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NCT01853748 · OUTCOME

Number of Patients Has Neuropathy

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
Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18. The data cutoff date is 18 month.

What was measured

Neuropathy evaluated by Patient Neurotoxicity Questionnaire (PNQ) defined per protocol.

Analysis population: The PNQ analysis was done on patients that completed at least baseline questionnaires and at least one follow-up questionnaire. Some patients did not complete this questionnaire at either baseline or follow-up. This is the reason for the reduced number of patients when reporting PNQ results.

Groups in this outcome

T-DM1 With no Baseline Neuropathy

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. No neuropathy at baseline

TH With no Baseline Neuropathy

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. No neuropathy at baseline

T-DM1 With Any Baseline Neuropathy

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

TH With Any Baseline Neuropathy

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. Neuropathy at baseline

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

Analysis denominator · Participants

GroupSource count
T-DM1 With no Baseline Neuropathy291
TH With no Baseline Neuropathy81
T-DM1 With Any Baseline Neuropathy58
TH With Any Baseline Neuropathy23

Reported measurements

Source class 1

No, mild, or moderate neuropathy

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-DM1 With no Baseline Neuropathy267Not reportedNot reportedNot reportedNot reported
TH With no Baseline Neuropathy64Not reportedNot reportedNot reportedNot reported
T-DM1 With Any Baseline Neuropathy36Not reportedNot reportedNot reportedNot reported
TH With Any Baseline Neuropathy11Not reportedNot reportedNot reportedNot reported

Moderate to severe and severe neuropathy

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-DM1 With no Baseline Neuropathy24Not reportedNot reportedNot reportedNot reported
TH With no Baseline Neuropathy17Not reportedNot reportedNot reportedNot reported
T-DM1 With Any Baseline Neuropathy22Not reportedNot reportedNot reportedNot reported
TH With Any Baseline Neuropathy12Not 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
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0012
    statistical Method
    Mantel Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0012
    statistical Method
    Mantel Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        267
      2. group Id
        OG001
        value
        64
      3. group Id
        OG002
        value
        36
      4. group Id
        OG003
        value
        11
      title
      No, mild, or moderate neuropathy
    2. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        22
      4. group Id
        OG003
        value
        12
      title
      Moderate to severe and severe neuropathy
denoms
  1. counts
    1. group Id
      OG000
      value
      291
    2. group Id
      OG001
      value
      81
    3. group Id
      OG002
      value
      58
    4. group Id
      OG003
      value
      23
    units
    Participants
description
Neuropathy evaluated by Patient Neurotoxicity Questionnaire (PNQ) defined per protocol.
groups
  1. description
    T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. No neuropathy at baseline
    id
    OG000
    title
    T-DM1 With no Baseline Neuropathy
  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. No neuropathy at baseline
    id
    OG001
    title
    TH With no Baseline Neuropathy
  3. description
    T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. Neuropathy at baseline
    id
    OG002
    title
    T-DM1 With Any Baseline Neuropathy
  4. 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. Neuropathy at baseline
    id
    OG003
    title
    TH With Any Baseline Neuropathy
param Type
COUNT_OF_PARTICIPANTS
population Description
The PNQ analysis was done on patients that completed at least baseline questionnaires and at least one follow-up questionnaire. Some patients did not complete this questionnaire at either baseline or follow-up. This is the reason for the reduced number of patients when reporting PNQ results.
reporting Status
POSTED
time Frame
Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18. The data cutoff date is 18 month.
title
Number of Patients Has Neuropathy
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice