TriangleNCT01524783 · OUTCOME
Time to Definitive Deterioration in World Health Organization (WHO) Performance Status (PS) Change
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
- From randomization to definitive deterioration of WHO performance status, assessed up to approximately 3 years
What was measured
WHO PS is a scale rated from 0 (fully active) to 5 (death) by a healthcare professional to assess the overall status of a patient: a lower score represents a higher ability to perform daily tasks. Deterioration is defined as an increase of at least one point compared to baseline. Deterioration is considered definitive if no improvements in the WHO PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. Death was considered as worsening of the WHO PS if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.
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 | 24.08 | Not reported | 17.05 | NA | NA. Not evaluable due to the low number of participants with an event of interest. |
| Placebo + BSC | 24.15 | Not reported | 8.31 | NA | NA. Not evaluable due to the low number of participants with an event of interest. |
Source statistical analyses
- ci Lower Limit
- 0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.61
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.539
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.61
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.539
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA. Not evaluable due to the low number of participants with an event of interest.
- group Id
- OG000
- lower Limit
- 17.05
- upper Limit
- NA
- value
- 24.08
- comment
- NA. Not evaluable due to the low number of participants with an event of interest.
- group Id
- OG001
- lower Limit
- 8.31
- upper Limit
- NA
- value
- 24.15
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 97
- units
- Participants
- description
- WHO PS is a scale rated from 0 (fully active) to 5 (death) by a healthcare professional to assess the overall status of a patient: a lower score represents a higher ability to perform daily tasks. Deterioration is defined as an increase of at least one point compared to baseline. Deterioration is considered definitive if no improvements in the WHO PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. Death was considered as worsening of the WHO PS if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.
- 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
- MEDIAN
- 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 to definitive deterioration of WHO performance status, assessed up to approximately 3 years
- title
- Time to Definitive Deterioration in World Health Organization (WHO) Performance Status (PS) Change
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice