TriangleNCT03397394 · OUTCOME
Overall Survival
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
- The total study time for reporting of deaths was approximately 19 months.
What was measured
Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
Analysis population: Intent-to-Treat population - all patients who received at least 1 dose of rucaparib
Groups in this outcome
HRD Unknown
Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
HRD Negative
Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.
HRD Positive
Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
Overall
All patients
| Group | Source count |
|---|---|
| HRD Unknown | 47 |
| HRD Negative | 30 |
| HRD Positive | 20 |
| Overall | 97 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HRD Unknown | 15 | Not reported | Not reported | Not reported | Not reported |
| HRD Negative | 15 | Not reported | Not reported | Not reported | Not reported |
| HRD Positive | 9 | Not reported | Not reported | Not reported | Not reported |
| Overall | 39 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 39
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 97
- units
- Participants
- description
- Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
- groups
- description
- Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
- id
- OG000
- title
- HRD Unknown
- description
- Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.
- id
- OG001
- title
- HRD Negative
- description
- Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
- id
- OG002
- title
- HRD Positive
- description
- All patients
- id
- OG003
- title
- Overall
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intent-to-Treat population - all patients who received at least 1 dose of rucaparib
- reporting Status
- POSTED
- time Frame
- The total study time for reporting of deaths was approximately 19 months.
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice