TriangleNCT00976911 · OUTCOME
Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)
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
- Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
What was measured
Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.
Analysis population: ITT Population; only participants with measurable disease at baseline were included in the analysis.
Groups in this outcome
Chemotherapy
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
Chemotherapy + Bevacizumab
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
| Group | Source count |
|---|---|
| Chemotherapy | 144 |
| Chemotherapy + Bevacizumab | 142 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy | 12.5 | Not reported | 7.1 | 17.9 | Not reported |
| Chemotherapy + Bevacizumab | 28.2 | Not reported | 20.8 | 35.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 6.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rates
- param Value
- 15.7
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0010
- statistical Comment
- unstratified analysis
- statistical Method
- Pearson's chi-square
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0007
- p Value Comment
- Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 6.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rates
- param Value
- 15.7
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0010
- statistical Comment
- unstratified analysis
- statistical Method
- Pearson's chi-square
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0007
- p Value Comment
- Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.1
- upper Limit
- 17.9
- value
- 12.5
- group Id
- OG001
- lower Limit
- 20.8
- upper Limit
- 35.6
- value
- 28.2
- denoms
- counts
- group Id
- OG000
- value
- 144
- group Id
- OG001
- value
- 142
- units
- Participants
- description
- Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
- id
- OG000
- title
- Chemotherapy
- description
- Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
- id
- OG001
- title
- Chemotherapy + Bevacizumab
- param Type
- NUMBER
- population Description
- ITT Population; only participants with measurable disease at baseline were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
- title
- Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice