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NCT01853748 · OUTCOME

Number of Patients Have Alopecia

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Median follow-up was 3.9 years. The AE data cutoff date is 21 April 2020.

What was measured

alopecia assessment is a 5-item questionnaire that will assess the impact alopecia has had on these patients and will be conducted electronically at pre-specified study visits. If electronic evaluation is not possible, paper evaluation will be conducted.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)157Not reportedNot reportedNot reportedNot reported
Paclitaxel + Trastuzumab0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    statistical Method
    Regression, Linear
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    statistical Method
    Regression, Linear
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        157
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      383
    2. group Id
      OG001
      value
      114
    units
    Participants
description
alopecia assessment is a 5-item questionnaire that will assess the impact alopecia has had on these patients and will be conducted electronically at pre-specified study visits. If electronic evaluation is not possible, paper evaluation will be conducted.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Median follow-up was 3.9 years. The AE data cutoff date is 21 April 2020.
title
Number of Patients Have Alopecia
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice