TriangleNCT02264574 · OUTCOME
Final Analysis: Rate of Sustained Platelet Improvement
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019).
What was measured
Percentage of participants with platelet counts increase ≥ 50% over baseline continuously for ≥ 56 days without blood transfusion or growth factors.
Analysis population: Intent to Treat population: all randomized participants
Groups in this outcome
IBR+OB
Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
CLB+OB
Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| IBR+OB | 113 |
| CLB+OB | 116 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IBR+OB | 30.1 | Not reported | Not reported | Not reported | Not reported |
| CLB+OB | 14.7 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0050
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0050
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- value
- 30.1
- group Id
- OG001
- value
- 14.7
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 116
- units
- Participants
- description
- Percentage of participants with platelet counts increase ≥ 50% over baseline continuously for ≥ 56 days without blood transfusion or growth factors.
- groups
- description
- Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- IBR+OB
- description
- Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.
- id
- OG001
- title
- CLB+OB
- param Type
- NUMBER
- population Description
- Intent to Treat population: all randomized participants
- reporting Status
- POSTED
- time Frame
- Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019).
- title
- Final Analysis: Rate of Sustained Platelet Improvement
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice