TriangleNCT01271712 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- 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
Duration of Response was defined as the time from date of first response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\] or Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation.
Analysis population: Full Analysis Set with response participants
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) | 6 |
| Placebo | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | 99 | Not reported | 42 | NA | A complete confidence interval (CI) cannot be calculated because there are too few patients in the data set. |
| Placebo | 30 | Not reported | NA | NA | CI cannot be calculated because there is only 1 patient in the data set. |
Complete source fields
- classes
- categories
- measurements
- comment
- A complete confidence interval (CI) cannot be calculated because there are too few patients in the data set.
- group Id
- OG000
- lower Limit
- 42
- upper Limit
- NA
- value
- 99
- comment
- CI cannot be calculated because there is only 1 patient in the data set.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 30
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Duration of Response was defined as the time from date of first response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\] or Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. 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
- MEDIAN
- population Description
- Full Analysis Set with response participants
- 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
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice