Table 4.

Rate of serious infections prior to and after immunoglobulin levels below the lower limit of normal (LLN) on at least 1 occasion. Multiple occurrences of the same event in 1 patient are counted multiple times. LLN was 5.2 to 6.7 mg/ml for immunoglobulin G (IgG) and 0.5 mg/ml for immunoglobulin M (IgM), depending on the laboratory.

Patients with IgG < LLN, n = 141Patients with IgM < LLN, n = 602Patients with IgM > LLN at All Times, n = 1803All Exposure Population, n = 2578
Total patient-yrs156.88212.58607.05781.013305.475013.50
No. of serious infections10182236137216
No. of serious infections per 100 patient-years6.378.473.624.614.144.31
95% CI3.43, 11.855.33, 13.442.39, 5.503.32, 6.393.51, 4.903.77, 4.92