Page last updated: 2024-12-08

bleomycin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Cross-References

ID SourceID
PubMed CID5460769
CHEMBL ID403664
CHEBI ID3139
SCHEMBL ID134155
MeSH IDM0002657

Synonyms (13)

Synonym
n(1)-[3-(dimethylsulfonio)propyl]bleomycinamide
CHEBI:3139 ,
bleomycins ,
C06854
bleomycin hexal
CHEMBL403664
blenamax
SCHEMBL134155
DTXSID20872327
AKOS032960358
Q26841044
bleo-kyowa
bdbm50547621
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
metaboliteAny intermediate or product resulting from metabolism. The term 'metabolite' subsumes the classes commonly known as primary and secondary metabolites.
[role 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]

Drug Classes (1)

ClassDescription
bleomycinA glycopeptide produced by the bacterium Streptomyces verticillus. The term, 'bleomycin' refers to a family of structurally related compounds. When used as an anti-cancer agent, the chemotherapeutical forms are primarily bleomycin A2 and B2.
[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 (2)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Aspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)IC50 (µMol)2.23000.02002.66099.4300AID1677972; AID1677973; AID1677974; AID1677975
[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)
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (17)

Processvia Protein(s)Taxonomy
muscle contractionAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
pattern specification processAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
cell population proliferationAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
negative regulation of cell population proliferationAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
regulation of protein stabilityAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
limb morphogenesisAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
positive regulation of proteolysisAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
roof of mouth developmentAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
face morphogenesisAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
activation of cysteine-type endopeptidase activityAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
regulation of protein depolymerizationAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
peptidyl-aspartic acid hydroxylationAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
protein polyubiquitinationBleomycin hydrolaseHomo sapiens (human)
proteolysisBleomycin hydrolaseHomo sapiens (human)
response to xenobiotic stimulusBleomycin hydrolaseHomo sapiens (human)
homocysteine catabolic processBleomycin hydrolaseHomo sapiens (human)
response to toxic substanceBleomycin hydrolaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (12)

Processvia Protein(s)Taxonomy
structural molecule activityAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
calcium ion bindingAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
protein bindingAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
structural constituent of muscleAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
electron transfer activityAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
peptidyl-aspartic acid 3-dioxygenase activityAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
aminopeptidase activityBleomycin hydrolaseHomo sapiens (human)
carboxypeptidase activityBleomycin hydrolaseHomo sapiens (human)
cysteine-type endopeptidase activityBleomycin hydrolaseHomo sapiens (human)
protein bindingBleomycin hydrolaseHomo sapiens (human)
identical protein bindingBleomycin hydrolaseHomo sapiens (human)
cysteine-type aminopeptidase activityBleomycin hydrolaseHomo sapiens (human)
cysteine-type peptidase activityBleomycin hydrolaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (9)

Processvia Protein(s)Taxonomy
endoplasmic reticulumAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
endoplasmic reticulum membraneAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
plasma membraneAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
cortical endoplasmic reticulumAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
sarcoplasmic reticulum membraneAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
endoplasmic reticulumAspartyl/asparaginyl beta-hydroxylaseHomo sapiens (human)
nucleusBleomycin hydrolaseHomo sapiens (human)
cytoplasmBleomycin hydrolaseHomo sapiens (human)
cytosolBleomycin hydrolaseHomo sapiens (human)
extracellular exosomeBleomycin hydrolaseHomo sapiens (human)
cytoplasmBleomycin hydrolaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (91)

Assay IDTitleYearJournalArticle
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.
AID110010Tested for the thymidine uptake against blenoxane at 10 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
AID1396141Substrate activity at recombinant human N-terminal His6-tagged BLMH expressed in Escherichia coli BL21(DE3) assessed as Kcat to Km ratio measured after 1 hr by HPLC-based Michaelis-Menten plot analysis2018Bioorganic & medicinal chemistry letters, 09-01, Volume: 28, Issue:16
Activities of recombinant human bleomycin hydrolase on bleomycins and engineered analogues revealing new opportunities to overcome bleomycin-induced pulmonary toxicity.
AID449366Toxicity against Artemia salina larvae after 24 hrs2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Synthesis and antibacterial activity of some new thiadiaza/triazaphospholes, thiadiaza/triaza/tetrazaphosphinines and thiadiaza/tetrazaphosphepines containing 1,2,4-triazinone moiety.
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).
AID26811Partition coefficient (logP)1980Journal of medicinal chemistry, Jun, Volume: 23, Issue:6
Relationship of octanol/water partition coefficient and molecular weight to rat brain capillary permeability.
AID559320Antimicrobial activity against Salmonella enterica serovar Typhimurium LT2 DA6192 grown in liquid culture2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genetic analysis of colistin resistance in Salmonella enterica serovar Typhimurium.
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).
AID102085In vitro cytotoxicity against MCF-7 cell line expressed as percent of viable cells compared to untreated control at a concentration of 10 uM2002Journal of medicinal chemistry, Dec-19, Volume: 45, Issue:26
Water stability and cytotoxic activity relationship of a series of ferrocenium derivatives. ESR insights on the radical production during the degradation process.
AID530286Antimicrobial activity against PR-39-resistant Salmonella enterica serovar Typhimurium LT2 DA10899 harboring Q179Stop mutant gene by Etest2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Mechanism and fitness costs of PR-39 resistance in Salmonella enterica serovar Typhimurium LT2.
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]
AID559322Antimicrobial activity against Salmonella enterica serovar Typhimurium LT2 DA10833 harboring pmrB (GAA to AAA, E161K mutant) grown in liquid culture2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genetic analysis of colistin resistance in Salmonella enterica serovar Typhimurium.
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]
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]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID189629The capillary permeability of radioligand was measured in Rat brain1980Journal of medicinal chemistry, Jun, Volume: 23, Issue:6
Relationship of octanol/water partition coefficient and molecular weight to rat brain capillary permeability.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID110005Tested for the inhibition of DNA synthesis against blenoxane at 80 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
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).
AID104047Concentration required to reduce to 50% the number of MCF-7 cells with respect to untreated control after exposure to compound for 24 h2002Journal of medicinal chemistry, Dec-19, Volume: 45, Issue:26
Water stability and cytotoxic activity relationship of a series of ferrocenium derivatives. ESR insights on the radical production during the degradation process.
AID1396143Substrate activity at recombinant human BLMH expressed in baculovirus infected Sf9 insect cells assessed as Kcat to Km ratio2018Bioorganic & medicinal chemistry letters, 09-01, Volume: 28, Issue:16
Activities of recombinant human bleomycin hydrolase on bleomycins and engineered analogues revealing new opportunities to overcome bleomycin-induced pulmonary toxicity.
AID559324Antimicrobial activity against Salmonella enterica serovar Typhimurium LT2 DA10845 harboring pmrB (ATG to ATA, M186I mutant) grown in liquid culture2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genetic analysis of colistin resistance in Salmonella enterica serovar Typhimurium.
AID530287Antimicrobial activity against PR-39-resistant sbmA-deficient Salmonella enterica serovar Typhimurium LT2 DA12088 by Etest2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Mechanism and fitness costs of PR-39 resistance in Salmonella enterica serovar Typhimurium LT2.
AID102093In vitro cytotoxicity against MCF-7 cell line expressed as percent of viable cells compared to untreated control at a concentration of 70 uM2002Journal of medicinal chemistry, Dec-19, Volume: 45, Issue:26
Water stability and cytotoxic activity relationship of a series of ferrocenium derivatives. ESR insights on the radical production during the degradation process.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1677970Binding affinity to human AspH assessed as change in melting temperature2020Bioorganic & medicinal chemistry, 10-15, Volume: 28, Issue:20
Small-molecule active pharmaceutical ingredients of approved cancer therapeutics inhibit human aspartate/asparagine-β-hydroxylase.
AID98162Concentration required to reduce 50% growth of L1210 cells in 48 hr1991Journal of medicinal chemistry, Mar, Volume: 34, Issue:3
Syntheses and in vitro evaluation of water-soluble "cationic metalloporphyrin-ellipticine" molecules having a high affinity for DNA.
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.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID106133Inhibitory concentration against the growth of 2SC/20 cell line after 72 hr of drug exposure by MTT test2002Journal of medicinal chemistry, Nov-21, Volume: 45, Issue:24
Effects of isoprenoid analogues of SDB-ethylenediamine on multidrug resistant tumor cells alone and in combination with chemotherapeutic drugs.
AID331134Growth inhibition of human HepG2 cells2008Bioorganic & medicinal chemistry letters, May-15, Volume: 18, Issue:10
Possible chemical mechanisms underlying the antitumor activity of S-deoxyleinamycin.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID102089In vitro cytotoxicity against MCF-7 cell line expressed as percent of viable cells compared to untreated control at a concentration of 35 uM2002Journal of medicinal chemistry, Dec-19, Volume: 45, Issue:26
Water stability and cytotoxic activity relationship of a series of ferrocenium derivatives. ESR insights on the radical production during the degradation process.
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).
AID169207DNA-cleaving ability expressed as % of closed circular pBR322 DNA cleaved at 10 uM conc 50 uM1988Journal of medicinal chemistry, Apr, Volume: 31, Issue:4
New actinomycin D analogues as superior chemotherapeutic agents against primary and advanced colon tumors and colon xenografts in nude mice.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID102088In vitro cytotoxicity against MCF-7 cell line expressed as percent of viable cells compared to untreated control at a concentration of 20 uM2002Journal of medicinal chemistry, Dec-19, Volume: 45, Issue:26
Water stability and cytotoxic activity relationship of a series of ferrocenium derivatives. ESR insights on the radical production during the degradation process.
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).
AID1231703Induction of ROS generation in human PANC1 cells incubated for 1 hr by DCFH-DA dye based assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Anticancer activity of koningic acid and semisynthetic derivatives.
AID559321Antimicrobial activity against Salmonella enterica serovar Typhimurium LT2 DA10826 harboring pmrA (GGG to GAG, G53E mutant) grown in liquid culture2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genetic analysis of colistin resistance in Salmonella enterica serovar Typhimurium.
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).
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).
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID697853Inhibition of horse BChE at 2 mg/ml by Ellman's method2012Bioorganic & medicinal chemistry, Nov-15, Volume: 20, Issue:22
Exploration of natural compounds as sources of new bifunctional scaffolds targeting cholinesterases and beta amyloid aggregation: the case of chelerythrine.
AID106134Inhibitory concentration against the growth of HET-SR-2SC-LNM cell line after 72 hr of drug exposure by MTT test2002Journal of medicinal chemistry, Nov-21, Volume: 45, Issue:24
Effects of isoprenoid analogues of SDB-ethylenediamine on multidrug resistant tumor cells alone and in combination with chemotherapeutic drugs.
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).
AID648275Growth inhibition of Drosophila melanogaster expressing Hrb87F mutant KG02089 assessed as reduction in eclosion rate at 25 uM after 15 days2011Bioorganic & medicinal chemistry, Dec-15, Volume: 19, Issue:24
Camptothecin (CPT) directly binds to human heterogeneous nuclear ribonucleoprotein A1 (hnRNP A1) and inhibits the hnRNP A1/topoisomerase I interaction.
AID99173Cross resistance profile versus L1210/R71 cells.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Structure-activity relationships of antineoplastic agents in multidrug resistance.
AID357846Binding affinity to yeast tRNA assessed as reduction in tRNA peak by pre-incubation method
AID530288Antimicrobial activity against PR-39-resistant Salmonella enterica serovar Typhimurium LT2 DA6192 by Etest2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Mechanism and fitness costs of PR-39 resistance in Salmonella enterica serovar Typhimurium LT2.
AID1396140Substrate activity at recombinant human N-terminal His6-tagged BLMH expressed in Escherichia coli BL21(DE3) measured after 1 hr by HPLC-based Michaelis-Menten plot analysis2018Bioorganic & medicinal chemistry letters, 09-01, Volume: 28, Issue:16
Activities of recombinant human bleomycin hydrolase on bleomycins and engineered analogues revealing new opportunities to overcome bleomycin-induced pulmonary toxicity.
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).
AID1677975Inhibition of N-His6-tagged human AspH (315-755) expressed in Escherichia coli BL21 (DE3) using high 10 uM hFX-CP as substrate mixture with 10 uM 2OG, 100 uM L-ascorbic acid and 2 uM FAS incubated for 35 mins by MS analysis2020Bioorganic & medicinal chemistry, 10-15, Volume: 28, Issue:20
Small-molecule active pharmaceutical ingredients of approved cancer therapeutics inhibit human aspartate/asparagine-β-hydroxylase.
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.
AID110003Tested for the inhibition of DNA synthesis against blenoxane at 4 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
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
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
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]
AID110002Tested for the inhibition of DNA synthesis against blenoxane at 10 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
AID110004Tested for the inhibition of DNA synthesis against blenoxane at 40 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
AID448520Toxicity against Artemia salina assessed as number of the nauplii died after 24 hrs2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Synthesis of some novel pyrazolo[3,4-b]pyridine and pyrazolo[3,4-d]pyrimidine derivatives bearing 5,6-diphenyl-1,2,4-triazine moiety as potential antimicrobial agents.
AID1677974Inhibition of N-His6-tagged human AspH (315-755) expressed in Escherichia coli BL21 (DE3) using 1 uM hFX-CP as substrate mixture with 3 uM 2OG, 100 uM L-ascorbic acid and high 20 uM FAS incubated for 35 mins by MS analysis2020Bioorganic & medicinal chemistry, 10-15, Volume: 28, Issue:20
Small-molecule active pharmaceutical ingredients of approved cancer therapeutics inhibit human aspartate/asparagine-β-hydroxylase.
AID110013Tested for the thymidine uptake against blenoxane at 80 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
AID110012Tested for the thymidine uptake against blenoxane at 40 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
AID1677971Inhibition of N-His6-tagged human AspH (315-755) expressed in Escherichia coli BL21 (DE3) at 20uM using 1 uM hFX-CP as substrate mixture with 3 uM 2OG, 100 uM L-ascorbic acid and 2 uM FAS incubated for 35 mins by MS analysis2020Bioorganic & medicinal chemistry, 10-15, Volume: 28, Issue:20
Small-molecule active pharmaceutical ingredients of approved cancer therapeutics inhibit human aspartate/asparagine-β-hydroxylase.
AID45400Effect on cross resistance of CHO cells resistant to colchicine (CHRC5)1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Structure-activity relationships of antineoplastic agents in multidrug resistance.
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).
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
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).
AID169208DNA-cleaving ability expressed as % of closed circular pBR322 DNA cleaved at 10 uM conc 10 uM1988Journal of medicinal chemistry, Apr, Volume: 31, Issue:4
New actinomycin D analogues as superior chemotherapeutic agents against primary and advanced colon tumors and colon xenografts in nude mice.
AID110011Tested for the thymidine uptake against blenoxane at 4 nm of drug/mg of cell protein in mice1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Cytotoxic and antitumor properties of bleomycin and several of its metal complexes.
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).
AID1079945Animal toxicity known. [column 'TOXIC' in source]
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]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID697852Inhibition of electric eel AChE at 2 mg/ml by Ellman's method2012Bioorganic & medicinal chemistry, Nov-15, Volume: 20, Issue:22
Exploration of natural compounds as sources of new bifunctional scaffolds targeting cholinesterases and beta amyloid aggregation: the case of chelerythrine.
AID1677972Inhibition of N-His6-tagged human AspH (315-755) expressed in Escherichia coli BL21 (DE3) using 1 uM hFX-CP as substrate mixture with 3 uM 2OG, 100 uM L-ascorbic acid and 2 uM FAS incubated for 35 mins by MS analysis2020Bioorganic & medicinal chemistry, 10-15, Volume: 28, Issue:20
Small-molecule active pharmaceutical ingredients of approved cancer therapeutics inhibit human aspartate/asparagine-β-hydroxylase.
AID1677973Inhibition of N-His6-tagged human AspH (315-755) expressed in Escherichia coli BL21 (DE3) using 1 uM hFX-CP as substrate mixture with high 200 uM 2OG, 100 uM L-ascorbic acid and 2 uM FAS incubated for 35 mins by MS analysis2020Bioorganic & medicinal chemistry, 10-15, Volume: 28, Issue:20
Small-molecule active pharmaceutical ingredients of approved cancer therapeutics inhibit human aspartate/asparagine-β-hydroxylase.
AID644953Binding affinity to human pre-hsa-mir-155 miRNA assessed as inhibition of dicer-catalysed (33P)-labelled pre-miRNA processing at 1 mM after 1 hr by PAGE analysis2012Bioorganic & medicinal chemistry letters, Feb-15, Volume: 22, Issue:4
Pre-microRNA binding aminoglycosides and antitumor drugs as inhibitors of Dicer catalyzed microRNA processing.
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).
AID102090In vitro cytotoxicity against MCF-7 cell line expressed as percent of viable cells compared to untreated control at a concentration of 50 uM2002Journal of medicinal chemistry, Dec-19, Volume: 45, Issue:26
Water stability and cytotoxic activity relationship of a series of ferrocenium derivatives. ESR insights on the radical production during the degradation process.
AID169332DNA-cleaving ability expressed as % of closed circular pBR322 DNA cleaved at 100 uM conc 100 uM1988Journal of medicinal chemistry, Apr, Volume: 31, Issue:4
New actinomycin D analogues as superior chemotherapeutic agents against primary and advanced colon tumors and colon xenografts in nude mice.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
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.
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).
AID1396142Substrate activity at recombinant human N-terminal His6-tagged BLMH expressed in Escherichia coli BL21(DE3) assessed as Kcat to Km ratio measured after 1 hr by HPLC-based Michaelis-Menten plot analysis relative to BLM B22018Bioorganic & medicinal chemistry letters, 09-01, Volume: 28, Issue:16
Activities of recombinant human bleomycin hydrolase on bleomycins and engineered analogues revealing new opportunities to overcome bleomycin-induced pulmonary toxicity.
AID559323Antimicrobial activity against Salmonella enterica serovar Typhimurium LT2 DA10840 harboring pmrA (CGC to CAC, R81H mutant) grown in liquid culture2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genetic analysis of colistin resistance in Salmonella enterica serovar Typhimurium.
AID23271Partition coefficient (logD7.4)1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Structure-activity relationships of antineoplastic agents in multidrug resistance.
AID357845Binding affinity to calf thymus DNA assessed as reduction in DNA peak by pre-incubation method
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (21)

TimeframeStudies, This Drug (%)All Drugs %
pre-19903 (14.29)18.7374
1990's2 (9.52)18.2507
2000's7 (33.33)29.6817
2010's8 (38.10)24.3611
2020's1 (4.76)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews1 (4.35%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other22 (95.65%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (160)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase III Study Comparing Rituximab-supplemented ABVD (R-ABVD) With ABVD Followed by Involved-field Radiotherapy (ABVD-RT) in Limited Stage (Stage I-IIA With no Areas of Bulk) Hodgkin's Lymphoma [NCT00992030]Phase 3112 participants (Actual)Interventional2009-09-30Terminated(stopped due to Low recruitment and difficulty in having study data)
A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors [NCT00053352]Phase 3302 participants (Actual)Interventional2003-11-03Completed
Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study [NCT00026208]Phase 276 participants (Actual)Interventional2001-06-30Completed
Electrochemotherapy as a Palliative Treatment for Brain Metastases [NCT01322100]Phase 11 participants (Actual)Interventional2011-04-30Terminated(stopped due to Due to slow patient recruitment)
A Randomized, Open-label, Multicenter, Phase III, 2-arm Study Comparing Efficacy and Tolerability of the Intensified Variant 'Dose-dense/Dose-intense ABVD' (ABVD DD-DI) With an Interim PET Response-adapted ABVD Program as Upfront Therapy in Advanced-stage [NCT03159897]Phase 3500 participants (Anticipated)Interventional2017-08-01Active, not recruiting
A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD +/- ISRT With A2VD +/- ISRT in Patients With Previously Untreated Stage IA/IIA Hodgkin Lymphoma [NCT04685616]Phase 31,042 participants (Anticipated)Interventional2022-04-14Recruiting
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia [NCT04638790]Phase 3300 participants (Anticipated)Interventional2020-02-01Recruiting
A Randomized Phase III Study Comparing One Course of Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) and One Course of Carboplatin AUC7 in Clinical Stage I Seminomatous Testicular Cancer [NCT02341989]Phase 3348 participants (Anticipated)Interventional2015-04-08Recruiting
Role of Propranolol as Compared to Bleomycin in Management of Hemangioma [NCT05327309]90 participants (Actual)Interventional2015-05-08Completed
PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II A/B Seminoma Treated With RA-RPLND [NCT06144736]Phase 260 participants (Anticipated)Interventional2023-08-28Recruiting
Electrochemotherapy on Head and Neck Cancer [NCT02549742]Phase 225 participants (Anticipated)Interventional2014-02-28Recruiting
A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors [NCT00104676]Phase 3263 participants (Actual)Interventional2003-11-26Active, not recruiting
Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts [NCT05023408]Phase 2154 participants (Actual)Interventional2021-01-01Completed
Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors [NCT02161692]Phase 20 participants Interventional1996-12-31Completed
Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups [NCT00005584]Phase 31,649 participants (Actual)Interventional1998-10-31Active, not recruiting
Endoscopic Assisted Electrochemotherapy in Addition to Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Randomized Clinical Phase II Trial [NCT03040180]Phase 240 participants (Anticipated)Interventional2017-01-31Recruiting
An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer [NCT00198276]Phase 488 participants (Actual)Interventional2004-02-29Completed
An Open-Label Study Using the Medpulser® Electroporation System to Treat Head and Neck Cancer [NCT00198263]Phase 495 participants (Actual)Interventional2004-01-31Completed
A Phase II, Multicenter, Open Label Study of Treatment Intensification With ACVD and Brentuximab-Vedotin in Advanced-stage Hodgkin Lymphoma Patients With a Positive Interim PET Scan After 2 ABVD Cycles [NCT03527628]Phase 2220 participants (Anticipated)Interventional2018-01-01Recruiting
A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors [NCT03067181]Phase 32,059 participants (Anticipated)Interventional2017-05-25Recruiting
HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma [NCT01356680]Phase 31,100 participants (Actual)Interventional2012-01-13Completed
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease [NCT00025259]Phase 31,734 participants (Actual)Interventional2002-09-30Completed
The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts [NCT03477448]Phase 440 participants (Anticipated)Interventional2018-04-01Not yet recruiting
Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A [NCT01858922]Phase 240 participants (Actual)Interventional2012-12-19Active, not recruiting
Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL) [NCT01251107]Phase 3331 participants (Actual)Interventional2000-03-31Completed
Fázis II, randomizált, kettős Vak vizsgálat a bőr metasztázisok kezelésére kálcium elektroporációval [NCT03628417]7 participants (Actual)Interventional2016-09-20Completed
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma [NCT01026220]Phase 3166 participants (Actual)Interventional2009-12-07Completed
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma [NCT00577993]Phase 3210 participants (Actual)Interventional1998-03-16Completed
Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer [NCT04281290]Phase 13 participants (Actual)Interventional2020-07-13Terminated(stopped due to After enrolling 3 participants the safety and efficacy of the planned treatment is questionable, thus we decided to terminate the study.)
Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors [NCT02784054]Phase 225 participants (Anticipated)Interventional2014-04-30Recruiting
Investigating Cardiovascular Adverse Events Related to Cancer Treatment: a Study of Extreme Toxicity Using Induced Pluripotent Stem Cells [NCT03199300]48 participants (Anticipated)Observational2017-12-12Recruiting
Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease [NCT00002462]Phase 3615 participants (Actual)Interventional1989-09-30Active, not recruiting
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) [NCT05008224]Phase 2146 participants (Actual)Interventional2021-10-07Active, not recruiting
Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania [NCT03596918]10 participants (Actual)Observational2018-10-10Completed
Phase I, Dose-escalating Study to Evaluate Safety and Tolerance of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies [NCT00993512]Phase 119 participants (Actual)Interventional2009-08-31Completed
Phase III Randomized, Multi-center Study to Evaluate the Effect of R-mabHDI in Patients With Lymphocytic Predominant Hodgkin's Lymphoma [NCT00816959]Phase 31,200 participants (Anticipated)Interventional2011-07-31Not yet recruiting
A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma [NCT00006916]Phase 219 participants (Actual)Interventional2001-06-30Terminated(stopped due to Low accrual)
Calcium Electroporation for Treatment of Cutaneous Metastases [NCT01941901]Phase 27 participants (Actual)Interventional2013-09-30Completed
Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy [NCT02782754]Phase 240 participants (Anticipated)Interventional2013-01-31Recruiting
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410]Phase 31,875 participants (Anticipated)Interventional2023-05-11Recruiting
Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma [NCT00352027]Phase 281 participants (Actual)Interventional2006-07-20Completed
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin's Lymphoma [NCT00369681]Phase 251 participants (Actual)Interventional2006-05-31Completed
A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging [NCT00822120]Phase 2371 participants (Actual)Interventional2009-07-31Completed
Bleomycin Infusion (MMP®) to Repigment Achromic Scars [NCT04046679]Phase 450 participants (Anticipated)Interventional2019-08-31Not yet recruiting
HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET [NCT00736320]Phase 31,150 participants (Actual)Interventional2009-11-30Active, not recruiting
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26) [NCT00689845]120 participants (Anticipated)Interventional2007-06-30Recruiting
Electrosclerotherapy as a Novel Treatment Option for Capillary Malformations: A Pilot Study [NCT02883023]Phase 220 participants (Anticipated)Interventional2016-11-30Recruiting
Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma [NCT00920153]Phase 3442 participants (Actual)Interventional2008-05-31Terminated(stopped due to Other new drugs)
A Randomized Phase II Study of Dose-Adjusted EPOCH-R and R-VACOP-B in Primary Mediastinal (Thymic) Large B-Cell Lymphoma [NCT00983944]Phase 20 participants (Actual)Interventional2009-09-30Withdrawn(stopped due to Inadequate Accrual)
A Phase II Open Label, Multicenter, Randomized, Parallel Study Comparing the Efficacy of R-mabHD Alone and a Combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD)in Treating Patients With Hodgkin's Disease. [NCT00797472]Phase 2120 participants (Anticipated)Interventional2011-07-31Not yet recruiting
A Randomized Phase II Study of Rituximab With ABVD Versus Standard ABVD for Patients With Advanced-Stage Classical Hodgkin Lymphoma With Poor Risk Features (IPS Score > 2) [NCT00654732]Phase 258 participants (Actual)Interventional2008-03-19Completed
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463]Phase 3600 participants (Actual)Interventional2015-03-19Active, not recruiting
Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects. [NCT00744653]Phase 217 participants (Actual)Interventional2008-10-31Terminated(stopped due to Primary endpoint measure not suitable for evaluation)
A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma [NCT00000681]Phase 124 participants InterventionalCompleted
A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma [NCT01060904]Phase 151 participants (Actual)Interventional2010-01-31Completed
Phase II Trial for the Treatment of Advanced Classical Kaposi's Sarcoma With the HIV Protease Inhibitor Indinavir in Combination With Chemotherapy [NCT01067690]Phase 225 participants (Actual)Interventional2008-06-30Completed
A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study [NCT00225173]Phase 245 participants (Anticipated)Interventional2001-10-31Terminated
Randomized Phase II Trial of Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-Risk Germ Cell Tumors [NCT01873326]Phase 292 participants (Actual)Interventional2013-06-30Active, not recruiting
Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma [NCT01132807]Phase 2164 participants (Actual)Interventional2010-05-31Completed
Efficacy of Intralesional Bleomycin Alone and in Combination With Dexamethasone in Infantile Haemangiomas [NCT06080724]114 participants (Actual)Interventional2021-03-22Completed
Open-label, Single Arm, Multi-centre, Phase II Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Cancer [NCT01606566]Phase 226 participants (Actual)Interventional2012-04-30Terminated(stopped due to Business reasons)
Electrochemotherapy for Non-curable Gastric Cancer [NCT04139070]Phase 18 participants (Anticipated)Interventional2020-06-15Recruiting
Germ Cell Tumour Study II [NCT00276718]100 participants (Anticipated)Interventional1989-04-30Active, not recruiting
Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy [NCT00918593]Phase 298 participants (Anticipated)Interventional2009-12-31Withdrawn(stopped due to No recruitment of patients)
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma [NCT01712490]Phase 31,334 participants (Actual)Interventional2012-11-09Active, not recruiting
Dose Escalating Study to Evaluate the Tolerability, Efficacy and Safety of Amphinex 0.125 mg/kg or Lower in Amphinex-based PCI of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies. [NCT01872923]Phase 13 participants (Actual)Interventional2012-01-31Completed
Phase I/II Study of Combination Chemotherapy (Adriamycin, Bleomycin, +/- Vincristine) and Dideoxyinosine (ddI) or Dideoxycytidine (ddC) in the Treatment of AIDS-Related Kaposi's Sarcoma [NCT00000954]Phase 172 participants InterventionalCompleted
A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942) [NCT00592111]Phase 221 participants (Actual)Interventional1996-03-31Completed
Open-Label, Multicenter, Phase Ⅱ Study Of Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin As First-Line Treatment In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck [NCT03830385]Phase 251 participants (Anticipated)Interventional2019-02-15Recruiting
Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors [NCT00066482]19 participants (Actual)Interventional2004-07-31Completed
[NCT00265018]Phase 31,370 participants (Actual)Interventional1998-05-31Completed
Hodgkin's Disease Study [NCT00416377]353 participants (Anticipated)InterventionalActive, not recruiting
A Randomized Phase III Toxicity Study of Day 2, 3, 8, 15 Short (30 Minute) Versus Day 1, 2, 3 Long (72 Hours) Infusion Bleomycin for Patients With IGCCCG Good Prognosis Germ Cell Tumors, TE3 [NCT00324298]Phase 3210 participants (Anticipated)Interventional2003-07-31Completed
Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor [NCT00453232]Phase 220 participants (Anticipated)Interventional2004-08-31Completed
A Phase II Study Evaluating the Efficacy and Safety of Bortezomib (Velcade™) Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT00136565]Phase 260 participants (Actual)Interventional2006-01-08Completed
RESPONSE DEPENDENT TREATMENT OF STAGES IA, IIA AND IIIA HODGKIN'S DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD: A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY [NCT00002827]Phase 3294 participants (Actual)Interventional1996-10-31Completed
A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease [NCT00504504]Phase 285 participants (Actual)Interventional2001-03-31Completed
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial [NCT05395962]Phase 292 participants (Anticipated)Interventional2022-04-08Recruiting
A Phase II Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) for Patients With Hodgkin's Disease [NCT01404936]Phase 235 participants (Actual)Interventional1996-07-31Completed
Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma [NCT00005867]Phase 3310 participants (Anticipated)Interventional1998-01-31Completed
An Open Label Lesion Controlled Study of Electroporation Therapy (EPT) for the Treatment of Cutaneous Metastatic Melanoma Using the Genetronics, Inc. Medpulser System and Bleomycin [NCT00006035]Phase 10 participants Interventional2000-06-30Active, not recruiting
HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD [NCT02661503]Phase 31,500 participants (Anticipated)Interventional2016-07-31Recruiting
A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE [NCT00002714]Phase 20 participants Interventional1995-04-30Completed
High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study [NCT00003811]Phase 227 participants (Actual)Interventional2000-04-30Completed
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma [NCT00002105]Phase 3220 participants InterventionalCompleted
Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation. [NCT00002657]Phase 220 participants (Actual)Interventional1995-05-31Completed
Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma [NCT00032149]Phase 1/Phase 230 participants (Anticipated)Interventional2001-10-31Active, not recruiting
Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma [NCT00000689]Phase 118 participants InterventionalCompleted
A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease [NCT00003389]Phase 3854 participants (Actual)Interventional1999-06-17Completed
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma [NCT00079105]Phase 2175 participants (Actual)Interventional2004-01-31Completed
Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma [NCT00135499]Phase 3138 participants (Actual)Interventional2001-10-16Terminated(stopped due to Recruitment too low)
Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III) [NCT00274950]Phase 3105 participants (Anticipated)Interventional2005-05-31Active, not recruiting
Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma [NCT00031902]Phase 10 participants Interventional2001-10-31Active, not recruiting
Protocol For The Treatment Of Children And Adolescents With Hodgkin's Disease [NCT00025064]Phase 2260 participants (Anticipated)Interventional2000-01-31Active, not recruiting
Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer [NCT00027521]Phase 10 participants (Actual)Interventional2000-12-31Withdrawn(stopped due to Program terminated)
Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy [NCT00038558]Phase 325 participants (Actual)Interventional2001-11-30Completed
Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease [NCT00041210]Phase 3850 participants (Anticipated)Interventional2001-10-31Active, not recruiting
A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial Effusion Associated With Lung Cancer (JCOG9811) [NCT00132613]Phase 380 participants (Actual)Interventional1999-08-31Completed
Intralesional Bleomycin Treatment of Keloids Using an Electronic Pneumatic Jet Injector: a Double-blind Randomized, Placebo-controlled Trial With Split-lesion Design [NCT04582305]Phase 414 participants (Actual)Interventional2022-03-18Active, not recruiting
Treatment of Primary Liver Tumors With Electrochemotherapy (ECT) [NCT02291133]Phase 1/Phase 225 participants (Actual)Interventional2014-06-30Completed
[NCT00284271]Phase 265 participants (Actual)Interventional2004-01-31Completed
[NCT00264953]Phase 31,395 participants (Actual)Interventional1998-05-31Completed
[NCT00265031]Phase 30 participants Interventional1999-01-31Completed
Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors [NCT00301782]Phase 288 participants (Anticipated)Interventional2005-06-30Completed
Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognos [NCT01659099]Phase 3671 participants (Actual)Interventional2012-09-30Terminated(stopped due to experimental treatment not Superior to standard - no need to continue the follow-up)
A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma [NCT00000987]Phase 136 participants InterventionalCompleted
Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma [NCT00001059]Phase 2120 participants InterventionalCompleted
"RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY (ATT) VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5" [NCT00002565]Phase 361 participants (Actual)Interventional1994-05-25Completed
Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II [NCT00002571]Phase 252 participants (Actual)Interventional1994-06-30Completed
A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease [NCT00002715]Phase 250 participants (Anticipated)Interventional1989-04-30Completed
A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma [NCT01468740]Phase 2130 participants (Anticipated)Interventional2004-03-31Recruiting
Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study [NCT05494710]20 participants (Anticipated)Interventional2020-12-01Recruiting
A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma [NCT00000658]Phase 3250 participants InterventionalCompleted
Phase III Randomized Study of Radiotherapy Alone vs With Concurrent Chemotherapy With MTX or VBMF (VCR/BLEO/MTX/5-FU) vs Subsequent Chemotherapy vs Concurrent and Subsequent Chemotherapy in Patients With Advanced Head and Neck Cancer [NCT00002476]Phase 30 participants Interventional1990-01-31Completed
Pilot Study in AIDS-Related Lymphomas [NCT00002524]Phase 246 participants (Actual)Interventional1993-06-30Completed
RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS [NCT00002596]Phase 3270 participants (Anticipated)Interventional1994-09-30Completed
"Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: Stanford V Regimen For Low Risk Patients, EBVP Regimen For High Risk Patients" [NCT00003262]Phase 230 participants (Anticipated)Interventional1997-05-31Active, not recruiting
Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study [NCT00005578]Phase 3219 participants (Actual)Interventional1997-03-31Completed
A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma [NCT00678327]Phase 31,202 participants (Actual)Interventional2008-08-29Active, not recruiting
Electrochemotherapy of Gynecological Cancers [NCT04760327]Phase 230 participants (Anticipated)Interventional2020-07-01Recruiting
A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of the Tongue, Post [NCT00198328]Phase 384 participants (Actual)Interventional2004-11-30Terminated(stopped due to Enrollment was stopped based on the Data Monitoring Committee's recommendation.)
Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study [NCT02292979]Phase 2170 participants (Actual)Interventional2015-03-31Completed
A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent [NCT02104986]Phase 2117 participants (Actual)Interventional2014-05-12Completed
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease [NCT00000626]Phase 227 participants InterventionalCompleted
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma [NCT00002318]Phase 3225 participants InterventionalActive, not recruiting
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members [NCT00000703]45 participants InterventionalCompleted
A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent Non-Hodgkin's Lymphoma [NCT00003110]Phase 25 participants (Actual)Interventional1997-07-31Completed
Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy [NCT00004010]Phase 299 participants (Actual)Interventional1999-10-31Completed
A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic [NCT00005090]Phase 311 participants (Actual)Interventional2000-04-30Terminated(stopped due to poor accrual)
A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease [NCT00003421]Phase 3800 participants (Anticipated)Interventional1998-06-30Completed
Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer [NCT00003643]Phase 2/Phase 3498 participants (Anticipated)Interventional1998-10-31Active, not recruiting
A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma. [NCT00002093]Phase 30 participants InterventionalCompleted
A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease [NCT00002561]Phase 3405 participants (Actual)Interventional1994-01-25Completed
"Minimal Initial Therapy (MIT) for Early Supradiaphragmatic Hodgkin's Disease: A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy (VAPEC-B) Plus Involved Field Radiotherapy (MIT) Versus Mantle Radiotherapy" [NCT00002987]Phase 3400 participants (Anticipated)Interventional1997-01-31Active, not recruiting
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II [NCT02352259]Phase 223 participants (Actual)Interventional2013-09-30Completed
Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL) [NCT01390584]Phase 26 participants (Actual)Interventional2013-05-24Terminated(stopped due to slow accrual)
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835]Phase 3116 participants (Actual)Interventional1995-10-30Completed
A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tumors [NCT02429700]Phase 3132 participants (Anticipated)Interventional2015-04-30Recruiting
A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors [NCT02429687]Phase 3129 participants (Anticipated)Interventional2015-04-30Recruiting
A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Anterior Oral Cavity, So [NCT00198315]Phase 3130 participants (Actual)Interventional2004-06-30Terminated(stopped due to Enrollment was stopped based on the Data Monitoring Committee's recommendation.)
A Clinical Trial Using Electrochemotherapy With Bleomycin for the Treatment of Non-metastatic Unresectable Pancreatic Cancer [NCT03225781]1 participants (Actual)Interventional2017-07-01Terminated(stopped due to Logistic reasons)
Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial] [NCT00379041]Phase 31,158 participants (Anticipated)Interventional1993-09-01Active, not recruiting
Comparison of Therapeutic Efficacy Between Intralesional Bleomycin and Cryotherapy in Plantar Warts [NCT05752435]102 participants (Actual)Interventional2022-07-01Completed
Intralesional Injection of Bleomycin Versus 5-fluorouracil in Treatment of Plantar Wart; a Comparative Study [NCT05057663]40 participants (Anticipated)Interventional2021-11-01Not yet recruiting
Electrochemotherapy for the Treatment of Vulvar Cancer [NCT05916690]20 participants (Anticipated)Interventional2021-03-01Recruiting
A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS. DOXYCYCLINE VS. TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS [NCT00002872]Phase 3480 participants (Anticipated)Interventional1997-01-10Completed
Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma [NCT03018626]Phase 3402 participants (Anticipated)Interventional2017-07-27Recruiting
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 [NCT03755804]Phase 2250 participants (Anticipated)Interventional2018-12-12Recruiting
A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary [NCT01042522]Phase 263 participants (Actual)Interventional2010-02-08Active, not recruiting
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma [NCT00049595]Phase 3552 participants (Actual)Interventional2002-08-31Completed
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667) [NCT03407144]Phase 2340 participants (Anticipated)Interventional2018-04-09Active, not recruiting
A Randomized Phase III Study of Sequential High-Dose Cisplatinum/Etoposide/Ifosfamide Plus Stem Cell Support Versus BEP in Patients With Poor Prognosis Germ Cell Cancer [NCT00003941]Phase 3222 participants (Anticipated)Interventional1999-04-30Completed
A Randomized Phase III Study of Chemotherapy and Radiotherapy Versus Radiotherapy Alone as Adjuvant Treatment to Patients With Node Positive Stages IB or IIA Cervix Cancer [NCT00003209]Phase 3700 participants (Anticipated)Interventional1997-12-31Completed
A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups [NCT00003815]Phase 30 participants Interventional1994-06-30Active, not recruiting
A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings [NCT01435018]Phase 3334 participants (Actual)Interventional2013-10-01Completed
A Phase 2 Front-Line PET/CT-2 Response-Adapted Brentuximab Vedotin and Nivolumab Incorporated and Radiation-Free Management of Early Stage Classical Hodgkin Lymphoma (cHL) [NCT03712202]Phase 2155 participants (Actual)Interventional2018-11-28Active, not recruiting
Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD [NCT02298283]Phase 240 participants (Actual)Interventional2015-04-30Completed
Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours [NCT02582697]Phase 3500 participants (Anticipated)Interventional2014-02-28Recruiting
Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations [NCT01347294]Phase 4135 participants (Actual)Interventional2011-08-31Active, not recruiting
Phase I/II of Nivolumab and A(B)VD in the Front-line Setting for High Risk Hodgkin Lymphoma [NCT03033914]Phase 1/Phase 281 participants (Anticipated)Interventional2017-01-25Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00003389 (3) [back to overview]Failure-free Survival at 5 Years
NCT00003389 (3) [back to overview]5-year Overall Survival
NCT00003389 (3) [back to overview]Incidence of Second Cancers
NCT00025259 (4) [back to overview]Disease Response Assessed by Modified RECIST Criteria
NCT00025259 (4) [back to overview]Event-free Survival
NCT00025259 (4) [back to overview]Grade 3 or 4 Non-hematologic Toxicity
NCT00025259 (4) [back to overview]Overall Survival
NCT00026208 (7) [back to overview]Early Treatment-related Toxicity
NCT00026208 (7) [back to overview]Frequency of Complete Response
NCT00026208 (7) [back to overview]Overall Survival (OS)
NCT00026208 (7) [back to overview]Progression-free Survival (PFS)
NCT00026208 (7) [back to overview]Second Hodgkin's Disease Progression
NCT00026208 (7) [back to overview]Late Treatment-related Toxicity
NCT00026208 (7) [back to overview]Survival at 5 and 10 Years
NCT00053352 (4) [back to overview]Days Hospitalized for Patients Who Receive Chemotherapy
NCT00053352 (4) [back to overview]Event-Free Survival (EFS)
NCT00053352 (4) [back to overview]Overall Survival (OS)
NCT00053352 (4) [back to overview]Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
NCT00104676 (2) [back to overview]Overall Survival
NCT00104676 (2) [back to overview]Progression-free Survival Rate After 1 Course of Treatment
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Age
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)
NCT00352027 (76) [back to overview]Local and Distant Failure for Children Treated With Tailored-field Radiation
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Gender
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Histology
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Stage
NCT00352027 (76) [back to overview]Toxicities With Grade >1
NCT00352027 (76) [back to overview]3-year Event-free Survival (EFS) Probability
NCT00352027 (76) [back to overview]3-year Event-Free Survival Probability
NCT00352027 (76) [back to overview]3-year Local Failure-free Survival Probability
NCT00352027 (76) [back to overview]3-year Overall Survival (OS) Probability
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Disease Failure Rate Within Radiation Fields
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), Symptom Distress Scale
NCT00369681 (3) [back to overview]Relationship Between Marker Detection and Clinical Outcome
NCT00369681 (3) [back to overview]Effect of Rituximab on EBV(+) Tumors
NCT00369681 (3) [back to overview]Event-free Survival
NCT00504504 (1) [back to overview]5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
NCT00577993 (2) [back to overview]Number of Participants With Progression Free Survival (10 Years) by Treatment
NCT00577993 (2) [back to overview]Number of Participants With Overall Survival (10 Years) by Treatment
NCT00654732 (1) [back to overview]Event-free Survival (EFS) Rate
NCT00744653 (3) [back to overview]Clinical Measure of Lesion Size.
NCT00744653 (3) [back to overview]Participants With Objective Response Evaluated With PET/CT
NCT00744653 (3) [back to overview]Safety and Toxicity
NCT00822120 (8) [back to overview]Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
NCT00822120 (8) [back to overview]Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
NCT00822120 (8) [back to overview]Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
NCT00822120 (8) [back to overview]Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
NCT00822120 (8) [back to overview]Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
NCT00822120 (8) [back to overview]Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00822120 (8) [back to overview]Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00822120 (8) [back to overview]Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
NCT01026220 (7) [back to overview]Relapse-free Survival
NCT01026220 (7) [back to overview]Event Free Survival
NCT01026220 (7) [back to overview]Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
NCT01026220 (7) [back to overview]Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
NCT01026220 (7) [back to overview]Overall Survival
NCT01026220 (7) [back to overview]Safety Analysis and Monitoring of Toxic Death
NCT01026220 (7) [back to overview]Second-event-free Survival
NCT01042522 (3) [back to overview]Tumor Response Rate
NCT01042522 (3) [back to overview]Progression-free Survival (PFS)
NCT01042522 (3) [back to overview]Overall Survival (OS)
NCT01132807 (3) [back to overview]36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
NCT01132807 (3) [back to overview]Complete Response Rate
NCT01132807 (3) [back to overview]Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
NCT01390584 (5) [back to overview]Proportion of Patients Who Are PET Negative After Induction Treatment
NCT01390584 (5) [back to overview]Progression-free Survival Rate
NCT01390584 (5) [back to overview]Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
NCT01390584 (5) [back to overview]Overall Survival
NCT01390584 (5) [back to overview]Complete Response (CR) Rate After Induction Treatment
NCT01404936 (1) [back to overview]Participants' Response
NCT01435018 (37) [back to overview]Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Number of Participants With Objective Response for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
NCT01435018 (37) [back to overview]Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
NCT01435018 (37) [back to overview]Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
NCT01435018 (37) [back to overview]Number of Participants With Peripheral Neuropathy (PN)
NCT01435018 (37) [back to overview]Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
NCT01435018 (37) [back to overview]Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)
NCT01435018 (37) [back to overview]Self-reported Adherence to ART Therapy
NCT01435018 (37) [back to overview]Number of Participants With Objective Response for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death for BV+ART vs PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Duration of Objective Response for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Duration of Objective Response for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART
NCT01712490 (19) [back to overview]A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE
NCT01712490 (19) [back to overview]Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy
NCT01712490 (19) [back to overview]Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF
NCT01712490 (19) [back to overview]Disease-free Survival (DFS) Per IRF
NCT01712490 (19) [back to overview]Duration of Complete Remission (DOCR) Per IRF
NCT01712490 (19) [back to overview]Duration of Response (DOR) Per IRF
NCT01712490 (19) [back to overview]Event-free Survival (EFS) Per IRF
NCT01712490 (19) [back to overview]Number of Participants With Abnormal Clinical Laboratory Values
NCT01712490 (19) [back to overview]Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
NCT01712490 (19) [back to overview]Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT
NCT01712490 (19) [back to overview]A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin
NCT01712490 (19) [back to overview]A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)
NCT01712490 (19) [back to overview]A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
NCT01712490 (19) [back to overview]A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb
NCT01712490 (19) [back to overview]Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2
NCT01712490 (19) [back to overview]Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy
NCT01712490 (19) [back to overview]Overall Survival (OS)
NCT01712490 (19) [back to overview]Overall Response Rate (ORR) Per IRF
NCT01712490 (19) [back to overview]Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
NCT02166463 (3) [back to overview]Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
NCT02166463 (3) [back to overview]Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
NCT02166463 (3) [back to overview]Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
NCT03596918 (1) [back to overview]Total Score on Quality of Life Assessed Using Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire
NCT03628417 (3) [back to overview]Adverse Events for Calcium Electroporation and Bleomycin Based Electrochemotherapy. The Adverse Reactions Are Classified According to CTCAE Version 4.0 (Common Terminology Criteria for Adverse Events).
NCT03628417 (3) [back to overview]Response Rate (RECIST1.1) of Calcium Electroporation and Bleomycin Based Electrochemotherapy on Cutaneous Metastases at Day 180.
NCT03628417 (3) [back to overview]The Tertiary Outcome is to Register if Calcium Affects the Current Strength in Electroporation Treatments.

Failure-free Survival at 5 Years

"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission." (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5

InterventionProportion of patients (Number)
Arm A (ABVD)0.74
Arm B (Stanford V)0.71

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5-year Overall Survival

Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years. (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

InterventionProportion of patients (Number)
Arm A (ABVD)0.88
Arm B (Stanford V)0.88

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Incidence of Second Cancers

Number of patients who developed second primary cancers (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

Interventionparticipants (Number)
Arm A (ABVD)15
Arm B (Stanford V)19

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Disease Response Assessed by Modified RECIST Criteria

Number of participants with complete response and very good partial response at the end of protocol therapy. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)5
Arm II (RER With CR [ABVE-PC, IFRT])370
Arm III (RER With CR [ABVE-PC])380
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])538
Arm V (RER With PD)29
Arm VI (SER [DECA, ABVE-PC, IFRT])105
Arm VII (SER [ABVE-PC, IFRT])100

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Event-free Survival

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.89
Arm II (RER With CR [ABVE-PC, IFRT])0.87
Arm III (RER With CR [ABVE-PC])0.84
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.87
Arm V (RER With PD)0.70
Arm VI (SER [DECA, ABVE-PC, IFRT])0.79
Arm VII (SER [ABVE-PC, IFRT])0.74

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Grade 3 or 4 Non-hematologic Toxicity

Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)10
Arm II (RER With CR [ABVE-PC, IFRT])153
Arm III (RER With CR [ABVE-PC])130
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])216
Arm V (RER With PD)11
Arm VI (SER [DECA, ABVE-PC, IFRT])62
Arm VII (SER [ABVE-PC, IFRT])45

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Overall Survival

Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.93
Arm II (RER With CR [ABVE-PC, IFRT])0.98
Arm III (RER With CR [ABVE-PC])0.98
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.98
Arm VI (SER [DECA, ABVE-PC, IFRT])0.96
Arm VII (SER [ABVE-PC, IFRT])0.93

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Frequency of Complete Response

"The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as complete regression of all palpable and radiographic demonstrable disease by computed tomography (CT) scan or positron emission tomography-CT (PET-CT)." (NCT00026208)
Timeframe: 5 weeks

InterventionParticipants (Count of Participants)
Stanford V-C + Low-dose Radiotherapy31

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Overall Survival (OS)

Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation. (NCT00026208)
Timeframe: 16 years

Interventionyears (Median)
Stanford V-C + Low-dose Radiotherapy10.4
Stanford V-C Only13.2

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Progression-free Survival (PFS)

Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression. (NCT00026208)
Timeframe: up to 3 years

Interventionpercentage of participants (Number)
Stanford V-C + Low-dose Radiotherapy89.7
Stanford V-C Only50

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Second Hodgkin's Disease Progression

Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis. (NCT00026208)
Timeframe: 16 years

InterventionParticipants (Count of Participants)
Stanford V-C + Low-dose Radiotherapy3
Stanford V-C Only1

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Survival at 5 and 10 Years

Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints. (NCT00026208)
Timeframe: 5 and 10 years

,
InterventionParticipants (Count of Participants)
5 years10 years
Stanford V-C + Low-dose Radiotherapy6741
Stanford V-C Only33

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Days Hospitalized for Patients Who Receive Chemotherapy

Calculated to quantify the treatment cost associated with this regimen. (NCT00053352)
Timeframe: Up to 126 days after the start of chemotherapy

InterventionDays in the hospital (Mean)
Arm I14.08

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Event-Free Survival (EFS)

Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients. (NCT00053352)
Timeframe: 3 Years after enrollment

InterventionPercent probability (Number)
Arm 187.0

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Overall Survival (OS)

Percentage probability of being alive at 3 years following enrollment. (NCT00053352)
Timeframe: 3 Years after enrollment

InterventionPercent Probability (Number)
Arm I97.0
Arm 299.0

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Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy (NCT00053352)
Timeframe: Up to 126 days after the start of chemotherapy

Interventionpatients (Number)
Abdominal painAcute kidney injuryLymphocyte count decreaseIincrease in alanine aminotransferaseNeutrophil count decreaseAnemiaIncrease in aspartate aminotransferaseCatheter related infectionConstipationDehydrationEncephalopathyFebrile neutropeniaFeverHyperglycemiaHyperkalemiaHypocalcemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemiaSmall intestine obstructionNauseaNon-cardiac chest painOther gastrointestinal disordersOther infectionPlatelet count decreaseSyncopeVomitingWhite blood cell decreaseWound infection
Arm I3121581011111931121116151110714171

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Overall Survival

To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment. (NCT00104676)
Timeframe: 3 years from randomization

Interventionpercentage of participants (Number)
Arm I65
Arm II73

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Progression-free Survival Rate After 1 Course of Treatment

Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment. (NCT00104676)
Timeframe: 3 years from randomization

Interventionpercentage of participants (Number)
Arm I48
Arm II59

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Prognostic Factors for Treatment Failure: Age

Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. (NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Interventionevents (Number)
Stanford V Chemotherapy11

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)

Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy680
Year 10 Off Therapy151
Year 2 Off Therapy571
Year 5 Off Therapy362

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)

Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy515
Year 10 Off Therapy106
Year 2 Off Therapy448
Year 5 Off Therapy244

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)

Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy4620
Year 10 Off Therapy91
Year 2 Off Therapy4120
Year 5 Off Therapy2511

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)

For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalHypothyroidHyperthyroidThyroid Nodule
Year 1 Off Therapy60820
Year 10 Off Therapy20300
Year 2 Off Therapy541110
Year 5 Off Therapy37810

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Local and Distant Failure for Children Treated With Tailored-field Radiation

The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field. (NCT00352027)
Timeframe: from first enrollment date up to 3 years follow-up

Interventionprobability that the event occurs (Number)
Cumulative incidence of distant failure at 3 yearsCumulative incidence of local failure at 3 years
Stanford V Chemotherapy0.03750.1127

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Prognostic Factors for Treatment Failure: Gender

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up

Interventionevents (Number)
MaleFemale
Stanford V Chemotherapy56

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.46

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Prognostic Factors for Treatment Failure: Histology

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up

Interventionevents (Number)
Classical, Nodular SclerosingOther
Stanford V Chemotherapy101

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Prognostic Factors for Treatment Failure: Stage

Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Interventionevents (Number)
Stage Stage ≥III
Stanford V Chemotherapy83

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Toxicities With Grade >1

Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT00352027)
Timeframe: 3 years

,,,,,,,
Interventionadverse events (Number)
Alanine transaminase (ALT)Aspartate transaminase (AST)Allergic reaction/hypersensitivityConstipationFebrile neutropeniaFever (in the absence of neutropenia)GlucoseGGT (gamma-Glutamyltranspeptidase)HemoglobinHypoxiaIleus, GI (functional obstruction of bowel)Infection with Grade 3 or 4 neutrophilsInfection - OtherInfection with normal ANC or Grade 1-2 neutrophilsInfection with unknown ANCInsomniaLeukocytes (total WBC)LymphopeniaMucositis/stomatitis (functional/symptomatic)NauseaNeuropathy: motorNeuropathy: sensoryNeutrophils/granulocytes (ANC/AGC)PainPhosphatePlateletsPotassiumSodiumSyndromes - OtherThrombosis/embolism (vascular access-related)Thrombosis/thrombus/embolismVomiting
HOD05 - Grade 200000000000000000000000000000000
HOD05 - Grade 3114072012611213014122010124510211202
HOD05 - Grade 40000100060000000157000032000000010
HOD05 - Grade 500000000000000000000000000000000
HOD99 - Grade 200000000000000000000000000000001
HOD99 - Grade 3000150002002011019012119103000004
HOD99 - Grade 4000020100000000050000030100000000
HOD99 - Grade 500000000000000000000000000000000

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3-year Event-free Survival (EFS) Probability

Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
HOD05 Participants0.887
HOD99 Participants0.844

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3-year Event-Free Survival Probability

The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
Stanford V Chemotherapy0.887

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3-year Local Failure-free Survival Probability

Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
HOD05 Participants0.887
HOD99 Participants0.932

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3-year Overall Survival (OS) Probability

Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3-years

Interventionprobability (Number)
HOD05 Participants1.00
HOD99 Participants0.978

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.46

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.35

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-2.31

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-2.52

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.20

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.87

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.41

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.96

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.06

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.56

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.9

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.92

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.21

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.79

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.0
Parent and Patient Scores at Week 120.14
Parent and Patient Scores at After Radiation-8.0
Parent and Patient Scores at Off-therapy-4.0

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.3
Parent and Patient Scores at Week 12-3.6
Parent and Patient Scores at After Radiation-7.4
Parent and Patient Scores at Off-therapy-6.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.2
Parent and Patient Scores at Week 12-3.4
Parent and Patient Scores at After Radiation-3.0
Parent and Patient Scores at Off-therapy-1.1

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-2.0
Parent and Patient Scores at Week 12-9.5
Parent and Patient Scores at After Radiation-5.6
Parent and Patient Scores at Off-therapy-5.4

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-2.5
Parent and Patient Scores at Week 12-9.5
Parent and Patient Scores at After Radiation-5.9
Parent and Patient Scores at Off-therapy-9.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.2
Parent and Patient Scores at Week 12-9.3
Parent and Patient Scores at After Radiation-2.2
Parent and Patient Scores at Off-therapy-8.7

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.5
Parent and Patient Scores at Week 12-5.2
Parent and Patient Scores at After Radiation-4.5
Parent and Patient Scores at Off-therapy-5

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-6.1
Parent and Patient Scores at Week 12-8.8
Parent and Patient Scores at After Radiation-7.9
Parent and Patient Scores at Off-therapy-6.6

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.7
Parent and Patient Scores at Week 12-3.9
Parent and Patient Scores at After Radiation-2.7
Parent and Patient Scores at Off-therapy-0.5

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-4.9
Parent and Patient Scores at Week 8-9.4
Parent and Patient Scores at Week 12-8.0
Parent and Patient Scores at After Radiation-10.8
Parent and Patient Scores at Off-therapy-1.7

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.9
Parent and Patient Scores at Week 8-2.3
Parent and Patient Scores at Week 12-1.9
Parent and Patient Scores at After Radiation-5.4
Parent and Patient Scores at Off-therapy-2

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.8
Parent and Patient Scores at Week 8-6.4
Parent and Patient Scores at Week 12-6.3
Parent and Patient Scores at After Radiation-5.6
Parent and Patient Scores at Off-therapy-3.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy1.3
Parent and Patient Scores at Week 8-5.3
Parent and Patient Scores at Week 12-4.1
Parent and Patient Scores at After Radiation-3.4
Parent and Patient Scores at Off-therapy-4.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-5.3
Parent and Patient Scores at Week 8-5.7
Parent and Patient Scores at Week 12-7.4
Parent and Patient Scores at After Radiation-5.0
Parent and Patient Scores at Off-therapy-3.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.9
Parent and Patient Scores at Week 8-4.8
Parent and Patient Scores at Week 12-4.8
Parent and Patient Scores at After Radiation-5
Parent and Patient Scores at Off-therapy-2.9

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Disease Failure Rate Within Radiation Fields

Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT00352027)
Timeframe: 3 years

Interventionproportion of participants (Number)
Stanford V Chemotherapy0.1125

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 877.6
Week 1279.5
After Radiation78.6
Off-therapy79.9

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 879.2
Week 1280.4
After Radiation80.3
Off-therapy84.3

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 861.2
Week 1257.4
After Radiation72.2
Off-therapy83.2

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 861.2
Week 1261.8
After Radiation73.1
Off-therapy82.7

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 874.9
Week 1272.2
After Radiation73.7
Off-therapy76.3

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 870.0
Week 1260.0
After Radiation63.1
Off-therapy73.8

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.7
Week 1269.3
After Radiation74.5
Off-therapy80.0

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 881.9
Week 1272.6
After Radiation78.5
Off-therapy81.8

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 870
Week 1269.2
After Radiation71.9
Off-therapy78.7

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy67.7
Week 865.4
Week 1268.1
After Radiation73.0
Off-therapy82.0

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy79.8
Week 865.3
Week 1267.3
After Radiation73.6
Off-therapy84.6

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy76.2
Week 871.0
Week 1274.1
After Radiation79.0
Off-therapy88.0

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy74.4
Week 862.8
Week 1270.8
After Radiation75.6
Off-therapy78.9

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy86.1
Week 883.0
Week 1280.7
After Radiation85.1
Off-therapy89.1

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy77.6
Week 869.1
Week 1272.3
After Radiation77.8
Off-therapy83.5

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Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 879.1
Week 1278.2
After Radiation87.0
Off-therapy82.0

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Patient Quality of Life (QoL), PedsQL v.3.0: Communication

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 880.7
Week 1283.0
After Radiation87.2
Off-therapy89.0

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Patient Quality of Life (QoL), PedsQL v.3.0: Nausea

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 862.7
Week 1260.1
After Radiation76.7
Off-therapy81.6

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Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 863.9
Week 1271.5
After Radiation79.9
Off-therapy88.0

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Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 877.6
Week 1281.3
After Radiation81.4
Off-therapy84.7

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Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.8
Week 1270.9
After Radiation68.1
Off-therapy80.1

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Patient Quality of Life (QoL), PedsQL v.3.0: Total Score

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 874.1
Week 1274.2
After Radiation81.7
Off-therapy83.5

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Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 889.2
Week 1282
After Radiation89.4
Off-therapy87.3

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Patient Quality of Life (QoL), PedsQL v.3.0: Worry

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.2
Week 1272.2
After Radiation74.5
Off-therapy76.0

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Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy72.6
Week 875.3
Week 1275.7
After Radiation84.5
Off-therapy81.6

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Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy83.2
Week 868.4
Week 1269.1
After Radiation80.8
Off-therapy85.2

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Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy79.3
Week 877.6
Week 1278.6
After Radiation84.3
Off-therapy84.3

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Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy73.1
Week 869.5
Week 1272.6
After Radiation78.4
Off-therapy81.3

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Patient Quality of Life (QoL), PedsQL v.4.0: Total Score

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy80.9
Week 874.4
Week 1275.3
After Radiation83.1
Off-therapy84.5

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Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy90.9
Week 888.6
Week 1288.0
After Radiation90.1
Off-therapy91.1

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Patient Quality of Life (QoL), Symptom Distress Scale

"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy17.3
Week 819.6
Week 1218.1
After Radiation15.1
Off-therapy14.3

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Relationship Between Marker Detection and Clinical Outcome

Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention. (NCT00369681)
Timeframe: 3 years

Interventionrelapses (Number)
No re-emergence of cloneRe-emergence of clone
R-ABVD02

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Effect of Rituximab on EBV(+) Tumors

Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV). (NCT00369681)
Timeframe: Up to 56 months

Interventionrelapses (Number)
R-ABVD0

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Event-free Survival

Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma. (NCT00369681)
Timeframe: 3 years

Interventionpercentage of participants (Number)
R-ABVD83

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5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD

Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months. (NCT00504504)
Timeframe: Baseline to 5 Years or until disease progression

Interventionpercentage of participants (Number)
Rituximab + ABVD Chemotherapy83

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Number of Participants With Progression Free Survival (10 Years) by Treatment

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00577993)
Timeframe: 10 years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Number of Participants With Overall Survival (10 Years) by Treatment

Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. (NCT00577993)
Timeframe: 10 Years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Event-free Survival (EFS) Rate

EFS will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate. (NCT00654732)
Timeframe: From the start of study treatment up to 3 years

InterventionParticipants (Count of Participants)
RABVD17
ABVD20

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Clinical Measure of Lesion Size.

Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size (NCT00744653)
Timeframe: up to one year

InterventionParticipants (Number)
Electrochemotherapy2

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Participants With Objective Response Evaluated With PET/CT

Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT. (NCT00744653)
Timeframe: 3, weeks, 8 weeks, and up to 6 months after treatment

Interventionparticipants (Number)
Electrochemotherapy4

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Safety and Toxicity

(NCT00744653)
Timeframe: up to 1 year

Interventionadverse events (Number)
Electrochemotherapy0

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Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD

Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. (NCT00822120)
Timeframe: 7 months after registration

Interventionpercentage of patients (Number)
PET-negative: Continued ABVD After 2 Cycles of ABVD100
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD93

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Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS

Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of participants (Number)
HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP64

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Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging

Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of participants (Number)
HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy98

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Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.

Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of participants (Number)
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap79

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Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.

Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of patients (Number)
HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap83

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Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.

Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 5 years

Interventionpercentage of participants (Number)
HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap89

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Relapse-free Survival

A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.82
Group 60.83
Group 70.79

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Event Free Survival

Survival from enrollment to first event: relapse/progression, second malignancy, or death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.81
Group 20.83
Group 30.78

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Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative

To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.84
Group 40.82
Group 50.90

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Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy

The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy. (NCT01026220)
Timeframe: During and after completion of study treatment.

Interventionparticipants (Number)
Group 172

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Overall Survival

Survival from enrollment to death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.97
Group 20.97
Group 30.97

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Safety Analysis and Monitoring of Toxic Death

The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment. (NCT01026220)
Timeframe: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).

Interventionparticipants (Number)
Group 10

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Second-event-free Survival

Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event. (NCT01026220)
Timeframe: At 4 years from enrollment

,
InterventionProbability of survival (Number)
Group 10.91
Group 20.94
Group 30.88

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Tumor Response Rate

"Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR)." (NCT01042522)
Timeframe: Median followup time was 48 months.

Interventionproportion of participants (Number)
Arm I (Paclitaxel, Carboplatin)0.43
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)0.54

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Progression-free Survival (PFS)

The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT01042522)
Timeframe: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.

Interventionmonths (Median)
Arm I (Paclitaxel, Carboplatin)27.7
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)19.7

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Overall Survival (OS)

The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported. (NCT01042522)
Timeframe: From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.

InterventionParticipants (Count of Participants)
Arm I (Paclitaxel, Carboplatin)5
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)8

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36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.

All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT. (NCT01132807)
Timeframe: at 36 months

Interventionproportion of participants (Number)
Treatment (ABVD:4 Cycles).91
Escalated BEACOPP and Involved Field Radiation Therapy.67

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Complete Response Rate

A Complete Response (CR) was defined as having the following conditions: 1. A complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. In patients with a PET scan that was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET-negative. A Complete Response rate was defined as the number of patients who achieved a CR divided by the number of patients that were eligible for analysis in each group. The CR rate was calculated for patients that completed 4 cycles of ABVD and for patients that completed 2 cycles of ABVD and 2 cycles of BEACOPP and IFRT. (NCT01132807)
Timeframe: Up to 5 years

Interventionproportion of participants (Number)
Treatment (ABVD: 4 Cycles).97
Escalated BEACOPP and Involved Field Radiation Therapy.85

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Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD

The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included. (NCT01132807)
Timeframe: 36 Months

Interventionproportion of patients (Number)
Treatment (ABVD: 4 Cycles).91

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Proportion of Patients Who Are PET Negative After Induction Treatment

(NCT01390584)
Timeframe: Assessed at end of Cycle 2

Interventionproportion of participants (Number)
Step 1: Induction Tx0.8

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Progression-free Survival Rate

Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionproportion of participants (Number)
ABVD + INRTNA
ABVD + BEACOPP + INRTNA

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Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment

Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionproportion of participants (Number)
ABVD + BEACOPP + INRTNA

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Overall Survival

Overall survival is defined as the time from study entry to death or date last known alive. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionmonths (Median)
ABVD + INRTNA
ABVD + BEACOPP + INRTNA

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Complete Response (CR) Rate After Induction Treatment

Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. (NCT01390584)
Timeframe: Assessed at end of Cycle 2

Interventionproportion of participants (Number)
Step 1: Induction Tx1.0

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Participants' Response

Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: > 25 % increase in size of any measurable lesion or appearance of significant new lesions. (NCT01404936)
Timeframe: After 6 courses (3 months)

Interventionparticipants (Number)
Complete ResponseUncomfirmed Complete ResponsePartial ResponseProgressive Disease
Interferon-2A + Chemotherapy23231

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Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART

KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12

InterventionParticipants (Count of Participants)
ET+ART6
PTX+ART0

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Number of Participants With Objective Response for ET+ART vs. PTX+ART

The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144

InterventionParticipants (Count of Participants)
ET+ART18
PTX+ART34

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Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART

Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240

Interventionweeks (Number)
BV+ART24.7
PTX+ART38.6

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Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART

Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or the participant's off study week, whichever is later. The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240

Interventionweeks (Number)
ET+ART17.9
PTX+ART30.0

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Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART

Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48

,
Interventioncells/mm^3 (Median)
Week 12 CD4 changeWeek 24 CD4 changeWeek 48 CD4 change
BV+ART2143112
PTX+ART3765105

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Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART

Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48

,
Interventioncells/mm^3 (Median)
Week 12 CD4 changeWeek 24 CD4 changeWeek 48 CD4 change
ET+ART3710669
PTX+ART4795157

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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2

IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 2 treatment arm. (NCT01435018)
Timeframe: From Step 2 study entry to Step 2 discontinuation, up to 144 weeks

,,
InterventionParticipants (Count of Participants)
With IERC-confirmed KS progressionWith dose-limiting toxicityDiedWith AIDS-defining eventsWith virologic failureWith objective response
BV+ART101127
ET+ART100010
PTX+ART105015

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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3

IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 3 treatment arm. (NCT01435018)
Timeframe: From Step 3 study entry to Step 3 discontinuation, up to 144 weeks

,,
InterventionParticipants (Count of Participants)
With IERC-confirmed KS progressionWith dose-limiting toxicityDiedWith AIDS-defining eventsWith virologic failureWith objective response
BV+ART6035218
ET+ART200025
PTX+ART8077129

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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4

IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 4 treatment arm. (NCT01435018)
Timeframe: From Step 4 study entry to Step 4 discontinuation, up to 96 weeks

,
InterventionParticipants (Count of Participants)
With IERC-confirmed KS progressionWith dose-limiting toxicityDiedWith AIDS-defining eventsWith virologic failureWith objective response
BV+ART203013
PTX+ART302003

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Number of Participants With Peripheral Neuropathy (PN)

Presence of PN is defined as having all of the following results: presence of symptomatic PN, abnormal perception of vibrations, and absent or hypoactive deep tendon reflexes. (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.

,,
InterventionParticipants (Count of Participants)
ScreeningWeek 3Week 6Week 9Week 12Week 15Week 18Week 21
BV+ART71133265
ET+ART10000000
PTX+ART00224312

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Number of Participants With Symptomatic Peripheral Neuropathy (SPN)

"SPN consists of three assessments: (1) pain, aching or burning in feet, legs, (2) pins and needles in feet, legs, and (3) numbness (lack of feeling) in feet, legs. SPN is graded on a severity scale from 0 (not present), 1 (mild) to 10 (severe). Presence of SPN is defined as having grade >=1 in at least one of the three assessments." (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.

,,
InterventionParticipants (Count of Participants)
ScreeningWeek 3Week 6Week 9Week 12Week 15Week 18Week 21
BV+ART7662464036262530
ET+ART2400140004
PTX+ART5934322723161520

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Self-reported Adherence to ART Therapy

ART adherence is based on participant's recall of the number of missed ART doses for the past month. Perfect adherence is defined as having zero missed ART doses. (NCT01435018)
Timeframe: At Weeks 6, 12, 18, 30 and 48

,,
InterventionParticipants (Count of Participants)
Week 6 Perfect AdherenceWeek 12 Perfect AdherenceWeek 18 Perfect adherenceWeek 30 Perfect adherenceWeek 48 Perfect adherence
BV+ART101101856613
ET+ART433629130
PTX+ART106103978520

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Number of Participants With Objective Response for BV+ART vs. PTX+ART

The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144

InterventionParticipants (Count of Participants)
BV+ART80
PTX+ART91

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Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART17.9
PTX+ART19.6

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Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART15.2
PTX+ART28.6

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Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART32.5
PTX+ART18.9

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Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART59.5
PTX+ART26.0

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Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to the death date. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART18.5
PTX+ART10.3

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Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to date of death. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART25.6
PTX+ART10.7

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Cumulative Rate of Death for BV+ART vs PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240

InterventionCumulative events per 100 persons (Number)
BV+ART18.5
PTX+ART10.3

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Cumulative Rate of Death for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240

InterventionCumulative events per 100 persons (Number)
ET+ART25.6
PTX+ART10.7

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Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART

Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART7.4
PTX+ART1.8

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Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART

Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART7.8
PTX+ART0.0

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Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART43.9
PTX+ART25.7

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Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART69.8
PTX+ART41.2

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART60.9
PTX+ART42.0

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART77.5
PTX+ART54.6

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART54.5
PTX+ART36.2

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART57.6
PTX+ART33.9

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Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART56.7
PTX+ART42.1

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Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART72.4
PTX+ART54.6

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Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART

Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART44.1
PTX+ART64.2

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Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART

Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART19.7
PTX+ART49.8

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Duration of Objective Response for BV+ART vs. PTX+ART

Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144

Interventionweeks (Number)
ET+ART21.0
PTX+ART45.7

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Duration of Objective Response for ET+ART vs. PTX+ART

Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144

Interventionweeks (Number)
ET+ART10.1
PTX+ART19.9

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Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART

KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12

InterventionParticipants (Count of Participants)
BV+ART2
PTX+ART0

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A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE

(NCT01712490)
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

Interventionday*nanogram per milliliter (day*ng/mL) (Mean)
A+AVD25.3

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Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy

CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease. (NCT01712490)
Timeframe: Baseline up to end of frontline therapy (approximately 4 years)

Interventionpercentage of participants (Number)
A+AVD73
ABVD71

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Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF

CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease. (NCT01712490)
Timeframe: Baseline up to end of randomized regimen (approximately 1 year)

Interventionpercentage of participants (Number)
A+AVD73
ABVD70

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Disease-free Survival (DFS) Per IRF

DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease. (NCT01712490)
Timeframe: From CR until PD or death (approximately up to 4 years)

Interventionmonths (Median)
A+AVDNA
ABVDNA

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Duration of Complete Remission (DOCR) Per IRF

DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. (NCT01712490)
Timeframe: From first documentation of CR until PD (approximately 4 years)

Interventionmonths (Median)
A+AVDNA
ABVDNA

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Duration of Response (DOR) Per IRF

DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. (NCT01712490)
Timeframe: From first documented response until PD (approximately 4 years)

Interventionmonths (Median)
A+AVDNA
ABVDNA

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Event-free Survival (EFS) Per IRF

EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir per IRF. (NCT01712490)
Timeframe: Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)

Interventionmonths (Median)
A+AVDNA
ABVDNA

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Number of Participants With Abnormal Clinical Laboratory Values

(NCT01712490)
Timeframe: Baseline up to 30 days after last dose of study drug (approximately 1 year)

Interventionparticipants (Number)
A+AVD662
ABVD658

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Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

(NCT01712490)
Timeframe: Baseline up to 30 days after last dose of study drug (approximately 1 year)

,
Interventionparticipants (Number)
TEAESAE
A+AVD653284
ABVD646178

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Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT

EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by >=50% of previously involved sites from nadir. (NCT01712490)
Timeframe: Baseline up to end of treatment (approximately 1 year)

,
Interventionunits on scale (Mean)
Baseline: With mPFS eventWithout mPFS eventChange at end of treatment: with mPFS eventChange at end of treatment: without mPFS event
A+AVD78.1579.852.683.35
ABVD76.6879.918.586.08

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A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin

The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit. (NCT01712490)
Timeframe: Baseline up to end of treatment (approximately 1 year)

Interventionparticipants (Number)
ATA positivenATA positive
A+AVD10912

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A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)

(NCT01712490)
Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

Interventionmicrogram per milliliter (microgm/mL) (Geometric Mean)
Cycle 1 Day 1: ADCCycle 3 Day 1: ADCCycle 1 Day 1: TAbCycle 3 Day 1: TAb
A+AVD22.923.622.626.4

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A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

(NCT01712490)
Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Cycle 1 Day 1Cycle 3 Day 1
A+AVD3.201.36

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A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb

(NCT01712490)
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

Interventionday*microgram per milliliter (day*ug/mL) (Mean)
Cycle 1 Day 1: ADCCycle 1 Day 1: TAb
A+AVD47.493.0

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Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2

PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (<=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans. (NCT01712490)
Timeframe: Cycle 2 Day 25

Interventionpercentage of participants (Number)
A+AVD89
ABVD86

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Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy

CR was defined as disappearance of all evidence of disease as determined by an IRF. (NCT01712490)
Timeframe: Baseline up to end of frontline therapy (approximately 4 years)

Interventionpercentage of participants (Number)
A+AVD8
ABVD13

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Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive. (NCT01712490)
Timeframe: Baseline until death (approximately up to 4 years)

Interventionmonths (Median)
A+AVDNA
ABVDNA

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Overall Response Rate (ORR) Per IRF

ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. (NCT01712490)
Timeframe: Baseline up to end of randomized regimen (approximately 1 year)

Interventionpercentage of participants (Number)
A+AVD86
ABVD83

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Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)

mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments. (NCT01712490)
Timeframe: Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)

Interventionmonths (Median)
A+AVDNA
ABVDNA

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Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death

Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment

Interventionpercentage of participants (Number)
Arm I (ABVE-PC)82.5
ARM II (Bv-AVEPC)92.1

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Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)5.5
ARM II (Bv-AVEPC)6.7

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Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review

The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)80.7
ARM II (Bv-AVEPC)81.2

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Total Score on Quality of Life Assessed Using Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire

"The four domains of the FACT-G questionnaire will be determined for each questionnaire: physical well-being, social/family well-being, emotional well-being, and functional well-being. Each of these four domains is scored on a subset of 6-7 statements with a 0-4 scale. The domain is scored by summing up the responses to these statements. The ranges for the domains are as follows: physical well-being 0-28, social/family well-being 0-28, emotional well-being 0-24, and functional well-being 0-28. Using general estimating equations, changes in these domains with time will be explored. Logistic regression analyses will be used to correlate changes in quality of life domains with clinical response.~The overall score is the sum of all the subscales and ranges from 0 to 108. Higher scores reflect better quality of life outcomes.~The FACT-G Total Score at 3 months is reported here" (NCT03596918)
Timeframe: Up to 3 months after treatment completion

Interventionscore on a scale (Mean)
Supportive Care (Vincristine Sulfate, Bleomycin Sulfate)56.9

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Adverse Events for Calcium Electroporation and Bleomycin Based Electrochemotherapy. The Adverse Reactions Are Classified According to CTCAE Version 4.0 (Common Terminology Criteria for Adverse Events).

"Adverse Event, AE: Any adverse events in a patient that occur or worsen during the trial and does not necessarily have a causal relationship to study treatment~Adverse Reaction, AR: All noxious and unintended reactions to a trial drug at any dose (possible relation between the study drug and the adverse reaction cannot be excluded)~Unexpected Adverse Reaction, UAR: An adverse reaction with a nature or severity that is not in accordance with the current product information (Investigator's Brochure)~Serious Adverse Event, SAE: an event or side effect that at any dose:~Results in death~Is life threatening~Leads to hospitalization or prolongation of hospital stay~Results in persistent or significant disability or incapacity~Leads to a congenital anomaly or birth defect~Is a major medical event~Suspected Unexpected Serious Adverse Reactions, SUSARs: adverse reactions that are not described in the product information for the experimental drug" (NCT03628417)
Timeframe: 180 days after treatment

,
Interventioncutaneous metastases (Number)
UlcerationHyperpigmentationFlu-like symptomsItch
Bleomycin Based Electrochemotherapy3600
Calcium Electroporation2200

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Response Rate (RECIST1.1) of Calcium Electroporation and Bleomycin Based Electrochemotherapy on Cutaneous Metastases at Day 180.

"Documentation was done with digital color photography, including a ruler to estimate tumor size. Primary evaluation of the response was based on criteria similar RECIST 1.1 guidelines and defined as complete response (CR) - disappearance of the lesion, partial response (PR) - at least 30% decrease in the largest diameter of the lesion, progressive disease - at least 20% increase in the largest diameter of the lesion and stable disease - neither 30% decrease nor 20% increase of the largest diameter of the lesion.~Change in the largest diameter:" (NCT03628417)
Timeframe: 180 days after treatment

,
Interventioncutaneous metastases (Number)
CRPRSDPD
Bleomycin Based Electrochemotherapy6252
Calcium Electroporation4266

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The Tertiary Outcome is to Register if Calcium Affects the Current Strength in Electroporation Treatments.

We measured the maximum electric current which was given to the metastases. The measurement was needed because the current is unknown during Ca-electroporation, and also we would like to determine wether there is a difference between bleomycin based electrochemotherapy and calcium electroporation in current. (NCT03628417)
Timeframe: Day 0 - During Ca-electroporation and bleomycin based electrochemotherapy interventions

InterventionAmper (Median)
Calcium Electroporation3.850
Bleomycin Based Electrochemotherapy4.000

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