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NCT04325828 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma · Source last updated 2026-08-28

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 13 months

What was measured

Number of participants with TEAEs were reported. Treatment-emergent adverse events (TEAEs) for the treatment phase included events with an onset date/time on or after the start of study intervention through the day of last dose plus 30 days were considered as treatment-emergent.

Analysis population: Safety analysis set included all participants who received at least 1 dose of study intervention.

Groups in this outcome

Apalutamide + Goserelin

Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.

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

Analysis denominator · Participants

GroupSource count
Apalutamide + Goserelin31

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Apalutamide + Goserelin28Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Number of participants with TEAEs were reported. Treatment-emergent adverse events (TEAEs) for the treatment phase included events with an onset date/time on or after the start of study intervention through the day of last dose plus 30 days were considered as treatment-emergent.
groups
  1. description
    Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
    id
    OG000
    title
    Apalutamide + Goserelin
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least 1 dose of study intervention.
reporting Status
POSTED
time Frame
Up to 13 months
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice