Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00375674 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer · Source last updated 2018-09-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Number of participants
Interval / dispersion
Not reported
Time frame
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later

What was measured

TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs. Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent.

Analysis population: The As-Treated (AT) population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. This population was the primary population for evaluating treatment administration/ compliance and safety.

Groups in this outcome

Sunitinib

Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.

Placebo

Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Sunitinib306
Placebo304

Reported measurements

Participants With Adverse Events (AEs)
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib305Not reportedNot reportedNot reportedNot reported
Placebo270Not reportedNot reportedNot reportedNot reported
Participants With Serious Adverse Events (SAEs)
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib67Not reportedNot reportedNot reportedNot reported
Placebo52Not reportedNot reportedNot reportedNot reported
Participants With Grade 3 or 4 AEs
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib189Not reportedNot reportedNot reportedNot reported
Placebo61Not reportedNot reportedNot reportedNot reported
Participants With Grade 5 AEs
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib5Not reportedNot reportedNot reportedNot reported
Placebo5Not reportedNot reportedNot reportedNot reported
Participants Discontinued Due to AEs
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib86Not reportedNot reportedNot reportedNot reported
Placebo16Not reportedNot reportedNot reportedNot reported
Participants With Dose Reduced Due to AEs
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib106Not reportedNot reportedNot reportedNot reported
Placebo6Not reportedNot reportedNot reportedNot reported
Temporary Discontinuation Due to AEs
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib141Not reportedNot reportedNot reportedNot reported
Placebo40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        305
      2. group Id
        OG001
        value
        270
    title
    Participants With Adverse Events (AEs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        52
    title
    Participants With Serious Adverse Events (SAEs)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        61
    title
    Participants With Grade 3 or 4 AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
    title
    Participants With Grade 5 AEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        86
      2. group Id
        OG001
        value
        16
    title
    Participants Discontinued Due to AEs
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        6
    title
    Participants With Dose Reduced Due to AEs
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        40
    title
    Temporary Discontinuation Due to AEs
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      304
    units
    Participants
description
TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs. Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent.
groups
  1. description
    Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
    id
    OG000
    title
    Sunitinib
  2. description
    Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
The As-Treated (AT) population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. This population was the primary population for evaluating treatment administration/ compliance and safety.
reporting Status
POSTED
time Frame
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
type
SECONDARY
unit Of Measure
Number of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice