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Table 2 Subject disposition by treatment sequence

From: Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design

   Randomization Sequence  
n (%) Discontinued Prior to Randomization (n = 15) LDX/Placebo (n = 63) Placebo/LDX (n = 64) All Subjects (N = 142)
Safety population 15 (100.0) 63 (100.0) 64 (100.0) 142 (100.0)
Randomized safety population - 63 (100.0) 64 (100.0) 127 (89.4)
Intention-to-treat population - 53 (84.1) 52 (81.3) 105 (73.9)
Per protocol population - 49 (77.8) 49 (76.6) 98 (69.0)
Completed study - 52 (82.5) 51 (79.7) 103 (72.5)
Discontinuations 15 (100.0) 11 (17.5) 13 (20.3) 39 (27.5)
Reasons for discontinuations
Total 15 (100.0) 11 (17.5) 13 (20.3) 39 (27.5)
   AE 4 (26.7) 0 2 (3.1) 6 (4.2)
   Lack of efficacy 0 0 0 0
   Refused further participation 5 (33.3) 3 (4.8) 2 (3.1) 10 (7.0)
   Protocol nonadherence/subject noncompliant 0 0 0 0
   Lost to follow-up 2 (13.3) 0 0 2 (1.4)
   Other 4 (26.7) 8 (12.7)a 9 (14.1)a 21 (14.8)
  1. aSeventeen subjects withdrew from the study during the double-blind crossover phase due to a natural disaster-related study site closure (ie, hurricane).
  2. AE = adverse event; LDX = lisdexamfetamine dimesylate.