Table 2

Incidence rates of adverse events, by system organ class

System organ classN=177Rate per 100 patient-years
n (%)Events
Infections and infestations136 (76.8)1036217.26
Gastrointestinal disorders99 (55.9)513107.58
Musculoskeletal and connective tissue disorders97 (54.8)46797.94
Respiratory, thoracic and mediastinal disorders82 (46.3)39182.0
General disorders and administration site conditions77 (43.5)22647.39
Skin and subcutaneous tissue disorders76 (42.9)24551.38
Nervous system disorders61 (34.5)22346.77
Injury, poisoning and procedural complications58 (32.8)16434.39
Investigations55 (31.1)16634.81
Blood and lymphatic system disorders34 (19.2)7415.52
Eye disorders30 (16.9)5411.32
Neoplasms benign, malignant and unspecified* (including cysts and polyps)24 (13.6)296.08
Psychiatric disorders21 (11.9)296.08
Hepatobiliary disorders19 (10.7)265.45
Ear and labyrinth disorders17 (9.6)398.18
Immune system disorders16 (9.0)245.03
Metabolism and nutrition disorders16 (9.0)265.45
Reproductive system and breast disorders16 (9.0)193.98
Vascular disorders12 (6.8)214.40
Renal and urinary disorders9 (5.1)122.52
Cardiac disorders8 (4.5)112.31
Endocrine disorders2 (1.1)20.42
Congenital, familial and genetic disorders*†1 (0.6)10.21
Social circumstances‡1 (0.6)10.21
  • 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.