TriangleNCT02180724 · OUTCOME
Summary of Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- months
- Interval / dispersion
- Standard Deviation
- Time frame
- Primary analysis occur when all subjects have completed Cycle 27 or have exit the study
What was measured
DOR is defined as the interval from the first documentation of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR) or Minor Response (MR) to the earlier of the first documentation of definitive PD or death from any cause. The summary statistics are provided for DOR.
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) | 86 |
| Treatment Naive (N=14) | 13 |
Reported measurements
DOR by Modified 3rd IWWM criteria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 21.9 | 8.1 | Not reported | Not reported | Not reported |
| Treatment Naive (N=14) | 19.6 | 8.41 | Not reported | Not reported | Not reported |
DOR by 6th IWWM Criteria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 21.7 | 8.11 | Not reported | Not reported | Not reported |
| Treatment Naive (N=14) | 19.5 | 8.45 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.1
- value
- 21.9
- group Id
- OG001
- spread
- 8.41
- value
- 19.6
- title
- DOR by Modified 3rd IWWM criteria
- categories
- measurements
- group Id
- OG000
- spread
- 8.11
- value
- 21.7
- group Id
- OG001
- spread
- 8.45
- value
- 19.5
- title
- DOR by 6th IWWM Criteria
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- DOR is defined as the interval from the first documentation of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR) or Minor Response (MR) to the earlier of the first documentation of definitive PD or death from any cause. The summary statistics are provided for DOR.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- 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 exit the study
- title
- Summary of Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice