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 = 141 | Patients with IgM < LLN, n = 602 | Patients with IgM > LLN at All Times, n = 1803 | All Exposure Population, n = 2578 | |||
|---|---|---|---|---|---|---|
| Before | After | Before | After | Anytime | Anytime | |
| Total patient-yrs | 156.88 | 212.58 | 607.05 | 781.01 | 3305.47 | 5013.50 |
| No. of serious infections | 10 | 18 | 22 | 36 | 137 | 216 |
| No. of serious infections per 100 patient-years | 6.37 | 8.47 | 3.62 | 4.61 | 4.14 | 4.31 |
| 95% CI | 3.43, 11.85 | 5.33, 13.44 | 2.39, 5.50 | 3.32, 6.39 | 3.51, 4.90 | 3.77, 4.92 |