TriangleNCT01885195 · OUTCOME
Duration of Response (DOR) as Per RECIST Version 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first documented response (CR or PR) to the date of the first documented PD or death (maximum up to 19.4 months)
What was measured
DOR was defined as the time from the first documented response (CR or PR) to the date of first documented disease progression, relapse or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to \<10 mm; PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of \>=1 new target or non-target lesions. The DOR was determined only in participants whose best response was PR or greater.
Analysis population: Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Binimetinib (MEK162)
Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
| Group | Source count |
|---|---|
| Binimetinib (MEK162) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Binimetinib (MEK162) | NA | Not reported | NA | NA | Median and 95% CI were not estimable due to low number of participants who had an event. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% CI were not estimable due to low number of participants who had an event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- units
- Participants
- description
- DOR was defined as the time from the first documented response (CR or PR) to the date of first documented disease progression, relapse or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to \<10 mm; PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of \>=1 new target or non-target lesions. The DOR was determined only in participants whose best response was PR or greater.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
- id
- OG000
- title
- Binimetinib (MEK162)
- param Type
- MEDIAN
- population Description
- Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From the first documented response (CR or PR) to the date of the first documented PD or death (maximum up to 19.4 months)
- title
- Duration of Response (DOR) as Per RECIST Version 1.1
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice