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. 2020 May 14;369:m1849. doi: 10.1136/bmj.m1849

Table 3.

Summary of adverse events in safety population. Values are numbers (percentages)

Adverse events* SOC plus HCQ (n=70) SOC (n=80)
Any adverse event 21 (30) 7 (9)
Serious adverse event 2 (3) 0
 Disease progression 1 (1) 0
 Upper respiratory tract infection 1 (1) 0
Non-serious adverse event 19 (27) 7 (9)
 Diarrhoea 7 (10) 0
 Vomiting 2 (3) 0
 Nausea 1 (1) 0
 Abdominal discomfort 1 (1) 0
 Thirst 1 (1) 0
 Abdominal bloating 0 1 (1)
 Sinus bradycardia 1 (1) 0
 Hypertension 1 (1) 0
 Orthostatic hypotension 1 (1) 0
 Hypertriglyceridaemia 1 (1) 0
 Decreased appetite 1 (1) 0
 Fatigue 1 (1) 0
 Fever 0 1 (1)
 Dyspnoea 1 (1) 0
 Flush 1 (1) 0
 Liver abnormality 0 1 (1)
 Kidney injury 1 (1) 0
 Coagulation dysfunction 1 (1) 0
 Hepatic steatosis 0 1 (1)
 Otitis externa 0 1 (1)
 Blurred vision 1 (1) 0
 Decreased white blood cells 1 (1) 0
 Increased alanine aminotransferase 1 (1) 1 (1)
 Increased serum amylase 1 (1) 0
 Decreased neutrophil count 1 (1) 0
 Increased serum amyloid A 0 1 (1)

HCQ=hydroxychloroquine; SOC=standard of care.

*

Multiple occurrences of same adverse event in one patient were counted.