TABLE 5.
Occurrence of Hypersensitivity Reactions in Analysis I
| Children, n = 2978 (%) | Adults, n = 86,663 (%) | Elderly, n = 43,209 (%) | Total, n = 132,850 (%) | |
|---|---|---|---|---|
| All patients with HSRs | 14 (0.47%) | 640 (0.74%) | 164 (0.38%) | 818 (0.62%) |
| Pruritus | 8 (0.27) | 232 (0.27) | 53 (0.12) | 293 (0.22) |
| Cough, sneezing* | 2 (0.07%) | 113 (0.13%) | 34 (0.08%) | 149 (0.11%) |
| Cough | 2 (0.07%) | 62 (0.07%) | 20 (0.05%) | 84 (0.06%) |
| Sneezing | 0 | 55 (0.06%) | 15 (0.03%) | 70 (0.05%) |
| Urticaria, rash, erythema* | 8 (0.27%) | 411 (0.47%) | 87 (0.20%) | 506 (0.38%) |
| Urticaria | 3 (0.10%) | 203 (0.23%) | 39 (0.09%) | 245 (0.18%) |
| Rash | 1 (0.03%) | 158 (0.18%) | 31 (0.07%) | 190 (0.14%) |
| Erythema | 4 (0.13%) | 80 (0.09%) | 21 (0.05%) | 105 (0.08%) |
| Dyspnea | 2 (<0.1) | 66 (<0.1) | 28 (<0.1) | 96 (<0.1) |
| Bronchospasm | 0 | 7 (<0.1) | 2 (<0.1) | 9 (<0.1) |
| Face edema | 0 | 4 (<0.1) | 0 | 4 (<0.1) |
| Throat irritation | 0 | 4 (<0.1) | 0 | 4 (<0.1) |
| Dysphagia | 0 | 2 (<0.1) | 1 (<0.1) | 3 (<0.1) |
| Dysphonia | 0 | 1 (<0.1) | 1 (<0.1) | 2 (<0.1) |
| Eye swelling | 0 | 0 | 2 (<0.1) | 2 (<0.1) |
| Nasal congestion | 0 | 2 (<0.1) | 0 | 2 (<0.1) |
| Anaphylactic shock | 0 | 0 | 1 (<0.1) | 1 (<0.1) |
| Lacrimation increased | 0 | 1 (<0.1) | 0 | 1 (<0.1%) |
| Laryngeal edema | 0 | 0 | 1 (<0.1) | 1 (<0.1%) |
| Respiratory arrest | 0 | 0 | 1 (<0.1) | 1 (<0.1%) |
| Rhinitis | 0 | 1 (<0.1) | 0 | 1 (<0.1%) |
*Multiple HSRs per subject were possible.
HSRs, hypersensitivity reactions.