TriangleNCT01958021 · OUTCOME
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score
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 baseline up to 23 months
What was measured
ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.
Analysis population: FAS including all randomized participants
Groups in this outcome
Ribociclib + Letrozole
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
Placebo + Letrozole
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
| Group | Source count |
|---|---|
| Ribociclib + Letrozole | 334 |
| Placebo + Letrozole | 334 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ribociclib + Letrozole | 22.6 | Not reported | 22.6 | NA | NA= Not estimable due to the insufficient number of participants with events |
| Placebo + Letrozole | NA | Not reported | NA | NA | NA= Not estimable due to the insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- NA= Not estimable due to the insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 22.6
- upper Limit
- NA
- value
- 22.6
- comment
- NA= Not estimable due to the insufficient number of participants with events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 334
- group Id
- OG001
- value
- 334
- units
- Participants
- description
- ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
- id
- OG000
- title
- Ribociclib + Letrozole
- description
- Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
- id
- OG001
- title
- Placebo + Letrozole
- param Type
- MEDIAN
- population Description
- FAS including all randomized participants
- reporting Status
- POSTED
- time Frame
- From baseline up to 23 months
- title
- Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice