Table 3 Comparison of adverse events (AE) between study groups after 1 month of follow-up
Placebo (n = 127) | Hydroxychloroquine (n=142) | ||||
|---|---|---|---|---|---|
n | % | n | % | p value | |
At least 1 adverse event | 42 | 33.1 | 53 | 37.3 | 0.548 |
Syndromic approach | |||||
General symptoms | 9 | 7.7 | 10 | 7.0 | > 0.999 |
Fever | 6 | 4.7 | 4 | 2.8 | 0.553 |
Chills | 0 | 0.0 | 2 | 1.4 | 0.552 |
Sweating | 0 | 0.0 | 0 | 0.0 | |
Malaise | 4 | 3.1 | 4 | 2.8 | > 0.999 |
Myalgia | 2 | 1.6 | 3 | 2.1 | > 0.999 |
Arthralgia | 0 | 0.0 | 0 | 0.0 | |
Gastrointestinal symptoms | 20 | 15.7 | 39 | 27.4 | 0.041 |
Nausea | 3 | 2.4 | 10 | 7.0 | 0.160 |
Abdominal pain | 11 | 8.3 | 15 | 10.9 | 0.825 |
Diarrhea | 8 | 6.3 | 24 | 16.9 | 0.028 |
Dysgeusia | 0 | 0.0 | 0 | 0.0 | |
Dermatological symptoms | 2 | 1.6 | 3 | 2.2 | > 0.999 |
Itching | 0 | 0.0 | 2 | 1.4 | 0.546 |
Rash | 2 | 1.6 | 2 | 1.4 | > 0.999 |
Respiratory symptoms | 9 | 7.1 | 5 | 3.7 | 0.257 |
Rhinorrea | 3 | 2.4 | 0 | 0.0 | 0.190 |
Sore throat/odynophagia | 5 | 3.9 | 3 | 2.2 | 0.556 |
Cough | 3 | 2.4 | 2 | 1.5 | 0.851 |
Pleuritic pain | 0 | 0.0 | 0 | 0.0 | |
Dyspnea | 0 | 0.0 | 0 | 0.0 | |
Neurological symptoms | 12 | 9.4 | 14 | 9.9 | > 0.999 |
Headache | 12 | 9.4 | 13 | 9.1 | 0.987 |
Visual disturbances | 0 | 0.0 | 1 | 0.7 | >0.999 |
Cardiovascular symptoms | 2 | 1.6 | 2 | 1.4 | 0.999 |
Other symptoms | 10 | 8.0 | 7 | 4.9 | 0.427 |
Severity | 0.249 | ||||
Mild | 43 | 33.8 | 63 | 44.4 | |
Moderate | 3 | 2.4 | 1 | 0.7 | |
Severe | 0 | 0.0 | 0 | 0.0 | |
Potential relationship with the study drug | |||||
Related (at least one AE) | 33 | 26.0 | 49 | 34.5 | 0.206 |
Non related (at least one AE) | 17 | 13.4 | 14 | 9.9 | 0.476 |
Withdrawal due to AE | 5 | 3.9 | 1 | 0.7 | 0.270 |