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) |
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.