TriangleNCT01889186 · OUTCOME
Time to 50% Reduction in Absolute Lymphocyte Count
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- weeks
- 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 50% reduction in absolute lymphocyte count (ALC) was defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC had reduced to 50% of the baseline value. Only participants with a baseline of ALC \> 5 × 10\^9 /L were included in the analysis. For participants who never achieved a 50% reduction in ALC, the participant's data were not included in the analysis.
Analysis population: All treated participants with a baseline of ALC \> 5 × 10\^9 /L, a 50% reduction in ALC, 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.
All Treated Participants
Participants in the Main Cohort received ABT-199 tablets once daily (QD) orally for up to 79 months,and those in the Safety Expansion Cohort received ABT-199 tablets once daily (QD) orally for up to 68 months. For both groups, 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 | 85 |
| All Treated Participants | 125 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Cohort | 1.1 | Not reported | 0.9 | 1.2 | Not reported |
| All Treated Participants | 1.2 | Not reported | 1.1 | 1.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 1.2
- value
- 1.1
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 1.4
- value
- 1.2
- denoms
- counts
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 125
- units
- Participants
- description
- Time to 50% reduction in absolute lymphocyte count (ALC) was defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC had reduced to 50% of the baseline value. Only participants with a baseline of ALC \> 5 × 10\^9 /L were included in the analysis. For participants who never achieved a 50% reduction in ALC, 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 in the Main Cohort received ABT-199 tablets once daily (QD) orally for up to 79 months,and those in the Safety Expansion Cohort received ABT-199 tablets once daily (QD) orally for up to 68 months. For both groups, 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
- All Treated Participants
- param Type
- MEAN
- population Description
- All treated participants with a baseline of ALC \> 5 × 10\^9 /L, a 50% reduction in ALC, 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 50% Reduction in Absolute Lymphocyte Count
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice