Table 3. Incidence of Adverse Events Occurring in at Least 2% of Patients (Safety Population)a.
| Patients, No. (%) | |||
|---|---|---|---|
| Sublingual dexmedetomidine | Placebo (n = 126) | ||
| 180 μg (n = 126) | 120 μg (n = 126) | ||
| Serious adverse event | 0 | 1 (0.8)b | 0 |
| Any treatment-emergent adverse event | 45 (35.7) | 44 (34.9) | 22 (17.5) |
| Any treatment-related adverse eventc | 39 (31.0) | 41 (32.5) | 15 (11.9) |
| Discontinuation for adverse event | 0 | 1 (0.8) | 0 |
| Somnolence | 27 (21.4) | 26 (20.6) | 6 (4.8) |
| Hypotension | 8 (6.3) | 6 (4.8) | 0 |
| Dizziness | 7 (5.6) | 7 (5.6) | 1 (0.8) |
| Dry mouth | 6 (4.8) | 9 (7.1) | 1 (0.8) |
| Orthostatic hypotension | 6 (4.8) | 5 (4.0) | 1 (0.8) |
| Hypoesthesia oral | 5 (4.0) | 2 (1.6) | 1 (0 .8) |
| Nausea | 5 (4.0) | 3 (2.4) | 3 (2.4) |
| Bradycardia | 3 (2.4) | 2 (1.6) | 0 |
| Paresthesia oral | 3 (2.4) | 2 (1.6) | 0 |
Each adverse event reported was assessed by the investigator for severity (mild, moderate, severe) and relationship to study drug (not related, unlikely or remotely related, possibly related, probably related, definitely related).
Judged by investigator to be unrelated to study drug.
Adverse events, clinical laboratory tests, electrocardiogram with rhythm strip, pulse oximetry, and vital signs were monitored for tolerability assessment. All observed and volunteered. Adverse events were recorded. The relationship of adverse events to the study drug were graded as not related, unlikely or remotely related, possibly related, probably related or definitely related by the investigators. Vital signs including systolic blood pressure, diastolic blood pressure, and heart rate were monitored.