TriangleNCT01001377 · OUTCOME
Overall Survival
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 until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
What was measured
Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
Analysis population: Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.
Groups in this outcome
Cetuximab
Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
Panitumumab
Panitumumab 6 mg/kg IV every 14 days.
| Group | Source count |
|---|---|
| Cetuximab | 500 |
| Panitumumab | 499 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab | 10.0 | Not reported | 9.3 | 11.0 | Not reported |
| Panitumumab | 10.4 | Not reported | 9.4 | 11.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.839
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.113
- estimate Comment
- Hazard ratio is presented as panitumumab : cetuximab. A value \< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.
- group Description
- Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Stratified Cox proportional hazard ratio
- param Value
- 0.966
- group Description
- A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- p Value
- 0.0007
- p Value Comment
- A synthesis approach with an asymptotic standard normal test statistic
- param Type
- Normal score
- param Value
- -3.19
- statistical Method
- Asymptotic standard normal test
Complete source fields
- analyses
- ci Lower Limit
- 0.839
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.113
- estimate Comment
- Hazard ratio is presented as panitumumab : cetuximab. A value \< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.
- group Description
- Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Stratified Cox proportional hazard ratio
- param Value
- 0.966
- group Description
- A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- p Value
- 0.0007
- p Value Comment
- A synthesis approach with an asymptotic standard normal test statistic
- param Type
- Normal score
- param Value
- -3.19
- statistical Method
- Asymptotic standard normal test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.3
- upper Limit
- 11.0
- value
- 10.0
- group Id
- OG001
- lower Limit
- 9.4
- upper Limit
- 11.6
- value
- 10.4
- denoms
- counts
- group Id
- OG000
- value
- 500
- group Id
- OG001
- value
- 499
- units
- Participants
- description
- Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
- id
- OG000
- title
- Cetuximab
- description
- Panitumumab 6 mg/kg IV every 14 days.
- id
- OG001
- title
- Panitumumab
- param Type
- MEDIAN
- population Description
- Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
- title
- Overall Survival
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice