TriangleNCT00075946 · OUTCOME
Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Assessed at baseline and 6 months after randomization.
What was measured
The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.
Analysis population: Patients with patient-reported outcomes (PRO) data available.
Groups in this outcome
Arm A: Rituximab Retreatment
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
Arm B: Rituximab Scheduled
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A: Rituximab Retreatment | 128 |
| Arm B: Rituximab Scheduled | 125 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Rituximab Retreatment | 1.04 | 12.82 | Not reported | Not reported | Not reported |
| Arm B: Rituximab Scheduled | -0.71 | 9.38 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.270
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.270
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.82
- value
- 1.04
- group Id
- OG001
- spread
- 9.38
- value
- -0.71
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 125
- units
- Participants
- description
- The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.
- dispersion Type
- Standard Deviation
- groups
- description
- Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
- id
- OG000
- title
- Arm A: Rituximab Retreatment
- description
- Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
- id
- OG001
- title
- Arm B: Rituximab Scheduled
- param Type
- MEAN
- population Description
- Patients with patient-reported outcomes (PRO) data available.
- reporting Status
- POSTED
- time Frame
- Assessed at baseline and 6 months after randomization.
- title
- Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice