TriangleNCT04062448 · OUTCOME
Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
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 up to 30 days post last dose of study drug (that is, up to 40.6 months)
What was measured
An adverse event was defined as any untoward medical event that occurred in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as any AE that occurred at or after the initial administration of study intervention through the day of last dose plus 30 days.
Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of ibrutinib.
Groups in this outcome
Ibrutinib + Rituximab
Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.
| Group | Source count |
|---|---|
| Ibrutinib + Rituximab | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib + Rituximab | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- An adverse event was defined as any untoward medical event that occurred in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as any AE that occurred at or after the initial administration of study intervention through the day of last dose plus 30 days.
- groups
- description
- Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.
- id
- OG000
- title
- Ibrutinib + Rituximab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all enrolled participants who received at least 1 dose of ibrutinib.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to 30 days post last dose of study drug (that is, up to 40.6 months)
- title
- Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice