Table 4.
Summary of the Most Common Treatment-Emergent Adverse Events (Incidence ≥2%) Encountered During the 2-Week Double-Blind Phase 5 (Safety Population)
| System organ class preferred term | MPH-MLR (n = 39) |
Placebo (n = 50) |
||
|---|---|---|---|---|
| n (%) | No. of events | n (%) | No. of events | |
| Any TEAE | 10 (25.6) | 14 | 6 (12.0) | 9 |
| Psychiatric disorders | ||||
| Emotional disorder | 0 | 0 | 1 (2.0) | 1 |
| Onychophagia | 1 (2.6) | 1 | 0 | 0 |
| Emotional poverty | 1 (2.6) | 1 | 0 | 0 |
| Negativism | 1 (2.6) | 1 | 0 | 0 |
| Infections and infestations | ||||
| Upper respiratory tract infection | 2 (5.1) | 2 | 0 | 0 |
| Cellulitis | 0 | 0 | 1 (2.0) | 1 |
| Sinusitis | 0 | 0 | 1 (2.0) | 1 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1 (2.6) | 1 | 0 | 0 |
| Gastrointestinal disorders | ||||
| Vomiting | 0 | 0 | 1 (2.0) | 1 |
| Gastritis | 1 (2.6) | 1 | 0 | 0 |
| Vascular disorders | ||||
| Hypertension | 3 (7.7) | 3 | 0 | 0 |
| General disorders and administration site conditions | ||||
| Pyrexia | 0 | 0 | 1 (2.0) | 1 |
| Adverse event | 1 (2.6) | 1 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Pain in extremity | 0 | 0 | 1 (2.0) | 2 |
| Renal and urinary disorders | ||||
| Pollakiuria | 1 (2.6) | 1 | 0 | 0 |
| Urinary incontinence | 1 (2.6) | 1 | 0 | 0 |
| Injury, poisoning, and procedural complications | ||||
| Injury corneal | 0 | 0 | 1 (2.0) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 0 | 0 | 1 (2.0) | 1 |
| Cardiac disorders | ||||
| Tachycardia | 1 (2.6) | 1 | 0 | 0 |
MPH-MLR, methylphenidate hydrochloride extended-release capsules; TEAE, treatment-emergent adverse event.