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NCT05070247 · OUTCOME

Dose Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors · Source last updated 2026-01-22

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to approximately 32.8 months

What was measured

AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).

Analysis population: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.

Groups in this outcome

Dose Expansion: TAK-500

Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.

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

Analysis denominator · Participants

GroupSource count
Dose Expansion: TAK-5000

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
groups
  1. description
    Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.
    id
    OG000
    title
    Dose Expansion: TAK-500
population Description
Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
reporting Status
POSTED
time Frame
Up to approximately 32.8 months
title
Dose Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice