TriangleNCT02242942 · OUTCOME
Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
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
- 95% Confidence Interval
- Time frame
- At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
What was measured
OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L.
Analysis population: ITT population was defined as all randomized participants.
Groups in this outcome
Obinutuzumab + Chlorambucil
Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
Obinutuzumab + Venetoclax
Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
| Group | Source count |
|---|---|
| Obinutuzumab + Chlorambucil | 216 |
| Obinutuzumab + Venetoclax | 216 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil | 71.3 | Not reported | 64.77 | 77.23 | Not reported |
| Obinutuzumab + Venetoclax | 84.7 | Not reported | 79.22 | 89.24 | Not reported |
Source statistical analyses
- ci Lower Limit
- 5.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.38
- estimate Comment
- 95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0007
- p Value Comment
- P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.
- param Type
- Difference in Response Rates
- param Value
- 13.43
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 5.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.38
- estimate Comment
- 95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0007
- p Value Comment
- P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.
- param Type
- Difference in Response Rates
- param Value
- 13.43
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 64.77
- upper Limit
- 77.23
- value
- 71.3
- group Id
- OG001
- lower Limit
- 79.22
- upper Limit
- 89.24
- value
- 84.7
- denoms
- counts
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 216
- units
- Participants
- description
- OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
- id
- OG000
- title
- Obinutuzumab + Chlorambucil
- description
- Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
- id
- OG001
- title
- Obinutuzumab + Venetoclax
- param Type
- NUMBER
- population Description
- ITT population was defined as all randomized participants.
- reporting Status
- POSTED
- time Frame
- At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
- title
- Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice