TriangleNCT03332017 · OUTCOME
Duration of Response (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 updated analysis data cutoff (25JUN2022) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up time was 20.21 months.
What was measured
Per the Food and Drug Adminstrations's request, an additional analysis of DOR was conducted 12 months after the last participant was randomized. 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: Participants in the ITT analysis set with a confirmed complete response (CR) or partial response (PR) per ICR assessment at the updated post-hoc analysis data cutoff (25 JUN 2022).
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 | 100 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab | 14.0 | Not reported | 9.2 | 25.1 | Not reported |
| Zanubrutinib + Obinutuzumab | NA | Not reported | 25.3 | NA | Not estimable due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.2
- upper Limit
- 25.1
- value
- 14.0
- comment
- Not estimable due to insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 25.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 100
- units
- Participants
- description
- Per the Food and Drug Adminstrations's request, an additional analysis of DOR was conducted 12 months after the last participant was randomized. 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
- Participants in the ITT analysis set with a confirmed complete response (CR) or partial response (PR) per ICR assessment at the updated post-hoc analysis data cutoff (25 JUN 2022).
- reporting Status
- POSTED
- time Frame
- From first dose to updated analysis data cutoff (25JUN2022) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up time was 20.21 months.
- title
- Duration of Response (DOR) as Determined by ICR
- type
- POST_HOC
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice