Adverse events considered related to study medication per dose group
| Adverse event1 (SOC/PT), n2 (%) | Treatment group | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 256 μg mRNA | 640 μg mRNA | 1280 μg mRNA | Total N = 44 | Total N = 44 | |||||
| N = 3 | N = 3 | N = 38 | |||||||
| Grade 1/2 | Grade ≥3 | Grade 1/2 | Grade ≥3 | Grade 1/2 | Grade ≥3 | Grade 1/2 | Grade ≥3 | All Grades | |
| Total patients with related AEs | 2 (67) | 1 (33) | 2 (67) | 1 (33) | 30 (79) | 3 (8) | 34 (77) | 5 (11) | 39 (89) |
| General disorders and administration site reactions | 2 (67) | 1 (33) | 3 (100) | 0 | 32 (84) | 0 | 37 (84) | 1 (2)*1 | 38 (86) |
| Injection site erythema | 2 (67) | 0 | 2 (67) | 0 | 23 (61) | 0 | 27 (61) | 0 | 27 (61) |
| Injection site reaction | 2 (67) | 0 | 1 (33) | 0 | 18 (47) | 0 | 21 (48) | 0 | 21 (48) |
| Fatigue | 2 (67) | 0 | 0 | 0 | 6 (16) | 0 | 8 (18) | 0 | 8 (18) |
| Pyrexia | 0 | 0 | 1 (33) | 0 | 6 (16) | 0 | 7 (16) | 0 | 7 (16) |
| Chills | 1 (33) | 0 | 0 | 0 | 4 (11) | 0 | 5 (11) | 0 | 5 (11) |
| Influenza-like symptoms | 0 | 0 | 0 | 0 | 5 (13) | 0 | 5 (11) | 0 | 5 (11) |
| Musculoskeletal and connective tissue disorders3 | 1 (33) | 0 | 0 | 0 | 5 (13) | 1 (3) | 6 (14) | 1 (2) *2 | 7 (16) |
| Nervous system disorders4 | 1 (33) | 0 | 1 (33) | 0 | 4 (11) | 0 | 6 (14) | 0 | 6 (14) |
| Renal and urinary disorders5 | 0 | 0 | 0 | 1 (33) | 3 (8) | 2 (5) | 3 (7) | 3 (7)*3 | 6 (14) |
| Skin and subcutaneous disorders6 | 0 | 0 | 0 | 0 | 6 (16) | 0 | 6 (14) | 0 | 6 (14) |
| Gastrointestinal disorders7 | 1 (33) | 0 | 0 | 0 | 3 (8) | 1 (3) | 4 (9) | 1 (2)*4 | 5 (11) |
1 Adverse events (AEs) by system organ class (SOC) and/or preferred term (PT) that occurred in at least 10% of patients
2 Multiple occurrences of the same AE in one patient are counted once
3 Musculoskeletal and connective tissue disorders includes the following terms: arthralgia, muscle spasms, muscular weakness and pain events
4 Nervous system disorders includes the following terms: somnolence, tremor, disturbance in attention, dizziness, dysgeusia
5 Renal and urinary disorders includes the following terms: urinary retention, urinary tract obstruction, dysuria, hydronephrosis, micturition urgency, obstructive uropathy and urinary incontinence
6 Skin and subcutaneous tissue disorders includes the following terms: erythema, pruritus
7 Gastrointestinal disorders include the following terms: diarrhea, constipation, abdominal pain, dry mouth, gingival bleeding, vomiting
*1disease progression; *2flank pain; *3urinary retention (n = 2); urinary retention and hydronephrosis (n = 1); *4vomiting