Table 7.
Overview of the adverse event (AE) profile in the population used for safety assessments
IqYmune® N = 22 | Kiovig® N = 21 | |
---|---|---|
Any AE | 83 (16; 72.7%) | 78 (15; 71.4%) |
Serious AEs | 0 | 0 |
All drug‐related AEs | 39 (10; 45.5%) | 32 (11; 52.4%) |
Drug‐related AEs occurring in at least two participants with either product | ||
Headache | 14 (6; 27.3%) | 14 (9; 42.9%) |
Neutropenia | 3 (1; 4.5%) | 5 (1; 4.8%) |
Pruritus | 6 (1; 4.5%) | 0 |
Fatigue | 3 (2; 9.1%) | 1 (1; 4.8%) |
Leukopenia | 1 (1; 4.5%) | 3 (1; 4.8%) |
Nausea | 2 (2; 9.1%) | 1 (1; 4.8%) |
Vomiting | 2 (1; 4.5%) | 1 (1; 4.8%) |
The data shown are the numbers of AEs occurring (number and percentage of participants).