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NCT03395197 · OUTCOME

Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC · Source last updated 2026-09-08

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
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)

What was measured

An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.

Analysis population: Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).

Groups in this outcome

Part 1: Talazoparib 1 mg QD+Enzalutamide

Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).

Part 1: Talazoparib 0.5 mg QD+Enzalutamide

Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).

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

Analysis denominator · Participants

GroupSource count
Part 1: Talazoparib 1 mg QD+Enzalutamide13
Part 1: Talazoparib 0.5 mg QD+Enzalutamide6

Reported measurements

Participants with TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide13Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide6Not reportedNot reportedNot reportedNot reported
Participants with medication error TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide0Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide0Not reportedNot reportedNot reportedNot reported
Participants with serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide2Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide1Not reportedNot reportedNot reportedNot reported
Participants with Maximum Grade 3 or 4 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide10Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide4Not reportedNot reportedNot reportedNot reported
Participants with Maximum Grade 5 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide1Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        6
    title
    Participants with TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Participants with medication error TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Participants with serious TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
    title
    Participants with Maximum Grade 3 or 4 TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Participants with Maximum Grade 5 TEAE
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      6
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
groups
  1. description
    Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
    id
    OG000
    title
    Part 1: Talazoparib 1 mg QD+Enzalutamide
  2. description
    Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).
    id
    OG001
    title
    Part 1: Talazoparib 0.5 mg QD+Enzalutamide
param Type
COUNT_OF_PARTICIPANTS
population Description
Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).
reporting Status
POSTED
time Frame
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
title
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice