Table 3.
Adverse events (safety analysis population) for the first year
| Pleconaril and ribavirin (n = 47) | Placebo (n = 49) | |
|---|---|---|
| n events (n patients) | ||
| Any adverse event | 188 (41) | 137 (42) |
| Leading to discontinuationa | 2 | 1 |
| Possibly related to the trial agentsb | 130 (36) | 81 (29) |
| Any serious adverse event | 0 (0) | 0 (0) |
| Death | 0 | 0 |
| Pregnancy | 0 | 0 |
| Any infection 0–6 monthsc | 47 (30) | 48 (32) |
| Any infection 0–12 monthsc | 66 (35) | 66 (36) |
| Serious infection | 0 | 0 |
| Serious hypoglycemiad | 0 | 2 (2) |
| Hemolysis | 80 (27) | 55 (23) |
| Skin and subcutaneous disorders | 4 (3) | 7 (5) |
| Gastrointestinal symptoms | 40 (21) | 21 (13) |
| Psychological stress and anxiety | 4 (1) | 0 |
aOne patient in the pleconaril and ribavirin group was withdrawn from the study on day 4 because of nausea; another patient in the same group withdrew on day 90 because of agitation and psychological stress. One patient in the placebo group withdrew from the study on day 36 because of abdominal pain.
bAn adverse event related to the trial agent was defined as any event that was deemed by the trial investigators to be very likely, probably or possibly related to the trial drug or placebo or if the data regarding the relationship to the trial agent were missing.
cRecorded via questionnaire at each study visit.
dDefined as unconsciousness or seizures.