Table 4.
Incidence of adverse events (AEs) and serious adverse events (SAEs) in 28 patients that physicians deemed at least possibly related to MPH (adverse drug reactions, ADR), by System Organ Class and Preferred Term
| MedDRA system organ class | AE | SAE | Total | |||
|---|---|---|---|---|---|---|
| Preferred term | N | % | N | % | N | % |
| Total of patients | 262 | 100 | 262 | 100 | 262 | 100 |
| Patients with ADR | 27 | 10.3 | 1 | 0.4 | 28 | 10.7 |
| Metabolism and nutritional disorders | 11 | 4.2 | 1 | 0.4 | 12 | 4.6 |
| Anorexia | 11 | 4.2 | 1 | 0.4 | 12 | 4.6 |
| Nervous system disorders | 10 | 3.8 | 0 | 0.0 | 10 | 3.8 |
| Dizziness | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Agitation | 2 | 0.8 | 0 | 0.0 | 2 | 0.8 |
| Confusional state | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Headache | 2 | 0.8 | 0 | 0.0 | 2 | 0.8 |
| Insomnia | 3 | 1.1 | 0 | 0.0 | 3 | 1.1 |
| Paralysis | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Psychiatric disorders | 9 | 3.4 | 1 | 0.4 | 10 | 3.8 |
| Aggression | 3 | 1.1 | 0 | 0.0 | 3 | 1.1 |
| Depression | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Affective disorder | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Dysphemia | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Mood swings | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Emotional disorders of childhood | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Sleep disorder | 1 | 0.4 | 1 | 0.4 | 1 | 0.4 |
| Gastrointestinal disorders | 8 | 3.1 | 0 | 0.0 | 8 | 3.1 |
| Nausea | 4 | 1.5 | 0 | 0.0 | 4 | 1.5 |
| Abdominal pain | 4 | 1.5 | 0 | 0.0 | 4 | 1.5 |
| General disorders & administration site conditions | 2 | 0.8 | 1 | 0.4 | 3 | 1.1 |
| Decreased activity | 0 | 0.0 | 1 | 0.4 | 1 | 0.4 |
| Rebound effect | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Asthenia | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Investigations | 3 | 1.1 | 0 | 0.0 | 3 | 1.1 |
| Weight decreased | 3 | 1.1 | 0 | 0.0 | 3 | 1.1 |
| Skin and subcutaneous tissue disorders | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Rash | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Respiratory, thoracic and mediastinal disorders | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Chest discomfort | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Social circumstances | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |
| Educational problem | 1 | 0.4 | 0 | 0.0 | 1 | 0.4 |