System Organ Class | Condition* | Events, n | Events per 100 Patient-Years |
---|---|---|---|
Infections and infestations | Gastroenteritis | 12 | 5.3 |
Pneumonia | 7 | 3.1 | |
Bronchitis | 2 | 0.9 | |
Subcutaneous abscess | 2 | 0.9 | |
Cellulitis | 2 | 0.9 | |
Nasopharyngitis | 2 | 0.9 | |
Peritonsillar abscess | 1 | 0.4 | |
Varicella | 1 | 0.4 | |
Infectious enteritis | 1 | 0.4 | |
Skeletal disorders | Juvenile arthritis | 4 | 1.8 |
Arthralgia | 2 | 0.9 | |
Arthritis | 1 | 0.9 | |
Aseptic necrosis bone | 1 | 0.9 | |
Laboratory test abnormalities | Alanine aminotransferase increased | 5 | 2.2 |
Aspartate aminotransferase increased | 5 | 2.2 | |
Neutrophil count decreased | 1 | 0.4 | |
Lymphocyte count decreased | 1 | 0.4 | |
Immune system disorders | Anaphylactoid reaction | 2 | 0.9 |
Hepatobiliary disorders | Hepatic function abnormality | 2 | 0.9 |
Surgical and medical procedures | Cataract operation | 4 | 1.8 |
Blood and lymphatic system disorders | Lymphadenitis | 1 | 0.4 |
Metabolism and nutrition disorders | Hypoglycemia | 1 | 0.4 |
Eye disorders | Cataract | 1 | 0.4 |
Respiratory, thoracic, and mediastinal disorders | Asthma | 1 | 0.4 |
Gastrointestinal disorders | Inguinal hernia | 2 | 0.9 |
Ileus | 2 | 0.9 | |
Enterocolitis | 1 | 0.4 | |
Gastrointestinal hemorrhage | 1 | 0.4 | |
Abdominal pain | 1 | 0.4 | |
Duodenal perforation | 1 | 0.4 | |
Intussusception | 1 | 0.4 | |
Skin and subcutaneous disorders | Erythema multiforme | 1 | 0.4 |
Rash | 1 | 0.4 | |
Urticaria | 1 | 0.4 | |
General disorders and administration site conditions | Chest pain | 1 | 0.4 |
Pyrexia | 1 | 0.4 | |
Injury, poisoning, and procedural complications | Femur fracture | 1 | 0.4 |
Joint dislocation | 1 | 0.4 |
↵* Preferred term.