TriangleNCT03734016 · OUTCOME
Duration of Response Assessed by the Independent Review Committee
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 randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
What was measured
DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by independent central review. Median DOR was estimated using the Kaplan-Meier method.
Analysis population: Participants in the ITT Analysis Set with an objective response assessed by the IRC
Groups in this outcome
Zanubrutinib
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
Ibrutinib
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
| Group | Source count |
|---|---|
| Zanubrutinib | 282 |
| Ibrutinib | 246 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | NA | Not reported | 31.3 | NA | Insufficient number of participants with events to estimate median and upper 95% confidence limit. |
| Ibrutinib | 33.9 | Not reported | 32.2 | 41.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of participants with events to estimate median and upper 95% confidence limit.
- group Id
- OG000
- lower Limit
- 31.3
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 32.2
- upper Limit
- 41.4
- value
- 33.9
- denoms
- counts
- group Id
- OG000
- value
- 282
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by independent central review. Median DOR was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
- id
- OG000
- title
- Zanubrutinib
- description
- Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
- id
- OG001
- title
- Ibrutinib
- param Type
- MEDIAN
- population Description
- Participants in the ITT Analysis Set with an objective response assessed by the IRC
- reporting Status
- POSTED
- time Frame
- From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
- title
- Duration of Response Assessed by the Independent Review Committee
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice