TriangleNCT05169567 · OUTCOME
Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
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
- Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)
What was measured
PFS is defined as the time from the date of randomization to the earliest date of disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
Analysis population: All randomized participants.
Groups in this outcome
Arm A: Abemaciclib Plus Fulvestrant
Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
Arm B: Placebo Plus Fulvestrant
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
| Group | Source count |
|---|---|
| Arm A: Abemaciclib Plus Fulvestrant | 182 |
| Arm B: Placebo Plus Fulvestrant | 186 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Abemaciclib Plus Fulvestrant | 12.9 | Not reported | 9.5 | NA | Upper limit of 95% CI was not estimable due to insufficient number of events. |
| Arm B: Placebo Plus Fulvestrant | 5.6 | Not reported | 3.9 | 7.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 9.5
- upper Limit
- NA
- value
- 12.9
- group Id
- OG001
- lower Limit
- 3.9
- upper Limit
- 7.7
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 186
- units
- Participants
- description
- PFS is defined as the time from the date of randomization to the earliest date of disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- OG000
- title
- Arm A: Abemaciclib Plus Fulvestrant
- description
- Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- OG001
- title
- Arm B: Placebo Plus Fulvestrant
- param Type
- MEDIAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)
- title
- Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice