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) |