Pre-pandemic (01-01-82 a 29-02-20) Pre-pandemic (01-01-82 a 29-02-20) Pandemic (01-03-20 a 19-02-21) Pandemic (01-03-20 a 19-02-21)
Adverse Reaction (SMQ narrow, MedDRA 24.0)
No cases
ROR (-ROR)a
No cases
ROR (-ROR)
Torsade de Pointes / QT prolongation 2 3.5 (0.9) 39 132.8 (76.7)
Cardiomyopathy 9 25.5 (13.1) 5 26.0 (9.1)
Cardiac arrhythmias 7 1.9 (0.9) 51 20.3 (14.6)
Drug related hepatic disorders - severe events only 8 0.8 (0.4) 103 18.7 (14.7)
Hepatic disorders 16 1.0 (0.6) 135 17.1 (13.8)
Dyslipidaemia 0 NA 10 12.1 (6.1)
Shock 8 1.1 (0.5) 47 9.5 (6.9)
Ischaemic colitis 0 NA 3 8.9 (2.6)
Severe cutaneous adverse reactions 15 3.2 (1.9) 23 8.8 (5.6)
Rhabdomyolysis/myopathy 8 5.2 (2.6) 5 8.0 (3.1)
Haemolytic disorders 3 3.6 (1.1) 3 6.6 (2.0)
Suicide/self-injury 4 3.1 (1.2) 6 5.9 (2.6)
Cardiac failure 3 1.6 (0.5) 7 5.5 (2.5)
Toxic-septic shock conditions 2 2.8 (0.7) 4 5.3 (1.9)
Retinal disorders 15 15.4 (9.2) 7 5.1 (2.3)
Chronic kidney disease 2 1.6 (0.4) 6 4.6 (2.0)
Noninfectious encephalopathy/delirium 1 0.6 (0.1) 5 4.3 (1.7)
Noninfectious meningitis 3 4.5 (1.4) 2 3.8 (0.9)
Pulmonary hypertension 3 13.0 (4.1) 1 3.6 (0.5)
Respiratory failure 3 1.0 (0.3) 7 3.4 (1.6)
Acute renal failure 4 0.7 (0.3) 14 3.3 (1.9)
Hearing impairment 8 4.7 (2.3) 5 3.2 (1.3)
Gastrointestinal perforation, ulceration, haemorrhage or obstruction 6 0.6 (0.3) 14 2.7 (1.6)
Sepsis 4 3.3 (1.2) 4 2.7 (1.0)
Infective pneumonia 7 3.1 (1.5) 6 2.2 (1.0)
Noninfectious diarrhoea 12 0.6 (0.3) 37 2.1 (1.5)
Malignant lymphomas 4 7.2 (2.7) 1 1.7 (0.2)
Haematopoietic cytopenias 30 2.5 (1.7) 14 1.2 (0.7)
Ocular motility disorders 3 4.4 (1.4) 1 1.2 (0.2)
Pregnancy and neonatal topics 18 5.2 (3.2) 5 1.2 (0.5)
Agranulocytosis 14 3.2 (1.9) 4 1.1 (0.4)
Opportunistic infections 8 3.6 (1.8) 3 1.0 (0.3)
Malignancies 11 2.3 (1.3) 1 0.2 (0.0)
Interstitial lung disease 9 5.0 (2.6) 0 NA