TriangleNCT02422615 · OUTCOME
Progression Free Survival (PFS) Per Investigator Assessment
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 first documented progression or death, assessed up to approximately 26 months
What was measured
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. The distribution of PFS between the two arms was compared using a stratified log-rank test at a one-sided 2.5% level of significance. The PFS hazard ratio with two-sided 95% confidence interval was derived from the stratified Cox proportional hazards model.
Analysis population: The Full Analysis Set (FAS) including all randomized patients.
Groups in this outcome
Ribociclib + Fulvestrant
Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment.
Placebo + Fulvestrant
Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
| Group | Source count |
|---|---|
| Ribociclib + Fulvestrant | 484 |
| Placebo + Fulvestrant | 242 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ribociclib + Fulvestrant | 20.5 | Not reported | 18.5 | 23.5 | Not reported |
| Placebo + Fulvestrant | 12.8 | Not reported | 10.9 | 16.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.480
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.732
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00000041
- param Type
- Cox Proportional Hazard
- param Value
- 0.593
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.480
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.732
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00000041
- param Type
- Cox Proportional Hazard
- param Value
- 0.593
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.5
- upper Limit
- 23.5
- value
- 20.5
- group Id
- OG001
- lower Limit
- 10.9
- upper Limit
- 16.3
- value
- 12.8
- denoms
- counts
- group Id
- OG000
- value
- 484
- group Id
- OG001
- value
- 242
- units
- Participants
- description
- PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. The distribution of PFS between the two arms was compared using a stratified log-rank test at a one-sided 2.5% level of significance. The PFS hazard ratio with two-sided 95% confidence interval was derived from the stratified Cox proportional hazards model.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment.
- id
- OG000
- title
- Ribociclib + Fulvestrant
- description
- Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- MEDIAN
- population Description
- The Full Analysis Set (FAS) including all randomized patients.
- reporting Status
- POSTED
- time Frame
- From randomization to first documented progression or death, assessed up to approximately 26 months
- title
- Progression Free Survival (PFS) Per Investigator Assessment
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice