TriangleNCT01412957 · OUTCOME
Overall Survival in Participants With Wild-type RAS
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
- From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
What was measured
A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 \[codons 12 and 13\], 3 \[codons 59 and 61\], and 4 \[codons 117 and 146\] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
Analysis population: Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS)
Groups in this outcome
Panitumumab + BSC
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
BSC Alone
Participants received best supportive care until disease progression, withdrawal of consent, or death.
| Group | Source count |
|---|---|
| Panitumumab + BSC | 142 |
| BSC Alone | 128 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panitumumab + BSC | 10.0 | Not reported | 8.7 | 11.6 | Not reported |
| BSC Alone | 6.9 | Not reported | 5.2 | 7.9 | Not reported |
Source statistical analyses
- estimate Comment
- A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.
- group Description
- Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0135
- param Type
- Normal score
- param Value
- -2.47
- statistical Comment
- Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
- statistical Method
- Log Rank
Complete source fields
- analyses
- estimate Comment
- A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.
- group Description
- Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0135
- param Type
- Normal score
- param Value
- -2.47
- statistical Comment
- Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.7
- upper Limit
- 11.6
- value
- 10.0
- group Id
- OG001
- lower Limit
- 5.2
- upper Limit
- 7.9
- value
- 6.9
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 128
- units
- Participants
- description
- A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 \[codons 12 and 13\], 3 \[codons 59 and 61\], and 4 \[codons 117 and 146\] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
- id
- OG000
- title
- Panitumumab + BSC
- description
- Participants received best supportive care until disease progression, withdrawal of consent, or death.
- id
- OG001
- title
- BSC Alone
- param Type
- MEDIAN
- population Description
- Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS)
- reporting Status
- POSTED
- time Frame
- From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
- title
- Overall Survival in Participants With Wild-type RAS
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice