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NCT04744831 · OUTCOME

Overall Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer · Source last updated 2026-01-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to data cut off, up to approximately 19 months.

What was measured

Overall Survival (OS) defined as the time from date of randomization/ registration until death from any cause, according to RECIST version 1.1. OS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.

Analysis population: OS was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.

Groups in this outcome

T-DXd 5.4 mg/kg Q3W

Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

T-DXd 6.4 mg/kg Q3W

Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

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-DXd 5.4 mg/kg Q3W82
T-DXd 6.4 mg/kg Q3W40

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W13.4Not reported13.416.8Not reported
T-DXd 6.4 mg/kg Q3WNANot reportedNANANot estimable due to insufficient data.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.4
        upper Limit
        16.8
        value
        13.4
      2. comment
        Not estimable due to insufficient data.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Overall Survival (OS) defined as the time from date of randomization/ registration until death from any cause, according to RECIST version 1.1. OS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    id
    OG000
    title
    T-DXd 5.4 mg/kg Q3W
  2. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
    id
    OG001
    title
    T-DXd 6.4 mg/kg Q3W
param Type
MEDIAN
population Description
OS was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
reporting Status
POSTED
time Frame
From randomization to data cut off, up to approximately 19 months.
title
Overall Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Independent clinical review pending · Not medical advice