Table 3 Common adverse events (>10%) reported by maximum grade of severity
|
AEs (N = 53) System organ class Preferred term | Overall, n (%) | Mild, n (%) | Moderate, n (%) | Severe, n (%) |
|---|---|---|---|---|
| Number of patients with at least one event | 52 (98.1) | 11 (20.8) | 27 (50.9) | 14 (26.4) |
| Infections and infestations | 40 (75.5) | 15 (28.3) | 21 (39.6) | 4 (7.5) |
| Rhinitis | 8 (15.1) | 8 (15.1) | 0 | 0 |
| Gastroenteritis | 7 (13.2) | 6 (11.3) | 0 | 1 (1.9) |
| Pharyngitis | 7 (13.2) | 4 (7.5) | 3 (5.7) | 0 |
| Urinary tract infection | 6 (11.3) | 3 (5.7) | 3 (5.7) | 0 |
| Gastrointestinal disorders | 36 (67.9) | 24 (45.3) | 12 (22.6) | 0 |
| Diarrhea | 14 (26.4) | 11 (20.8) | 3 (5.7) | 0 |
| Nausea | 12 (22.6) | 9 (17.0) | 3 (5.7) | 0 |
| Vomiting | 12 (22.6) | 9 (17.0) | 3 (5.7) | 0 |
| Upper abdominal pain | 11 (20.8) | 7 (13.2) | 4 (7.5) | 0 |
| Abdominal pain | 10 (18.9) | 7 (13.2) | 3 (5.7) | 0 |
| General disorders and administration site conditions | 24 (45.3) | 16 (30.2) | 8 (15.1) | 0 |
| Asthenia | 10 (18.9) | 8 (15.1) | 2 (3.8) | 0 |
| Influenza | 9 (17.0) | 3 (5.7) | 6 (11.3) | 0 |
| Pyrexia | 13 (24.5) | 7 (13.2) | 6 (11.3) | 0 |
| Respiratory, thoracic and mediastinal disorders | 20 (37.7) | 13 (24.5) | 7 (13.2) | 0 |
| Cough | 12 (22.6) | 9 (17.0) | 3 (5.7) | 0 |
| Oropharyngeal pain | 9 (17.0) | 6 (11.3) | 3 (5.7) | 0 |
| Investigationsa | 17 (32.1) | 6 (11.3) | 9 (17.0) | 2 (3.8) |
| Urine protein/creatinine ratio increased | 8 (15.1) | 5 (9.4) | 1 (1.9) | 2 (3.8) |
| Musculoskeletal and connective tissue disorders | 17 (32.1) | 14 (26.4) | 1 (1.9) | 2 (3.8) |
| Musculoskeletal pain | 6 (11.3) | 6 (11.3) | 0 | 0 |
| Nervous system disorders | 16 (30.2) | 10 (18.9) | 5 (9.4) | 1 (1.9) |
| Headache | 14 (26.4) | 9 (17.0) | 4 (7.5) | 1 (1.9) |