Table 2 Treatment-related AEs

	mRNA-1944	mRNA-1944	mRNA-1944	mRNA-1944	mRNA-1944	mRNA-1944	Placebo
	0.1 mg kg⁻¹^a	0.3 mg kg⁻¹^a	0.6 mg kg⁻¹^b	0.6 mg kg⁻¹ + steroid^c	0.3 mg kg⁻¹ 2-dose^d,e	All	All
AE, n (%)	n = 6	n = 6	n = 4	n = 6	n = 6	n = 28	n = 10
Any	1 (16.7)	1 (16.7)	4 (100.0)	6 (100.0)	5 (83.3)	17 (60.7)	2 (20.0)
Grade 1	1 (16.7)	1 (16.7)	2 (50.0)	4 (66.7)	2 (33.3)	10 (35.7)	2 (20.0)
Grade 2	0	0	1 (25.0)	2 (33.3)	3 (50.0)	6 (21.4)	0
Grade 3	0	0	1 (25.0)^f	0	0	1 (3.6)	0
Grade 4	0	0	0	0	0	0	0
Serious	0	0	0	0	0	0	0
Leading to death	0	0	0	0	0	0	0
Leading to discontinuation	0	0	0	0	0	0	0
Occurring in >5% of participant SOC, preferred term, CTCAE^g
Headache	0	1 (16.7)	3 (75.0)	4 (66.7)	1 (16.7)	9 (32.1)	0
Nausea	0	0	2 (50.0)	2 (33.3)	3 (50.0)	7 (25.0)	1 (10.0)
Myalgia	0	0	0	4 (66.7)	1 (16.7)	5 (17.9)	0
Dizziness	0	0	2 (50.0)	1 (16.7)	1 (16.7)	4 (14.3)	0
Chills	0	0	2 (50.0)	1 (16.7)	1 (16.7)	4 (14.3)	1 (10.0)
Vomiting	0	0	2 (50.0)	0	2 (33.3)	4 (14.3)	0
Flushing	0	0	1 (25.0)	1 (16.7)	2 (33.3)	4 (14.3)	0
Increased heart rate	0	0	0	3 (50.0)	0	3 (10.7)	0
Pyrexia	0	0	2 (50.0)	0	0	2 (7.1)	0
Back pain	0	0	0	1 (16.7)	1 (16.7)	2 (7.1)	0
Musculoskeletal stiffness	0	0	2 (50.0)	0	0	2 (7.1)	0
Increased white blood cell count	0	0	1 (25.0)	1 (16.7)	0	2 (7.1)	0
Sinus tachycardia	0	0	2 (50.0)	0	0	2 (7.1)	0
Decreased appetite	0	0	0	0	2 (33.3)	2 (7.1)	0
Hyperhidrosis	0	0	0	1 (16.7)	1 (16.7)	2 (7.1)	0
Fatigue	0	0	0	0	1 (16.7)	1 (3.6)	1 (10.0)

n = number of participants randomized and exposed to the specified study treatment. Treatment-emergent, treatment-related AEs were defined as any event not present before exposure to the study treatment or any event already present that worsened in intensity or frequency after exposure and was considered treatment-related by the investigator. In each group, a participant was counted once if the participant reported one or more AEs. Percentages are based on the number of participants in the safety population who received the specified treatment and total (n) in the group. AEs were coded using the Medical Dictionary for Regulatory Activities v.23.0 (grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening). ^aParticipants received loratadine and ranitidine 90 min before infusion. ^bParticipants received loratadine, ranitidine (sentinel, expansion) and acetaminophen (expansion) 90 min before infusion. ^cParticipants received steroid (dexamethasone) and diphenhydramine and famotidine 90 min before infusion. ^dParticipants received diphenhydramine and famotidine 90 min before infusion. ^eParticipants were administered two 0.3 mg kg⁻¹ doses on days 1 and 8. ^fOne participant had 2 grade 3 AEs (one of increased white blood cell count and one of sinus tachycardia). ^gAEs are listed in order of decreasing frequency of treatment-related AEs >5% for the active treatment group. SOC, system organ class.

Search