Adverse events, n (%) | All lanadelumab groups (total) | |||||
---|---|---|---|---|---|---|
Race | Ethnicity | |||||
HELP (n = 84) | White (n = 74) | Black/African American (n = 8) | Asian (n = 2) | Other (NA) | Non-Hispanic/non-Latino (n = 77) | Hispanic/Latino (n = 6) |
Any TEAE | 68 (91.9) | 7 (87.5) | 1 (50.0) | – | 69 (89.6) | 6 (100.0) |
Most frequently reported TEAEs (in ≥ 5% of White or non-Hispanic/non-Latino groups) |  |  | ||||
 Injection site pain | 30 (40.5) | 5 (62.5) | 1 (50.0) | – | 34 (44.2) | 2 (33.3) |
 Viral upper respiratory tract | 19 (25.7) | 1 (12.5) | 0 | – | 18 (23.4) | 1 (16.7) |
 Headache | 14 (18.9) | 3 (37.5) | 0 | – | 15 (19.5) | 2 (33.3) |
 Injection site erythema | 8 (10.8) | 0 | 0 | – | 8 (10.4) | 0 |
 Injection site bruising | 6 (8.1) | 0 | 0 | – | 6 (7.8) | 0 |
 Dizziness | 5 (6.8) | 0 | 0 | – | 5 (6.5) | 0 |
 Abdominal pain | 4 (5.4) | 0 | 0 | – | 2 (2.6) | 0 |
 Respiratory tract infection | 4 (5.4) | 0 | 1 (50.0) | – | 1 (1.3) | 1 (16.7) |
 Urinary tract infection | 4 (5.4) | 0 | 0 | – | 3 (3.9) | 1 (16.7) |
 Myalgia | 4 (5.4) | 0 | 0 | – | 3 (3.9) | 1 (16.7) |
 Rash | 3 (4.1) | 1 (12.5) | 0 | – | 4 (5.2) | 0 |
 Toothache | 0 | 0 | 0 | – | 4 (5.2) | 0 |
Any treatment-related TEAE | 42 (56.8) | 7 (87.5) | 1 (50.0) | – | 47 (61.0) | 3 (50.0) |
Most frequently reported treatment-related AEs (in ≥ 5% of White or non-Hispanic/non-Latino) |  |  | ||||
 Injection site pain | 29 (39.2) | 5 (62.5) | 1 (50.0) | – | 33 (42.9) | 1 (16.7) |
 Injection site erythema | 8 (10.8) | 0 | 0 | – | 8 (10.4) | 0 |
 Injection site bruising | 5 (6.8) | 0 | 0 | – | 5 (6.5) | 0 |
 Headache | 4 (5.4) | 2 (25.0) | 0 | – | 4 (5.2) | 2 (33.3) |
Any serious AE | 4 (5.4) | 0 | 0 | – | 4 (5.2) | 0 |
Any treatment-related serious AE | 0 | 0 | 0 | – | 0 | 0 |
Any AE leading to discontinuation | 1 (1.4) | 0 | 0 | – | 1 (1.3) | 0 |
Adverse events, n (%) | Lanadelumab 300Â mg q2w | |||||
---|---|---|---|---|---|---|
Race | Ethnicity | |||||
HELP OLE (n = 212) | White (n = 198) | Black/African American (n = 10) | Asian (n = 2) | Other (n = 2) | Non-Hispanic/non-Latino (n = 198) | Hispanic/Latino (n = 13) |
Any TEAE | 194 (98.0) | 8 (80) | 2 (100) | 2 (100) | 192 (97.0) | 13 (100.0) |
Most frequently reported TEAEs (in ≥ 10% of White or non-Hispanic/non-Latino groups) | ||||||
 Injection site pain | 94 (47.5) | 4 (40) | 1 (50) | 1 (50) | 97 (49.0) | 3 (23.1) |
 Viral upper respiratory tract infection | 87 (43.9) | 1 (10) | 1 (50) | 0 | 86 (40.3) | 3 (23.1) |
 Upper respiratory tract infection | 54 (27.3) | 1 (10) | 0 | 0 | 51 (25.8) | 3 (23.1) |
 Headache | 48 (24.2) | 1 (10) | 1 (50) | 2 (100) | 52 (26.3) | 0 |
 Injection site erythema | 36 (18.2) | 0 | 0 | 0 | 36 (18.2) | 0 |
 Injection site bruising | 26 (13.1) | 0 | 0 | 0 | 25 (12.6) | 1 (7.7) |
 Arthralgia | 25 (12.6) | 2 (20) | 0 | 0 | 26 (13.1) | 0 |
 Back pain | 24 (12.1) | 0 | 0 | 0 | 26 (13.1) | 0 |
 Diarrhea | 23 (11.6) | 0 | 0 | 0 | 23 (11.6) | 0 |
 Nausea | 22 (11.1) | 0 | 0 | 0 | 21 (10.6) | 1 (7.7) |
 Sinusitis | 22 (11.1) | 1 (10) | 0 | 0 | 23 (11.6) | 0 |
 Abdominal pain | 21 (10.6) | 1 (10) | 0 | 0 | 22 (11.1) | 0 |
 Influenza | 21 (10.6) | 1 (10) | 0 | 0 | 21 (10.6) | 0 |
 Urinary tract infection | 21 (10.6) | 2 (20) | 0 | 0 | 20 (10.1) | 0 |
 Pain in extremity | 20 (10.1) | 0 | 0 | 0 | 20 (10.1) | 1 (7.7) |
 Fatigue | 19 (9.6) | 1 (10) | 0 | 0 | 20 (10.1) | 0 |
Any treatment-related TEAE | 109 (55.1) | 5 (50) | 1 (50) | 1 (50.0) | 112 (56.6) | 3 (23.1) |
Most frequently reported treatment-related AEs (in ≥ 5% of White or non-Hispanic/non-Latino) | ||||||
 Injection site pain | 75 (37.9) | 4 (40.0) | 1 (50.0) | 1 (50.0) | 80 (40.4) | 1 (7.7) |
 Injection site erythema | 29 (14.6) | 0 | 0 | 0 | 29 (14.6) | 0 |
 Injection site bruising | 15 (7.6) | 0 | 0 | 0 | 14 (7.1) | 1 (7.7) |
 Injection site swelling | 10 (5.1) | 0 | 0 | 0 | 10 (5.1) | 0 |
Any serious AE | 18 (9.1) | 2 (20) | 0 (0) | Â | 19 (9.6) | 2 (15.4) |
Any treatment-related serious AE | 0 (0) | 0 (0) | 0 (0) | Â | 0 (0) | 0 (0) |
Any AE leading to discontinuation | 6 (3) | 0 (0) | 0 (0) | Â | 4 (2.0) | 1 (7.7) |