TABLE 4

Treatment-Emergent Adverse Events With 5% or Greater Incidence in the CLON-XR + Stimulant (Methylphenidate or Amphetamine) Group (Safety Population)

Adverse EventPlacebo Plus Stimulant (n = 96), n (%)CLON-XR Plus Stimulant (n = 102), n (%)
Any Stimulanta (n = 96)Methylphenidate (n = 59)Amphetamine (n = 37)Any Stimulanta (n = 102)Methylphenidate (n = 59)Amphetamine (n = 43)
Somnolenceb8 (8)6 (10)2 (5)20 (20)13 (22)7 (16)
Headache20 (21)12 (20)8 (22)19 (19)10 (17)9 (21)
Fatiguec4 (4)2 (3)2 (5)16 (16)7 (12)9 (21)
Upper abdominal pain8 (8)6 (10)2 (5)12 (12)4 (7)8 (19)
Nasal congestion6 (6)6 (10)0 (0)9 (9)4 (7)5 (12)
Pharyngolaryngeal pain4 (4)4 (7)0 (0)8 (8)4 (7)4 (9)
Cough8 (8)6 (10)2 (5)6 (6)2 (3)4 (9)
Irritability9 (9)6 (10)3 (8)5 (5)1 (2)4 (9)
Insomnia3 (3)2 (3)1 (3)5 (5)2 (3)2 (5)
Increased body temperature2 (2)1 (2)1 (3)5 (5)1 (2)4 (9)
Dizziness2 (2)0 (0)2 (5)5 (5)3 (5)2 (5)
  • a Methylphenidate or amphetamine.

  • b Somnolence includes the terms somnolence and sedation.

  • c Fatigue includes the terms fatigue and lethargy.