NCT02319837 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Enzalutamide or Placebo Discontinuation - at PCD Cut-off Date of 31 January 2023

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) · Source last updated 2026-07-09

This outcome was registered, but no numerical results were posted in the captured record.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)

What was measured

An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day.

Groups in this outcome

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

Reported measurements

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

Complete source fields

anticipated Posting Date: 2027-09
denom Units Selected: Participants
description: An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day.
reporting Status: NOT_POSTED
time Frame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
title: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Enzalutamide or Placebo Discontinuation - at PCD Cut-off Date of 31 January 2023
type: SECONDARY

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Preserved source evidence · Not medical advice