Summary of overall AEs and by frequency (≥5%) in the safety analysis set (n=78)
| Placebo (n=38) | Anti-NKG2D (n=40) | |
|---|---|---|
| System organ class | N (%), E | N (%), E |
| AEs | 27 (71), 87 | 29 (73), 93 |
| Mild AEs | 22 (58), 47 | 15 (38), 42 |
| Moderate AEs | 17 (45), 34 | 20 (50), 43 |
| Severe AEs | 6 (16), 6 | 7 (18), 8 |
| Life-threatening AEs* | 0 (0), 0 | 1 (3), 1 |
| AEs leading to death | 0 (0), 0 | 0 (0), 0 |
| Frequency (≥5%) | ||
| GI disorders | 14 (37), 27 | 17 (43), 33 |
| General disorders and administration site conditions | 7 (18), 10 | 6 (15), 11 |
| Musculoskeletal and connective tissue disorders | 7 (18), 7 | 7 (18), 10 |
| Blood and lymphatic system disorders | 2 (5), 3 | 8 (20), 9 |
| Infections and infestations | 12 (32), 19 | 6 (15), 8 |
| Investigations | 3 (8), 4 | 4 (10), 7 |
| Skin and subcutaneous tissue disorders | 2 (5), 2 | 2 (5), 3 |
| Injury, poisoning and procedural complications | 1 (3), 1 | 2 (5), 2 |
| Nervous system disorders | 4 (11), 6 | 1 (3), 2 |
*One patient had ‘Exacerbation of Crohn's disease’ on day 54, which was rated serious and severe, not recovered, but unlikely related to trial product.
%, percentage of patients with event; AEs, adverse events; E, number of events; N, number of patients with event.