TriangleNCT01245062 · OUTCOME
Number of Participants With OR Following Cross-over to Trametinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- 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
OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1. Cross-over Population included the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.
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 | 70 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cross-over From Chemotherapy to Trametinib | 2 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cross-over From Chemotherapy to Trametinib | 29 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 29
- title
- PR
- denoms
- counts
- group Id
- OG000
- value
- 70
- units
- Participants
- description
- OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1. Cross-over Population included the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.
- 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
- NUMBER
- 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
- Number of Participants With OR Following Cross-over to Trametinib
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice