TriangleNCT03053440 · OUTCOME
Duration of Response (DOR) as Assessed by IRC
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 2 years and 7 months
What was measured
DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as ≥50% reduction of serum IgM from baseline.
Analysis population: 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 | NA | Not reported | 8.0 | NA | NA = Not estimable due to insufficient number of events |
| Arm B: Zanubrutinib | NA | Not reported | NA | NA | NA = Not estimable due to insufficient number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = Not estimable due to insufficient number of events
- group Id
- OG000
- lower Limit
- 8.0
- upper Limit
- NA
- value
- NA
- comment
- NA = Not estimable due to insufficient number of events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as ≥50% reduction of serum IgM from baseline.
- 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
- MEDIAN
- population Description
- ITT Analysis Set
- reporting Status
- POSTED
- time Frame
- Up to approximately 2 years and 7 months
- title
- Duration of Response (DOR) as Assessed by IRC
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice