Overall summary of treatment emergent adverse events and most frequent adverse events (≥2% in any treatment group) for the safety set of main phase 1 and for the modified safety set (main and extension phases combined)
| Placebo (n (%)) | Tregalizumab 25 mg (n (%)) | Tregalizumab 100 mg (n (%)) | Tregalizumab 200 mg (n (%)) | |
| Main phase 1 | n=80 | n=83 | n=80 | n=78 |
| Any TEAE | 30 (37.5) | 31 (37.3) | 29 (36.3) | 35 (44.9) |
| Any serious TEAE | 1 (1.3) | 1 (1.2) | 1 (1.3) | 3 (3.8) |
| Any treatment-related TEAE | 11 (13.8) | 10 (12.0) | 8 (10.0) | 11 (14.1) |
| Any serious treatment-related TEAE | 0 | 0 | 0 | 0 |
| Any TEAE leading to death | 0 | 1 (1.2) | 1 (1.3) | 1 (1.3) |
| Main and extension phases combined (modified safety set) | n=54 | n=56 | n=68 | |
| Any TEAE | 59 (56.2) | 53 (53.5) | 57 (56.4) | |
| Any serious TEAE | 3 (2.9) | 1 (1.0) | 7 (6.9) | |
| Any treatment-related TEAE | 21 (20.0) | 17 (17.2) | 26 (25.7) | |
| Any serious treatment-related TEAE | 0 | 0 | 2 (2.0) | |
| Any TEAE leading to death | 0 | 0 | 0 | |
| Most frequent TEAEs (≥2%) by SOC and PT | ||||
| Infections and infestations | 33 (31.4) | 22 (22.2) | 21 (20.8) | |
| Musculoskeletal and connective tissue disorders | 14 (13.3) | 8 (8.1) | 12 (11.9) | |
| Investigations | 11 (10.5) | 11 (11.1) | 19 (18.8) | |
| CD4 lymphocytes decrease | 1 (1.0) | 0 | 4 (4.0) | |
| General disorders and injection-site reactions | 12 (11.4) | 6 (6.1) | 14 (13.9) | |
| Gastrointestinal disorders | 11 (10.5) | 4 (4.0) | 14 (13.9) | |
| Nervous system disorders | 7 (6.7) | 10 (10.1) | 10 (9.9) | |
| Skin and subcutaneous tissue disorders | 7 (6.7) | 7 (7.1) | 10 (9.9) | |
| Blood and lymphatic system disorders | 3 (2.9) | 9 (9.1) | 5 (5.0) | |
| Vascular disorders | 3 (2.9) | 5 (5.1) | 4 (4.0) | |
| Injury, poisoning and procedural complications | 2 (1.9) | 4 (4.0) | 5 (5.0) | |
| Endocrine disorders | 2 (1.9) | 2 (2.0) | 0 |
Denominator: percentages for main phase 1 are based on patients who received study medication at week 0. Percentages for the modified safety set are based on patients receiving active study medication at any time during the study, and patients are presented according to the first active treatment they actually received. Patients with multiple events in the same category were counted only once in that category. Patients with events in more than one category were counted once in each of those categories. Treatment-related TEAEs were those related to the study drug. AEs were coded to SOC and PT using MedDRA V.17.1.
AEs, adverse events; PT, preferred term; SOC, system organ class; TEAE, treatment emergent adverse event.