TriangleNCT01412957 · OUTCOME
Progression Free Survival (PFS) 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
PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Analysis population: Wild-type RAS Efficacy Analysis Set
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 | 5.2 | Not reported | 3.5 | 5.3 | Not reported |
| BSC Alone | 1.7 | Not reported | 1.6 | 2.2 | 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
- PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Normal score
- param Value
- -5.98
- 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
- PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Normal score
- param Value
- -5.98
- 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
- 3.5
- upper Limit
- 5.3
- value
- 5.2
- group Id
- OG001
- lower Limit
- 1.6
- upper Limit
- 2.2
- value
- 1.7
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 128
- units
- Participants
- description
- PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment 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
- 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
- Progression Free Survival (PFS) in Participants With Wild-type RAS
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice