Table 3.
Prefilled Syringe‐Abdomen(n = 20) | Autoinjector‐Abdomen(n = 20) | Prefilled Syringe‐Thigh(n = 20) | Autoinjector‐Thigh(n = 21) | Total (n = 81) | |
---|---|---|---|---|---|
Any a AE, n (%) | 5 (25) | 12 (60) | 13 (65) | 11 (52) | 41 (51) |
Headache | 2 (10) | 3 (15) | 5 (25) | 0 | 10 (12) |
Upper respiratory tract infection | 0 | 1 (5) | 3 (15) | 1 (5) | 5 (6) |
Viral upper respiratory tract infection | 2 (10) | 1 (5) | 1 (5) | 1 (5) | 5 (6) |
Pruritis | 0 | 1 (5) | 2 (10) | 1 (5) | 4 (5) |
Abdominal pain | 0 | 0 | 0 | 2 (10) | 2 (2) |
Gastroenteritis | 0 | 2 (10) | 0 | 0 | 2 (2) |
Injection‐site pruritus | 0 | 0 | 2 (10) | 0 | 2 (2) |
Drug‐related b AE, n (%) | 0 | 0 | 5 (25) | 4 (19) | 9 (11) |
Injection‐site erythema | 0 | 0 | 1 (5) | 1 (5) | 2 (2) |
Injection‐site pruritus | 0 | 0 | 2 (10) | 0 | 2 (2) |
Nausea | 0 | 0 | 1 (5) | 1 (5) | 2 (2) |
Abdominal pain | 0 | 0 | 0 | 1 (5) | 1 (1) |
Contusion | 0 | 0 | 0 | 1 (5) | 1 (1) |
Decreased appetite | 0 | 0 | 1 (5) | 0 | 1 (1) |
Injection‐site urticaria | 0 | 0 | 1 (5) | 0 | 1 (1) |
Nasal congestion | 0 | 0 | 1 (5) | 0 | 1 (1) |
Urticaria | 0 | 0 | 1 (5) | 0 | 1 (1) |
AE, adverse event.
AEs occurring in ≥10% of subjects in any study group are listed.
All related AEs are listed.