TriangleNCT00266227 · OUTCOME
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Score on a scale
- Interval / dispersion
- Full Range
- Time frame
- Baseline, Week 48
What was measured
FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.
Analysis population: Participants from the Intent-to-treat population, that includes all randomized participants, with data available for analyses.
Groups in this outcome
Arm A: Rituximab Re-treatment
1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
Arm B: Placebo Re-treatment
1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
| Group | Source count |
|---|---|
| Arm A: Rituximab Re-treatment | 317 |
| Arm B: Placebo Re-treatment | 157 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Rituximab Re-treatment | -5.0 | Not reported | -29.0 | 27.0 | Not reported |
| Arm B: Placebo Re-treatment | -4.0 | Not reported | -32.0 | 22.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -29.0
- upper Limit
- 27.0
- value
- -5.0
- group Id
- OG001
- lower Limit
- -32.0
- upper Limit
- 22.0
- value
- -4.0
- denoms
- counts
- group Id
- OG000
- value
- 317
- group Id
- OG001
- value
- 157
- units
- Participants
- description
- FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.
- dispersion Type
- Full Range
- groups
- description
- 1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
- id
- OG000
- title
- Arm A: Rituximab Re-treatment
- description
- 1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
- id
- OG001
- title
- Arm B: Placebo Re-treatment
- param Type
- MEDIAN
- population Description
- Participants from the Intent-to-treat population, that includes all randomized participants, with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 48
- title
- Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice