TABLE 4.
Anaphylactic events | IvIg administrations | IR per 10 000 IvIg administrations (0.95 CI) | Crude IRR 1 (0.95 CI) | Adjusted IRR 1 , 2 (0.95 CI) | |
---|---|---|---|---|---|
Total IvIg administrations | 128 | 174 413 | 7.34 (6.12–8.73) | ||
Predictors | |||||
Age (years) | |||||
<18 | 39 | 18 504 | 21.08 (14.98–28.82) | 3.69 (2.52–5.41) | 2.94 (1.91–4.52) |
≥18 or unknown | 89 | 155 909 | 5.71 (4.58–7.03) | 1 | 1 |
Sequence of IvIg treatment | |||||
First IvIg administration | 57 | 24 919 | 22.87 (17.32–29.64) | 1 | 1 |
Effectively IvIg‐naive administration 3 | 20 | 18 551 | 10.78 (6.58–16.66) | 0.47 (0.28–0.78) | 0.76 (0.44–1.32) |
Subsequent administration 4 | 51 | 130 943 | 3.89 (2.89–5.13) | 0.17 (0.12–0.25) | 0.27 (0.17–0.42) |
Non‐predictors | |||||
Sex | |||||
Male | 58 | 77 451 | 7.49 (5.68–9.69) | 1 | 1 |
Female | 70 | 96 962 | 7.22 (5.62–9.13) | 0.96 (0.68–1.37) | 1.07 (0.75–1.52) |
Transfusion of blood component | |||||
No transfusion | 116 | 168 122 | 6.90 (5.70–8.28) | 1 | 1 |
Red blood cells ± other blood products | 11 | 5615 | 19.59 (9.77–35.06) | 2.84 (1.53–5.27) | 1.53 (0.79–2.95) |
Other blood products only | 1 | 676 | NA | NA | NA |
IvIg Indication | |||||
Low‐dose indication 5 | 36 | 68 045 | 5.29 (3.70–7.33) | 1 | 1 |
High‐dose indication 6 | 78 | 95 335 | 8.18 (6.46–10.22) | 1.55 (1.04–2.31) | 1.20 (0.76–1.88) |
CI = confidence interval; IR = incidence rate; IRR = incidence rate ratio; IvIg = intravenous immunoglobulin; NA = not applicable due to cell counts ≤3.
Estimated from Poisson regression models clustering for patients.
IRR estimates adjusted for age (<18, 18+), sex, race, sequence of IvIg treatment, hospital setting, transfusion of blood components, IvIg indication dose group and calendar period.
No IvIg administration in the previous 42 days except the first IvIg administration.
IvIg administration in the previous 42 days.
Including neurological, hematological and autoimmune diseases.
Including immunodeficiency, malignant lymphoid or hematopoietic neoplasm, anti‐cancer treatment and sepsis/septicemia.