Table 3.
Summary of Incidence of Drug-Related Adverse Events (Safety Population)
| Adverse events | ORADUR®-MPH (N = 110) |
Placebo (N = 101) |
Fisher's exact |
||
|---|---|---|---|---|---|
| Event | Participant (%) | Event | Participant (%) | p-Value | |
| Decreased appetite | 81 | 53 (48.2) | 1 | 1 (1.0) | <0.0001 |
| Gastrointestinal symptoms | 38 | 22 (20.0) | 3 | 1 (1.0) | <0.0001 |
| Nausea | 20 | 15 (13.6) | 0 | 0 (0.0) | <0.0001 |
| Vomiting | 4 | 4 (3.6) | 0 | 0 (0.0) | 0.1228 |
| Stomachache | 7 | 5 (4.5) | 1 | 1 (1.0) | 0.2146 |
| Abdominal discomfort | 3 | 2 (1.8) | 0 | 0 (0.0) | 0.4985 |
| Abdominal pain | 2 | 2 (1.8) | 0 | 0 (0.0) | 0.4985 |
| Diarrhea | 2 | 2 (1.8) | 2 | 1 (1.0) | 1.0000 |
| Neurological symptoms | |||||
| Dizziness | 13 | 7 (6.4) | 0 | 0 (0.0) | 0.0147 |
| Headache | 12 | 9 (8.2) | 1 | 1 (1.0) | 0.0197 |
| Palpitations/tachycardia | 5 | 5 (4.5) | 0 | 0 (0.0) | 0.0607 |
| Psychiatric conditions | |||||
| Sleep problems | 34 | 22 (20.0) | 0 | 0 (0.0) | <0.0001 |
| Agitation | 4 | 4 (3.6) | 0 | 0 (0.0) | 0.1228 |
| Moody | 2 | 2 (1.8) | 0 | 0 (0.0) | 0.4985 |
| Irritability | 3 | 3 (2.7) | 0 | 0 (0.0) | 0.2478 |
| Tics | 2 | 2 (1.8) | 0 | 0 (0.0) | 0.4985 |
| Decreased weight | 4 | 4 (3.6) | 0 | 0 0.00 | 0.1228 |
| Other general symptoms | |||||
| Chest discomfort/pain | 3 | 3 (2.7) | 0 | 0 (0.0) | 0.2478 |
| Dyspnea | 1 | 1 (0.9) | 0 | 0 (0.0) | 1.0000 |
| Fatigue | 2 | 2 (1.8) | 0 | 0 (0.0) | 0.4985 |
| Edema peripheral | 1 | 1 (0.9) | 0 | 0 (0.0) | 1.0000 |
| Thirst | 1 | 1 (0.9) | 0 | 0 (0.0) | 1.0000 |
| Musculoskeletal stiffness | 1 | 1 (0.9) | 0 | 0 (0.00) | 1.0000 |
| Asthenia | 1 | 1 (0.9) | 0 | 0 (0.0) | 1.0000 |
| Oropharyngeal pain | 1 | 1 (0.9) | 0 | 0 (0.0) | 1.0000 |
Bold values: p < 0.05.
MPH, methylphenidate.