TriangleNCT02422615 · OUTCOME
Overall Response Rate (ORR) Per Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 26 months
What was measured
ORR was defined as the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per investigator assessment. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Analysis population: FAS including all randomized participants.
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.
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 | 32.4 | Not reported | 28.3 | 36.6 | Not reported |
| Placebo + Fulvestrant | 21.5 | Not reported | 16.3 | 26.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.3
- upper Limit
- 36.6
- value
- 32.4
- group Id
- OG001
- lower Limit
- 16.3
- upper Limit
- 26.7
- value
- 21.5
- denoms
- counts
- group Id
- OG000
- value
- 484
- group Id
- OG001
- value
- 242
- units
- Participants
- description
- ORR was defined as the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per investigator assessment. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
- 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.
- 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
- NUMBER
- population Description
- FAS including all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 26 months
- title
- Overall Response Rate (ORR) Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice