Table 4 Adverse events (incidence: ≥ 2%)
| Â | Medication phase I | Medication phase II | ||
|---|---|---|---|---|
N = 99 | N = 97 | |||
Episodes, n | Cases, n (%) | Episodes, n | Cases, n (%) | |
| Â | 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) |