TriangleNCT03332017 · OUTCOME
DOR as Determined by ICR
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
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
What was measured
DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
Analysis population: The ITT analysis set for this endpoint only included participants with a confirmed (CR or PR) per ICR assessment.
Groups in this outcome
Obinutuzumab
Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
Zanubrutinib + Obinutuzumab
Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
| Group | Source count |
|---|---|
| Obinutuzumab | 33 |
| Zanubrutinib + Obinutuzumab | 99 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab | NA | Not reported | 9.0 | NA | Not estimable due to insufficient number of participants with events |
| Zanubrutinib + Obinutuzumab | NA | Not reported | 24.7 | NA | Not estimable due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 9.0
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 24.7
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 99
- units
- Participants
- description
- DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
- id
- OG000
- title
- Obinutuzumab
- description
- Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
- id
- OG001
- title
- Zanubrutinib + Obinutuzumab
- param Type
- MEDIAN
- population Description
- The ITT analysis set for this endpoint only included participants with a confirmed (CR or PR) per ICR assessment.
- reporting Status
- POSTED
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- title
- DOR as Determined by ICR
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice