TriangleNCT01980888 · 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 22 months
What was measured
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Analysis population: Intent to Treat (ITT) analysis set: all participants who are randomized in the study with treatment group designated according to initial randomization. Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments.
Groups in this outcome
Idelalisib+Bendamustine+Rituximab
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
Placebo+Bendamustine+Rituximab
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
| Group | Source count |
|---|---|
| Idelalisib+Bendamustine+Rituximab | 157 |
| Placebo+Bendamustine+Rituximab | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Idelalisib+Bendamustine+Rituximab | NA | Not reported | 19.3 | NA | NA: not reached |
| Placebo+Bendamustine+Rituximab | NA | Not reported | 19.6 | NA | NA: not reached |
Complete source fields
- classes
- categories
- measurements
- comment
- NA: not reached
- group Id
- OG000
- lower Limit
- 19.3
- upper Limit
- NA
- value
- NA
- comment
- NA: not reached
- group Id
- OG001
- lower Limit
- 19.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
- id
- OG000
- title
- Idelalisib+Bendamustine+Rituximab
- description
- Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
- id
- OG001
- title
- Placebo+Bendamustine+Rituximab
- param Type
- MEDIAN
- population Description
- Intent to Treat (ITT) analysis set: all participants who are randomized in the study with treatment group designated according to initial randomization. Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments.
- reporting Status
- POSTED
- time Frame
- Up to 22 months
- title
- Progression-Free Survival
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice