TriangleNCT03053440 · OUTCOME
Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC)
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 approximately 2 years and 7 months
What was measured
Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
Analysis population: Intent To Treat (ITT) Analysis Set
Groups in this outcome
Arm A: Ibrutinib
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
| Group | Source count |
|---|---|
| Arm A: Ibrutinib | 99 |
| Arm B: Zanubrutinib | 102 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Ibrutinib | 19.2 | Not reported | 12.0 | 28.3 | Not reported |
| Arm B: Zanubrutinib | 28.4 | Not reported | 19.9 | 38.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.0
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0921
- param Type
- Risk Difference (RD)
- param Value
- 10.2
- statistical Comment
- Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.0
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0921
- param Type
- Risk Difference (RD)
- param Value
- 10.2
- statistical Comment
- Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 28.3
- value
- 19.2
- group Id
- OG001
- lower Limit
- 19.9
- upper Limit
- 38.2
- value
- 28.4
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
- id
- OG000
- title
- Arm A: Ibrutinib
- description
- Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
- id
- OG001
- title
- Arm B: Zanubrutinib
- param Type
- NUMBER
- population Description
- Intent To Treat (ITT) Analysis Set
- reporting Status
- POSTED
- time Frame
- Up to approximately 2 years and 7 months
- title
- Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice