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NCT00375674 · OUTCOME

Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)

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
MEAN
Unit
Weeks
Interval / dispersion
Standard Deviation
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: AT population: All participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. The numbers of participants analyzed were the participants with any adverse event of special interest (AESI) and that one participant could have reported more than one AESI

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

Benign Neoplasm of Thyroid Gland

Analysis denominator · Participants

GroupSource count
Sunitinib0
Placebo1
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo35.1Not reportedNot reportedNot reportedNot reported
Goitre

Analysis denominator · Participants

GroupSource count
Sunitinib0
Placebo2
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo305.697.08Not reportedNot reportedNot reported
Hyperthyroidism

Analysis denominator · Participants

GroupSource count
Sunitinib12
Placebo2
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sunitinib23.225.95Not reportedNot reportedNot reported
Placebo110.8146.57Not reportedNot reportedNot reported
Hypothyroidism

Analysis denominator · Participants

GroupSource count
Sunitinib56
Placebo4
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sunitinib46.975.30Not reportedNot reportedNot reported
Placebo58.062.06Not reportedNot reportedNot reported
Papillary Thyroid Cancer

Analysis denominator · Participants

GroupSource count
Sunitinib0
Placebo1
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo22.1Not reportedNot reportedNot reportedNot reported
Thyroid Disorder

Analysis denominator · Participants

GroupSource count
Sunitinib1
Placebo0
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sunitinib19Not reportedNot reportedNot reportedNot reported
Thyroid Mass

Analysis denominator · Participants

GroupSource count
Sunitinib0
Placebo1
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo20.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        35.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Benign Neoplasm of Thyroid Gland
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        97.08
        value
        305.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Goitre
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.95
        value
        23.2
      2. group Id
        OG001
        spread
        146.57
        value
        110.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Hyperthyroidism
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.30
        value
        46.9
      2. group Id
        OG001
        spread
        62.06
        value
        58.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Hypothyroidism
  5. categories
    1. measurements
      1. group Id
        OG001
        value
        22.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Papillary Thyroid Cancer
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Thyroid Disorder
  7. categories
    1. measurements
      1. group Id
        OG001
        value
        20.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Thyroid Mass
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.
dispersion Type
Standard Deviation
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
MEAN
population Description
AT population: All participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. The numbers of participants analyzed were the participants with any adverse event of special interest (AESI) and that one participant could have reported more than one AESI
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
Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)
type
SECONDARY
unit Of Measure
Weeks

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Preserved source evidence · Not medical advice