TriangleNCT01847274 · OUTCOME
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
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 6 (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
gBRCA Niraparib
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
| Group | Source count |
|---|---|
| gBRCA Niraparib | 95 |
| gBRCA Placebo | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| gBRCA Niraparib | 0.5 | 3.77 | Not reported | Not reported | Not reported |
| gBRCA Placebo | -0.5 | 4.27 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.77
- value
- 0.5
- group Id
- OG001
- spread
- 4.27
- value
- -0.5
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 36
- 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 with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
- id
- OG000
- title
- gBRCA Niraparib
- description
- Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
- id
- OG001
- title
- 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 6 (Each cycle was of 28 days)
- title
- Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice