TriangleNCT03397394 · OUTCOME
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
What was measured
PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
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 | 1.8 | Not reported | 1.6 | 2.0 | Not reported |
| HRD Negative | 1.8 | Not reported | 1.5 | 2.0 | Not reported |
| HRD Positive | 1.4 | Not reported | 1.2 | 3.6 | Not reported |
| Overall | 1.8 | Not reported | 1.6 | 1.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.6
- upper Limit
- 2.0
- value
- 1.8
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 2.0
- value
- 1.8
- group Id
- OG002
- lower Limit
- 1.2
- upper Limit
- 3.6
- value
- 1.4
- group Id
- OG003
- lower Limit
- 1.6
- upper Limit
- 1.9
- value
- 1.8
- 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
- PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Intent-to-Treat population - all patients who received at least 1 dose of rucaparib
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
- title
- Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice