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Table 5 Treatment emergent adverse events with an incidence >1

From: A Phase I, open-label, randomized, crossover study in three parallel groups to evaluate the effect of Rifampicin, Ketoconazole, and Omeprazole on the pharmacokinetics of THC/CBD oromucosal spray in healthy volunteers

Primary system organ class Preferred term* No. of subjects (%) No. of subjects (%) No. of subjects (%)
  THC/CBD spray (n= 36)
Psychiatric disorders
Euphoric mood 2 (6) - -
Nervous system disorders    
Dizziness 2 (6) - -
Dizziness postural 3 (8) - -
Headache 5 (14) - -
Somnolence 11 (31) - -
Gastrointestinal disorders    
Nausea 2 (6) - -
  Rifampicin ( n= 12 ) THC/CBD spray and Rifampicin ( n= 12 ) THC/CBD spray ( n= 12 )
Nervous system disorders    
Dysgeusia 1 (8) 0 1 (8)
Headache 0 1 (8) 1 (8)
Somnolence 0 0 2 (17)
  Ketoconazole ( n= 12 ) THC/CBD spray and Ketoconazole ( n= 11 ) THC/CBD spray ( n= 12 )
Nervous system disorders    
Somnolence 0 4 (36) 4 (33)
Dizziness 0 3 (27) 2 (17)
Lethargy 0 3 (27) 0
Dysgeusia 0 2 (18) 0
Headache 0 2 (18) 0
Somnolence 0 1 (9) 1 (8)
Psychiatric disorders    
Euphoric mood 0 7 (64) 0
Anxiety 0 1 (9) 1 (8)
Disorientation 0 1 (9) 1 (8)
  Omeprazole ( n= 12 ) THC/CBD spray and Omeprazole ( n= 12 ) THC/CBD spray ( n= 12 )
Nervous system disorders    
Dizziness 0 3 (25) 0
Dizziness postural 0 0 2 (17)
Headache 1 (8) 0 4 (33)
Somnolence 0 2 (17) 5 (42)
Gastrointestinal disorders    
Dry mouth 0 2 (17) 1 (8)
  1. *MedDRA version 10.0.