Trial · NCT02470585
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. | Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2. | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. | Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors. | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. | Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants). | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1) | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. | Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1) | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. | Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1) | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. | Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the BRCA-deficient Population | From the time of randomization to the end of the study, up to 98 months | BRCA-Deficient population: All randomized participants with germline and/or tissue deleterious/suspected deleterious BRCA1/2 mutation | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the Homologous Recombination Deficiency Population | From the time of randomization to the end of the study, up to 98 months | All randomized participants considered BRCA-Deficient and those determined to have HRD tumors based on HRD score | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the Whole Population | From the time of randomization to the end of the study, up to 98 months | All randomized participants | months | MEDIAN |
| SECONDARY | Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 | BRCA-mutation population, participants with available data at each time point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 | HRD population, participants with available data at each time point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Related Symptom (DRS) Score in the Whole Population | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 | All randomized participants with available data at each time point | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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