NCT03748641 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 212
- group Id
- BG001
- value
- 211
- group Id
- BG002
- value
- 123
- group Id
- BG003
- value
- 124
- group Id
- BG004
- value
- 95
- group Id
- BG005
- value
- 765
- units
- Participants
- groups
- description
- Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
- id
- BG000
- title
- Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
- id
- BG001
- title
- Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
- id
- BG002
- title
- Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
- id
- BG003
- title
- Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.
- id
- BG004
- title
- Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.79
- value
- 69.2
- group Id
- BG001
- spread
- 8.17
- value
- 68.6
- group Id
- BG002
- spread
- 7.11
- value
- 71.2
- group Id
- BG003
- spread
- 7.52
- value
- 71.1
- group Id
- BG004
- spread
- 8.99
- value
- 69.2
- group Id
- BG005
- spread
- 8.25
- value
- 69.7
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 212
- group Id
- BG001
- value
- 211
- group Id
- BG002
- value
- 123
- group Id
- BG003
- value
- 124
- group Id
- BG004
- value
- 95
- group Id
- BG005
- value
- 765
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 26
- group Id
- BG001
- value
- 25
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 12
- group Id
- BG005
- value
- 83
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 166
- group Id
- BG001
- value
- 169
- group Id
- BG002
- value
- 110
- group Id
- BG003
- value
- 105
- group Id
- BG004
- value
- 77
- group Id
- BG005
- value
- 627
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 20
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 55
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 3
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 41
- group Id
- BG002
- value
- 45
- group Id
- BG003
- value
- 37
- group Id
- BG004
- value
- 14
- group Id
- BG005
- value
- 166
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 160
- group Id
- BG001
- value
- 153
- group Id
- BG002
- value
- 72
- group Id
- BG003
- value
- 83
- group Id
- BG004
- value
- 70
- group Id
- BG005
- value
- 538
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 49
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 18
- title
- ARGENTINA
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 51
- title
- AUSTRALIA
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- title
- BELGIUM
- categories
- measurements
- group Id
- BG000
- value
- 20
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 44
- title
- BRAZIL
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- BULGARIA
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 19
- title
- CANADA
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- title
- CHINA
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 11
- title
- CZECH REPUBLIC
- categories
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 37
- title
- FRANCE
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 9
- title
- GERMANY
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 17
- title
- HUNGARY
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 3
- title
- ISRAEL
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 212
- group Id
- BG001
- value
- 211
- group Id
- BG002
- value
- 123
- group Id
- BG003
- value
- 124
- group Id
- BG004
- value
- 95
- group Id
- BG005
- value
- 765
- units
- Participants
- groups
- description
- Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
- id
- BG000
- title
- Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
- id
- BG001
- title
- Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
- id
- BG002
- title
- Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
- id
- BG003
- title
- Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
- description
- Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.
- id
- BG004
- title
- Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.79
- value
- 69.2
- group Id
- BG001
- spread
- 8.17
- value
- 68.6
- group Id
- BG002
- spread
- 7.11
- value
- 71.2
- group Id
- BG003
- spread
- 7.52
- value
- 71.1
- group Id
- BG004
- spread
- 8.99
- value
- 69.2
- group Id
- BG005
- spread
- 8.25
- value
- 69.7
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 212
- group Id
- BG001
- value
- 211
- group Id
- BG002
- value
- 123
- group Id
- BG003
- value
- 124
- group Id
- BG004
- value
- 95
- group Id
- BG005
- value
- 765
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 26
- group Id
- BG001
- value
- 25
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 12
- group Id
- BG005
- value
- 83
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 166
- group Id
- BG001
- value
- 169
- group Id
- BG002
- value
- 110
- group Id
- BG003
- value
- 105
- group Id
- BG004
- value
- 77
- group Id
- BG005
- value
- 627
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 20
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 55
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 3
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 41
- group Id
- BG002
- value
- 45
- group Id
- BG003
- value
- 37
- group Id
- BG004
- value
- 14
- group Id
- BG005
- value
- 166
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 160
- group Id
- BG001
- value
- 153
- group Id
- BG002
- value
- 72
- group Id
- BG003
- value
- 83
- group Id
- BG004
- value
- 70
- group Id
- BG005
- value
- 538
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 49
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 18
- title
- ARGENTINA
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 51
- title
- AUSTRALIA
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- title
- BELGIUM
- categories
- measurements
- group Id
- BG000
- value
- 20
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 44
- title
- BRAZIL
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- BULGARIA
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 19
- title
- CANADA
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- title
- CHINA
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 11
- title
- CZECH REPUBLIC
- categories
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 37
- title
- FRANCE
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 9
- title
- GERMANY
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 17
- title
- HUNGARY
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 3
- title
- ISRAEL
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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