TriangleNCT01587703 · OUTCOME
Overall Response Rate-Part 1 BID
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 1.41 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
Groups in this outcome
Part 1: GSK525762 20 mg BID
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
| Group | Source count |
|---|---|
| Part 1: GSK525762 20 mg BID | 4 |
| Part 1: GSK525762 30 mg BID | 10 |
| Part 1: GSK525762 40 mg BID | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 20 mg BID | 0 | Not reported | 0.0 | 60.2 | Not reported |
| Part 1: GSK525762 30 mg BID | 0 | Not reported | 0.0 | 30.8 | Not reported |
| Part 1: GSK525762 40 mg BID | 0 | Not reported | 0.0 | 52.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 30.8
- value
- 0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- 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
- Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 20 mg BID
- description
- Participants were administered twice daily oral dose of 30 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 30 mg BID
- description
- Participants were administered twice daily oral dose of 40 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 40 mg BID
- param Type
- NUMBER
- population Description
- All Treated Population
- reporting Status
- POSTED
- time Frame
- Median of 1.41 months of drug exposure
- title
- Overall Response Rate-Part 1 BID
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice