TriangleNCT00510068 · OUTCOME
Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})
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
- Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
What was measured
Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
Analysis population: The Full Analysis Set (FAS) consists of all patients who were randomized.
Groups in this outcome
Everolimus 10 mg/Day
Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
Placebo
Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
| Group | Source count |
|---|---|
| Everolimus 10 mg/Day | 207 |
| Placebo | 203 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 4.8 | Not reported | 2.3 | 8.7 | Not reported |
| Placebo | 2.0 | Not reported | 0.5 | 5.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.3
- upper Limit
- 8.7
- value
- 4.8
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 5.0
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 203
- units
- Participants
- description
- Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
- id
- OG000
- title
- Everolimus 10 mg/Day
- description
- Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- The Full Analysis Set (FAS) consists of all patients who were randomized.
- reporting Status
- POSTED
- time Frame
- Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
- title
- Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice