NCT03395197 · OUTCOME
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of 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 Day 66 in Part 1
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. Medical Dictionary for Regulatory Activities (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
| Group | Source count |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 13 |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 6 |
|---|
Reported measurements
Grade 2 Anemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 Anemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 1 Neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2 Neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 Neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2 Leukopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 Leukopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Grade 2 Anemia
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- title
- Grade 3 Anemia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 1 Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 2 Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- title
- Grade 3 Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 2 Leukopenia
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Grade 3 Leukopenia
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Grade 3 Thrombocytopenia
- denoms
- counts
- group Id
- OG000
- value
- 13
- 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. Medical Dictionary for Regulatory Activities (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
- 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
- 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 Day 66 in Part 1
- title
- Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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