TriangleNCT02180724 · OUTCOME
Overall Survival (OS) of Acalabrutinib by Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of subjects
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Primary analysis occur when all subjects have completed Cycle 27 or have discontinued before Cycle 27.
What was measured
Outcome Measure was pre-specified to summarize data per investigator assessment with respect to subject's vital/survival status is presented in the RRF and irrespective of iWWM 3rd or 6th criteria. Kaplan-Meier (K-M) estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive by the given time over all patients at risk.
Analysis population: In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
Groups in this outcome
Previously Treated (N=92)
100 mg BID N=87 + 200 mg QD N= 5
Treatment Naive (N=14)
100 mg BID N= 13 + 200 mg QD N=1
| Group | Source count |
|---|---|
| Previously Treated (N=92) | 92 |
| Treatment Naive (N=14) | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 89.0 | Not reported | 80.6 | 93.9 | Not reported |
| Treatment Naive (N=14) | 90.9 | Not reported | 50.8 | 98.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 80.6
- upper Limit
- 93.9
- value
- 89.0
- group Id
- OG001
- lower Limit
- 50.8
- upper Limit
- 98.7
- value
- 90.9
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Outcome Measure was pre-specified to summarize data per investigator assessment with respect to subject's vital/survival status is presented in the RRF and irrespective of iWWM 3rd or 6th criteria. Kaplan-Meier (K-M) estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive by the given time over all patients at risk.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 100 mg BID N=87 + 200 mg QD N= 5
- id
- OG000
- title
- Previously Treated (N=92)
- description
- 100 mg BID N= 13 + 200 mg QD N=1
- id
- OG001
- title
- Treatment Naive (N=14)
- param Type
- NUMBER
- population Description
- In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
- reporting Status
- POSTED
- time Frame
- Primary analysis occur when all subjects have completed Cycle 27 or have discontinued before Cycle 27.
- title
- Overall Survival (OS) of Acalabrutinib by Investigator
- type
- SECONDARY
- unit Of Measure
- Percentage of subjects
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice