TABLE 4

Adverse events reported during treatment, by system organ class: safety analysis set

AZD5069 80 mg twice dailyPlacebo
Subjects2626
Patients with any adverse event23 (88.5)16 (61.5)
Infections and infestations9 (34.6)8 (30.8)
Respiratory, thoracic and mediastinal disorders9 (34.6)5 (19.2)
Nervous system disorders7 (26.9)6 (23.1)
Gastrointestinal disorders6 (23.1)4 (15.4)
General disorders and administration-site conditions5 (19.2)3 (11.5)
Musculoskeletal and connective tissue disorders3 (11.5)5 (19.2)
Investigations3 (11.5)2 (7.7)
Renal and urinary disorders2 (7.7)1 (3.8)
Skin and subcutaneous tissue disorders2 (7.7)0
Ear and labyrinth disorders1 (3.8)2 (7.7)
Injury, poisoning and procedural complications1 (3.8)0
Psychiatric disorders1 (3.8)0
Eye disorders02 (7.7)
Metabolism and nutrition disorders01 (3.8)
  • Data are presented as n or n (%). Patients who had at least one adverse event in any system organ class, presented in order of decreasing frequency (sorted by total number on AZD5069 80mg twice daily) using MedDRA (version 14.1; www.meddra.org).