TriangleNCT01524783 · OUTCOME
Overall Response Rate (ORR) as Per Modified RECIST 1.0 According to Central Evaluation
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 until end of treatment, assessed up to approximately 2.5 years
What was measured
ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), according to central evaluation and as per modified RECIST 1.0. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
Analysis population: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
Groups in this outcome
Everolimus + BSC
Participants received everolimus 10 mg once daily BSC throughout the study
Placebo + BSC
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
| Group | Source count |
|---|---|
| Everolimus + BSC | 205 |
| Placebo + BSC | 97 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus + BSC | 2.0 | Not reported | 0.5 | 4.9 | Not reported |
| Placebo + BSC | 1.0 | Not reported | 0.0 | 5.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 4.9
- value
- 2.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 5.6
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 97
- units
- Participants
- description
- ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), according to central evaluation and as per modified RECIST 1.0. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received everolimus 10 mg once daily BSC throughout the study
- id
- OG000
- title
- Everolimus + BSC
- description
- Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
- id
- OG001
- title
- Placebo + BSC
- param Type
- NUMBER
- population Description
- The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
- reporting Status
- POSTED
- time Frame
- From randomization until end of treatment, assessed up to approximately 2.5 years
- title
- Overall Response Rate (ORR) as Per Modified RECIST 1.0 According to Central Evaluation
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice