TriangleNCT01847274 · OUTCOME
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
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 4 (Each cycle was of 28 days)
What was measured
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). 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 | 155 |
| Non-gBRCA Placebo | 80 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-gBRCA Niraparib | -0.004 | 0.1077 | Not reported | Not reported | Not reported |
| Non-gBRCA Placebo | -0.014 | 0.0870 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.1077
- value
- -0.004
- group Id
- OG001
- spread
- 0.0870
- value
- -0.014
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 80
- units
- Participants
- description
- EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). 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 4 (Each cycle was of 28 days)
- title
- Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice