NCT01587703 · OUTCOME
Progression Free Survival-Part 1 QD
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
- Median of 1.38 months of drug exposure
What was measured
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Analysis population: All Treated Population
Groups in this outcome
Part 1: GSK525762 2 mg QD
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
Part 1: GSK525762 4 mg QD
Participants were administered once daily oral dose of 4 mg GSK525762
Part 1: GSK525762 8 mg QD
Participants were administered once daily oral dose of 8 mg GSK525762.
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 3 |
| Part 1: GSK525762 4 mg QD | 4 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 9 |
| Part 1: GSK525762 80 mg QD | 32 |
| Part 1: GSK525762 100 mg QD | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 0.3 | Not reported | 0.3 | 0.4 | Not reported |
| Part 1: GSK525762 4 mg QD | 4.1 | Not reported | 0.9 | 13.9 | Not reported |
| Part 1: GSK525762 8 mg QD | 2.2 | Not reported | NA | NA | Confidence interval could not be calculated as only one participant was analyzed |
| Part 1: GSK525762 16 mg QD | 9.1 | Not reported | 1.4 | 13.9 | Not reported |
| Part 1: GSK525762 30 mg QD | 3.8 | Not reported | 0.9 | 5.4 | Not reported |
| Part 1: GSK525762 60 mg QD | 3.6 | Not reported | 1.4 | 8.9 | Not reported |
| Part 1: GSK525762 80 mg QD | 6.5 | Not reported | 2.6 | 9.1 | Not reported |
| Part 1: GSK525762 100 mg QD | 7.5 | Not reported | 6.0 | 18.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.3
- upper Limit
- 0.4
- value
- 0.3
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 13.9
- value
- 4.1
- comment
- Confidence interval could not be calculated as only one participant was analyzed
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 2.2
- group Id
- OG003
- lower Limit
- 1.4
- upper Limit
- 13.9
- value
- 9.1
- group Id
- OG004
- lower Limit
- 0.9
- upper Limit
- 5.4
- value
- 3.8
- group Id
- OG005
- lower Limit
- 1.4
- upper Limit
- 8.9
- value
- 3.6
- group Id
- OG006
- lower Limit
- 2.6
- upper Limit
- 9.1
- value
- 6.5
- group Id
- OG007
- lower Limit
- 6.0
- upper Limit
- 18.0
- value
- 7.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 32
- group Id
- OG007
- value
- 9
- units
- Participants
- description
- Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 2 mg QD
- description
- Participants were administered once daily oral dose of 4 mg GSK525762
- id
- OG001
- title
- Part 1: GSK525762 4 mg QD
- description
- Participants were administered once daily oral dose of 8 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 8 mg QD
- description
- Participants were administered once daily oral dose of 16 mg GSK525762.
- id
- OG003
- title
- Part 1: GSK525762 16 mg QD
- description
- Participants were administered once daily oral dose of 30 mg GSK525762.
- id
- OG004
- title
- Part 1: GSK525762 30 mg QD
- description
- Participants were administered once daily oral dose of 60 mg GSK525762.
- id
- OG005
- title
- Part 1: GSK525762 60 mg QD
- description
- Participants were administered once daily oral dose of 80 mg GSK525762.
- id
- OG006
- title
- Part 1: GSK525762 80 mg QD
- description
- Participants were administered once daily oral dose of 100 mg GSK525762.
- id
- OG007
- title
- Part 1: GSK525762 100 mg QD
- param Type
- MEDIAN
- population Description
- All Treated Population
- reporting Status
- POSTED
- time Frame
- Median of 1.38 months of drug exposure
- title
- Progression Free Survival-Part 1 QD
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice
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