Table 2. Number of observations of serum IgG below the target.
Period of study | Subjects < 12 y | Subjects ≥ 12 y | ||||||
---|---|---|---|---|---|---|---|---|
Observations | Patients (N = 15) | Observations | Patients (N = 34) | |||||
n | IgG <4 g/L | n | IgG <4 g/L | n | IgG <6 g/L | n | IgG <6 g/L | |
Pre-Subgam | 21 | 1 | 11 | 1 | 75 | 5 | 34 | 3 |
Stage 1, months 0 to 6 a | 122 | 3 | 15 | 1 | 463 | 16 | 34 | 5 |
Stage 2, months | ||||||||
>6 to 12 b | 18 | 0 | 13 | 0 | 61 | 5 | 30 | 3 |
>12 to 18 | 16 | 0 | 11 | 0 | 61 | 5 | 27 | 4 |
>18 to 24 | 16 | 0 | 10 | 0 | 64 | 8 | 27 | 4 |
>24 to 30 | 14 | 0 | 8 | 0 | 58 | 8 | 28 | 4 |
>30 to 36 | 16 | 0 | 10 | 0 | 46 | 2 | 26 | 2 |
>36 to 42 | 5 | 0 | 4 | 0 | 32 | 7 | 21 | 4 |
>42 to 48 | 2 | 0 | 2 | 0 | 22 | 3 | 16 | 3 |
>48 to 54 | 0 | 0 | 0 | 0 | 8 | 1 | 7 | 1 |
Total in Stage 2 | 87 | 0 | 13 | 0 | 352 | 39 | 30 | 6 |
a Stage 1 lasted approximately 6 months, depending upon the number of infusions received by the patient and contains post-Subgam data only
b This interval lasted approximately 6 months, from the first infusion in Stage 2 until 12 months after the first infusion of Subgam