Table 3.
Summary of treatment-emergent adverse effects, safety analysis set
| Flexible-dose study | Forced-dose study | ||||||
|---|---|---|---|---|---|---|---|
| Placebo (n = 91) | LDX (n = 184) | OROS-MPH (n = 184) | Placebo (n = 110) | LDX (n = 218) | OROS-MPH (n = 219) | ||
| Any TEAE, n (%) | 58 (63.7) | 153 (83.2) | 151 (82.1) | Any TEAE, n (%) | 49 (44.5) | 145 (66.5) | 129 (58.9) |
| Serious TEAEs | 0 | 1 (0.5) | 1 (0.5) | Serious TEAEs | 1 (0.9) | 1 (0.5) | 1 (0.5) |
| Severe TEAEsa | 2 (2.2) | 10 (5.4) | 7 (3.8) | Severe TEAEsa | 1 (0.9) | 3 (1.4) | 6 (2.7) |
| Study drug-related TEAEs | 28 (30.8) | 136 (73.9) | 122 (66.3) | Study drug-related TEAEs | 31 (28.2) | 117 (53.7) | 98 (44.7) |
| TEAEs leading to discontinuation | 3 (3.3) | 14 (7.6) | 3 (1.6) | TEAEs leading to discontinuation | 1 (0.9) | 16 (7.3) | 15 (6.8) |
| Fatal adverse events | 0 | 0 | 0 | Fatal adverse events | 0 | 0 | 0 |
| Most frequently reported TEAEs (≥ 5% in any treatment group) | Most frequently reported TEAEs (≥ 5% in any treatment group) | ||||||
| Decreased appetite | 7 (7.7) | 98 (53.3) | 77 (41.8) | Decreased appetite | 11 (10.0) | 69 (31.7) | 51 (23.3) |
| Decreased weight | 1 (1.1) | 37 (20.1) | 24 (13.0) | Headache | 9 (8.2) | 33 (15.1) | 35 (16.0) |
| Irritability | 9 (9.9) | 37 (20.1) | 14 (7.6) | Decreased weight | 0 | 23 (10.6) | 11 (5.0) |
| Headache | 7 (7.7) | 28 (15.2) | 28 (15.2) | Insomnia | 3 (2.7) | 17 (7.8) | 17 (7.8) |
| Insomnia | 0 | 16 (8.7) | 15 (8.2) | Dry mouth | 1 (0.9) | 16 (7.3) | 7 (3.2) |
| Initial insomnia | 2 (2.2) | 15 (8.2) | 12 (6.5) | Dizziness | 0 | 12 (5.5) | 11 (5.0) |
| Dry mouth | 1 (1.1) | 15 (8.2) | 11 (6.0) | Irritability | 7 (6.4) | 11 (5.0) | 15 (6.8) |
| Nausea | 4 (4.4) | 14 (7.6) | 15 (8.2) | Nausea | 3 (2.7) | 11 (5.0) | 11 (5.0) |
| Abdominal pain, upper | 4 (4.4) | 12 (6.5) | 10 (5.4) | Abdominal pain, upper | 2 (1.8) | 11 (5.0) | 8 (3.7) |
| Dizziness | 1 (1.1) | 12 (6.5) | 8 (4.3) | ||||
| Nasopharyngitis | 1 (1.1) | 11 (6.0) | 13 (7.1) | ||||
| Somnolence | 4 (4.4) | 10 (5.4) | 6 (3.3) | ||||
| Fatigue | 3 (3.3) | 10 (5.4) | 5 (2.7) | ||||
| URTI | 8 (8.8) | 9 (4.9) | 6 (3.3) | ||||
| Increased heart rate | 0 | 8 (4.3) | 11 (6.0) | ||||
LDX lisdexamfetamine dimesylate, OROS-MPH osmotic controlled-release methylphenidate, TEAE treatment-emergent adverse event, URTI upper respiratory tract infection
aSevere TEAEs flexible-dose study [abdominal pain: OROS-MPH (n = 1); dry mouth: LDX (n = 1); vomiting: OROS-MPH (n = 1); influenza: LDX (n = 1); pharyngitis streptococcal: LDX (n = 1); decreased appetite: LDX (n = 3); headache: OROS-MPH (n = 1); migraine: LDX (n = 1); psychomotor hyperactivity: OROS-MPH (n = 1); somnolence: placebo (n = 1); aggression: LDX (n = 1); confusional state: placebo (n = 1); initial insomnia: LDX (n = 1) and OROS-MPH (n = 1); insomnia: LDX (n = 1) and OROS-MPH (n = 3); renal cyst: OROS-MPH (n = 1); cough: placebo (n = 1); pleurisy: OROS-MPH (n = 1)]; forced-dose study [feeling abnormal: LDX (n = 1); viral infection: OROS-MPH (n = 1); wrist fracture: OROS-MPH (n = 1); increased blood pressure: OROS-MPH (n = 1); headache: LDX (n = 1) and OROS-MPH (n = 1); anxiety: LDX (n = 1); insomnia: OROS-MPH (n = 1); psychotic disorder: placebo (n = 1); dysmenorrhea: OROS-MPH (n = 1); orthostatic hypotension: OROS-MPH (n = 1)]