TriangleNCT02246621 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)
What was measured
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. 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. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Analysis population: All randomized participants who had evaluable data. Censored participants: Abemaciclib + NSAI = 112 and Placebo + NSAI =28.
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 | 163 |
| Placebo + NSAI | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | 27.39 | Not reported | 25.74 | NA | The upper limit of the 95% CI was not evaluable due to the high censoring rate. |
| Placebo + NSAI | 17.46 | Not reported | 11.21 | 22.19 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the 95% CI was not evaluable due to the high censoring rate.
- group Id
- OG000
- lower Limit
- 25.74
- upper Limit
- NA
- value
- 27.39
- group Id
- OG001
- lower Limit
- 11.21
- upper Limit
- 22.19
- value
- 17.46
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. 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. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
- 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
- MEDIAN
- population Description
- All randomized participants who had evaluable data. Censored participants: Abemaciclib + NSAI = 112 and Placebo + NSAI =28.
- reporting Status
- POSTED
- time Frame
- CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice