System organ class | N=177 | Rate per 100 patient-years | |
n (%) | Events | ||
Infections and infestations | 136 (76.8) | 1036 | 217.26 |
Gastrointestinal disorders | 99 (55.9) | 513 | 107.58 |
Musculoskeletal and connective tissue disorders | 97 (54.8) | 467 | 97.94 |
Respiratory, thoracic and mediastinal disorders | 82 (46.3) | 391 | 82.0 |
General disorders and administration site conditions | 77 (43.5) | 226 | 47.39 |
Skin and subcutaneous tissue disorders | 76 (42.9) | 245 | 51.38 |
Nervous system disorders | 61 (34.5) | 223 | 46.77 |
Injury, poisoning and procedural complications | 58 (32.8) | 164 | 34.39 |
Investigations | 55 (31.1) | 166 | 34.81 |
Blood and lymphatic system disorders | 34 (19.2) | 74 | 15.52 |
Eye disorders | 30 (16.9) | 54 | 11.32 |
Neoplasms benign, malignant and unspecified* (including cysts and polyps) | 24 (13.6) | 29 | 6.08 |
Psychiatric disorders | 21 (11.9) | 29 | 6.08 |
Hepatobiliary disorders | 19 (10.7) | 26 | 5.45 |
Ear and labyrinth disorders | 17 (9.6) | 39 | 8.18 |
Immune system disorders | 16 (9.0) | 24 | 5.03 |
Metabolism and nutrition disorders | 16 (9.0) | 26 | 5.45 |
Reproductive system and breast disorders | 16 (9.0) | 19 | 3.98 |
Vascular disorders | 12 (6.8) | 21 | 4.40 |
Renal and urinary disorders | 9 (5.1) | 12 | 2.52 |
Cardiac disorders | 8 (4.5) | 11 | 2.31 |
Endocrine disorders | 2 (1.1) | 2 | 0.42 |
Congenital, familial and genetic disorders*† | 1 (0.6) | 1 | 0.21 |
Social circumstances‡ | 1 (0.6) | 1 | 0.21 |
N denotes the total number of patients; a patient with multiple occurrences of an adverse event (AE) under one category is counted only once in the AE category.
*Neoplasms reported here are benign and unspecified.
†MedDRA PT: keratosis follicular.
‡MedDRA PT: dental prosthesis.
MedDRA PT, Medical Dictionary for Regulatory Activities preferred term.