Safety profile
| BI 655064 (n=44) | Placebo (n=23) | |
| Any AE | 29 (65.9) | 18 (78.3) |
| Other significant AEs* | 1 (2.3) | 3 (13.0) |
| AEs leading to drug discontinuation | 2 (4.5) | 4 (17.4) |
| Serious AEs | 2 (4.5) | 2 (8.7) |
| Death | 1 (2.3)† | 0 |
| Myocardial infarction | 1 (2.3) | 0 |
| Pleural effusion | 0 | 1 (4.3) |
| Anaemia | 0 | 1 (4.3) |
| RCTC AE grade ≥3 | 2 (4.5) | 1 (4.3) |
| Common AEs‡ | ||
| Nasopharyngitis | 6 (13.6) | 5 (21.7) |
| Diarrhoea | 3 (6.8) | 0 |
| Fatigue | 0 | 2 (8.7) |
| Headache | 3 (6.8) | 3 (13.0) |
| Arthralgia | 2 (4.5) | 2 (8.7) |
| Liver disorder | 2 (4.5) | 2 (8.7) |
| Laboratory AEs | ||
| RCTC grade ≥3 | 0 | 0 |
| 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).