Table 2

Safety profile

BI 655064 (n=44)Placebo (n=23)
Any AE29 (65.9)18 (78.3)
Other significant AEs* 1 (2.3)3 (13.0)
AEs leading to drug discontinuation2 (4.5)4 (17.4)
Serious AEs2 (4.5)2 (8.7)
 Death1 (2.3) 0
 Myocardial infarction1 (2.3)0
 Pleural effusion01 (4.3)
 Anaemia01 (4.3)
RCTC AE grade ≥32 (4.5)1 (4.3)
Common AEs
 Nasopharyngitis6 (13.6)5 (21.7)
 Diarrhoea3 (6.8)0
 Fatigue02 (8.7)
 Headache3 (6.8)3 (13.0)
 Arthralgia2 (4.5)2 (8.7)
 Liver disorder2 (4.5)2 (8.7)
Laboratory AEs
 RCTC grade ≥300
 RCTC grade 2§ 2 (4.5)3 (13.0)
 RCTC grade 1 2 (4.5)1 (4.3)
  • Data are n (%). AEs were coded using MedDRA V.18.0.

  • *Per ICH E3 Guideline; in the BI 655064 group there was one case of iron deficiency anaemia and in the placebo group there was one case of elevated liver enzymes, one case of worsening RA and one case of nasopharyngitis.

  • †Patient had pre-existing hypertension and developed cerebral haemorrhage and cardiopulmonary failure.

  • ‡Common AEs are reported by preferred term for ≥5% of patients in any treatment group (ie, for ≥3 patients in the BI 655064 group or ≥2 patients in the placebo group).

  • §In the BI 655064 group, there was one case of iron deficiency anaemia and one case of hypoglycaemia and in the placebo group there was one case of anaemia, one case of elevated liver enzymes and one case of elevated uric acid.

  • ¶In the BI 655064 group, there was one case of anaemia and one case of elevated liver enzymes and in the placebo group there was one case of hyperglycaemia.

  • AE, adverse event;ICH, International Conference on Harmonisation;MedDRA, Medical Dictionary for Regulatory Activities;RA, rheumatoid arthritis;RCTC, Rheumatology Common Toxicity Criteria (V.2.0).