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NCT01853748 · OUTCOME

Percentage of Activity Impairment Because of Health

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
MEAN
Unit
percentage of time
Interval / dispersion
Standard Deviation
Time frame
Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

What was measured

Effects of therapy on work productivity and activity - Activity Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

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 (TH)

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 + Trastuzumab (TH)114

Reported measurements

Baseline
Values in percentage of time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)1422Not reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)2226Not reportedNot reportedNot reported
3 weeks
Values in percentage of time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)1219Not reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)2227Not reportedNot reportedNot reported
12 weeks
Values in percentage of time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)1319Not reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)3331Not reportedNot reportedNot reported
6 months
Values in percentage of time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)1521Not reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)1722Not reportedNot reportedNot reported
12 months
Values in percentage of time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)1521Not reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)1423Not reportedNot reportedNot reported
18 months
Values in percentage of time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)717Not reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)1527Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22
        value
        14
      2. group Id
        OG001
        spread
        26
        value
        22
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19
        value
        12
      2. group Id
        OG001
        spread
        27
        value
        22
    title
    3 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19
        value
        13
      2. group Id
        OG001
        spread
        31
        value
        33
    title
    12 weeks
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21
        value
        15
      2. group Id
        OG001
        spread
        22
        value
        17
    title
    6 months
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        21
        value
        15
      2. group Id
        OG001
        spread
        23
        value
        14
    title
    12 months
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17
        value
        7
      2. group Id
        OG001
        spread
        27
        value
        15
    title
    18 months
denoms
  1. counts
    1. group Id
      OG000
      value
      383
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Effects of therapy on work productivity and activity - Activity Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.
dispersion Type
Standard Deviation
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 (TH)
param Type
MEAN
reporting Status
POSTED
time Frame
Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.
title
Percentage of Activity Impairment Because of Health
type
SECONDARY
unit Of Measure
percentage of time

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

Preserved source evidence · Not medical advice