TriangleNCT01774344 · OUTCOME
Objective Tumor Response Rate (ORR)
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
Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \< 10 mm. 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. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis.
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 | 4.1 | Not reported | Not reported | Not reported | Not reported |
| Regorafenib 160 mg (BAY73-4506) | 10.8 | Not reported | Not reported | Not reported | Not reported |
RECIST 1.1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 2.6 | Not reported | Not reported | Not reported | Not reported |
| Regorafenib 160 mg (BAY73-4506) | 6.6 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -11.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -2.63
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.003650
- param Type
- Difference
- param Value
- -6.88
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -7.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.75
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.019991
- param Type
- Difference
- param Value
- -4.15
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -11.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -2.63
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.003650
- param Type
- Difference
- param Value
- -6.88
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -7.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.75
- group Description
- Comparison of treatments were calculated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.019991
- param Type
- Difference
- param Value
- -4.15
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4.1
- group Id
- OG001
- value
- 10.8
- title
- mRECIST
- categories
- measurements
- group Id
- OG000
- value
- 2.6
- group Id
- OG001
- value
- 6.6
- title
- RECIST 1.1
- denoms
- counts
- group Id
- OG000
- value
- 194
- group Id
- OG001
- value
- 379
- units
- Participants
- description
- Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \< 10 mm. 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. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis.
- 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
- Objective Tumor Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of subjects
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice