Treatment-related adverse events (AEs) observed in 3% or more of patients
| N=230 Seviprotimut-L | N=117 Placebo | N=347 Total | # (%) any grade | % any grade Seviprotimut-L | % any grade Placebo | |||||||||||
| Category | AE | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | G1—G3 | G1—G3 | G1—G3 |
| Participant maximum grade | **** | 245 (71) | ||||||||||||||
| General and administration site | Any | 130 | 14 | 68 | 5 | 198 | 19 | 217 (63) | 63 | 62 | ||||||
| Skin/subcutaneous tissue | Any | 27 | 6 | 3 | 17 | 4 | 44 | 10 | 3 | 57 (16) | 16 | 18 | ||||
| Nervous system | Any | 19 | 2 | 1 | 16 | 35 | 2 | 1 | 38 (11) | 10 | 14 | |||||
| Gastrointestinal | Any | 23 | 1 | 9 | 1 | 32 | 2 | 34 (10) | 10 | 9 | ||||||
| Musculoskeletal/connective tissue | Any | 16 | 4 | 11 | 1 | 27 | 5 | 32 (9) | 9 | 10 | ||||||
| General and administration site | Injection site erythema | 72 | 1 | 48 | 120 | 1 | 121 (35) | 32 | 41 | |||||||
| General and administration site | Fatigue | 34 | 8 | 23 | 3 | 57 | 11 | 68 (20) | 18 | 22 | ||||||
| General and administration site | Injection site pruritus | 44 | 2 | 13 | 1 | 57 | 3 | 60 (17) | 20 | 12 | ||||||
| General and administration site | Injection site pain | 29 | 2 | 12 | 1 | 41 | 3 | 44 (13) | 13 | 11 | ||||||
| Nervous system | Headache | 13 | 2 | 1 | 12 | 25 | 2 | 1 | 28 (8) | 7 | 10 | |||||
| General and administration site | Injection site swelling | 15 | 6 | 21 | 21 (6) | 7 | 5 | |||||||||
| Gastrointestinal | Nausea | 13 | 1 | 4 | 1 | 17 | 2 | 19 (5) | 6 | 4 | ||||||
| General and administration site | Injection site bruising | 12 | 6 | 18 | 18 (5) | 5 | 5 | |||||||||
| Skin/subcutaneous tissue | Pruritus | 11 | 2 | 5 | 16 | 2 | 18 (5) | 6 | 4 | |||||||
| Musculoskeletal/connective tissue | Myalgia | 9 | 4 | 1 | 13 | 1 | 14 (4) | 4 | 4 | |||||||
| Skin/subcutaneous tissue | Rash | 7 | 1 | 4 | 2 | 11 | 2 | 1 | 14 (4) | 3 | 5 | |||||
| General and administration site | Influenza-like illness | 6 | 3 | 3 | 9 | 3 | 12 (3) | 4 | 3 | |||||||
| General and administration site | Injection site induration | 9 | 3 | 12 | 12 (3) | 4 | 3 | |||||||||
| Gastrointestinal | Diarrhea | 5 | 6 | 11 | 11 (3) | 2 | 5 | |||||||||
| General and administration site | Injection site rash | 8 | 3 | 11 | 11 (3) | 3 | 3 | |||||||||