TriangleNCT01266967 · OUTCOME
Duration of Intracranial Response for the Subset of V600E Mutation-positive Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 27 weeks)
What was measured
Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or 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 \[e.g., percent change from Baseline\]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).
Analysis population: V600E Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.
Groups in this outcome
GSK2118436 150 mg: No Prior Local Therapy
Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
GSK2118436 150 mg: Prior Local Therapy
Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
| Group | Source count |
|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 30 |
| GSK2118436 150 mg: Prior Local Therapy | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 24.1 | Not reported | 16.1 | 30.3 | Not reported |
| GSK2118436 150 mg: Prior Local Therapy | 28.1 | Not reported | 24.1 | 44.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.1
- upper Limit
- 30.3
- value
- 24.1
- group Id
- OG001
- lower Limit
- 24.1
- upper Limit
- 44.1
- value
- 28.1
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or 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 \[e.g., percent change from Baseline\]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
- id
- OG000
- title
- GSK2118436 150 mg: No Prior Local Therapy
- description
- Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
- id
- OG001
- title
- GSK2118436 150 mg: Prior Local Therapy
- param Type
- MEDIAN
- population Description
- V600E Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.
- reporting Status
- POSTED
- time Frame
- Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 27 weeks)
- title
- Duration of Intracranial Response for the Subset of V600E Mutation-positive Participants
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice