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NCT00567190 · OUTCOME

Overall Number of Adverse Events by Severity (NCI-CTCAE v3.0 All Grades and Grades 3 to 5) Per 100 Patient-Years of Exposure During the Treatment Period

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer · Source last updated 2019-12-13

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

Measure
NUMBER
Unit
Events per 100 patient-years
Interval / dispersion
90% Confidence Interval
Time frame
From Baseline to 42 days after the last dose of study treatment (total patient-years of exposure on study treatment in Placebo vs. Pertuzumab arms: 526.81 vs. 989.88 patient-years)

What was measured

Adverse event (AE) severity, including serious and non-serious AEs, was assessed according to the NCI-CTCAE version 3.0; if the AE was not specifically listed, the following grades of severity were used: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; Grade 4 is life-threatening or disabling; and Grade 5 is death. Multiple occurrences of the same AE in 1 participant were counted multiple times. Only AEs that started during the overall study treatment period were included. The cutoff date for inclusion of events and for calculation of patient-years was the date of the most recent follow-up of the participant, defined as the last available date during the treatment period, excluding pre-treatment and safety follow-up data. Confidence intervals were calculated assuming the number of events followed a Poisson distribution. Data reported prior to the date of first crossover treatment were included under the Placebo arm for participants who crossed over from placebo to pertuzumab.

Analysis population: Safety Population: All participants who received at least one dose of any study medication.

Groups in this outcome

Placebo + Trastuzumab + Docetaxel

This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

Pertuzumab + Trastuzumab + Docetaxel

This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

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

Analysis denominator · Participants

GroupSource count
Placebo + Trastuzumab + Docetaxel396
Pertuzumab + Trastuzumab + Docetaxel408

Analysis denominator · Adverse Events

GroupSource count
Placebo + Trastuzumab + Docetaxel9062
Pertuzumab + Trastuzumab + Docetaxel11908

Reported measurements

All Grades

Analysis denominator · Participants

GroupSource count
Placebo + Trastuzumab + Docetaxel396
Pertuzumab + Trastuzumab + Docetaxel408

Analysis denominator · Adverse Events

GroupSource count
Placebo + Trastuzumab + Docetaxel9062
Pertuzumab + Trastuzumab + Docetaxel11908
Values in Events per 100 patient-years · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Trastuzumab + Docetaxel1720.2Not reported1690.61750.2Not reported
Pertuzumab + Trastuzumab + Docetaxel1203.0Not reported1184.91221.3Not reported
Grades 3 to 5

Analysis denominator · Participants

GroupSource count
Placebo + Trastuzumab + Docetaxel396
Pertuzumab + Trastuzumab + Docetaxel408

Analysis denominator · Adverse Events

GroupSource count
Placebo + Trastuzumab + Docetaxel1187
Pertuzumab + Trastuzumab + Docetaxel1304
Values in Events per 100 patient-years · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Trastuzumab + Docetaxel225.3Not reported214.7236.4Not reported
Pertuzumab + Trastuzumab + Docetaxel131.7Not reported125.8137.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1690.6
        upper Limit
        1750.2
        value
        1720.2
      2. group Id
        OG001
        lower Limit
        1184.9
        upper Limit
        1221.3
        value
        1203.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        396
      2. group Id
        OG001
        value
        408
      units
      Participants
    2. counts
      1. group Id
        OG000
        value
        9062
      2. group Id
        OG001
        value
        11908
      units
      Adverse Events
    title
    All Grades
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        214.7
        upper Limit
        236.4
        value
        225.3
      2. group Id
        OG001
        lower Limit
        125.8
        upper Limit
        137.9
        value
        131.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        396
      2. group Id
        OG001
        value
        408
      units
      Participants
    2. counts
      1. group Id
        OG000
        value
        1187
      2. group Id
        OG001
        value
        1304
      units
      Adverse Events
    title
    Grades 3 to 5
denom Units Selected
Adverse Events
denoms
  1. counts
    1. group Id
      OG000
      value
      396
    2. group Id
      OG001
      value
      408
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      9062
    2. group Id
      OG001
      value
      11908
    units
    Adverse Events
description
Adverse event (AE) severity, including serious and non-serious AEs, was assessed according to the NCI-CTCAE version 3.0; if the AE was not specifically listed, the following grades of severity were used: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; Grade 4 is life-threatening or disabling; and Grade 5 is death. Multiple occurrences of the same AE in 1 participant were counted multiple times. Only AEs that started during the overall study treatment period were included. The cutoff date for inclusion of events and for calculation of patient-years was the date of the most recent follow-up of the participant, defined as the last available date during the treatment period, excluding pre-treatment and safety follow-up data. Confidence intervals were calculated assuming the number of events followed a Poisson distribution. Data reported prior to the date of first crossover treatment were included under the Placebo arm for participants who crossed over from placebo to pertuzumab.
dispersion Type
90% Confidence Interval
groups
  1. description
    This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    OG000
    title
    Placebo + Trastuzumab + Docetaxel
  2. description
    This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    OG001
    title
    Pertuzumab + Trastuzumab + Docetaxel
param Type
NUMBER
population Description
Safety Population: All participants who received at least one dose of any study medication.
reporting Status
POSTED
time Frame
From Baseline to 42 days after the last dose of study treatment (total patient-years of exposure on study treatment in Placebo vs. Pertuzumab arms: 526.81 vs. 989.88 patient-years)
title
Overall Number of Adverse Events by Severity (NCI-CTCAE v3.0 All Grades and Grades 3 to 5) Per 100 Patient-Years of Exposure During the Treatment Period
type
SECONDARY
type Units Analyzed
Adverse Events
unit Of Measure
Events per 100 patient-years

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

Preserved source evidence · Not medical advice