NCT02975934 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
- id
- FG000
- title
- Rucaparib
- description
- Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
- id
- FG001
- title
- Abiraterone Acetate or Enzalutamide or Docetaxel
- description
- Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
- id
- FG002
- title
- Rucaparib (Cross-Over Phase)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 0
- type
- Never initiated study drug
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 135
- group Id
- FG002
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 130
- group Id
- FG002
- num Subjects
- 0
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 130
- group Id
- FG002
- num Subjects
- 0
- type
- Safety Population
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 130
- group Id
- FG002
- num Subjects
- 0
- comment
- Treatment period completion was defined as discontinuation when criteria for treatment discontinuation were met.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Treatment Phase
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- type
- Safety Population
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- comment
- Crossover period completion was defined as discontinuation when criteria for treatment discontinuation were met, or study closure.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cross-Over Phase
Complete source fields
- groups
- description
- Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
- id
- FG000
- title
- Rucaparib
- description
- Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
- id
- FG001
- title
- Abiraterone Acetate or Enzalutamide or Docetaxel
- description
- Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
- id
- FG002
- title
- Rucaparib (Cross-Over Phase)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 0
- type
- Never initiated study drug
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 135
- group Id
- FG002
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 130
- group Id
- FG002
- num Subjects
- 0
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 130
- group Id
- FG002
- num Subjects
- 0
- type
- Safety Population
- achievements
- group Id
- FG000
- num Subjects
- 270
- group Id
- FG001
- num Subjects
- 130
- group Id
- FG002
- num Subjects
- 0
- comment
- Treatment period completion was defined as discontinuation when criteria for treatment discontinuation were met.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Treatment Phase
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- type
- Safety Population
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 70
- comment
- Crossover period completion was defined as discontinuation when criteria for treatment discontinuation were met, or study closure.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cross-Over Phase
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Preserved source evidence · Not medical advice
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