TriangleNCT03673124 · OUTCOME
Objective Response Rate (ORR)
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
- 90% Confidence Interval
- Time frame
- Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months.
What was measured
ORR was defined as the percentage of participants in the analysis population who achieved a complete response or partial response, as assessed by RECIST 1.1.
Analysis population: Eligible participants who received any amount of protocol therapy
Groups in this outcome
Ribociclib and Letrozole
Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days.
| Group | Source count |
|---|---|
| Ribociclib and Letrozole | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ribociclib and Letrozole | 30.6 | Not reported | 19.9 | 43.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.9
- upper Limit
- 43.2
- value
- 30.6
- denoms
- counts
- group Id
- OG000
- value
- 49
- units
- Participants
- description
- ORR was defined as the percentage of participants in the analysis population who achieved a complete response or partial response, as assessed by RECIST 1.1.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days.
- id
- OG000
- title
- Ribociclib and Letrozole
- param Type
- NUMBER
- population Description
- Eligible participants who received any amount of protocol therapy
- reporting Status
- POSTED
- time Frame
- Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months.
- title
- Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice