ADR of special interest | Patients, n (%) All patients (N = 20,000) | At-risk patients (N = 153) |
Injection site warmth/and or feeling hot | 119 (0.60) | 1 (0.65) |
Nausea and/or vomiting | 200 (1.0) | 4 (2.6) |
Urticaria, erythema, rash and/or papular rash | 94 (0.47) | 4 (2.6) |
Cough and/or sneezing | 20 (0.10) | 3 (2.0) |
Dyspnea and /or bronchospasm | 11 (0.06) | 1 (0.65) |
Blood pressure increase and/or decrease | 6 (0.03) | 0 |