Table 1.
“Serious” Individual Case Safety Reports (ICSRs) registered in Vigibase® between 1 January 2010 and 31 December 2019 according to Standardised MedDRA Queries (SMQs) classification
| Number of “serious” ICSRs, SMQ (narrow) > 1% | 5219 | 100.0% |
|---|---|---|
| Hypersensitivity | 1229 | 23.5% |
| Arthralgia | 882 | 16.9% |
| Gastrointestinal (nausea, vomiting, diarrhea, constipation) | 727 | 13.9% |
| Haemodynamic_oedema, effusions, fluid overload | 517 | 9.9% |
| Retinal | 348 | 6.7% |
| Cytopenia | 328 | 6.3% |
| Non_infectious_diarrhea | 253 | 4.8% |
| Haemorrhage | 216 | 4.1% |
| Angioedema | 215 | 4.1% |
| Infective_pneumonia | 209 | 4.0% |
| Shock | 194 | 3.7% |
| Cardiac_arrhytmias | 180 | 3.4% |
| Cardiomyopathy | 172 | 3.3% |
| Embolic_thombotic_event | 158 | 3.0% |
| Cardiac_failure | 143 | 2.7% |
| Interstitial_lung | 132 | 2.5% |
| Arterial hypertension | 129 | 2.5% |
| Agranulocytosis | 118 | 2.3% |
| Hearing | 116 | 2.2% |
| Gastrointestinal_perforation | 112 | 2.1% |
| Acute_renal_failure | 102 | 2.0% |
| Depression | 90 | 1.7% |
| Suicide | 89 | 1.7% |
| Torsades de pointes/QT prolongation | 86 | 1.6% |
| Rhabdomyolysis | 71 | 1.4% |
| Psychosis | 66 | 1.3% |
| Respiratory_failure | 65 | 1.2% |
| Acute_central_respiratory_depression | 55 | 1.1% |