TriangleNCT00510068 · OUTCOME
Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology
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
- 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
Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: 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 | 11.04 | Not reported | 8.41 | 13.86 | Not reported |
| Placebo | 4.60 | Not reported | 3.06 | 5.39 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.41
- upper Limit
- 13.86
- value
- 11.04
- group Id
- OG001
- lower Limit
- 3.06
- upper Limit
- 5.39
- value
- 4.60
- denoms
- counts
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 203
- units
- Participants
- description
- Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: 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
- MEDIAN
- 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
- Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice