TriangleNCT01412957 · OUTCOME
Objective Response Rate 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Response was assessed at Week 4, Week 8, and then every 8 weeks until 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
Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.
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 | 30.99 | Not reported | 23.50 | 39.28 | Not reported |
| BSC Alone | 2.34 | Not reported | 0.49 | 6.70 | Not reported |
Source statistical analyses
- ci Lower Limit
- 5.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 101.62
- estimate Comment
- The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.
- group Description
- ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 20.00
- statistical Comment
- Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
- statistical Method
- Stratified exact test
Complete source fields
- analyses
- ci Lower Limit
- 5.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 101.62
- estimate Comment
- The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.
- group Description
- ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 20.00
- statistical Comment
- Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
- statistical Method
- Stratified exact test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.50
- upper Limit
- 39.28
- value
- 30.99
- group Id
- OG001
- lower Limit
- 0.49
- upper Limit
- 6.70
- value
- 2.34
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 128
- units
- Participants
- description
- Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.
- 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
- NUMBER
- population Description
- Wild-type RAS Efficacy Analysis Set
- reporting Status
- POSTED
- time Frame
- Response was assessed at Week 4, Week 8, and then every 8 weeks until 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
- Objective Response Rate in Participants With Wild-type RAS
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice