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 event21 (30)7 (9)
Serious adverse event2 (3)0
 Disease progression1 (1)0
 Upper respiratory tract infection1 (1)0
Non-serious adverse event19 (27)7 (9)
 Diarrhoea7 (10)0
 Vomiting2 (3)0
 Nausea1 (1)0
 Abdominal discomfort1 (1)0
 Thirst1 (1)0
 Abdominal bloating01 (1)
 Sinus bradycardia1 (1)0
 Hypertension1 (1)0
 Orthostatic hypotension1 (1)0
 Hypertriglyceridaemia1 (1)0
 Decreased appetite1 (1)0
 Fatigue1 (1)0
 Fever01 (1)
 Dyspnoea1 (1)0
 Flush1 (1)0
 Liver abnormality01 (1)
 Kidney injury1 (1)0
 Coagulation dysfunction1 (1)0
 Hepatic steatosis01 (1)
 Otitis externa01 (1)
 Blurred vision1 (1)0
 Decreased white blood cells1 (1)0
 Increased alanine aminotransferase1 (1)1 (1)
 Increased serum amylase1 (1)0
 Decreased neutrophil count1 (1)0
 Increased serum amyloid A01 (1)

HCQ=hydroxychloroquine; SOC=standard of care.

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