NCT02141282 · 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
- At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
What was measured
DOR is defined as the number of days from the date of first response (complete response \[CR\], complete response with incomplete marrow recovery \[CRi\], nodular partial remission \[nPR\], or partial remission \[PR\]) to the earliest recurrence or progressive disease. DOR was analyzed by Kaplan-Meier (K-M) methodology.
Analysis population: All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response of PR or better
Groups in this outcome
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
| Group | Source count |
|---|---|
| ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts | 59 |
| ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts | 35.1 | Not reported | 19.4 | 50.5 | Not reported |
| ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts | 55.4 | Not reported | 32.0 | NA | Not calculable/estimable due to low number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.4
- upper Limit
- 50.5
- value
- 35.1
- comment
- Not calculable/estimable due to low number of participants with events
- group Id
- OG001
- lower Limit
- 32.0
- upper Limit
- NA
- value
- 55.4
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- DOR is defined as the number of days from the date of first response (complete response \[CR\], complete response with incomplete marrow recovery \[CRi\], nodular partial remission \[nPR\], or partial remission \[PR\]) to the earliest recurrence or progressive disease. DOR was analyzed by Kaplan-Meier (K-M) methodology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
- id
- OG000
- title
- ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
- description
- Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
- id
- OG001
- title
- ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
- param Type
- MEDIAN
- population Description
- All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response of PR or better
- reporting Status
- POSTED
- time Frame
- At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
- 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
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