Table 2.
A summary of adverse event (AE) results from recent IVIG clinical trials performed in the United States
| Parameter | Gamunex 10 % | Gamimune N 10 % | Octagam 5 % | Gammagard liquid 10 % | Flebogamma 5 % DIF | Privigen 10 % | Flebogamma 10 % DIF | Gammaplex 5 % | Biotest 10 % IVIG |
|---|---|---|---|---|---|---|---|---|---|
| Subjects (N) | PP = 73 | PP = 73 | 46 | 61 | 50 | 80 | 46 | 50 | 63 |
| Infusions (n) | 825 | 865 | 654 | 826 | 709 | 1,038 | 601 | 703 | 746 |
| AEs (n) | NR | NR | 793 | 896 | 595 | 1,330 | 719 | 237 | 937 |
| All AEs (% of infusions) | 17.1 % | 18.8 % | 33.7 % | ||||||
| Related AEs (% of infusions) | 5.7 % | 5.5 % | 5 % | 14.1 % | 9 % | 27.6 % | 16.4 % | ||
| Related AEs (% of subjects) |
21 days = 26 % 28 days = 44 % |
83 % | 48 % | 63.5 % | |||||
| SAEs (related to study IVIG) | NR | NR | 0 | 2 aseptic meningitis episodes in 1 patient | 0 | 5 in 1 patient | 0 | 2 | 2 in 1 patient |
| SAEs (unrelated to study IVIG) | NR | NR | 12 SAEs in 6 patients (none related to study IVIG) | 13 in 7 patients | 0 | 36 in 15 patients | 4 in 3 patients | 5 | 9 in 6 patients |
| Temporally associated AEs (0–72 h) by infusion, n (%) | (0–48 h) 17.1 % | (0–48 h) 18.8 % | (0–30 min) 23 % | 345 total NR | 216 total 30.5 % | 397 total (38.2 %) | 291 (48.4 %) | 431 total | |
| Infusions with ≥1 temporal (72 h) AEs (%) | 20.1 % (upper 95 % CI = 24.4 %) | 20.8 % (upper 97.5 % CI = 23.8 %) | 47.0 % | 21.2 % (upper 97.5 % CI = 24.2 %)a | 27.7 % (upper 95 % CI = 30.6 %) | ||||
| Most frequent AEs | Headache | Headache | Headache > nausea > chills | Headache > fever > fatigue | Headache > fever | Headache > pain > fatigue | Headache > fever > rigors | Headache > pyrexia > nausea | Headache > fatigue |
| Coombs-positive subjects (%) | 33 % | 19 % | NR | NR | NR | 46.8 % | 23.3 % | 8.5 % | NR |
NR not reported
aIncludes infections