TriangleNCT02211014 · OUTCOME
Safety Profile of Acalabrutinib With and Without Dexamethasone
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 Cycle 12 (48 weeks). Subjects who showed benefit from study drugs were allowed to continue until disease progression.
What was measured
AEs and SAEs were coded by system organ class (SOC) and preferred term (PT) based on the Medical Dictionary for Regulatory Activities (MedDRA) reporting system. All AEs summarized were treatment-emergent. Summaries were also presented by the severity of the AE (per Common Toxicity Criteria for Adverse Events \[CTCAE\]) and by relationship to study drug as assessed by the investigator. Events of clinical interest (ECIs) selected for dedicated analysis were evaluated using Standardized MedDRA Queries, where available, by SOC, or by Sponsor-defined baskets of MedDRA Adverse Event Grouped Terms (AEGTs). The following ECIs were summarized: Cardiac events (including a subset of atrial fibrillation), cytopenias (anemia, leukopenia, neutropenia, and thrombocytopenia), hemorrhage (including a subset of major hemorrhage), hepatic events, hypertension, infection, interstitial lung disease/pneumonitis, second primary malignancies (second primary malignancies excluding skin), tumor lysis syndrome.
Groups in this outcome
Cohort 1
Acalabrutinib 100 mg twice daily (bid) continuously
Cohort 2
Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
| Group | Source count |
|---|---|
| Cohort 1 | 13 |
| Cohort 2 | 14 |
Reported measurements
Treatment-emergent adverse events (TEAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 14 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 7 | Not reported | Not reported | Not reported | Not reported |
SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 9 | Not reported | Not reported | Not reported | Not reported |
Treatment-related SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 2 | Not reported | Not reported | Not reported | Not reported |
TEAE leading to actions taken on study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 14
- title
- Treatment-emergent adverse events (TEAE)
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- title
- Treatment-related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 9
- title
- SAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Treatment-related SAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 8
- title
- TEAE leading to actions taken on study drug
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- AEs and SAEs were coded by system organ class (SOC) and preferred term (PT) based on the Medical Dictionary for Regulatory Activities (MedDRA) reporting system. All AEs summarized were treatment-emergent. Summaries were also presented by the severity of the AE (per Common Toxicity Criteria for Adverse Events \[CTCAE\]) and by relationship to study drug as assessed by the investigator. Events of clinical interest (ECIs) selected for dedicated analysis were evaluated using Standardized MedDRA Queries, where available, by SOC, or by Sponsor-defined baskets of MedDRA Adverse Event Grouped Terms (AEGTs). The following ECIs were summarized: Cardiac events (including a subset of atrial fibrillation), cytopenias (anemia, leukopenia, neutropenia, and thrombocytopenia), hemorrhage (including a subset of major hemorrhage), hepatic events, hypertension, infection, interstitial lung disease/pneumonitis, second primary malignancies (second primary malignancies excluding skin), tumor lysis syndrome.
- groups
- description
- Acalabrutinib 100 mg twice daily (bid) continuously
- id
- OG000
- title
- Cohort 1
- description
- Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
- id
- OG001
- title
- Cohort 2
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to Cycle 12 (48 weeks). Subjects who showed benefit from study drugs were allowed to continue until disease progression.
- title
- Safety Profile of Acalabrutinib With and Without Dexamethasone
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice