NCT02354586 · OUTCOME
Progression Free Survival
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
- Up to 3 years
What was measured
Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1) or clinical criteria. Progression is defined using RECIST version1.1 as at least a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.
Analysis population: ITT Population. Only those participants with data available at the specified time points were analyzed.
Groups in this outcome
Niraparib 300 mg
Participants received Niraparib (300 milligram \[mg\], taken as 3 capsules of 100 mg once daily \[QD\]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
| Group | Source count |
|---|---|
| Niraparib 300 mg | 461 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Niraparib 300 mg | 3.5 | Not reported | 3.2 | 3.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.2
- upper Limit
- 3.7
- value
- 3.5
- denoms
- counts
- group Id
- OG000
- value
- 461
- units
- Participants
- description
- Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1) or clinical criteria. Progression is defined using RECIST version1.1 as at least a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Niraparib (300 milligram \[mg\], taken as 3 capsules of 100 mg once daily \[QD\]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
- id
- OG000
- title
- Niraparib 300 mg
- param Type
- MEDIAN
- population Description
- ITT Population. Only those participants with data available at the specified time points were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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