TriangleNCT01245062 · OUTCOME
DoR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator
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
- Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
What was measured
DoR is defined as the time from the first documented evidence of CR (disappearance of all extra nodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR data were summarized per RECIST, Version 1.1Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Analysis population: Cross-over Population
Groups in this outcome
Cross-over From Chemotherapy to Trametinib
Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
| Group | Source count |
|---|---|
| Cross-over From Chemotherapy to Trametinib | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cross-over From Chemotherapy to Trametinib | 2.7 | Not reported | 1.3 | NA | There were too few events to provide an estimable UL of the CI. |
Complete source fields
- classes
- categories
- measurements
- comment
- There were too few events to provide an estimable UL of the CI.
- group Id
- OG000
- lower Limit
- 1.3
- upper Limit
- NA
- value
- 2.7
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- DoR is defined as the time from the first documented evidence of CR (disappearance of all extra nodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR data were summarized per RECIST, Version 1.1Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
- id
- OG000
- title
- Cross-over From Chemotherapy to Trametinib
- param Type
- MEDIAN
- population Description
- Cross-over Population
- reporting Status
- POSTED
- time Frame
- Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
- title
- DoR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice