TriangleNCT04975308 · OUTCOME
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm C and Arm A)
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
- Randomization until measured progressive disease (up to 26 months)
What was measured
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Analysis population: All participants who were randomly assigned to either arm A or arm C concurrently.
Groups in this outcome
Arm C: Imlunestrant + Abemaciclib
Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
Arm A: Imlunestrant
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
| Group | Source count |
|---|---|
| Arm C: Imlunestrant + Abemaciclib | 213 |
| Arm A: Imlunestrant | 213 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm C: Imlunestrant + Abemaciclib | 21.1 | Not reported | 15.6 | 26.6 | Not reported |
| Arm A: Imlunestrant | 9.4 | Not reported | 5.5 | 13.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.6
- upper Limit
- 26.6
- value
- 21.1
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- 13.3
- value
- 9.4
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 213
- units
- Participants
- description
- ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
- id
- OG000
- title
- Arm C: Imlunestrant + Abemaciclib
- description
- Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
- id
- OG001
- title
- Arm A: Imlunestrant
- param Type
- NUMBER
- population Description
- All participants who were randomly assigned to either arm A or arm C concurrently.
- reporting Status
- POSTED
- time Frame
- Randomization until measured progressive disease (up to 26 months)
- title
- Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm C and Arm A)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice