Table 4.
Adverse events (incidence: ≥ 2%)
| Medication phase I | Medication phase II | |||
|---|---|---|---|---|
| N = 99 | N = 97 | |||
| Episodes, n | Cases, n (%) | Episodes, n | Cases, n (%) | |
| 133 | 59 (59.6) | 166 | 66 (68.0) | |
| Infections and infestations | 56 | 39 (39.4) | 72 | 48 (49.5) |
| Bronchitis | 3 | 3 (3.0) | 1 | 1 (1.0) |
| Gastroenteritis | 5 | 5 (5.1) | 6 | 5 (5.2) |
| Influenza | 4 | 4 (4.0) | 9 | 9 (9.3) |
| Nasopharyngitis | 22 | 17 (17.2) | 34 | 23 (23.7) |
| Otitis media | 1 | 1 (1.0) | 2 | 2 (2.1) |
| Pharyngitis | 5 | 5 (5.1) | 9 | 8 (8.2) |
| Upper respiratory tract infection | 5 | 5 (5.1) | 3 | 3 (3.1) |
| Neoplasms benign, malignant and unspecified | 0 | 0 (0.0) | 2 | 2 (2.1) |
| Skin papilloma | 0 | 0 (0.0) | 2 | 2 (2.1) |
| Immune system disorders | 2 | 2 (2.0) | 2 | 2 (2.1) |
| Hypersensitivity | 2 | 2 (2.0) | 0 | 0 (0.0) |
| Seasonal allergy | 0 | 0 (0.0) | 2 | 2 (2.1) |
| Metabolism and nutrition disorders | 4 | 4 (4.0) | 0 | 0 (0.0) |
| Decreased appetite | 2 | 2 (2.0) | 0 | 0 (0.0) |
| Psychiatric disorders | 4 | 4 (4.0) | 7 | 7 (7.2) |
| Attention deficit/hyperactivity disorder | 0 | 0 (0.0) | 2 | 2 (2.1) |
| Irritability | 0 | 0 (0.0) | 3 | 3 (3.1) |
| Nervous system disorders | 6 | 5 (5.1) | 10 | 9 (9.3) |
| Headache | 4 | 3 (3.0) | 4 | 3 (3.1) |
| Somnolence | 2 | 2 (2.0) | 4 | 4 (4.1) |
| Respiratory, thoracic, and mediastinal disorders | 10 | 8 (8.1) | 10 | 6 (6.2) |
| Epistaxis | 3 | 1 (1.0) | 5 | 2 (2.1) |
| Rhinitis allergic | 2 | 2 (2.0) | 2 | 2 (2.1) |
| Upper respiratory tract inflammation | 3 | 3 (3.0) | 1 | 1 (1.0) |
| Gastrointestinal disorders | 22 | 15 (15.2) | 25 | 12 (12.4) |
| Abdominal pain | 6 | 4 (4.0) | 0 | 0 (0.0) |
| Constipation | 3 | 3 (3.0) | 3 | 3 (3.1) |
| Enterocolitis | 2 | 2 (2.0) | 0 | 0 (0.0) |
| Nausea | 2 | 2 (2.0) | 0 | 0 (0.0) |
| Stomatitis | 3 | 3 (3.0) | 4 | 3 (3.1) |
| Vomiting | 3 | 3 (3.0) | 9 | 3 (3.1) |
| Skin and subcutaneous tissue disorders | 10 | 7 (7.1) | 12 | 8 (8.2) |
| Dermatitis | 0 | 0 (0.0) | 2 | 2 (2.1) |
| Eczema | 1 | 1 (1.0) | 2 | 2 (2.1) |
| Rash | 2 | 2 (2.0) | 0 | 0 (0.0) |
| Urticaria | 2 | 1 (1.0) | 3 | 2 (2.1) |
| Renal and urinary disorders | 2 | 2 (2.0) | 0 | 0 (0.0) |
| Proteinuria | 2 | 2 (2.0) | 0 | 0 (0.0) |
| General disorders and administration site conditions | 3 | 3 (3.0) | 3 | 3 (3.1) |
| Pyrexia | 2 | 2 (2.0) | 1 | 1 (1.0) |
| Investigations | 7 | 5 (5.1) | 2 | 2 (2.1) |
| Weight increased | 0 | 0 (0.0) | 2 | 2 (2.1) |
| Urobilinogen urine | 2 | 2 (2.0) | 0 | 0 (0.0) |
| Injury, poisoning and procedural complications | 5 | 5 (5.1) | 14 | 12 (12.4) |
| Arthropod sting | 0 | 0 (0.0) | 4 | 4(4.1) |
| Contusion | 2 | 2 (2.0) | 5 | 5(5.2) |
| Wound | 1 | 1 (1.0) | 3 | 3(3.1) |