TriangleNCT01889186 · OUTCOME
Progression-free Survival
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
- Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
What was measured
Duration of progression-free survival (PFS) was defined as the number of days from the date of first dose to the date of earliest disease progression or death. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant does not experience disease progression or death, then the data was censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
Analysis population: All treated participants in the Main Cohort and the Safety Expansion Cohort with 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 | 107 |
| Safety Expansion Cohort | 51 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Cohort | 24.7 | Not reported | 21.7 | 35.9 | Not reported |
| Safety Expansion Cohort | 30.2 | Not reported | 24.7 | NA | Not calculable/estimable due to insufficient number of events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.7
- upper Limit
- 35.9
- value
- 24.7
- comment
- Not calculable/estimable due to insufficient number of events
- group Id
- OG001
- lower Limit
- 24.7
- upper Limit
- NA
- value
- 30.2
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 51
- units
- Participants
- description
- Duration of progression-free survival (PFS) was defined as the number of days from the date of first dose to the date of earliest disease progression or death. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant does not experience disease progression or death, then the data was censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
- 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
- MEDIAN
- population Description
- All treated participants in the Main Cohort and the Safety Expansion Cohort with available data
- reporting Status
- POSTED
- time Frame
- Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice