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.