Adverse drug reactions* | Safety analysis population | ||||||
---|---|---|---|---|---|---|---|
Overall (%) n = 82 | Continuously treated patients (%) n = 17 | Newly treated patients (%) n = 65 | |||||
Number of patients who experienced adverse drug reactions (%) | 18 | (22.0) | 4 | (23.5) | 14 | (21.5) | |
Number of adverse drug reactions | 28 | 4 | 24 | ||||
Infections and infestations | 7 | (8.5) | 2 | (11.8) | 5 | (7.7) | |
Acute sinusitis | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Bronchitis | 2 | (2.4) | 0 | (0.0) | 2 | (3.1) | |
Gastroenteritis | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Herpes simplex | 1 | (1.2) | 1 | (5.9) | 0 | (0.0) | |
Influenza | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Nasopharyngitis | 1 | (1.2) | 1 | (5.9) | 0 | (0.0) | |
Otitis media acute | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Pneumonia | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Subcutaneous abscess | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Varicella | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Fungal esophagitis | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Immune system disorders | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Hypersensitivity | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Eye disorders | 1 | (1.2) | 1 | (5.9) | 0 | (0.0) | |
Chalazion | 1 | (1.2) | 1 | (5.9) | 0 | (0.0) | |
Ear and labyrinth disorders | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Ear discomfort | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Respiratory, thoracic, and mediastinal disorders | 2 | (2.4) | 0 | (0.0) | 2 | (3.1) | |
Upper respiratory tract inflammation | 2 | (2.4) | 0 | (0.0) | 2 | (3.1) | |
Gastrointestinal disorders | 4 | (4.9) | 0 | (0.0) | 4 | (6.2) | |
Abdominal pain | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Stomatitis | 3 | (3.7) | 0 | (0.0) | 3 | (4.6) | |
Skin and subcutaneous tissue disorders | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Dry skin | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Erythema | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Perioral dermatitis | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Musculoskeletal and connective tissue disorders | 1 | (1.2) | 1 | (5.9) | 0 | (0.0) | |
Arthritis | 1 | (1.2) | 1 | (5.9) | 0 | (0.0) | |
Investigations | 3 | (3.7) | 0 | (0.0) | 3 | (4.6) | |
Transaminases increased | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Hepatic enzyme increased | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Matrix metalloproteinase-3 increased | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) |