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NCT01853748 · OUTCOME

Incidence Rate of Grade 3-4 Treatment-Related Toxicity

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) · Source last updated 2026-02-19

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.

What was measured

All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade \>=3 AE of any type during the time of observation.

Groups in this outcome

Trastuzumab Emtansine (T-DM1)

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

Paclitaxel + Trastuzumab

paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

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

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine (T-DM1)383
Paclitaxel + Trastuzumab114

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)0.16Not reported0.120.2Not reported
Paclitaxel + Trastuzumab0.23Not reported0.150.32Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.12
        upper Limit
        0.2
        value
        0.16
      2. group Id
        OG001
        lower Limit
        0.15
        upper Limit
        0.32
        value
        0.23
denoms
  1. counts
    1. group Id
      OG000
      value
      383
    2. group Id
      OG001
      value
      114
    units
    Participants
description
All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade \>=3 AE of any type during the time of observation.
dispersion Type
95% Confidence Interval
groups
  1. description
    T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
    id
    OG000
    title
    Trastuzumab Emtansine (T-DM1)
  2. description
    paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
    id
    OG001
    title
    Paclitaxel + Trastuzumab
param Type
NUMBER
reporting Status
POSTED
time Frame
AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.
title
Incidence Rate of Grade 3-4 Treatment-Related Toxicity
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice