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NCT03395197 · OUTCOME

Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - 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. 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. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. 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

Grade 3 Anemia
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+Enzalutamide3Not reportedNot reportedNot reportedNot reported
Grade 1 Neutropenia
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
Grade 2 Neutropenia
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
Grade 3 Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide6Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide0Not reportedNot reportedNot reportedNot reported
Grade 2 Leukopenia
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
Grade 3 Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide5Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide0Not reportedNot reportedNot reportedNot reported
Grade 3 Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Talazoparib 1 mg QD+Enzalutamide3Not reportedNot reportedNot reportedNot reported
Part 1: Talazoparib 0.5 mg QD+Enzalutamide0Not reportedNot reportedNot reportedNot reported
Grade 4 Anemia
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+Enzalutamide1Not reportedNot reportedNot reportedNot reported
Grade 2 Lymphopenia
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
Grade 3 Lymphopenia
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+Enzalutamide0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
    title
    Grade 3 Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 1 Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 2 Neutropenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
    title
    Grade 3 Neutropenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 2 Leukopenia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    title
    Grade 3 Leukopenia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Grade 3 Thrombocytopenia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Grade 4 Anemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 2 Lymphopenia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Grade 3 Lymphopenia
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. 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. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. 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 All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice