corrected) (Mean)
BaselineWeek 12
Ondansetron0.340.17
Placebo0.450.20

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Hamilton Rating Scale for Depression (HAMD)

The Hamilton Rating Scale for Depression (HAMD) is a 17-item observer-rated measure of depressive symptomatology. HAMD is scored between 0 and 4 points, with the total score ranging from 0 to 52. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. The higher scores are associated with greater depressive symptom severity and poorer outcome. (NCT02082678)
Timeframe: Baseline and Week 12

,
Interventionscore on a scale (Mean)
BaselineWeek 12
Ondansetron13.778.52
Placebo14.238.86

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Overall Complete Control Rate

To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV. (NCT02106494)
Timeframe: 0 - 120 Hours

Interventionpercentage of participants (Number)
APF530 + Fosaprepitant + Dexamethasone54.7
Ondansetron + Fosaprepitant + Dexamethasone49.6

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Overall Complete Response Rate

To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV. (NCT02106494)
Timeframe: 0 - 120 Hours

Interventionpercentage of participants (Number)
APF530 + Fosaprepitant + Dexamethasone58.4
Ondansetron + Fosaprepitant + Dexamethasone52.9

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Rate of No Emetic Episodes

To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV. (NCT02106494)
Timeframe: 0 - 120 Hours

Interventionpercentage of participants (Number)
APF530 + Fosaprepitant + Dexamethasone82.2
Ondansetron + Fosaprepitant + Dexamethasone79.2

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Delayed Complete Control (CC) Rate

To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV. (NCT02106494)
Timeframe: 24 - 120 Hours

Interventionpercentage of participants (Number)
APF530 + Fosaprepitant + Dexamethasone60.7
Ondansetron + Fosaprepitant + Dexamethasone53.1

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Delayed Phase Complete Response (CR) Rate

Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV. (NCT02106494)
Timeframe: 24 - 120 Hours

Interventionpercentage of participants (Number)
APF530 + Fosaprepitant + Dexamethasone64.7
Ondansetron + Fosaprepitant + Dexamethasone56.6

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Frequency of Rescue Medication

Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire. (NCT02116530)
Timeframe: Day 2 to Day 6 after chemotherapy

InterventionParticipants (Count of Participants)
Day 272213840Day 272213839Day 372213839Day 372213840Day 472213839Day 472213840Day 572213840Day 572213839Day 672213839Day 672213840
More than twiceTwiceNoneOnce
Olanzapine156
Placebo117
Olanzapine21
Placebo35
Placebo19
Olanzapine2
Olanzapine158
Placebo124
Olanzapine11
Placebo24
Olanzapine7
Placebo20
Olanzapine4
Placebo10
Olanzapine141
Olanzapine16
Olanzapine10
Placebo17
Olanzapine3
Placebo11
Olanzapine145
Placebo131
Olanzapine19
Placebo23
Olanzapine5
Placebo7
Olanzapine143
Placebo130
Olanzapine12
Placebo16
Placebo14

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Proportion of Patients With Complete Response

Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire. (NCT02116530)
Timeframe: 0 to 120 hours after chemotherapy

,
Interventionpercentage of participants (Number)
0-24 hours after chemotherapy25-120 hours after chemotherapy0-120 hours after chemotherapy
Olanzapine85.766.963.6
Placebo64.652.440.6

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Median Nausea Scores

Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be). (NCT02116530)
Timeframe: Baseline and Day 2 to Day 6 after chemotherapy

,
Interventionunits on a scale (Median)
BaselineDay 2Day 3Day 4Day 5Day 6
Olanzapine000000
Placebo011111

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Proportion of Patients With no Nausea

No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy. (NCT02116530)
Timeframe: 0 to 120 hours after chemotherapy

,
Interventionpercentage of participants (Number)
0-24 hours after chemotherapy25-120 hours after chemotherapy0-120 hours after chemotherapy
Olanzapine73.842.437.3
Placebo45.325.421.9

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Drinks Per Drinking Day

self-reported number of standard drinks of alcohol (14 g alcohol) consumed per drinking day (NCT02354703)
Timeframe: 16-week treatment period

Interventiondrinks per drinking day (Mean)
Ondansetron-responsive Genotype3.70
Ondansetron--non-responsive Genotype3.60
Placebo--responsive Genotype3.37
Placebo--non-responsive Genotype3.99

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Percent Drinking Days

self-reported percentage of days on which the participant drank alcohol (NCT02354703)
Timeframe: 16-week treatment period

Interventionpercentage of drinking days (Mean)
Ondansetron--non-responsive Genotype71.92
Ondansetron-responsive Genotype67.51
Placebo--responsive Genotype68.00
Placebo--non-responsive Genotype66.84

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Percent Heavy Drinking Days

self-reported percentage of days with heavy drinking (at least 5 drinks/day for men, at least 4 drinks/day for women) (NCT02354703)
Timeframe: 16-week treatment period

Interventionpercentage of days with heavy drinking (Mean)
Ondansetron--non-responsive Genotype32.93
Ondansetron-responsive Genotype40.49
Placebo--responsive Genotype31.96
Placebo--non-responsive Genotype35.13

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Number of Participants Experiencing Symptoms

Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline (NCT02456662)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Placebo45
Ondansetron19

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Percentage of Participants Who Experienced No Vomiting, Regardless of Rescue Medication Use, During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1

Vomiting was assessed, regardless of rescue medicine use, following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. Rescue medication was permitted to alleviate symptoms of established nausea or vomiting; but not as preventive medication. The percentage of participants with no vomiting and no retching episodes in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy in Cycle 1, was calculated. (NCT02519842)
Timeframe: 0 to 120 hours post initiation of chemotherapy (up to 15 days after the dose of study drug)

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen Cycle 140.5
Control Regimen Cycle 132.4

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Percentage of Participants Who Experienced a Complete Response During the Acute Phase (0 to 24 Hours Post Initiation of Chemotherapy) in Cycle 1

Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the acute phase, defined as the time period of 0 to 24 hours post initiation of chemotherapy in Cycle 1, was calculated. (NCT02519842)
Timeframe: 0 to 24 hours post initiation of chemotherapy (up to 1 day after the dose of study drug)

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen Cycle 170.3
Control Regimen Cycle 158.8

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Percentage of Participants Who Experienced One or More Adverse Events

An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A statistical analysis was performed for Tier 2 AEs in Cycle 1 to compare the percentage of participants who received fosaprepitant regimen and experienced at least 1 Tier 2 AE compared with the percentage of participants in the control regimen. The Tier 2 endpoint included broad clinical and laboratory AE categories consisting of the percentage of participants with any AE, drug-related AE, serious AE, and AEs that are both drug-related and serious. Tier 2 AEs were not pre-specified as events of interest and inclusion in the Tier 2 analysis required that at least 4 participants in any treatment group exhibited the AE. (NCT02519842)
Timeframe: Up to 6.5 months (up to 2 weeks after last dose of study drug)

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen Cycle 189.2
Control Regimen Cycle 179.4
Fosaprepitant Regimen Cycles 2-678.2

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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A statistical analysis was performed to compare the percentage of participants who discontinued in Cycle 1 due to an AE and received fosaprepitant regimen compared with the percentage of participants who received control regimen. (NCT02519842)
Timeframe: Up to 6 months (up to last dose of study drug)

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen Cycle 15.4
Control Regimen Cycle 10.0
Fosaprepitant Regimen Cycles 2-60.0

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Percentage of Participants Who Experienced a Complete Response During the Delayed Phase (>24 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1

Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the delayed phase, defined as the time period of >24 to120 hours post initiation of chemotherapy in Cycle 1, was calculated. (NCT02519842)
Timeframe: >24 to 120 hours post initiation of chemotherapy (1 to 15 days after the dose of study drug)

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen Cycle 148.6
Control Regimen Cycle 141.2

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Percentage of Participants Who Experienced a Complete Response During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1

Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy in Cycle 1, was calculated. (NCT02519842)
Timeframe: 0 to 120 hours post initiation of chemotherapy (up to 15 days after the dose of study drug)

InterventionPercentage of Participants (Number)
Fosaprepitant Regimen Cycle 140.5
Control Regimen Cycle 132.4

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Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1

The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only. (NCT02592707)
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

InterventionL/h (Mean)
Part B: All Participants9.58

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Maximal Uptake (%) of 177Lu-IPN01072 in Blood in Cycle 1

177Lu-IPN01072 uptake in blood was evaluated on site/locally using a gamma counter calibrated for 177Lu-IPN01072 according to the dosimetry operational manual. (NCT02592707)
Timeframe: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

Interventionpercentage/liter (L) (Median)
Part A: 177Lu-IPN01072 4.5 GBq3.66
Part B Cohort 1: 177Lu-IPN01072 6 GBq2.98
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq2.77
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq3.32
All Participants3.03

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Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1

Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 for Part B only. (NCT02592707)
Timeframe: 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 in Part B

Interventionpercentage of drug excreted into urine (Mean)
Part B: All Participants52.9

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Disease Control Rate (DCR)

The DCR was defined as the percentage of participants who achieved a CR, a PR or a stable disease (SD) as BOR according to Investigator assessment RECIST version 1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. (NCT02592707)
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

Interventionpercentage of participants (Number)
Part A: 177Lu-IPN01072 4.5 GBq93.3
Part B Cohort 1: 177Lu-IPN01072 6 GBq100.0
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq100.0
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq90.0
All Participants95.0

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Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1

Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 only. (NCT02592707)
Timeframe: 0 to 6 hours, 6 to 24 hours, 24 to 48 hours post-infusion in Cycle 1 of Part A; 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part B.

InterventionMbq (Median)
Part A: 177Lu-IPN01072 4.5 GBq2586
Part B Cohort 1: 177Lu-IPN01072 6 GBq3106
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq2640
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq2621
All Participants2787

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AUC of 177Lu-IPN01072 in Blood in Cycle 1

The AUC of 177Lu-IPN01072 radioactivity in blood were computed for each administration of 177Lu-IPN01072. (NCT02592707)
Timeframe: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

InterventionMBq*hour/L (Median)
Part A: 177Lu-IPN01072 4.5 GBq623
Part B Cohort 1: 177Lu-IPN01072 6 GBq901
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq690
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq720
All Participants726

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AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1

The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only. (NCT02592707)
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

Interventionng*hour (h)/mL (Mean)
Part B: All Participants45.8

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Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1

The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only. (NCT02592707)
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

InterventionLiter (Mean)
Part B: All Participants68.7

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Ae (0-48h) of IPN01072 in Cycle 1

Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 for Part B only. (NCT02592707)
Timeframe: 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part B

Interventionmcg (Mean)
Part B: All Participants141

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Overall Response Rate (ORR)

The ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) as best overall response (BOR) according centralized to response evaluation criteria in solid tumours (RECIST) version 1.1 from investigator assessment. Participants with no tumour assessment after the start of study treatment were not evaluated. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT02592707)
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

Interventionpercentage of participants (Number)
Part A: 177Lu-IPN01072 4.5 GBq40.0
Part B Cohort 1: 177Lu-IPN01072 6 GBq16.7
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq22.2
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq40.0
All Participants32.5

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Progression Free Survival (PFS)

The PFS was defined as the time from start of study treatment until occurrence of tumour progression or death, according to Investigator assessment RECIST version 1.1. Estimation of the median was based on the Kaplan-Meier method. (NCT02592707)
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

Interventionmonths (Median)
Part A: 177Lu-IPN01072 4.5 GBq29.7
Part B Cohort 1: 177Lu-IPN01072 6 GBq21.2
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq25.1
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq11.1
All Participants28.1

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T1/2 of IPN01072 in Cycle 1

The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only. (NCT02592707)
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

Interventionhours (Mean)
Part B: All Participants6.09

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Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1

The terminal half-life was defined as the largest half-life of the decay curve of blood activity. (NCT02592707)
Timeframe: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

Interventionhours (Median)
Part A: 177Lu-IPN01072 4.5 GBq68.3
Part B Cohort 1: 177Lu-IPN01072 6 GBq109
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq123
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq145
All Participants127

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Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1

The specific absorbed dose was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Data are presented for all lesions, regardless of their anatomical localization. The organs considered for 177Lu-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. The specific absorbed dose to the lesions was the absorbed dose by the lesion (unit: Gray) divided by the injected radioactivity (unit: GBq) for each lesion selected for dosimetry evaluation. The specific absorbed dose for a given organ was the absorbed dose by this organ (unit: Gray) divided by the injected radioactivity (unit: GBq). (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

,
InterventionGray/GBq (Median)
LesionsBone marrow (image-based)Kidney (left + right)Spleen
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq6.820.08500.8800.985
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq13.50.06500.7650.805

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Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1

The specific absorbed dose was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Data are presented for all lesions, regardless of their anatomical localization. The organs considered for 177Lu-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. The specific absorbed dose to the lesions was the absorbed dose by the lesion (unit: Gray) divided by the injected radioactivity (unit: GBq) for each lesion selected for dosimetry evaluation. The specific absorbed dose for a given organ was the absorbed dose by this organ (unit: Gray) divided by the injected radioactivity (unit: GBq). (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

,,
InterventionGray/GBq (Median)
LesionsBone marrow (image-based)Kidney (left + right)LiverSpleen
All Participants5.000.09000.8790.1790.840
Part A: 177Lu-IPN01072 4.5 GBq2.560.07961.050.1860.769
Part B Cohort 1: 177Lu-IPN01072 6 GBq3.900.1350.7200.1700.945

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

AE is defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product, which did not necessarily have a causal relationship with this treatment. A serious AE (SAE) was classified as any untoward medical occurrence that at any dose results in death; AE was life threatening; required inpatient hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was an important medical event that may not result in death. TEAEs are defined as AEs that developed or worsened after start of treatment. (NCT02592707)
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, maximum of 33 months

,,,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEs
All Participants408
Part A: 177Lu-IPN01072 4.5 GBq152
Part B Cohort 1: 177Lu-IPN01072 6 GBq61
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq92
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq103

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Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1

177Lu-IPN01072 uptake in organs and lesions was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Uptake activity for organs of interest (i.e., body, bone marrow, kidney [left + right], healthy liver, and spleen) was determined. The maximal uptake in lesions was calculated for each lesion as: maximal activity divided injected activity*100. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

,,
Interventionpercentage of injected drug activity (Median)
Bone marrow (image-based)LiverKidney (left + right)SpleenAll lesions
Part B Cohort 1: 177Lu-IPN01072 6 GBq0.04204.311.761.272.36
All Participants0.03802.631.761.670.932
Part A: 177Lu-IPN01072 4.5 GBq0.04691.521.961.500.651

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Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1

177Lu-IPN01072 uptake in organs and lesions was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Uptake activity for organs of interest (i.e., body, bone marrow, kidney [left + right], healthy liver, and spleen) was determined. The maximal uptake in lesions was calculated for each lesion as: maximal activity divided injected activity*100. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

,
Interventionpercentage of injected drug activity (Median)
Bone marrow (image-based)Kidney (left + right)SpleenAll lesions
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq0.02501.601.781.18
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq0.02191.671.791.43

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Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1

The absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. The organs considered for 177LU-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. Highest absorbed dose of 177Lu-IPN01072 was calculated as described in the Dosimetry calculation procedure manual. Maximum value observed for each discernible organs across participants has been reported. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 and 144 to 168 hours post infusion in Cycle 1

,
InterventionGray (Number)
Bone marrow (image-based assay)Kidney (left + right)Spleen
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq0.505.865.90
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq0.695.074.09

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Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1

The absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. The organs considered for 177LU-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. Highest absorbed dose of 177Lu-IPN01072 was calculated as described in the Dosimetry calculation procedure manual. Maximum value observed for each discernible organs across participants has been reported. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 and 144 to 168 hours post infusion in Cycle 1

,,
InterventionGray (Number)
Bone marrow (image-based assay)Kidney (left + right)LiverSpleen
All Participants3.598.551.268.07
Part A: 177Lu-IPN01072 4.5 GBq0.978.551.268.07
Part B Cohort 1: 177Lu-IPN01072 6 GBq3.594.870.816.00

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Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

The cumulative absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycles 1 and 3

,
InterventionGray (Median)
Cycle 1: Bone marrow (image-based)Cycle 1: Kidney (left + right)Cycle 1: LiverCycle 1: SpleenCycle 3: Bone marrow (image-based)Cycle 3: Kidney (left + right)Cycle 3: LiverCycle 3: Spleen
All Participants0.4003.730.7653.451.1010.82.088.32
Part A: 177Lu-IPN01072 4.5 GBq0.3194.310.7202.881.1112.32.086.93

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Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

The cumulative absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycles 1 and 3

InterventionGray (Median)
Cycle 1: Bone marrow (image-based)Cycle 1: Kidney (left + right)Cycle 1: LiverCycle 1: SpleenCycle 3: Bone marrow (image-based)Cycle 3: Kidney (left + right)Cycle 3: Spleen
Part B Cohort 1: 177Lu-IPN01072 6 GBq0.7153.850.8104.351.489.417.58

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Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

The cumulative absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycles 1 and 3

,
InterventionGray (Median)
Cycle 1: Bone marrow (image-based)Cycle 1: Kidney (left + right)Cycle 1: SpleenCycle 3: Bone marrow (image-based)Cycle 3: Kidney (left + right)Cycle 3: Spleen
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq0.3753.254.001.098.919.21
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq0.2853.553.550.84010.18.08

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Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit

The European Organisation for Research and Treatment of Cancer (EORTC) score questionnaire (QLQ-C30) was used for QoL evaluation. Each scale in the questionnaire were scored (0 to 100) according to the EORTC recommendations in the EORTC QLQ-C30 scoring manual. The scale included a global health status, where high score for the global health status represents a high QoL. The functional scales consisted of physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, where a higher value reflects a better level of function. Nine symptoms scales included nausea and vomiting, pain, fatigue, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties, where a higher value reflects worse symptoms. Baseline was defined as the last non-missing measurement collected prior to the first dose of study drug (Day 1). (NCT02592707)
Timeframe: Baseline (Day 1) and EOCT visit (30 months)

,,,,
Interventionscore on a scale (Mean)
Global Health StatusPhysical functioningRole functioningEmotional functioningCognitive functioningSocial functioning
All Participants3.840.263.855.123.208.97
Part A: 177Lu-IPN01072 4.5 GBq1.27-2.053.8511.526.4115.38
Part B Cohort 1: 177Lu-IPN01072 6 GBq16.700.000.00-25.000.000.00
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq-6.24-0.82-0.01-4.16-6.26-2.09
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq29.1510.0012.5010.4312.5012.50

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Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit

The GI.NET21 module was intended for use among participants with gastrointestinal related (GI.- related) neuroendocrine tumours, who vary in disease stage and treatments. The module comprises 21 questions, consisting of 5 scales (endocrine symptoms, G.I. symptoms, treatment related symptom, social function, disease related worries) and 4 single items that assessed muscle /bone pain symptom, sexual function, information/communication function, and body image. Each question was quoted from 1 (not at all) to 4 (very much). Each scale in the questionnaire was scored from 0 to 100. A higher value was equivalent to worse or more problems. Baseline was defined as the last non-missing measurement collected prior to the first dose of study drug (Day 1). (NCT02592707)
Timeframe: Baseline (Day 1) and EOCT visit (30 months)

,,,,
Interventionscore on a scale (Mean)
Endocrine symptomsG. I. symptomsTreatment related symptomSocial functionDisease related worries
All Participants-2.98-3.335.28-16.67-7.06
Part A: 177Lu-IPN01072 4.5 GBq-5.12-3.585.62-19.67-8.98
Part B Cohort 1: 177Lu-IPN01072 6 GBq11.10-6.70-6.70-22.30-22.20
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq-0.002.509.01-4.153.46
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq-5.55-13.30-0.30-30.53-18.05

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Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1

The AUC of 177Lu-IPN01072 radioactivity in discernible organs were computed for each administration of 177Lu-IPN01072. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

,,
InterventionMBq*hour (Median)
Bone marrow (Image-based)Kidney (left + right)LiverSpleen
All Participants1758239111337772
Part A: 177Lu-IPN01072 4.5 GBq174959667456701
Part B Cohort 1: 177Lu-IPN01072 6 GBq3528966179187949

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Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1

The AUC of 177Lu-IPN01072 radioactivity in discernible organs were computed for each administration of 177Lu-IPN01072. (NCT02592707)
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

,
InterventionMBq*hour (Median)
Bone marrow (Image-based)Kidney (left + right)Spleen
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq13862397727
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq15775788179

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Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1

The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only. (NCT02592707)
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

Interventionhours (Median)
Part B: All Participants0.083

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Number of Participants With Dose Limiting Toxicities (DLT)

DLTs were defined as study medication-related AEs with a severity of Grade 3 or higher are considered DLT, with the exception of hair loss, lymphopenia, nonfebrile neutropenia lasting <4 weeks and thrombocytopenia lasting <4 weeks. (NCT02592707)
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to EOCT, maximum of 16 weeks.

InterventionParticipants (Count of Participants)
Part A: 177Lu-IPN01072 4.5 GBq3
Part B Cohort 1: 177Lu-IPN01072 6 GBq0
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq2
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq1
All Participants6

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Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1

The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only. (NCT02592707)
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

Interventionnanogram (ng)/milliliter (mL) (Mean)
Part B: All Participants10.7

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Time to First Bowel Movement

Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.67
Placebo1.62

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Time to Ambulation

Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.28
Placebo1.45

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Post-operative Pain Score

Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation. (NCT02601027)
Timeframe: 2 days

Interventionunits on a scale (Mean)
0.125% Bupivacaine3.76
Placebo3.96

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Post-operative Anti-emetic Usage

Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine5.14
Placebo9.93

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Post-operative Narcotic Usage

Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine139.3
Placebo169.2

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Quality of Life Measurement

Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation. (NCT02601027)
Timeframe: Pre-operative Baseline and Post-operative (2-6 months)

,
Interventionscore on a scale (Mean)
Pre-operative baselinePost-operative (2 to 6 month)
0.125% Bupivacaine97.30342.11
Placebo99.08358.00

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Time to Nausea Reduction by 50% by Visual Analog Scale.

A visual analog scale (VAS) will be utilized to determine level of nausea. The VAS scale will be utilized before enrollment, at the time of medication administration, then every 2 minutes after administration for 10 minutes. The scale is a numbered linear scale from 0-10, with 0 = no nausea and 10 = worst nausea possible (NCT02618343)
Timeframe: Baseline and up to 10 minutes

InterventionMinutes (Mean)
Isopropyl Alcohol4.3
Ondansetron Group3.5

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Number of Subjects That Required Rescue Ondansetron

We will compare the number of times that a subject required ondansetron administration after IPA administration, and the number of times ondansetron repeat dose is required in the control group. (NCT02618343)
Timeframe: 15 minutes

InterventionParticipants (Count of Participants)
Isopropyl Alcohol0
Ondansetron Group2

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Adherence to PONV Guidelines

PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case

InterventionParticipants (Count of Participants)
Baseline Measurement666
CDS Email Recommendations5260
CDS Email + Real TIme Recommenations5863

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Time to Discharge From the Postanesthesia Care Unit (PACU)

This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU

Interventionminutes (Mean)
Baseline Measurement266
CDS Email Recommendations264
CDS Email + Real TIme Recommenations266

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The Number of Prophylactic Interventions for PONV

the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case

Interventionprophylactic antiemetics administered (Mean)
Baseline Measurement2.196
CDS Email Recommendations2.176
CDS Email + Real TIme Recommenations2.129

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PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting

The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU. (NCT02625181)
Timeframe: PACU recovery period

InterventionParticipants (Count of Participants)
Baseline Measurement139
CDS Email Recommendations1323
CDS Email + Real TIme Recommenations1343

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Nausea

Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum nausea. A change of 0 mm corresponds to no change in nausea level, and a negative value indicates worsening of the nausea after the medication. (NCT02657031)
Timeframe: 0-60 minutes

Interventionmm (Mean)
Control Arm38.9
Study Arm22.9

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Headache Following Intervention

Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication. (NCT02657031)
Timeframe: 0-60 minutes

Interventionmm (Mean)
Control Arm63.5
Study Arm43.5

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The Number of Participants Experiencing Vomiting

Yes/No (NCT02657031)
Timeframe: 0-60 minutes

Interventionparticipants (Number)
Control Arm2
Study Arm3

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The Number of Patients Experiencing Restlessness

Yes/No (NCT02657031)
Timeframe: 0-60 minutes

Interventionparticipants (Number)
Control Arm3
Study Arm3

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Anxiety

Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum anxiety. A change of 0 mm corresponds to no change in anxiety level, and a negative value indicates worsening of the anxiety after the medication. (NCT02657031)
Timeframe: 0-60 minutes

Interventionmm (Mean)
Control Arm33.7
Study Arm21.2

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Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose

Complete response (CR) no emetic episodes and no rescue medications. (NCT02732015)
Timeframe: Days 1-10

InterventionParticipants (Count of Participants)
Cohort 10
Cohort 25

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Number of Participants Who Required Rescue Anti-emetics

Whether patient required rescue anti-emetics (binary variable). Measured using nurse drug administration record. (NCT02760069)
Timeframe: Study duration (up to 5 hours post intervention)

InterventionParticipants (Count of Participants)
Inhaled ISO + Oral Ondansetron11
Inhaled ISO + Oral Placebo10
Inhaled Placebo + Oral Ondansetron18

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Nausea 100 mm Visual Analogue Scale (VAS)

Full Scale Name: Nausea 100-mm visual analogue scale. Scale Construct: Measures nausea as reported by the patient Scale Range: Minimum is 0 (no nausea) to 100 (worst nausea imaginable). These values quantify, on an interval scale anchored at 0, the patient's subjective sensation of nausea. Higher values represent worse outcomes (e.g., more nausea). Patient makes a single vertical mark on a 100 mm horizontal line with 0 at the left and 100 on the right to depict their nausea. (NCT02760069)
Timeframe: 30 minutes post intervention

Interventionunits on a scale (Mean)
Inhaled ISO + Oral Ondansetron23
Inhaled ISO + Oral Placebo19
Inhaled Placebo + Oral Ondansetron42

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CSF to Plasma Concentration Ratio

CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample (NCT02901054)
Timeframe: 0-180 min from the beginning of infusion

InterventionRatio (Mean)
Open Label Infusion Ondansetron0.15

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Vomiting

The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control27
Metoclopramide, Ondansetron10
Acupressure Point P6 Stimulator8

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Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)

The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control10
Metoclopramide, Ondansetron1
Acupressure Point P6 Stimulator3

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Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)

The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control0
Metoclopramide, Ondansetron2
Acupressure Point P6 Stimulator0

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Nausea

The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control44
Metoclopramide, Ondansetron14
Acupressure Point P6 Stimulator22

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Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control33
Metoclopramide, Ondansetron7
Acupressure Point P6 Stimulator14

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Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control12
Metoclopramide, Ondansetron6
Acupressure Point P6 Stimulator5

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Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control3
Metoclopramide, Ondansetron4
Acupressure Point P6 Stimulator0

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Overall Anesthetic Care Satisfaction

Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control53
Metoclopramide, Ondansetron58
Acupressure Point P6 Stimulator56

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Satisfaction of Anti-emetic Treatment

Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control49
Metoclopramide, Ondansetron58
Acupressure Point P6 Stimulator55

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Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)

The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02959840)
Timeframe: During the surgical procedure

InterventionParticipants (Count of Participants)
Control20
Metoclopramide, Ondansetron5
Acupressure Point P6 Stimulator4

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Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes

The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing. (NCT02991456)
Timeframe: Weeks 1 and 2

Interventionproportion of participants (Number)
Sequence A0.6000
Sequence B0.6522

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Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)

The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). (NCT02991456)
Timeframe: Weeks 1 and 2

Interventionproportion of participants (Number)
Sequence A0.5717
Sequence B0.7368

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Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes

The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing. (NCT02991456)
Timeframe: Weeks 1 and 2

Interventionproportion of participants (Number)
Sequence A0.8000
Sequence B0.9565

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Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks

The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). (NCT02991456)
Timeframe: Weeks 1 and 2

Interventionproportion of participants (Number)
Sequence A0.8095
Sequence B1.0000

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Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks

The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). (NCT02991456)
Timeframe: Weeks 1-6

Interventionproportion of participants (Number)
Sequence A0.7368
Sequence B0.8947

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Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes

The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing. (NCT02991456)
Timeframe: Weeks 1 and 2

Interventionproportion of participants (Number)
Sequence A0.6000
Sequence B0.6087

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Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks

The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). (NCT02991456)
Timeframe: Weeks 1 and 2

Interventionproportion of participants (Number)
Sequence A0.6160
Sequence B0.6842

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Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks

The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). (NCT02991456)
Timeframe: Weeks 1-6

Interventionproportion of participants (Number)
Sequence A0.4737
Sequence B0.4737

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Week 6 Patient Satisfaction: Convenience

Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience. (NCT02991456)
Timeframe: Weeks 4-6

Interventionscore on a scale (Mean)
Sequence A86.11
Sequence B91.98

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Week 3 Patient Satisfaction: Overall Satisfaction

Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction. (NCT02991456)
Timeframe: Weeks 1-3

Interventionscore on a scale (Mean)
Sequence A81.88
Sequence B90.94

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Ondansetron Medication Compliance Weeks 1-3

Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3. (NCT02991456)
Timeframe: Weeks 1-3

Interventionpercentage of participants (Number)
Sequence A91.30
Sequence B100

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Week 3 Patient Satisfaction: Effectiveness

Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness. (NCT02991456)
Timeframe: Weeks 1-3

Interventionscore on a scale (Mean)
Sequence A83.60
Sequence B94.44

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Ondansetron Medication Compliance Weeks 4-6

Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6. (NCT02991456)
Timeframe: Weeks 4-6

Interventionpercentage of participants (Number)
Sequence A95
Sequence B95.24

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Week 3 Patient Satisfaction: Convenience

Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience. (NCT02991456)
Timeframe: Weeks 1-3

Interventionscore on a scale (Mean)
Sequence A85.71
Sequence B94.15

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Week 6 Patient Satisfaction: Overall Satisfaction

Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction. (NCT02991456)
Timeframe: Weeks 4-6

Interventionscore on a scale (Mean)
Sequence A81.39
Sequence B88.58

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Week 6 Patient Satisfaction: Effectiveness

Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness. (NCT02991456)
Timeframe: Weeks 4-6

Interventionscore on a scale (Mean)
Sequence A83.89
Sequence B88.27

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Nausea and Vomiting During PACU Staying

The occurrence of PONV will be registered during the PACU (NCT03035942)
Timeframe: 4h

InterventionParticipants (Count of Participants)
O Group3
D Group9
S Group9

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Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)

Pain were assessed every 15 minutes during postanesthesia care unit, where zero meant no pain and 10 the worst imaginable pain (higher values represent worse outcome). Twenty four hours after surgery, patients were asked to describe the highest pain score (NRS) during ward stay. (NCT03035942)
Timeframe: 24 hours

InterventionScore on a scale (NRS) (Median)
D Group0
O Group5
S Group2

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Number of Participants With Pruritus

The occurrence of localized or generalized itching (patients who answered yes or no) (NCT03035942)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
O Group4
D Group7
S Group8

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Quality of Recovery

Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome (NCT03035942)
Timeframe: Twenty four hours after surgery by a blinded investigator

InterventionScore on a scale (Median)
O Group184
D Group187
S Group185

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Change in Nausea Score

"Difference in the nausea score before and after treatment. Nausea is scored on a scale from 1 to 10 with 1 being no nausea and 10 being severe nausea with impending vomiting.~A greater difference is indicative of a better outcome" (NCT03075163)
Timeframe: Time to discharge from post anesthetic care unit

Interventionscore on a scale (Mean)
Acupressure1.88
Ondansetron1.25

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Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during overall phase of the second chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy. (NCT03237611)
Timeframe: 24 hours following the second cycle of chemotherapy

InterventionParticipants (Count of Participants)
VomitingNausea
Low Dose Aprepitant or Fosaprepitant33

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Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during the overall phase of the first carboplatin-based chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy. (NCT03237611)
Timeframe: From 24 to 120 hours following the first cycle of chemotherapy, approximately 5 days

InterventionParticipants (Count of Participants)
VomitingNausea
Low Dose Aprepitant or Fosaprepitant99

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Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during overall phase of the second chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy. (NCT03237611)
Timeframe: From 24 to 120 hours following the second cycle of chemotherapy, approximately 5 days

InterventionParticipants (Count of Participants)
VomitingNausea
Low Dose Aprepitant or Fosaprepitant33

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Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during the overall phase of the first carboplatin-based chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy. (NCT03237611)
Timeframe: 24 hours following the first cycle of chemotherapy

InterventionParticipants (Count of Participants)
VomitingNausea
Low Dose Aprepitant or Fosaprepitant1110

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Change in Sensory Phenomena Scale (SPS) Score

"The SPS is a clinician-rated scale that assesses presence or absence of sensory phenomena. It contains a checklist with examples of different types of sensory phenomena, including physical sensations, just right sensations, incompleteness, general energy or inner tension buildup, and urges. The total score ranges from 0-15, with higher scores indicating more severe sensory phenomena. A score of 6 or more is defined as moderate or greater severity of sensory phenomena. An decrease in scores indicates severity decreased during the observational period." (NCT03239210)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Mean)
Ondansetron (OND)1.646
Placebo (PL)1.204

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Change in Brain Activation - Somatosensory Cortex

"Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the somatosensory cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed body-focused videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left postcentral gyrus regions of interest." (NCT03239210)
Timeframe: Baseline, Week 4

InterventionPercent BOLD Signal Change (Median)
Ondansetron (OND)-0.097
Placebo (PL)-0.0052

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Change in Brain Activation - Insula Cortex

"Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the insula cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed body-focused videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left insula regions of interest." (NCT03239210)
Timeframe: Baseline, Week 4

InterventionPercent BOLD Signal Change (Mean)
Ondansetron (OND)-0.071
Placebo (PL)-0.0094

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Change in Yale Global Tic Severity Scale (YGTSS) Score

The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The total score is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity. A decrease in scores indicates severity decreased during the observational period. (NCT03239210)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Mean)
Ondansetron (OND)1.4
Placebo (PL)3.6

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Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score

Y-BOCS is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity. A decrease in scores indicates symptom severity decreased during the observational period. (NCT03239210)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Median)
Ondansetron (OND)2.25
Placebo (PL)1

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Incidence of Post Operative Nausea or Vomiting

number of participants with any incidence of postoperative nausea or vomiting (NCT03262038)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Ondansetron IV8
Placebo23

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Incidence of Pruritus

number of participants with any incidence of pruritus (NCT03262038)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Ondansetron IV14
Placebo24

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Severity of Post Operative Nausea or Vomiting

number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed) (NCT03262038)
Timeframe: 24 hours

,
InterventionParticipants (Count of Participants)
Mild / no treatment requiredSevere / requiring treatment
Ondansetron IV26
Placebo419

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Severity of Pruritus

number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed) (NCT03262038)
Timeframe: 24 hours

,
InterventionParticipants (Count of Participants)
Mild / no treatment neededSevere / requiring treatment
Ondansetron IV113
Placebo420

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Nausea Scale

Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea (NCT03297021)
Timeframe: average of 4 hours in PACU and POD1

,,
Interventionscore on a scale (Mean)
PACUPOD1
Ondansetron 4mg Pre-emergence3.52.0
Ondansetron 8mg Pre-emergence4.01.0
Ondansetron Pre-Incision and Pre-emergence4.08.0

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Number of Participants With Symptoms on POD 1

Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one (NCT03297021)
Timeframe: Day 1

,,
InterventionParticipants (Count of Participants)
NauseaVomitingHeadache
Ondansetron 4mg Pre-emergence915
Ondansetron 8mg Pre-emergence415
Ondansetron Pre-Incision and Pre-emergence103

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Total Anesthesia Time

(NCT03297021)
Timeframe: intraoperative, up to 3.5 hours

Interventionminutes (Mean)
Ondansetron 4mg Pre-emergence116.0
Ondansetron 8mg Pre-emergence128.5
Ondansetron Pre-Incision and Pre-emergence118.0

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Number of Participants Who Needed Rescue Anti-emetics

Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU (NCT03297021)
Timeframe: average of 4 hours

InterventionParticipants (Count of Participants)
Ondansetron 4mg Pre-emergence4
Ondansetron 8mg Pre-emergence1
Ondansetron Pre-Incision and Pre-emergence2

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Number of Participants With Episodes of Vomiting in the PACU

Number of participants with episodes of vomiting in the Post Anesthesia Care Unit (NCT03297021)
Timeframe: average of 4 hours

InterventionParticipants (Count of Participants)
Ondansetron 4mg Pre-emergence2
Ondansetron 8mg Pre-emergence0
Ondansetron Pre-Incision and Pre-emergence1

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Nausea

% of patients with nausea (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)71.4
Lumbar Plexus Catheter (6 Years and Older)55.6
Patient Controlled Analgesia (6 Years and Older)71.4

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Muscle Spasm

% of patients w/ muscle spasm (NCT03435692)
Timeframe: Post-Operative days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)80
Lumbar Plexus Catheter (< 6 Years Old)55.6
Lumbar Epidural Catheter (6 Years and Older)100
Lumbar Plexus Catheter (6 Years and Older)44.4
Patient Controlled Analgesia (6 Years and Older)71.4

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Maximum Pain Score

"Mean of Maximum Pain Score POD 0-2~Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC) for children 1-3 years of age, Faces Pain Scale - Revised (FPS-R) for children over age 3 and the Numeric scale (0-10) for children over age 7.~minimum value = 0, maximum value 10 (higher score is worse)" (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionscore on a scale (Mean)
Lumbar Epidural Catheter (< 6 Years Old)5.5
Lumbar Plexus Catheter (< 6 Years Old)4.3
Lumbar Epidural Catheter (6 Years and Older)6.4
Lumbar Plexus Catheter (6 Years and Older)5.5
Patient Controlled Analgesia (6 Years and Older)6.5

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Itching

% of patients with itching (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)28.6
Lumbar Plexus Catheter (6 Years and Older)22.2
Patient Controlled Analgesia (6 Years and Older)42.9

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Hospital Length of Stay

Total hospital length of stay (NCT03435692)
Timeframe: Through hospital stay, an average of 2-3 days.

Interventiondays (Mean)
Lumbar Epidural Catheter (< 6 Years Old)1.9
Lumbar Plexus Catheter (< 6 Years Old)2
Lumbar Epidural Catheter (6 Years and Older)2.9
Lumbar Plexus Catheter (6 Years and Older)2.5
Patient Controlled Analgesia (6 Years and Older)3.2

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Total Perioperative Morphine Equivalents

All administered opioids measured as morphine equivalents (mg/kg) (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionmg/kg (Mean)
Lumbar Epidural Catheter (< 6 Years Old)0.54
Lumbar Plexus Catheter (< 6 Years Old)0.7
Lumbar Epidural Catheter (6 Years and Older)0.85
Lumbar Plexus Catheter (6 Years and Older)0.83
Patient Controlled Analgesia (6 Years and Older)2.23

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Episodes of Postoperative Nausea

The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication. (NCT03503292)
Timeframe: 0-48 hours post bariatric surgery

Interventionepisodes (Number)
CYP2D6 Rapid Metabolizer (Granisetron)0
CYP2D6 Normal Metabolizer (Ondansetron)16

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Episodes of Postoperative Vomiting

The total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication. (NCT03503292)
Timeframe: 0-48 hours post bariatric surgery

Interventionepisodes (Number)
CYP2D6 Rapid Metabolizer (Granisetron)0
CYP2D6 Normal Metabolizer (Ondansetron)4

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Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire

The specific measure will be based on the single item : number of extra nausea/vomiting pills taken (None, One , Twice, More than twice) of the Nausea and Vomiting Daily Diary/Questionnaire. (NCT03578081)
Timeframe: Over 5 Days per each of the 4 cycles

,
Interventionepisodes (Number)
ZeroOneTwoMore than two
Arm I (Fosaprepitant Dimeglumine, Olanzapine)361435017056
Arm II (Placebo, Olanzapine)354140516274

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Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire

Potential toxicities includes nausea, undesired sedation, and undesired appetite, measured by three individual items ( nausea, undesired sedation, undesired appetite) of the Nausea and Vomiting Daily Dairy/Questionnaire(scale 0-10, 0 is no symptoms, 10 is worst symptoms). Incidences of toxicities will be summarized by type and by treatment arm. Incidences of toxicities will be compared between arms using a Chi-squared test or the Fisher's exact test as appropriate. In addition, undesired sedation and appetite increase as collected in the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed by repeated measures analyses including descriptive statistics, graphical approaches, and growth curve models to account for the factor of day and time trend. (NCT03578081)
Timeframe: Up to 120 hours

,
InterventionParticipants (Count of Participants)
Overall No Appetite IncreaseOverall Any Appetite IncreaseAcute No Appetite IncreaseAcute Any Appetite IncreaseDelayed No Appetite IncreaseDelayed Any Appetite Increase
Arm I (Fosaprepitant Dimeglumine, Olanzapine)14018623591147179
Arm II (Placebo, Olanzapine)13618423684143177

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No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods

The specific measure will be based on the proportion of patients with a value of 0, as measured by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Questionnaire. A modified intent-to-treat principle will be applied for statistical analysis of efficacy in evaluable patients. The proportions of patients with no nausea during the overall, the acute, and the delayed period will be summarized by treatment arm. They will be tested in a sequential manner, using a Simes gatekeeping procedure to maintain the overall significance level at the specified by the Lan-DeMets family of alpha spending function. The difference in no nausea proportions between arms will be estimated along with a one-sided 95% confidence interval. The tests and the confidence intervals will be constructed using normal approximation of the binomial distribution adjusted for the non-inferiority margin. (NCT03578081)
Timeframe: Up to 120 hours

,
InterventionParticipants (Count of Participants)
Overall No NauseaOverall Any NauseaAcute No NauseaAcute Any NauseaDelayed No NauseaDelayed Any Nausea
Arm I (Fosaprepitant Dimeglumine, Olanzapine)123203202124140186
Arm II (Placebo, Olanzapine)97223201119114206

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Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire

"The specific measure will be based on the proportion of patients who answered None to both questions concerning Vomiting episode(None, Once, Twice, More than twice) and number of extra nausea/vomiting pills taken (None, One, Two, More than two) in the Nausea and Vomiting Daily Diary/Questionnaire. The CR rate for the overall, the acute, and the delayed period will be summarized by treatment arm and will be compared using a Chi-squared test. The difference in CR rates between arms will be estimated along with a 95% confidence interval." (NCT03578081)
Timeframe: Up to 120 hours

,
InterventionParticipants (Count of Participants)
Complete Response - >> OverallComplete Response - >> AcuteComplete Response ->> Delayed
Arm I (Fosaprepitant Dimeglumine, Olanzapine)179256193
Arm II (Placebo, Olanzapine)151247166

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Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire

The specific measure will be based on the by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Nausea and Vomiting Daily Diary/Questionnaire. Nausea scores (0-10) repeatedly measured by the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed using the repeated measures analyses and growth curve models as described above for undesired sedation and increase in appetite. (NCT03578081)
Timeframe: Up to 1 year

Interventionscore on a scale (Mean)
Arm I (Fosaprepitant Dimeglumine, Olanzapine)0.8211364
Arm II (Placebo, Olanzapine)0.9177778

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Percentage of Participants With Emesis Within 24 Hours Post-Surgery

Percentage of participants with emesis, defined as vomiting (the forceful discharge of even the smallest amount of stomach contents) or retching (the same muscular movements as vomiting but without expulsion of stomach contents) were reported. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: Within 24 hours post-surgery (up to Day 2)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV24.4
TAK-951 4 mg SC10.3

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Percentage of Participants With Total Response

Percentage of participants with total response, defined as no emesis, no nausea (VRS score <1), and no need for rescue therapy were reported. VRS was used to score postoperative nausea on 11-point numerical scale, where 0 represents 'no nausea' and 10 represents 'worst nausea possible'. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: Within 24 hours post-surgery (up to Day 2)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV34.1
TAK-951 4 mg SC48.7

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Percentage of Participants With Complete Response Within 24 Hours Post-Surgery

Percentage of participants with complete response, defined as no emesis (vomiting or retching) and no need for rescue therapy (indicated if vomiting/retching and/or nausea score ≥4 or upon participant's request) were reported. The severity of nausea was scored using a self-reported, 11-point numerical Verbal Rating Scale (VRS), where 0 represents no nausea and 10 represents the worst nausea possible. Significant nausea was defined as a VRS score ≥4. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: Within 24 hours post-surgery (up to Day 2)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV41.5
TAK-951 4 mg SC59.0

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Peak Nausea Verbal Rating Scale (VRS) Score

VRS was used to score postoperative nausea on 11-point numerical scale. The score ranges from 0-10, where 0 represents 'no nausea' and 10 represents 'worst nausea possible'. Higher score represents worsening of disease. Mixed-effects model for repeated measures (MMRM) was used for analysis. Least square mean (LSM) estimates extracted from MMRM are presented in the data table for each time point. (NCT04557189)
Timeframe: 30 minutes; 1, 2, 6, and 24 hours post-surgery (up to Day 2)

,
Interventionscore on a scale (Least Squares Mean)
30 Minutes Post Surgery1 Hour Post Surgery2 Hours Post Surgery6 Hours Post Surgery24 Hours Post Surgery
Ondansetron 4 mg IV0.1590.0990.043-0.0200.203
TAK-951 4 mg SC0.3470.5000.3080.0770.000

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Percentage of Participants With Markedly Abnormal Clinical Laboratory Values

Laboratory parameters included hematology and serum chemistry. Percentage of participants with markedly abnormal clinical laboratory values were reported. Percentages are rounded off to whole number at the nearest single decimal. Only categories with at least 1 participant with data are reported. (NCT04557189)
Timeframe: From first administration of study drug up to Day 14

,,
Interventionpercentage of participants (Number)
Erythrocytes (10^12 per liter [10^12/L]): Low: <0.8*Lower Limit of Normal (LLN)Hemoglobin (grams per liter [g/L]): Low: <0.8*LLNHematocrit (percent [%]): Low: <0.8*LLNAspartate Aminotransferase (units per liter[U/L]): High: >3*Upper Limit of Normal (ULN)Alanine Aminotransferase (U/L): High: >3*ULNAlbumin (g/L): Low: <25Protein (g/L): Low: <0.8*LLNGamma Glutamyl Transferase (U/L): High: >3*ULNGlucose (millimoles per liter [mmol/L]): Low: <3Glucose (millimoles per liter [mmol/L]): High: >10Potassium (mmol/L): High: >5.5
Ondansetron 4 mg IV14.614.612.20.00.00.02.40.00.04.92.4
TAK-951 4 mg SC14.323.823.84.84.84.84.85.04.80.00.0
TAK-951 Redacted mg SC27.811.111.10.00.00.016.70.00.00.00.0

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Percentage of Participants With Markedly Abnormal Vital Signs

Vital signs included heart rate, respiratory rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP), body temperature and BMI. Percentage of participants with markedly abnormal vital sign values were reported. Percentages are rounded off to whole number at the nearest single decimal. Only categories with at least 1 participant with data are reported. (NCT04557189)
Timeframe: From first administration of study drug up to Day 14

,,
Interventionpercentage of participants (Number)
Heart Rate (beats per minute [beats/min]): Low: <60Heart Rate (beats/min): High: >100Respiratory Rate (breaths per minute [breaths/min]): Low: <12Respiratory Rate (breaths/min): High: >16SBP (millimeters of mercury [mmHg]): Low: <85SBP (mmHg): High: >140DBP (mmHg): Low: <50DBP (mmHg): High: >90BMI (kg/m^2): High: >25.0
Ondansetron 4 mg IV36.614.646.3100.07.370.722.043.990.2
TAK-951 4 mg SC19.066.719.0100.09.542.933.314.385.7
TAK-951 Redacted mg SC22.272.255.6100.016.777.855.638.988.9

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Percentage of Participants With TAK-951 Antidrug Antibodies (ADA)

Percentage of participants with ADA results as: ADA negative, ADA positive were reported. Participants with ADA positive status are defined as those who had confirmed positive ADA status in baseline or at least 1 postbaseline assessments. Participants with ADA negative status are defined as those who did not have positive ADA response at baseline and in all postbaseline assessments. (NCT04557189)
Timeframe: Within 6 hours post-surgery (Day 1)

,
Interventionpercentage of participants (Number)
Any Antidrug Antibody PositiveAny Antidrug Antibody Negative
TAK-951 4 mg SC0.0100.0
TAK-951 Redacted mg SC0.0100.0

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TAK-951 Plasma Concentrations

(NCT04557189)
Timeframe: 1-3, 4-6, 7-9, 10-18, and 22-26 hours post-dose (up to Day 2)

Interventionpicograms per milliliter(pg/mL) (Mean)
1-3 Hours Post Dose4-6 Hours Post Dose7-9 Hours Post Dose
TAK-951 Redacted mg SC58229.4136950.0017741.76

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TAK-951 Plasma Concentrations

(NCT04557189)
Timeframe: 1-3, 4-6, 7-9, 10-18, and 22-26 hours post-dose (up to Day 2)

Interventionpicograms per milliliter(pg/mL) (Mean)
1-3 Hours Post Dose4-6 Hours Post Dose7-9 Hours Post Dose10-18 Hours Post Dose22-26 Hours Post Dose
TAK-951 4 mg SC24734.5018456.1110568.314478.22672.63

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Percentage of Participants With Complete Response in the Immediate Postoperative Period

Percentage of participants with complete response, defined as no emesis (vomiting or retching) and no need for rescue therapy (indicated if vomiting/retching and/or nausea score ≥4 or upon participant's request) were reported. The severity of nausea was scored using a self-reported, 11-point numerical Verbal Rating Scale (VRS), where 0 represents no nausea and 10 represents the worst nausea possible. Significant nausea was defined as a VRS score ≥4. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: 6 hours post-surgery (Day 1)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV48.8
TAK-951 4 mg SC71.8

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Percentage of Participants With Emesis in the First 6 Hours Post-Surgery

Percentage of participants with emesis, defined as vomiting (the forceful discharge of even the smallest amount of stomach contents) or retching (the same muscular movements as vomiting but without expulsion of stomach contents) were reported. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: Within 6 hours post-surgery (Day 1)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV17.1
TAK-951 4 mg SC7.7

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Percentage of Participants With Clinically Significant Electrocardiogram (ECG)

Percentage of participants with clinically significant ECG interpretation were reported. Percentages are rounded off to whole number at the nearest single decimal. A combined ECG interpretation was derived using ECG heart rate, PR interval, RR interval, QRS duration, QT interval, and QT interval with Fridericia correction method (QTcF). (NCT04557189)
Timeframe: From first administration of study drug up to Day 14

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV2.4
TAK-951 4 mg SC0.0
TAK-951 Redacted mg SC0.0

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Percentage of Participants With Any Treatment Emergent Adverse Event (TEAE)

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: From first administration of study drug up to Day 14

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV87.8
TAK-951 4 mg SC71.4
TAK-951 Redacted mg SC88.9

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Percentage of Participants With Absence of Nausea in the First 6 Hours Post-Surgery

Percentage of participants without nausea, defined as urge to vomit without the presence of expulsive muscular movements were reported. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: Within 6 hours post-surgery (Day 1)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV41.5
TAK-951 4 mg SC59.0

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Percentage of Participants With Absence of Nausea in the First 24 Hours Post-Surgery

Percentage of participants without nausea, defined as urge to vomit without the presence of expulsive muscular movements were reported. CMH method was used for analysis. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: Within 24 hours post-surgery (up to Day 2)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV34.1
TAK-951 4 mg SC48.7

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Percentage of Participants Requiring Rescue Therapy for Breakthrough PONV Within 24 Hours Post-Surgery

Percentage of participants to whom rescue therapy was given as per local standard of care guidelines were reported. Percentages are rounded off to whole number at the nearest single decimal. (NCT04557189)
Timeframe: Within 24 hours post-surgery (up to Day 2)

Interventionpercentage of participants (Number)
Ondansetron 4 mg IV56.1
TAK-951 4 mg SC33.3

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Time From End of Surgery to First Emetic Event

Duration between end of wound closure to first emetic event i.e., vomiting or retching was reported. If a participant did not have an emetic event within 24 hours post-surgery, they were censored at 24 hours post-surgery. Cox proportional hazard model was used for analysis. (NCT04557189)
Timeframe: Within 24 hours post-surgery (up to Day 2)

Interventionhours (Median)
Ondansetron 4 mg IVNA
TAK-951 4 mg SCNA

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