TriangleNCT01958021 · OUTCOME
Overall Response Rate (ORR) by 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 23 months
What was measured
ORR is 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 non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 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 + 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 | 40.7 | Not reported | 35.4 | 46.0 | Not reported |
| Placebo + Letrozole | 27.5 | Not reported | 22.8 | 32.3 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.000155
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.000155
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.4
- upper Limit
- 46.0
- value
- 40.7
- group Id
- OG001
- lower Limit
- 22.8
- upper Limit
- 32.3
- value
- 27.5
- denoms
- counts
- group Id
- OG000
- value
- 334
- group Id
- OG001
- value
- 334
- units
- Participants
- description
- ORR is 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 non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 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 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
- NUMBER
- population Description
- FAS including all randomized participants
- reporting Status
- POSTED
- time Frame
- Up to 23 months
- title
- Overall Response Rate (ORR) by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice