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NCT01772472 · OUTCOME

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From signing of informed consent till end of follow up (up to approximately 131 months)

What was measured

AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AE can therefore be any unfavorable \& unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of a medicinal product, whether or not considered related to medicinal product. SAE=any AE that met any given criteria: fatal (i.e. AE causes/leads to death); life-threatening (i.e. AE, in view of investigator, placed the participant at immediate risk of death); required/prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e. AE results in substantial disruption of participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in investigator's judgment. Percentages have been rounded off.

Analysis population: SE population included all randomized participants who received any amount of study treatment.

Groups in this outcome

Trastuzumab

Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

Trastuzumab Emtansine

Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

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

Analysis denominator · Participants

GroupSource count
Trastuzumab720
Trastuzumab Emtansine740

Reported measurements

AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab93.3Not reportedNot reportedNot reportedNot reported
Trastuzumab Emtansine98.8Not reportedNot reportedNot reportedNot reported
SAEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab8.1Not reportedNot reportedNot reportedNot reported
Trastuzumab Emtansine12.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        93.3
      2. group Id
        OG001
        value
        98.8
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8.1
      2. group Id
        OG001
        value
        12.7
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      720
    2. group Id
      OG001
      value
      740
    units
    Participants
description
AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AE can therefore be any unfavorable \& unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of a medicinal product, whether or not considered related to medicinal product. SAE=any AE that met any given criteria: fatal (i.e. AE causes/leads to death); life-threatening (i.e. AE, in view of investigator, placed the participant at immediate risk of death); required/prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e. AE results in substantial disruption of participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in investigator's judgment. Percentages have been rounded off.
groups
  1. description
    Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    OG000
    title
    Trastuzumab
  2. description
    Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    OG001
    title
    Trastuzumab Emtansine
param Type
NUMBER
population Description
SE population included all randomized participants who received any amount of study treatment.
reporting Status
POSTED
time Frame
From signing of informed consent till end of follow up (up to approximately 131 months)
title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice