TriangleNCT01968213 · OUTCOME
Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18
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
- Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
What was measured
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
Analysis population: Intent-to-treat: All patients randomized
Groups in this outcome
Rucaparib 600 mg Tablets
Taken orally twice daily (continuous 28 day treatment cycles)
Placebo Tablets
Taken orally twice daily (continuous 28 day treatment cycles)
| Group | Source count |
|---|---|
| Rucaparib 600 mg Tablets | 375 |
| Placebo Tablets | 189 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib 600 mg Tablets | 1.9 | Not reported | 1.8 | 2.8 | Not reported |
| Placebo Tablets | 6.4 | Not reported | 4.6 | 9.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 2.8
- value
- 1.9
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 9.2
- value
- 6.4
- denoms
- counts
- group Id
- OG000
- value
- 375
- group Id
- OG001
- value
- 189
- units
- Participants
- description
- The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Taken orally twice daily (continuous 28 day treatment cycles)
- id
- OG000
- title
- Rucaparib 600 mg Tablets
- description
- Taken orally twice daily (continuous 28 day treatment cycles)
- id
- OG001
- title
- Placebo Tablets
- param Type
- MEDIAN
- population Description
- Intent-to-treat: All patients randomized
- reporting Status
- POSTED
- time Frame
- Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
- title
- Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice