TriangleNCT01847274 · OUTCOME
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
What was measured
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Analysis population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Groups in this outcome
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
| Group | Source count |
|---|---|
| Non-gBRCA Niraparib | 181 |
| Non-gBRCA Placebo | 97 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-gBRCA Niraparib | -1.0 | 3.79 | Not reported | Not reported | Not reported |
| Non-gBRCA Placebo | -0.3 | 2.84 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.79
- value
- -1.0
- group Id
- OG001
- spread
- 2.84
- value
- -0.3
- denoms
- counts
- group Id
- OG000
- value
- 181
- group Id
- OG001
- value
- 97
- units
- Participants
- description
- Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
- id
- OG000
- title
- Non-gBRCA Niraparib
- description
- Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
- id
- OG001
- title
- Non-gBRCA Placebo
- param Type
- MEAN
- population Description
- Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
- title
- Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice