TriangleNCT02246621 · OUTCOME
Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
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 to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
What was measured
DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Analysis population: All randomized participants.
Groups in this outcome
Abemaciclib + NSAI
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
| Group | Source count |
|---|---|
| Abemaciclib + NSAI | 328 |
| Placebo + NSAI | 165 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | 88.7 | Not reported | 85.3 | 92.1 | Not reported |
| Placebo + NSAI | 86.7 | Not reported | 81.5 | 91.9 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.501
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.501
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.3
- upper Limit
- 92.1
- value
- 88.7
- group Id
- OG001
- lower Limit
- 81.5
- upper Limit
- 91.9
- value
- 86.7
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- description
- DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG000
- title
- Abemaciclib + NSAI
- description
- Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG001
- title
- Placebo + NSAI
- param Type
- NUMBER
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
- title
- Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice