Table 6.
Adverse events
| Events | Arm 1: HCQ + SOC |
Arm 2: SOC |
|---|---|---|
| Number randomized | 55 | 50 |
| Participants who had any adverse event (AE), n (%)a | 33 (60) | 27 (54.0) |
| Participants who had any severe adverse event (SAE), n (%)a | 0 | 0 |
| Participants who had any grade 3 or 4 adverse events, n (%)b | 2 (6.1) | 3 (11.1) |
| Number of grade 3 or 4 AEs | 2 | 3 |
| Grade 3 or 4 adverse events listing, number | ||
| Elevated QTc (> 450 males, > 470 females) | 1 | 3 |
| Painful eye after HCQ dosages | 1 | 0 |
| Grade 3 or 4 relationship with study drug, number | ||
| Definitec | 1 | N/A |
| Probable | 0 | N/A |
| Possible | 0 | N/A |
| Unlikely | 0 | N/A |
| Unrelated | 1 | N/A |
aPercent of total participants randomized
bPercent of those who had any AE
cDefinite related to study drugs was elevated QTc