fluorouracil and Adverse Drug Event

fluorouracil has been researched along with Adverse Drug Event in 201 studies

Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.
5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.

Research

Studies (201)

Authors

Clinical Trials (31)

Trial Overview

Trial Outcomes

Objective Tumor Response Rate (Irinotecan)

Best overall response of complete or partial response within irinotecan stratum (NCT00115765)
Timeframe: Overall Study

Objective Tumor Response Rate (Mutant KRAS)

Best overall response of complete or partial response in participants treated with irinotecan and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) (NCT00115765)
Timeframe: Overall Study

Objective Tumor Response Rate (Oxaliplatin)

Best overall response of complete or partial response within oxaliplatin stratum (NCT00115765)
Timeframe: Overall study

Objective Tumor Response Rate (Wild-type KRAS)

Best overall response of complete or partial response in participants treated with irinotecan and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) (NCT00115765)
Timeframe: Overall Study

Objective Tumor Response Through Week 12 (Irinotecan)

Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum (NCT00115765)
Timeframe: Overall Study

Overall Survival (Irinotecan)

Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm. (NCT00115765)
Timeframe: Overall study

Overall Survival (Mutant KRAS)

Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median. (NCT00115765)
Timeframe: Overall Study

Overall Survival (Oxaliplatin)

Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin (NCT00115765)
Timeframe: Overall study

Overall Survival (Wild-type KRAS)

Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median (NCT00115765)
Timeframe: Overall Study

Progression-free Survival (Irinotecan)

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression (NCT00115765)
Timeframe: Overall Study

Progression-free Survival (Mutant KRAS)

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) (NCT00115765)
Timeframe: Overall Study

Progression-Free Survival (Oxaliplatin)

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression (NCT00115765)
Timeframe: Overall study

Progression-free Survival (Wild-type KRAS)

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) (NCT00115765)
Timeframe: Overall Study

Time to Progression (Irinotecan)

Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum (NCT00115765)
Timeframe: Overall Study

Time to Progression (Oxaliplatin)

Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum (NCT00115765)
Timeframe: Overall Study

Time to Treatment Failure (Irinotecan)

Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum (NCT00115765)
Timeframe: Overall Study

Time to Treatment Failure (Oxaliplatin)

Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum. (NCT00115765)
Timeframe: Overall study

Duration of Response

Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009. (NCT00384176)
Timeframe: Up until data cut-off date of 15/11/2007

Objective Response Rate

"Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:~CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs." (NCT00384176)
Timeframe: Up until data cut-off

Overall Survival

Number of months from randomisation to the date of death from any cause (NCT00384176)
Timeframe: Randomisation until data cut-off

Percentage Change in Tumour Size

Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100 (NCT00384176)
Timeframe: Baseline to Week 8

Progression Free Survival

Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. (NCT00384176)
Timeframe: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression

Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)

Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded. (NCT00384176)
Timeframe: Baseline through to data cut-off

Duration of Response

Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review. (NCT00364013)
Timeframe: Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.

Overall Survival

The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date. (NCT00364013)
Timeframe: From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.

Percentage of Participants With an Objective Response

Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. (NCT00364013)
Timeframe: Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.

Progression-free Survival

Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions. (NCT00364013)
Timeframe: From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.

Time to Progression

Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria. (NCT00364013)
Timeframe: From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.

Number of Participants With Adverse Events (AEs)

"A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: Is there a reasonable possibility that the event may have been caused by the study treatment?" (NCT00364013)
Timeframe: From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.

Overall Objective Response Rate (ORR)

"Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.~Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study)." (NCT00851084)
Timeframe: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)

Overall Survival (OS)

"Overall survival was defined as the time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earliest between the last date the patient was known to be alive and the study cutoff date.~The study was not powered for comparison of OS between the two arms (non-comparative, open-label study)." (NCT00851084)
Timeframe: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)

Progression Free Survival (PFS)

"PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.~The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).~Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions." (NCT00851084)
Timeframe: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)

Progression Free Survival (PFS) Rate at 12 Months

PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. (NCT00851084)
Timeframe: 12 months

Immunogenicity of Intravenous (IV) Aflibercept

The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept. (NCT00851084)
Timeframe: Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status

Number of Participants With Treatment-emergent Adverse Events (TEAE)

Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs. (NCT00851084)
Timeframe: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized

Duration of Response (DoR)

DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to < 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.) (NCT01111604)
Timeframe: Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)

Number of Participants With Serum Ramucirumab Antibody Assessment

A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals. (NCT01111604)
Timeframe: 31 Weeks

Overall Survival (OS)

Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. (NCT01111604)
Timeframe: Baseline Until Death from Any Cause (Up to 163 Weeks)

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression. (NCT01111604)
Timeframe: Baseline until Disease Progression (Up to 95 Weeks)

Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5

Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum. (NCT01111604)
Timeframe: Cycle 5, 1 Hour Post End of Infusion

Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5

Trough (prior to infusion, Ctrough) concentrations measured in serum. (NCT01111604)
Timeframe: Cycle 5, Prior to Infusion

Progression-Free Survival (PFS)

PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit. (NCT01111604)
Timeframe: Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)

Number of Participants With Adverse Events

A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module. (NCT01111604)
Timeframe: Baseline up to 165 weeks

Reviews

25 reviews available for fluorouracil and Adverse Drug Event

Trials

48 trials available for fluorouracil and Adverse Drug Event

Other Studies

129 other studies available for fluorouracil and Adverse Drug Event