Table 2

Adverse event (AE) rates by treatment allocation; number of participants in each arm developing at least one AE within each individual organ system

CTCAE system classMethylphenidate
No of participants with ≥1 event (%)
Placebo
No of participants with ≥1 event (%)
Ear and labyrinth2 (13.3)0
Eye1 (6.7)3 (42.9)
Gastrointestinal7 (46.7)1 (14.3)
General disorders2 (13.3)2 (28.6)
Infections and infestations1 (6.7)1 (14.3)
Investigations2 (13.3)0
Metabolism and nutrition1 (6.7)0
Musculoskeletal5 (33.3)1 (14.3)
Nervous system10 (66.7), 1 SAE (6.7)3 (42.9)
Psychiatric5 (33.3)3 (42.9)
Respiratory7 (46.7)6 (85.7)
Reproductive system and breast1 (6.7)0
Skin and subcutaneous tissue4 (26.7)1 (14.3)
Vascular disorders2 (13.3)0
Any14 (93.3)7 (100.0)
  • CTCAE, Common Terminology Criteria for Adverse Events; SAE, serious AE.