TriangleNCT00738530 · OUTCOME
Percentage of Participants With Objective Response According to mRECIST
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
- Not reported
- Time frame
- Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
What was measured
Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (\>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate.
Analysis population: ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.
Groups in this outcome
Bevacizumab + IFN-Alfa-2A
Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
Placebo + IFN-Alfa-2A
Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
| Group | Source count |
|---|---|
| Bevacizumab + IFN-Alfa-2A | 306 |
| Placebo + IFN-Alfa-2A | 289 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bevacizumab + IFN-Alfa-2A | 32.4 | Not reported | Not reported | Not reported | Not reported |
| Placebo + IFN-Alfa-2A | 12.5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 13.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 26.6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <.0001
- param Type
- Difference in response rates
- param Value
- 19.90
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 13.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 26.6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <.0001
- param Type
- Difference in response rates
- param Value
- 19.90
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 32.4
- group Id
- OG001
- value
- 12.5
- denoms
- counts
- group Id
- OG000
- value
- 306
- group Id
- OG001
- value
- 289
- units
- Participants
- description
- Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (\>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate.
- groups
- description
- Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
- id
- OG000
- title
- Bevacizumab + IFN-Alfa-2A
- description
- Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
- id
- OG001
- title
- Placebo + IFN-Alfa-2A
- param Type
- NUMBER
- population Description
- ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.
- reporting Status
- POSTED
- time Frame
- Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
- title
- Percentage of Participants With Objective Response According to mRECIST
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice