TriangleNCT01774344 · OUTCOME
Disease Control Rate (DCR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of subjects
- Interval / dispersion
- Not reported
- Time frame
- From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
What was measured
Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating.
Groups in this outcome
Placebo
Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Regorafenib 160 mg (BAY73-4506)
Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
| Group | Source count |
|---|---|
| Placebo | 194 |
| Regorafenib 160 mg (BAY73-4506) | 379 |
Reported measurements
mRECIST
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 36.1 | Not reported | Not reported | Not reported | Not reported |
| Regorafenib 160 mg (BAY73-4506) | 65.2 | Not reported | Not reported | Not reported | Not reported |
RECIST 1.1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 34.5 | Not reported | Not reported | Not reported | Not reported |
| Regorafenib 160 mg (BAY73-4506) | 65.7 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -37.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -21.11
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.000001
- param Type
- Difference
- param Value
- -29.31
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -39.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -23.22
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.000001
- param Type
- Difference
- param Value
- -31.39
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -37.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -21.11
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.000001
- param Type
- Difference
- param Value
- -29.31
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -39.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -23.22
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.000001
- param Type
- Difference
- param Value
- -31.39
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 36.1
- group Id
- OG001
- value
- 65.2
- title
- mRECIST
- categories
- measurements
- group Id
- OG000
- value
- 34.5
- group Id
- OG001
- value
- 65.7
- title
- RECIST 1.1
- denoms
- counts
- group Id
- OG000
- value
- 194
- group Id
- OG001
- value
- 379
- units
- Participants
- description
- Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating.
- groups
- description
- Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
- id
- OG000
- title
- Placebo
- description
- Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
- id
- OG001
- title
- Regorafenib 160 mg (BAY73-4506)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
- title
- Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- percentage of subjects
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice