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Table 3 Common TEAEs with frequency ≥5% in the LDX (all doses) group and greater than placebo

From: Efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder previously treated with amphetamines: analyses from a randomized, double-blind, multicenter, placebo-controlled titration study

Preferred terminology (MedDRA 9.1) Participants, n (%)
Prior AMPH subgroup Overall safety population
Placebo n = 2 LDX (All Doses) Placebo n = 62 LDX (All Doses)
n = 39 n = 358
All TEAEs 2 (100) 22 (56.4) 36 (58.1) 282 (78.8)
Anorexia 0 0 0 18 (5.0)
Anxiety 0 1 (2.6) 0 21 (5.9)
Decreased appetite 0 2 (5.1) 1 (1.6) 95 (26.5)
Diarrhea 0 0 0 24 (6.7)
Dry mouth 0 5 (12.8) 2 (3.2) 92 (25.7)
Fatigue 0 3 (7.7) 3 (4.8) 17 (4.7)
Headache 0 5 (12.8) 8 (12.9) 74 (20.7)
Initial insomnia 0 1 (2.6) 2 (3.2) 18 (5.0)
Insomnia 0 3 (7.7) 3 (4.8) 69 (19.3)
Irritability 0 1 (2.6) 4 (6.5) 22 (6.1)
Nausea 0 2 (5.1) 0 25 (7.0)
Upper respiratory tract infection 0 1 (2.6) 3 (4.8) 20 (5.6)