Summary of AEs
| n (%) | BMS-936557 n=55 | Placebo n=52 |
|---|---|---|
| AEs | 22 (40.0) | 17 (32.7) |
| Related AEs | 11 (20.0) | 7 (13.5) |
| AEs resulting in discontinuation | 2 (3.6) | 0 |
| SAEs | 4 (7.3) | 1 (1.9) |
| Serious infections | 3 (5.5) | 1 (1.9) |
| Deaths | 0 | 0 |
| Infections and infestations | 7 (12.7) | 3 (5.8) |
| Peri-infusional AEs* | 6 (10.9) | 2 (3.8) |
*Infusion reaction within 24 h of infusion. All Grade 1−2, all recovered and none led to early termination; clinical laboratory data, vital signs, physical examinations, ECG or chest radiographs assessed during the study did not highlight any safety concerns; safety was assessed through Day 113.
AE, adverse event; SAE serious adverse event.