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

Table 2 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		Total N = 44		Total N = 44
	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