TriangleNCT00009737 · OUTCOME
Mean Change From Baseline in Global Health Status at Week 25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline (Days -7 to 1) and at Week 25
What was measured
Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
Analysis population: The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).
Groups in this outcome
Capecitabine
Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
5-Fluorouracil + Leucovorin
Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
| Group | Source count |
|---|---|
| Capecitabine | 836 |
| 5-Fluorouracil + Leucovorin | 769 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Capecitabine | 2.1 | 0.80 | Not reported | Not reported | Not reported |
| 5-Fluorouracil + Leucovorin | 2.6 | 0.78 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.80
- value
- 2.1
- group Id
- OG001
- spread
- 0.78
- value
- 2.6
- denoms
- counts
- group Id
- OG000
- value
- 836
- group Id
- OG001
- value
- 769
- units
- Participants
- description
- Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
- dispersion Type
- Standard Error
- groups
- description
- Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
- id
- OG000
- title
- Capecitabine
- description
- Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
- id
- OG001
- title
- 5-Fluorouracil + Leucovorin
- param Type
- MEAN
- population Description
- The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).
- reporting Status
- POSTED
- time Frame
- Baseline (Days -7 to 1) and at Week 25
- title
- Mean Change From Baseline in Global Health Status at Week 25
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice