Table 3.
Number and percentage of patients experiencing TEAEs according to treatment group (safety population)
| TEAE—preferred term, n (%) | LDX (n = 128) | ATX (n = 134) |
|---|---|---|
| Any TEAE | 92 (71.9) | 95 (70.9) |
| Mild | 51 (39.8) | 54 (40.3) |
| Moderate | 34 (26.6) | 37 (27.6) |
| Severe | 7 (5.5) | 4 (3.0) |
| Any serious TEAEa | 0 | 0 |
| Any TEAE leading to discontinuation of study drug | 8 (6.3) | 10 (7.5) |
| TEAEs reported by ≥5.0 % of patients in either treatment group | ||
| Decreased appetite | 33 (25.8) | 14 (10.4) |
| Decreased weight | 28 (21.9) | 9 (6.7) |
| Headache | 17 (13.3) | 22 (16.4) |
| Nausea | 16 (12.5) | 21 (15.7) |
| Insomnia | 15 (11.7) | 8 (6.0) |
| Fatigue | 12 (9.4) | 14 (10.4) |
| Nasopharyngitis | 8 (6.3) | 8 (6.0) |
| Constipation | 8 (6.3) | 2 (1.5) |
| Dry mouth | 8 (6.3) | 4 (3.0) |
| Irritability | 8 (6.3) | 3 (2.2) |
| Vomiting | 6 (4.7) | 13 (9.7) |
| Sedation | 5 (3.9) | 8 (6.0) |
| Somnolence | 4 (3.1) | 16 (11.9) |
| Upper abdominal pain | 3 (2.3) | 10 (7.5) |
| Abdominal pain | 3 (2.3) | 8 (6.0) |
| Upper respiratory tract infection | 3 (2.3) | 8 (6.0) |
| Diarrhoea | 2 (1.6) | 9 (6.7) |
ATX atomoxetine, LDX lisdexamfetamine dimesylate, TEAE treatment-emergent adverse event
aA serious TEAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital abnormality/birth defect; or is an Important Medical Event. Important Medical Events may have been considered as serious TEAEs when, based upon medical judgement, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above. The sponsor required any new onset of seizures, syncope or loss of consciousness to be reported as a serious TEAE