Table 3. Adverse Events and Safety during the Treatment Period (Safety Population).* .
| Variable | Xanomeline–Trospium (N = 89) |
Placebo (N = 90) |
|---|---|---|
| Any adverse event — no (%) | 48 (54) | 39 (43) |
| Serious adverse event — no. (%)† | 1 (1) | 0 |
| Severe adverse event — no. (%)‡ | 1 (1) | 1 (1) |
| Adverse event leading to discontinuation of the active drug or placebo — no. (%) | 2 (2) | 2 (2) |
| Adverse events occurring in ≥2% of the patients in the xanomeline–trospium group — no. (%) | ||
| Constipation | 15 (17) | 3 (3) |
| Nausea | 15 (17) | 4 (4) |
| Dry mouth | 8 (9) | 1 (1) |
| Dyspepsia | 8 (9) | 4 (4) |
| Vomiting | 8 (9) | 4 (4) |
| Headache | 6 (7) | 5 (6) |
| Somnolence | 5 (6) | 4 (4) |
| Akathisia | 3 (3) | 0 |
| Dizziness | 3 (3) | 3 (3) |
| Increased weight | 3 (3) | 4 (4) |
| Tachycardia | 3 (3) | 2 (2) |
| Sedation | 2 (2) | 2 (2) |
| Diarrhea | 2 (2) | 4 (4) |
| Increased γ-glutamyltransferase level | 2 (2) | 0 |
| Agitation | 2 (2) | 1 (1) |
| Insomnia | 2 (2) | 2 (2) |
| Decreased appetite | 2 (2) | 0 |
| Hyperhidrosis | 2 (2) | 1 (1) |
| Mean change from baseline in body weight at wk 5 — kg | 1.5±2.8 | 1.1±3.5 |
| Mean change from baseline in score on Simpson–Angus Scale at wk 5§ | −0.1±0.7 | −0.1±0.8 |
| Mean change from baseline in score on Barnes Akathisia Rating Scale at wk 5¶ | −0.1±1.0 | 0.0±0.7 |
The safety population included all the patients who had undergone randomization and had received at least one dose of xanomeline–trospium or placebo. Adverse events that occurred during the treatment period were defined as those that started or worsened from the time of the first dose of xanomeline–trospium or placebo (visit 1 at day 2) to the time of discharge (visit 9 at day 35). Plus–minus values are means ±SD.
A serious adverse event was defined as any adverse event that resulted in death, was immediately life-threatening, led to inpatient hospitalization or prolongation of hospitalization, or caused persistent or clinically significant disability or incapacity.
A severe adverse event was defined as any event that was incapacitating or caused an inability to perform normal activities of daily living.
Scores on the Simpson–Angus Scale range from 0 to 40; higher scores indicate greater severity of drug-induced parkinsonian symptoms.
Scores on the Barnes Akathisia Rating Scale range from 0 to 14; higher scores indicate greater symptoms of akathisia.