Table 2.
MedDRA preferred term | Phase I and II combined (n = 108), n (%) |
---|---|
Patients with and serious treatment‐emergent adverse event | 59 (55) |
Encephalopathy | 19 (18) |
Lung infection | 8 (7) |
Pyrexia | 8 (7) |
Pneumonia | 6 (6) |
Confusional state | 5 (5) |
Febrile neutropenia | 5 (5) |
Aphasia | 4 (4) |
Atrial fibrillation | 4 (4) |
B‐cell lymphoma | 4 (4) |
Cardiac arrest | 4 (4) |
Urinary tract infection | 4 (4) |
Acute kidney injury | 3 (3) |
Agitation | 3 (3) |
Ejection fraction decreased | 3 (3) |
Hypotension | 3 (3) |
Hypoxia | 3 (3) |
Neutropenia | 3 (3) |
Somnolence | 3 (3) |
Atrial flutter | 2 (2) |
Delirium | 2 (2) |
Preferred terms are sorted in descending order of total frequency count. Adverse events are coded using MedDRA version 19.0 and graded per Common Terminology Criteria for Adverse Events version 4.03. Percentages are calculated using n in each column as the denominator.
Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.