Double-blind Crossover Phase | Open-label Phase | ||
---|---|---|---|
Prolastin-C (n = 24) 8 Weeks | Prolastin (n = 24) 8 Weeks | Prolastin-C (n = 24) 8 Weeks | |
AEs by subject | |||
Any AE, n (%) | 11 (45.8) | 9 (37.5) | 11 (45.8) |
AEs by total number and rate per infusion | |||
Total number of AEs (rate per infusion) | 22 (0.117) | 15 (0.078) | 14 (0.073) |
Total number of AEs occurring in ≥ 2 subjects (rate per infusion) | |||
Upper respiratory tract infection | 2 (0.011) | 1 (0.005) | 1 (0.005) |
Urinary tract infection | 1 (0.005) | 0 | 2 (0.010) |
Headache | 1 (0.005) | 2 (0.010) | 0 |
Rales | 0 | 0 | 2 (0.010) |
Arthralgia | 0 | 2 (0.010) | 0 |
AEs leading to withdrawal | 0 | 0 | 0 |
Total number of SAEs (rate per infusion) | 0 | 2 (0.010) | 0 |
Deaths | 0 | 0 | 0 |