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NCT04466891 · OUTCOME

Incidence of Adverse Events (AEs)

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers · Source last updated 2025-09-15

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
Up to 45 months

What was measured

Number of subjects who experienced AEs or serious adverse events

Groups in this outcome

Cohort I

Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+

Cohort II

Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.

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

Analysis denominator · Participants

GroupSource count
Cohort I80
Cohort II7

Reported measurements

Any Treatment Emergent Adverse Event (TEAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort I78Not reportedNot reportedNot reportedNot reported
Cohort II6Not reportedNot reportedNot reportedNot reported
Zanidatamab related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort I61Not reportedNot reportedNot reportedNot reported
Cohort II2Not reportedNot reportedNot reportedNot reported
Any Treatment Emergent Serious Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort I43Not reportedNot reportedNot reportedNot reported
Cohort II3Not reportedNot reportedNot reportedNot reported
Zanidatamab related serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort I8Not reportedNot reportedNot reportedNot reported
Cohort II0Not reportedNot reportedNot reportedNot reported
Zanidatamab related TEAE resulting in treatment discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort I2Not reportedNot reportedNot reportedNot reported
Cohort II0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        78
      2. group Id
        OG001
        value
        6
    title
    Any Treatment Emergent Adverse Event (TEAE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        2
    title
    Zanidatamab related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        3
    title
    Any Treatment Emergent Serious Adverse Event
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
    title
    Zanidatamab related serious TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Zanidatamab related TEAE resulting in treatment discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Number of subjects who experienced AEs or serious adverse events
groups
  1. description
    Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+
    id
    OG000
    title
    Cohort I
  2. description
    Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.
    id
    OG001
    title
    Cohort II
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 45 months
title
Incidence of Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice