Table 2.
Summary of adverse events of the MAD study considered probably or possibly related to study treatment
PRI‐002 | ||||
---|---|---|---|---|
Cohort 1 (160 mg) | Cohort 2 (320 mg) | Placebo | Total | |
System organ class, preferred term, n (%) | n = 8 | n = 7 | n = 8 | n = 23 |
Nervous system disorders | ||||
Disoriented three times | 1 | 0 | 0 | 1 |
(12.5%) | (4.3%) | |||
Headache (grade 2) | 0 | 0 | 1 | 1 |
(12.5%) | (4.3%) | |||
Total number of events | 1 | 0 | 1 | 2 |
(12.5%) | (12.5%) | (8.7%) |