Table 2.
Summary of AEs (Safety Analysis Set)
| Type of AE |
Number of Events (Number of Patients Reporting Event) |
|---|---|
| Total AEs | 228 (29) |
| Moderate AEs | 48 (19) |
| Severe AEs | 15 (7) |
| Serious AEs | 1 (1) |
| Serious adverse drug reactions | 0 (0) |
| Life‐threatening AEs/deaths | 0 (0) |
| AEs leading to drug withdrawal | 0 (0) |
| AEs reported in 2 or more subjects: | |
| Ear and labyrinth disorders | |
| Ear pain | 2 (2) |
| Gastrointestinal disorders | |
| Abdominal pain | 4 (3) |
| Diarrhea | 11 (6) |
| Nausea | 4 (4) |
| Toothache | 3 (2) |
| Vomiting | 3 (3) |
| General disorders and administration site conditions | |
| Fatigue | 13 (7) |
| Influenza‐like illness | 5 (4) |
| Injection‐site hematoma | 2 (2) |
| Edema peripheral | 3 (3) |
| Infections and infestations | |
| Candidiasis | 2 (2) |
| Gastroenteritis | 3 (3) |
| Nasopharyngitis | 7 (6) |
| Urinary tract infection | 9 (7) |
| Viral infection | 2 (2) |
| Musculoskeletal and connective tissue disorders | |
| Arthralgia | 8 (5) |
| Back pain | 2 (2) |
| Pain in extremity | 2 (2) |
| Nervous system disorders | |
| Dizziness | 5 (4) |
| Headache | 41 (15) |
| Lethargy | 3 (3) |
| Syncope | 3 (2) |
| Respiratory, thoracic, and mediastinal disorders | |
| Cough | 3 (3) |
| Oropharyngeal pain | 8 (5) |
| Skin and subcutaneous tissue disorders | |
| Pruritus | 14 (10) |
| Vascular disorder | |
| Hot flush | 2 (2) |