TriangleNCT03112174 · OUTCOME
Number of Participants With TLS TEAEs (Randomization Phase)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug until the end of treatment + 7 days, with an overall median treatment duration 19.5 months
What was measured
Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug (SD). Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).
Analysis population: All randomized and treated participants
Groups in this outcome
Randomization Phase: Ibrutinb + Venetoclax
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
| Group | Source count |
|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 134 |
| Randomization Phase: Ibrutinib + Placebo | 132 |
Reported measurements
Any Grade
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 7 | Not reported | Not reported | Not reported | Not reported |
| Randomization Phase: Ibrutinib + Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
Grades 3 and 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 6 | Not reported | Not reported | Not reported | Not reported |
| Randomization Phase: Ibrutinib + Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- title
- Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- title
- Grades 3 and 4
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 132
- units
- Participants
- description
- Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug (SD). Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).
- groups
- description
- Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG000
- title
- Randomization Phase: Ibrutinb + Venetoclax
- description
- Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG001
- title
- Randomization Phase: Ibrutinib + Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized and treated participants
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until the end of treatment + 7 days, with an overall median treatment duration 19.5 months
- title
- Number of Participants With TLS TEAEs (Randomization Phase)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice