Table 4.
DMQ (n = 58) | Placebo (n = 57) | |||||
---|---|---|---|---|---|---|
Adverse event characteristic | # of Events | # of Subjects | % of Subjects | # of Events | # of Subjects | % of Subjects |
Severity | ||||||
No AEs reported | 0 | 32 | 55% | 0 | 32 | 56% |
Mild | 52 | 15 | 26% | 32 | 10 | 18% |
Moderate | 17 | 9 | 16% | 16 | 12 | 21% |
Severe | 2 | 2 | 3% | 3 | 3 | 5% |
Relationship to Study Drug | ||||||
No AEs reported | 0 | 32 | 55% | 0 | 32 | 56% |
Not related | 18 | 5 | 9% | 30 | 13 | 23% |
Unlikely related | 28 | 12 | 21% | 14 | 8 | 14% |
Possibly related | 15 | 6 | 10% | 7 | 4 | 7% |
Probably related | 10 | 3 | 5% | 0 | 0 | 0% |
The number and severity of all adverse events (AEs) occurring during placebo and Nuedexta (DMQ) intervals of the trial are listed, along with their likelihood of being related to study treatment. Counts and percentages of patients summarize the most severe or most closely related event reported for each patient during a given treatment interval