TriangleNCT00434642 · 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 through July 19, 2013 (up to 6 years, 3 months)
What was measured
Overall survival was defined as the time from randomization to death from any cause.
Analysis population: Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).
Groups in this outcome
Carboplatin and Gemcitabine + Bevacizumab
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
Carboplatin and Gemcitabine + Placebo
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
| Group | Source count |
|---|---|
| Carboplatin and Gemcitabine + Bevacizumab | 242 |
| Carboplatin and Gemcitabine + Placebo | 242 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carboplatin and Gemcitabine + Bevacizumab | 33.6 | Not reported | 30.32 | 35.84 | Not reported |
| Carboplatin and Gemcitabine + Placebo | 32.9 | Not reported | 29.80 | 37.68 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.771
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.176
- estimate Comment
- The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.6479
- p Value Comment
- Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.952
- statistical Comment
- The analysis was stratified for time since the last platinum therapy (≤12, \>12 months) and cytoreductive surgery for recurrent disease (Yes, No).
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.771
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.176
- estimate Comment
- The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.6479
- p Value Comment
- Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.952
- statistical Comment
- The analysis was stratified for time since the last platinum therapy (≤12, \>12 months) and cytoreductive surgery for recurrent disease (Yes, No).
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.32
- upper Limit
- 35.84
- value
- 33.6
- group Id
- OG001
- lower Limit
- 29.80
- upper Limit
- 37.68
- value
- 32.9
- denoms
- counts
- group Id
- OG000
- value
- 242
- group Id
- OG001
- value
- 242
- units
- Participants
- description
- Overall survival was defined as the time from randomization to death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
- id
- OG000
- title
- Carboplatin and Gemcitabine + Bevacizumab
- description
- Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
- id
- OG001
- title
- Carboplatin and Gemcitabine + Placebo
- param Type
- MEDIAN
- population Description
- Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).
- reporting Status
- POSTED
- time Frame
- From randomization through July 19, 2013 (up to 6 years, 3 months)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice