TriangleNCT01587703 · OUTCOME
Overall Response Rate-Besylate Sub-study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Median of 1.87 months of drug exposure
What was measured
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Analysis population: All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.
Groups in this outcome
All Participants in Besylate Substudy
All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
| Group | Source count |
|---|---|
| All Participants in Besylate Substudy | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants in Besylate Substudy | 0 | Not reported | 0.0 | 30.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 30.8
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
- id
- OG000
- title
- All Participants in Besylate Substudy
- param Type
- NUMBER
- population Description
- All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.
- reporting Status
- POSTED
- time Frame
- Median of 1.87 months of drug exposure
- title
- Overall Response Rate-Besylate Sub-study
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice