TriangleNCT01611090 · OUTCOME
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score at End of Treatment
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
- Baseline to EOT (up to 2 years)
What was measured
EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.
Analysis population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.
Groups in this outcome
Ibrutinib+BR
Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
Placebo+BR
Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Ibrutinib+BR | 38 |
| Placebo+BR | 104 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib+BR | -2.1 | 16.34 | Not reported | Not reported | Not reported |
| Placebo+BR | -4.1 | 22.52 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.34
- value
- -2.1
- group Id
- OG001
- spread
- 22.52
- value
- -4.1
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 104
- units
- Participants
- description
- EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Ibrutinib+BR
- description
- Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo+BR
- param Type
- MEAN
- population Description
- ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.
- reporting Status
- POSTED
- time Frame
- Baseline to EOT (up to 2 years)
- title
- Change From Baseline in EORTC QLQ-C30 Physical Functioning Score at End of Treatment
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice