TriangleNCT02343120 · OUTCOME
Part 1 and Part 2: Partial Response (PR) or Better
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
- Up to 6 years and 7 months
What was measured
PR or better is defined as the percentage of participants who achieve a partial response or better, as assessed by the investigator. For CLL/SLL, includes PR, nPR, CRi, CR and for WM includes PR, VGPR, and CR. Efficacy results are reported for the B-cell malignancy subtypes chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and Waldenström macroglobulinemia (WM).
Analysis population: Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
Groups in this outcome
Part 1 and Part 2: Overall
The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
| Group | Source count |
|---|---|
| Part 1 and Part 2: Overall | 385 |
Reported measurements
CLL/SLL
| Group | Source count |
|---|---|
| Part 1 and Part 2: Overall | 125 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 and Part 2: Overall | 92.0 | Not reported | 85.8 | 96.1 | Not reported |
WM
| Group | Source count |
|---|---|
| Part 1 and Part 2: Overall | 73 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 and Part 2: Overall | 82.2 | Not reported | 71.5 | 90.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.8
- upper Limit
- 96.1
- value
- 92.0
- denoms
- counts
- group Id
- OG000
- value
- 125
- units
- Participants
- title
- CLL/SLL
- categories
- measurements
- group Id
- OG000
- lower Limit
- 71.5
- upper Limit
- 90.2
- value
- 82.2
- denoms
- counts
- group Id
- OG000
- value
- 73
- units
- Participants
- title
- WM
- denoms
- counts
- group Id
- OG000
- value
- 385
- units
- Participants
- description
- PR or better is defined as the percentage of participants who achieve a partial response or better, as assessed by the investigator. For CLL/SLL, includes PR, nPR, CRi, CR and for WM includes PR, VGPR, and CR. Efficacy results are reported for the B-cell malignancy subtypes chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and Waldenström macroglobulinemia (WM).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
- id
- OG000
- title
- Part 1 and Part 2: Overall
- param Type
- NUMBER
- population Description
- Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
- reporting Status
- POSTED
- time Frame
- Up to 6 years and 7 months
- title
- Part 1 and Part 2: Partial Response (PR) or Better
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice