TriangleNCT02343120 · OUTCOME
Part 1 and Part 2: Number of Participants With Adverse Events
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
- Up to approximately 6 years and 7 months
What was measured
Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements
Analysis population: The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
Groups in this outcome
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Parts 1 and 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Parts 1 and 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
| Group | Source count |
|---|---|
| Part 1: 40 mg QD | 3 |
| Part 1: 80 mg QD | 4 |
| Part 1: 160 mg QD | 5 |
| Parts 1 and 2: 160 mg BID | 278 |
| Parts 1 and 2: 320 mg QD | 95 |
Reported measurements
At least one treatment-emergent adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 40 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 80 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 160 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: 160 mg BID | 274 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: 320 mg QD | 94 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 40 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 80 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 160 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: 160 mg BID | 157 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: 320 mg QD | 45 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 274
- group Id
- OG004
- value
- 94
- title
- At least one treatment-emergent adverse event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 157
- group Id
- OG004
- value
- 45
- title
- Serious adverse events
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 278
- group Id
- OG004
- value
- 95
- units
- Participants
- description
- Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements
- groups
- description
- Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
- id
- OG000
- title
- Part 1: 40 mg QD
- description
- Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
- id
- OG001
- title
- Part 1: 80 mg QD
- description
- Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
- id
- OG002
- title
- Part 1: 160 mg QD
- description
- Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
- id
- OG003
- title
- Parts 1 and 2: 160 mg BID
- description
- Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
- id
- OG004
- title
- Parts 1 and 2: 320 mg QD
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- Up to approximately 6 years and 7 months
- title
- Part 1 and Part 2: Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice