TriangleNCT00510068 · OUTCOME
Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- % of participants with no deterioration
- Interval / dispersion
- Not reported
- Time frame
- 3 months, 6 months
What was measured
Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO \>= 2, or from a baseline value of 2 to WHO \>= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \& able to do light work; Grade 2: Ambulatory \& capable of all self-care but unable to carry out any work. Up \& about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled \& cannot carry on any self-care; totally confined to bed or chair.
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
Month 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 94.4 | Not reported | 90.0 | 96.8 | Not reported |
| Placebo | 91.8 | Not reported | 86.8 | 95.0 | Not reported |
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 90.6 | Not reported | 85.2 | 94.0 | Not reported |
| Placebo | 86.3 | Not reported | 79.3 | 91.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 90.0
- upper Limit
- 96.8
- value
- 94.4
- group Id
- OG001
- lower Limit
- 86.8
- upper Limit
- 95.0
- value
- 91.8
- title
- Month 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.2
- upper Limit
- 94.0
- value
- 90.6
- group Id
- OG001
- lower Limit
- 79.3
- upper Limit
- 91.0
- value
- 86.3
- title
- Month 6
- denoms
- counts
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 203
- units
- Participants
- description
- Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO \>= 2, or from a baseline value of 2 to WHO \>= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \& able to do light work; Grade 2: Ambulatory \& capable of all self-care but unable to carry out any work. Up \& about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled \& cannot carry on any self-care; totally confined to bed or chair.
- 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
- 3 months, 6 months
- title
- Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier
- type
- SECONDARY
- unit Of Measure
- % of participants with no deterioration
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Preserved source evidence · Not medical advice