TriangleNCT00863655 · OUTCOME
Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2, 4, 6, 9 months
What was measured
The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, \& physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature. 2: Ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement.
Analysis population: All randomized patients were included in the Full Analysis Set.
Groups in this outcome
Everolimus + Exemestane
Everolimus 10 mg daily in combination with exemestane 25 mg daily
Placebo + Exemestane
Placebo of everolimus in combination with exemestane 25 mg daily
| Group | Source count |
|---|---|
| Everolimus + Exemestane | 485 |
| Placebo + Exemestane | 239 |
Reported measurements
2 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus + Exemestane | 0.84 | Not reported | 0.80 | 0.87 | Not reported |
| Placebo + Exemestane | 0.87 | Not reported | 0.82 | 0.91 | Not reported |
4 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus + Exemestane | 0.74 | Not reported | 0.70 | 0.78 | Not reported |
| Placebo + Exemestane | 0.80 | Not reported | 0.73 | 0.85 | Not reported |
6 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus + Exemestane | 0.64 | Not reported | 0.58 | 0.69 | Not reported |
| Placebo + Exemestane | 0.67 | Not reported | 0.57 | 0.75 | Not reported |
9 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus + Exemestane | 0.57 | Not reported | 0.50 | 0.63 | Not reported |
| Placebo + Exemestane | 0.47 | Not reported | 0.32 | 0.61 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.80
- upper Limit
- 0.87
- value
- 0.84
- group Id
- OG001
- lower Limit
- 0.82
- upper Limit
- 0.91
- value
- 0.87
- title
- 2 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.70
- upper Limit
- 0.78
- value
- 0.74
- group Id
- OG001
- lower Limit
- 0.73
- upper Limit
- 0.85
- value
- 0.80
- title
- 4 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.58
- upper Limit
- 0.69
- value
- 0.64
- group Id
- OG001
- lower Limit
- 0.57
- upper Limit
- 0.75
- value
- 0.67
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.50
- upper Limit
- 0.63
- value
- 0.57
- group Id
- OG001
- lower Limit
- 0.32
- upper Limit
- 0.61
- value
- 0.47
- title
- 9 Months
- denoms
- counts
- group Id
- OG000
- value
- 485
- group Id
- OG001
- value
- 239
- units
- Participants
- description
- The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, \& physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature. 2: Ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Everolimus 10 mg daily in combination with exemestane 25 mg daily
- id
- OG000
- title
- Everolimus + Exemestane
- description
- Placebo of everolimus in combination with exemestane 25 mg daily
- id
- OG001
- title
- Placebo + Exemestane
- param Type
- NUMBER
- population Description
- All randomized patients were included in the Full Analysis Set.
- reporting Status
- POSTED
- time Frame
- 2, 4, 6, 9 months
- title
- Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier
- type
- SECONDARY
- unit Of Measure
- Proportion of patients
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Preserved source evidence · Not medical advice