NCT02470585 · 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
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- groups
- description
- Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- BG000
- title
- Placebo + Carboplatin + Paclitaxel -> Placebo
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- BG001
- title
- Veliparib + Carboplatin + Paclitaxel -> Placebo
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
- id
- BG002
- title
- Veliparib + Carboplatin + Paclitaxel -> Veliparib
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 33.0
- upper Limit
- 86.0
- value
- 62.0
- group Id
- BG001
- lower Limit
- 22.0
- upper Limit
- 88.0
- value
- 62.0
- group Id
- BG002
- lower Limit
- 30.0
- upper Limit
- 85.0
- value
- 62.0
- group Id
- BG003
- lower Limit
- 22.0
- upper Limit
- 88.0
- value
- 62.0
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 233
- group Id
- BG001
- value
- 226
- group Id
- BG002
- value
- 228
- group Id
- BG003
- value
- 687
- title
- < 65 years
- measurements
- group Id
- BG000
- value
- 142
- group Id
- BG001
- value
- 157
- group Id
- BG002
- value
- 154
- group Id
- BG003
- value
- 453
- title
- ≥ 65 years
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 27
- group Id
- BG002
- value
- 26
- group Id
- BG003
- value
- 81
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 347
- group Id
- BG001
- value
- 356
- group Id
- BG002
- value
- 356
- group Id
- BG003
- value
- 1059
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 299
- group Id
- BG001
- value
- 297
- group Id
- BG002
- value
- 300
- group Id
- BG003
- value
- 896
- title
- White
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 43
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 59
- group Id
- BG001
- value
- 69
- group Id
- BG002
- value
- 56
- group Id
- BG003
- value
- 184
- title
- Asian
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 3
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- title
- Native Hawaiian or other Pacific Islander
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- title
- Multi-race
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 8
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 266
- group Id
- BG001
- value
- 261
- group Id
- BG002
- value
- 267
- group Id
- BG003
- value
- 794
- title
- North America
- measurements
- group Id
- BG000
- value
- 23
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 25
- group Id
- BG003
- value
- 78
- title
- Japan
- measurements
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 92
- group Id
- BG002
- value
- 90
- group Id
- BG003
- value
- 268
- title
- Rest of World
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Geographic Region
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 92
- group Id
- BG001
- value
- 98
- group Id
- BG002
- value
- 108
- group Id
- BG003
- value
- 298
- title
- Germline or tissue BRCA1/2 mutation
- measurements
- group Id
- BG000
- value
- 254
- group Id
- BG001
- value
- 243
- group Id
- BG002
- value
- 245
- group Id
- BG003
- value
- 742
- title
- Germline or tissue BRCA1/2 wildtype
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 42
- group Id
- BG002
- value
- 29
- group Id
- BG003
- value
- 100
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- The BRCA-mutation cohort was defined as participants who had deleterious or suspected deleterious germline (gBRCA) or tissue-based (tBRCA) mutations as determined by the Myriad BRACAnalysis® companion diagnostic (CDx) or myChoice® HRD CDx assay, respectively, in BRCA1 or BRCA2.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- BRCA-Deficient Status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 207
- group Id
- BG001
- value
- 206
- group Id
- BG002
- value
- 214
- group Id
- BG003
- value
- 627
- title
- HRD
- measurements
- group Id
- BG000
- value
- 124
- group Id
- BG001
- value
- 123
- group Id
- BG002
- value
- 125
- group Id
- BG003
- value
- 372
- title
- Non-HRD
- measurements
- group Id
- BG000
- value
- 44
- group Id
- BG001
- value
- 54
- group Id
- BG002
- value
- 43
- group Id
- BG003
- value
- 141
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- The HRD cohort consisted of participants who had tumors that were BRCA-mutated or had HRD according to the Myriad myChoice® assay, on which a score of ≥ 33 was considered to indicate HRD status, and a score of \< 33 was considered to indicate non-HRD status.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Homologous Recombination Deficiency (HRD) Status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 292
- group Id
- BG001
- value
- 288
- group Id
- BG002
- value
- 295
- group Id
- BG003
- value
- 875
- title
- Stage III
- measurements
- group Id
- BG000
- value
- 82
- group Id
- BG001
- value
- 94
- group Id
- BG002
- value
- 87
- group Id
- BG003
- value
- 263
- title
- Stage IV
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- Staging of primary ovarian carcinomas according to the International Federation of Gynecology and Obstetrics (FIGO) criteria, based on clinical examination, surgical exploration, histologic characteristics and cytologic testing. STAGE III: Tumor involves 1 or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastases to the retroperitoneal lymph nodes. STAGE IV: Distant metastases excluding peritoneal metastases
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Stage of Disease
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 250
- group Id
- BG001
- value
- 253
- group Id
- BG002
- value
- 261
- group Id
- BG003
- value
- 764
- title
- Primary
- measurements
- group Id
- BG000
- value
- 107
- group Id
- BG001
- value
- 114
- group Id
- BG002
- value
- 99
- group Id
- BG003
- value
- 320
- title
- Interval
- measurements
- group Id
- BG000
- value
- 18
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 22
- group Id
- BG003
- value
- 56
- title
- No surgery received
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval), determined at the discretion of the investigator.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Type of Surgery Received
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 116
- group Id
- BG001
- value
- 118
- group Id
- BG002
- value
- 124
- group Id
- BG003
- value
- 358
- title
- No residual disease
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 46
- group Id
- BG002
- value
- 54
- group Id
- BG003
- value
- 158
- title
- Microscopic residual disease only
- measurements
- group Id
- BG000
- value
- 76
- group Id
- BG001
- value
- 89
- group Id
- BG002
- value
- 83
- group Id
- BG003
- value
- 248
- title
- Any macroscopic residual disease
- denoms
- counts
- group Id
- BG000
- value
- 250
- group Id
- BG001
- value
- 253
- group Id
- BG002
- value
- 261
- group Id
- BG003
- value
- 764
- units
- Participants
- description
- Data were collected after interval surgery after cycle 3.
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who underwent primary surgery
- title
- Residual Disease After Primary Surgery
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 50
- group Id
- BG001
- value
- 46
- group Id
- BG002
- value
- 45
- group Id
- BG003
- value
- 141
- title
- No residual disease
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 24
- group Id
- BG003
- value
- 76
- title
- Microscopic residual disease only
- measurements
- group Id
- BG000
- value
- 31
- group Id
- BG001
- value
- 34
- group Id
- BG002
- value
- 27
- group Id
- BG003
- value
- 92
- title
- Any macroscopic residual disease
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 11
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 107
- group Id
- BG001
- value
- 114
- group Id
- BG002
- value
- 99
- group Id
- BG003
- value
- 320
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who underwent interval surgery
- title
- Residual Disease After Interval Surgery
- unit Of Measure
- Participants
- population Description
- The intention-to-treat (ITT) population consisted of all randomized participants.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- groups
- description
- Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- BG000
- title
- Placebo + Carboplatin + Paclitaxel -> Placebo
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- BG001
- title
- Veliparib + Carboplatin + Paclitaxel -> Placebo
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
- id
- BG002
- title
- Veliparib + Carboplatin + Paclitaxel -> Veliparib
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 33.0
- upper Limit
- 86.0
- value
- 62.0
- group Id
- BG001
- lower Limit
- 22.0
- upper Limit
- 88.0
- value
- 62.0
- group Id
- BG002
- lower Limit
- 30.0
- upper Limit
- 85.0
- value
- 62.0
- group Id
- BG003
- lower Limit
- 22.0
- upper Limit
- 88.0
- value
- 62.0
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 233
- group Id
- BG001
- value
- 226
- group Id
- BG002
- value
- 228
- group Id
- BG003
- value
- 687
- title
- < 65 years
- measurements
- group Id
- BG000
- value
- 142
- group Id
- BG001
- value
- 157
- group Id
- BG002
- value
- 154
- group Id
- BG003
- value
- 453
- title
- ≥ 65 years
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 27
- group Id
- BG002
- value
- 26
- group Id
- BG003
- value
- 81
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 347
- group Id
- BG001
- value
- 356
- group Id
- BG002
- value
- 356
- group Id
- BG003
- value
- 1059
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 299
- group Id
- BG001
- value
- 297
- group Id
- BG002
- value
- 300
- group Id
- BG003
- value
- 896
- title
- White
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 43
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 59
- group Id
- BG001
- value
- 69
- group Id
- BG002
- value
- 56
- group Id
- BG003
- value
- 184
- title
- Asian
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 3
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- title
- Native Hawaiian or other Pacific Islander
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- title
- Multi-race
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 8
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 266
- group Id
- BG001
- value
- 261
- group Id
- BG002
- value
- 267
- group Id
- BG003
- value
- 794
- title
- North America
- measurements
- group Id
- BG000
- value
- 23
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 25
- group Id
- BG003
- value
- 78
- title
- Japan
- measurements
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 92
- group Id
- BG002
- value
- 90
- group Id
- BG003
- value
- 268
- title
- Rest of World
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Geographic Region
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 92
- group Id
- BG001
- value
- 98
- group Id
- BG002
- value
- 108
- group Id
- BG003
- value
- 298
- title
- Germline or tissue BRCA1/2 mutation
- measurements
- group Id
- BG000
- value
- 254
- group Id
- BG001
- value
- 243
- group Id
- BG002
- value
- 245
- group Id
- BG003
- value
- 742
- title
- Germline or tissue BRCA1/2 wildtype
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 42
- group Id
- BG002
- value
- 29
- group Id
- BG003
- value
- 100
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- The BRCA-mutation cohort was defined as participants who had deleterious or suspected deleterious germline (gBRCA) or tissue-based (tBRCA) mutations as determined by the Myriad BRACAnalysis® companion diagnostic (CDx) or myChoice® HRD CDx assay, respectively, in BRCA1 or BRCA2.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- BRCA-Deficient Status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 207
- group Id
- BG001
- value
- 206
- group Id
- BG002
- value
- 214
- group Id
- BG003
- value
- 627
- title
- HRD
- measurements
- group Id
- BG000
- value
- 124
- group Id
- BG001
- value
- 123
- group Id
- BG002
- value
- 125
- group Id
- BG003
- value
- 372
- title
- Non-HRD
- measurements
- group Id
- BG000
- value
- 44
- group Id
- BG001
- value
- 54
- group Id
- BG002
- value
- 43
- group Id
- BG003
- value
- 141
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- The HRD cohort consisted of participants who had tumors that were BRCA-mutated or had HRD according to the Myriad myChoice® assay, on which a score of ≥ 33 was considered to indicate HRD status, and a score of \< 33 was considered to indicate non-HRD status.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Homologous Recombination Deficiency (HRD) Status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 292
- group Id
- BG001
- value
- 288
- group Id
- BG002
- value
- 295
- group Id
- BG003
- value
- 875
- title
- Stage III
- measurements
- group Id
- BG000
- value
- 82
- group Id
- BG001
- value
- 94
- group Id
- BG002
- value
- 87
- group Id
- BG003
- value
- 263
- title
- Stage IV
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- Staging of primary ovarian carcinomas according to the International Federation of Gynecology and Obstetrics (FIGO) criteria, based on clinical examination, surgical exploration, histologic characteristics and cytologic testing. STAGE III: Tumor involves 1 or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastases to the retroperitoneal lymph nodes. STAGE IV: Distant metastases excluding peritoneal metastases
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Stage of Disease
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 250
- group Id
- BG001
- value
- 253
- group Id
- BG002
- value
- 261
- group Id
- BG003
- value
- 764
- title
- Primary
- measurements
- group Id
- BG000
- value
- 107
- group Id
- BG001
- value
- 114
- group Id
- BG002
- value
- 99
- group Id
- BG003
- value
- 320
- title
- Interval
- measurements
- group Id
- BG000
- value
- 18
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 22
- group Id
- BG003
- value
- 56
- title
- No surgery received
- denoms
- counts
- group Id
- BG000
- value
- 375
- group Id
- BG001
- value
- 383
- group Id
- BG002
- value
- 382
- group Id
- BG003
- value
- 1140
- units
- Participants
- description
- Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval), determined at the discretion of the investigator.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Type of Surgery Received
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 116
- group Id
- BG001
- value
- 118
- group Id
- BG002
- value
- 124
- group Id
- BG003
- value
- 358
- title
- No residual disease
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 46
- group Id
- BG002
- value
- 54
- group Id
- BG003
- value
- 158
- title
- Microscopic residual disease only
- measurements
- group Id
- BG000
- value
- 76
- group Id
- BG001
- value
- 89
- group Id
- BG002
- value
- 83
- group Id
- BG003
- value
- 248
- title
- Any macroscopic residual disease
- denoms
- counts
- group Id
- BG000
- value
- 250
- group Id
- BG001
- value
- 253
- group Id
- BG002
- value
- 261
- group Id
- BG003
- value
- 764
- units
- Participants
- description
- Data were collected after interval surgery after cycle 3.
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who underwent primary surgery
- title
- Residual Disease After Primary Surgery
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 50
- group Id
- BG001
- value
- 46
- group Id
- BG002
- value
- 45
- group Id
- BG003
- value
- 141
- title
- No residual disease
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 24
- group Id
- BG003
- value
- 76
- title
- Microscopic residual disease only
- measurements
- group Id
- BG000
- value
- 31
- group Id
- BG001
- value
- 34
- group Id
- BG002
- value
- 27
- group Id
- BG003
- value
- 92
- title
- Any macroscopic residual disease
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 11
- title
- Missing
- denoms
- counts
- group Id
- BG000
- value
- 107
- group Id
- BG001
- value
- 114
- group Id
- BG002
- value
- 99
- group Id
- BG003
- value
- 320
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who underwent interval surgery
- title
- Residual Disease After Interval Surgery
- unit Of Measure
- Participants
- population Description
- The intention-to-treat (ITT) population consisted of all randomized participants.
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Preserved source evidence · Not medical advice
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