TriangleNCT01271712 · OUTCOME
Objective Response Rate
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
- From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.
What was measured
Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (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.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.
Analysis population: Full Analysis Set (FAS)
Groups in this outcome
Regorafenib (Stivarga, BAY73-4506)
Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
Placebo
Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
| Group | Source count |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) | 133 |
| Placebo | 66 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | 4.5 | Not reported | 1.7 | 9.6 | Not reported |
| Placebo | 1.5 | Not reported | 0.0 | 8.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.7
- upper Limit
- 9.6
- value
- 4.5
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 8.2
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 133
- group Id
- OG001
- value
- 66
- units
- Participants
- description
- Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (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.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
- id
- OG000
- title
- Regorafenib (Stivarga, BAY73-4506)
- description
- Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS)
- reporting Status
- POSTED
- time Frame
- From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.
- title
- Objective Response Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice