TriangleNCT01227889 · OUTCOME
Progression-free Survival (PFS) as Assessed by the Investigator
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
- Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)
What was measured
PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 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). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.
Analysis population: Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered
Groups in this outcome
GSK2118436 150 mg BID
Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
DTIC 1000 mg/m^2 in RP
In the RP, participants received intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (mg/m\^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
| Group | Source count |
|---|---|
| GSK2118436 150 mg BID | 187 |
| DTIC 1000 mg/m^2 in RP | 63 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK2118436 150 mg BID | 6.9 | Not reported | 5.5 | 9.0 | Not reported |
| DTIC 1000 mg/m^2 in RP | 2.7 | Not reported | 1.4 | 3.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.60
- estimate Comment
- HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- The p value from a stratified log-rank test was adjusted for disease stage at screening.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.40
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.60
- estimate Comment
- HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- The p value from a stratified log-rank test was adjusted for disease stage at screening.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.40
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 9.0
- value
- 6.9
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 3.2
- value
- 2.7
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 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). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
- id
- OG000
- title
- GSK2118436 150 mg BID
- description
- In the RP, participants received intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (mg/m\^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
- id
- OG001
- title
- DTIC 1000 mg/m^2 in RP
- param Type
- MEDIAN
- population Description
- Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered
- reporting Status
- POSTED
- time Frame
- Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)
- title
- Progression-free Survival (PFS) as Assessed by the Investigator
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice