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Table 2 Adverse events considered related to study medication per dose group

From: Self-adjuvanted mRNA vaccination in advanced prostate cancer patients: a first-in-man phase I/IIa study

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. 1 Adverse events (AEs) by system organ class (SOC) and/or preferred term (PT) that occurred in at least 10% of patients
  2. 2 Multiple occurrences of the same AE in one patient are counted once
  3. 3 Musculoskeletal and connective tissue disorders includes the following terms: arthralgia, muscle spasms, muscular weakness and pain events
  4. 4 Nervous system disorders includes the following terms: somnolence, tremor, disturbance in attention, dizziness, dysgeusia
  5. 5 Renal and urinary disorders includes the following terms: urinary retention, urinary tract obstruction, dysuria, hydronephrosis, micturition urgency, obstructive uropathy and urinary incontinence
  6. 6 Skin and subcutaneous tissue disorders includes the following terms: erythema, pruritus
  7. 7 Gastrointestinal disorders include the following terms: diarrhea, constipation, abdominal pain, dry mouth, gingival bleeding, vomiting
  8. *1disease progression; *2flank pain; *3urinary retention (n = 2); urinary retention and hydronephrosis (n = 1); *4vomiting