TriangleNCT02107703 · OUTCOME
Overall Survival (OS)
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 Date of Randomization until Death Due to Any Cause (Up To 72 Months)
What was measured
OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The final analysis of the OS outcome was conducted after 440 OS events had been observed.
Analysis population: All randomized participants. Censored participants: Abemaciclib=163 (36.5%), Placebo = 66 (29.6).
Groups in this outcome
Abemaciclib + Fulvestrant
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Placebo + Fulvestrant
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
| Group | Source count |
|---|---|
| Abemaciclib + Fulvestrant | 446 |
| Placebo + Fulvestrant | 223 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + Fulvestrant | 45.80 | Not reported | 38.96 | 52.64 | Not reported |
| Placebo + Fulvestrant | 37.25 | Not reported | 34.36 | 43.20 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.96
- upper Limit
- 52.64
- value
- 45.80
- group Id
- OG001
- lower Limit
- 34.36
- upper Limit
- 43.20
- value
- 37.25
- denoms
- counts
- group Id
- OG000
- value
- 446
- group Id
- OG001
- value
- 223
- units
- Participants
- description
- OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The final analysis of the OS outcome was conducted after 440 OS events had been observed.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
- id
- OG000
- title
- Abemaciclib + Fulvestrant
- description
- Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- MEDIAN
- population Description
- All randomized participants. Censored participants: Abemaciclib=163 (36.5%), Placebo = 66 (29.6).
- reporting Status
- POSTED
- time Frame
- From Date of Randomization until Death Due to Any Cause (Up To 72 Months)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice