TABLE 10.
Preferred term |
n (%)a
|
||||
---|---|---|---|---|---|
Placebo (N = 4) | 60 mg, SD (N = 6) | 120 mg, SD (N = 6) | 30 mg, BID (N = 6) | 60 mg, BID (N = 12) | |
Any AE | 4 (100) | 0 | 0 | 2 (33) | 8 (67) |
Headacheb | 0 | 0 | 0 | 0 | 3 (25) |
Malaise | 0 | 0 | 0 | 0 | 3 (25) |
Feeling hot | 0 | 0 | 0 | 0 | 2 (17) |
Vomiting | 0 | 0 | 0 | 0 | 2 (17) |
N, total number of participants; n, number of participants with observations.
Considered related to treatment by the investigator.