TriangleNCT01889186 · OUTCOME
Time to First Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
What was measured
Time to first response was defined as the number of days from the date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR) given the participant has had a CR, CRi, confirmed nPR, or confirmed PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. The first response could have been an assessment by physical exam as long as the results were later confirmed per the 2008 Modified IWCLL NCI-WG criteria. For participants who never experienced a response, the participant's data were not included in the analysis.
Analysis population: All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data
Groups in this outcome
Main Cohort
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Safety Expansion Cohort
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
| Group | Source count |
|---|---|
| Main Cohort | 80 |
| Safety Expansion Cohort | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Cohort | 1.1 | Not reported | 1.0 | 1.3 | Not reported |
| Safety Expansion Cohort | 1.3 | Not reported | 1.1 | 1.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 1.3
- value
- 1.1
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 1.5
- value
- 1.3
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Time to first response was defined as the number of days from the date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR) given the participant has had a CR, CRi, confirmed nPR, or confirmed PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. The first response could have been an assessment by physical exam as long as the results were later confirmed per the 2008 Modified IWCLL NCI-WG criteria. For participants who never experienced a response, the participant's data were not included in the analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
- id
- OG000
- title
- Main Cohort
- description
- Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
- id
- OG001
- title
- Safety Expansion Cohort
- param Type
- MEAN
- population Description
- All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data
- reporting Status
- POSTED
- time Frame
- Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
- title
- Time to First Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice