TriangleNCT02655016 · OUTCOME
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline (Day 1, Pre-dose) and Up to 34 months
What was measured
EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal \[GI\] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus \[average score minus 1\] divided by 3\*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
Analysis population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Groups in this outcome
Placebo
Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Niraparib
Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
| Group | Source count |
|---|---|
| Placebo | 244 |
| Niraparib | 475 |
Reported measurements
Body Image, n=244,475
| Group | Source count |
|---|---|
| Placebo | 244 |
| Niraparib | 475 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 10.069 | 1.4820 | Not reported | Not reported | Not reported |
| Niraparib | 8.488 | 1.0138 | Not reported | Not reported | Not reported |
Sexuality, n=240,471
| Group | Source count |
|---|---|
| Placebo | 240 |
| Niraparib | 471 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 3.257 | 1.1886 | Not reported | Not reported | Not reported |
| Niraparib | 3.625 | 0.8004 | Not reported | Not reported | Not reported |
Attitude to disease/Treatment, n=244,475
| Group | Source count |
|---|---|
| Placebo | 244 |
| Niraparib | 475 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 12.216 | 1.3257 | Not reported | Not reported | Not reported |
| Niraparib | 13.660 | 0.9309 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.4820
- value
- 10.069
- group Id
- OG001
- spread
- 1.0138
- value
- 8.488
- denoms
- counts
- group Id
- OG000
- value
- 244
- group Id
- OG001
- value
- 475
- units
- Participants
- title
- Body Image, n=244,475
- categories
- measurements
- group Id
- OG000
- spread
- 1.1886
- value
- 3.257
- group Id
- OG001
- spread
- 0.8004
- value
- 3.625
- denoms
- counts
- group Id
- OG000
- value
- 240
- group Id
- OG001
- value
- 471
- units
- Participants
- title
- Sexuality, n=240,471
- categories
- measurements
- group Id
- OG000
- spread
- 1.3257
- value
- 12.216
- group Id
- OG001
- spread
- 0.9309
- value
- 13.660
- denoms
- counts
- group Id
- OG000
- value
- 244
- group Id
- OG001
- value
- 475
- units
- Participants
- title
- Attitude to disease/Treatment, n=244,475
- denoms
- counts
- group Id
- OG000
- value
- 244
- group Id
- OG001
- value
- 475
- units
- Participants
- description
- EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal \[GI\] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus \[average score minus 1\] divided by 3\*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- dispersion Type
- Standard Error
- groups
- description
- Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
- id
- OG000
- title
- Placebo
- description
- Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
- id
- OG001
- title
- Niraparib
- param Type
- LEAST_SQUARES_MEAN
- population Description
- ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1, Pre-dose) and Up to 34 months
- title
- Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
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Preserved source evidence · Not medical advice