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. 2019 Sep 6;25(2):121–e213. doi: 10.1634/theoncologist.2019-0599
Adverse event by SOC/PT Grade 1, n (%) Grade 2, n (%) Grade 3, n (%) Grade 4, n (%) All grades, n (%)
Hematologic 2 (11) 2 (11) 1 (6) 0 (0) 4 (22)
Anemia 0 (0) 1 (6) 0 (0) 0 (0) 1 (6)
Leukopenia 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Lymphopenia 1 (6) 1 (6) 1 (6) 0 (0) 3 (17)
General 16 (89) 4 (22) 1 (6) 0 (0) 18 (100)
Fatigue 2 (11) 1 (6) 0 (0) 0 (0) 3 (17)
Induration 2 (11) 0 (0) 0 (0) 0 (0) 2 (11)
Injection site bruising 6 (33) 0 (0) 0 (0) 0 (0) 6 (33)
Injection site erythema 15 (83) 2 (11) 0 (0) 0 (0) 17 (94)
Injection site extravasation 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Injection site induration 10 (56) 0 (0) 0 (0) 0 (0) 10 (56)
Injection site irritation 2 (11) 0 (0) 0 (0) 0 (0) 2 (11)
Injection site edema 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Injection site pain 10 (56) 2 (11) 1 (6) 0 (0) 13 (72)
Injection site pruritus 14 (78) 1 (6) 0 (0) 0 (0) 15 (83)
Injection site reaction 2 (11) 0 (0) 0 (0) 0 (0) 2 (11)
Injection site scab 2 (11) 0 (0) 0 (0) 0 (0) 2 (11)
Injection site swelling 11 (61) 3 (17) 0 (0) 0 (0) 14 (78)
Injection site warmth 6 (33) 1 (6) 0 (0) 0 (0) 7 (39)
Pain 4 (22) 0 (0) 0 (0) 0 (0) 4 (22)
Nervous system 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Headache 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Skin 3 (17) 0 (0) 0 (0) 0 (0) 3 (17)
Blister 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Pruritus 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Rash 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Urticaria 1 (6) 0 (0) 0 (0) 0 (0) 1 (6)
Vascular 0 (0) 1 (6) 0 (0) 0 (0) 1 (6)
Hypotension 0 (0) 1 (6) 0 (0) 0 (0) 1 (6)
Total 17 (94) 7 (39) 2 (11) 0 (0) 18 (100)

graphic file with name ONCO-25-121-g004.jpg

Treatment‐emergent adverse events attributed to HyperAcute Renal.

If a subject experienced more than one event within a given SOC, that subject was counted once for that SOC. If a subject experienced more than one event within a given PT, that subject was counted only once for that PT. The most severe event is counted.

Abbreviations: PT, preferred term; SOC, system organ class.