Chronic lymphocytic leukemia
Conditions
Brief summary
Frequency, severity and relatedness of all AEs, which will also include: - Grade ≥3 AEs - SAEs - AESI defined as ventricular arrhythmias - AEs that lead to discontinuation of treatment - ECIs defined as cardiac events, hepatotoxicity, hypertension, infections, interstitial lung disease/pneumonitis, hemorrhage (major hemorrhage), cytopenias (anemia, leukopenia, thrombocytopenia), second primary malignancies, and tumor lysis syndrome.
Detailed description
Overall response; Duration of response; Progression-free survival.
Interventions
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, severity and relatedness of all AEs, which will also include: - Grade ≥3 AEs - SAEs - AESI defined as ventricular arrhythmias - AEs that lead to discontinuation of treatment - ECIs defined as cardiac events, hepatotoxicity, hypertension, infections, interstitial lung disease/pneumonitis, hemorrhage (major hemorrhage), cytopenias (anemia, leukopenia, thrombocytopenia), second primary malignancies, and tumor lysis syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response; Duration of response; Progression-free survival. | — |
Countries
Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden
Outcome results
None listed