Table 2

Adverse events. (A) Number and percent of patients in each treatment group who (i) had any AE, (ii) had an SAE, (iii) died, or (iv) discontinued the study because of an AE. AEs were assigned to a primary body system using the Medical Dictionary for Regulatory Activities (MedDRA). In each treatment group, the number (%) of patients who experienced an AE in each primary body system was calculated. (B) Body systems in which >10% of patients in at least one of the active AIN457 groups experienced an AE. Individual AEs with an event rate of >10% in at least one of the active AIN457 groups are also presented underneath the related body system. Body systems and AEs (within relevant body system) are displayed in alphabetical order. A subject experiencing multiple AEs within a body system is counted only once in the respective body system category row.

EventsPsoriasisRheumatoid arthritisUveitis
AIN457 (3 mg/kg)PlaceboAIN457 (10 mg/kg)PlaceboAIN457 (10 mg/kg)
n = 18n = 18n = 26n = 26n = 16
(A) General, n (%)
  Any AE9 (50)8 (44)2117 (65)10 (63)
  Any SAE1 (6)01 (4)20
  Death00000
  Discontinuation of follow-up owing to AE0021 (4)0
(B) Body system, n (%)
  Eye disorders01 (6)1 (4)04 (25)
      Eye pain00002 (13)
      Ocular hyperemia00003 (19)
      Vision blurred00002 (13)
  Gastrointestinal disorders1 (6)1 (6)3 (12)5 (19)6 (38)
      Abdominal pain, upper00003 (19)
      Vomiting001 (4)3 (12)2 (13)
  General disorders and administration site conditions3 (17)1 (6)6 (23)1 (4)2 (13)
      Fatigue2 (11)1 (6)21 (4)2 (13)
  Infections and infestations5 (28)3 (17)9 (35)9 (35)2 (13)
  Injury, poisoning, and procedural complications003 (12)20
  Investigations3 (17)3 (17)001 (6)
      Blood cholesterol increased2 (11)0000
      Blood glucose increased2 (11)1 (6)000
      Blood triglycerides increased2 (11)2 (11)001 (6)
  Metabolism and nutrition disorders2 (11)0220
  Musculoskeletal and connective tissue disorders01 (6)8 (31)4 (15)4 (25)
      Back pain003 (12)1 (4)2 (13)
      Muscle spasm00202 (13)
      Rheumatoid arthritis003 (12)20
  Nervous system disorders1 (6)1 (6)5 (19)6 (23)9 (56)
      Dizziness003 (12)3 (12)1 (6)
      Headache1 (6)1 (6)1 (4)29 (56)
      Sinus headache00002 (13)
  Respiratory, thoracic, and mediastinal disorders1 (6)04 (15)3 (12)1 (6)
  Skin and subcutaneous tissue disorders2 (11)04 (15)20
  Vascular disorders2 (11)1 (6)3 (12)21 (6)
      Hypertension2 (11)1 (6)200