TABLE 4.

Occurrence of common adverse drug reactions (with an incidence of ≥5%) ^a by severity

Occurrence of ADR (SOC/PT)	Grade 1	Grade 2	Grade 3	Grade 4 b	Grade 5
Phase 1, Cohort 1 (N = 6)
Cardiac disorders
Myocarditis	0	0	1 (16.7)	0	0
General disorders and administration site conditions
Injection‐site reaction	2 (33.3)	1 (16.7)	3 (50.0)	0	0
Pyrexia	0	0	1 (16.7)	0	0
Musculoskeletal and connective tissue conditions
Myalgia	1 (16.7)	0	0	0	0
Nervous system disorders
Dysgeusia	0	2 (33.3)	0	0	0
Phase 1, Cohort 2 (N = 6)
Cardiac disorders
Supraventricular tachycardia	0	0	1 (16.7)	0	0
General disorders and administration site conditions
Injection‐site reaction	2 (33.3)	0	4 (66.7)	0	0
Phase 2 (N = 35)
Blood and lymphatic system disorders
Febrile neutropenia	0	0	4 (11.4)	0	0
General disorders and administration site conditions
Injection‐site reaction	8 (22.9)	15 (42.9)	8 (22.9)	0	0
Pyrexia	4 (11.4)	0	0	0	0
Total (N = 47)
Blood and lymphatic system disorders
Febrile neutropenia	0	0	4 (8.5)	0	0
General disorders and administration site conditions
Injection‐site reaction	12 (25.5)	16 (34.0)	15 (31.9)	0	0
Pyrexia	4 (8.5)	0	1 (2.1)	0	0

Data are presented as n (%).

ADR, adverse drug reaction; PT, preferred term; SOC, system organ class.

^a Rows that contain any event with a frequency of ≥5% are presented.

^b An instance of Grade 4 pancytopenia occurred in one patient (2.1%) during the study.