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Table 3 Adverse events from initiation of treatment to 3-month follow-up, by MedDRA System Organ Class (SOC) and Preferred Term (PT)

From: Medical cannabis authorization patterns, safety, and associated effects in older adults

   Product profile
SOC
PT
Overall
n (%)
CBD-dominant
n (%)
Balanced
n (%)
THC-dominant
n (%)
Unknown
n (%)
Nervous system disorders 10 (30.3) 3 (18.7) 5 (38.5) 1 (33.0) 1 (100.0)
 Dizziness 6 (18.2) 1 (6.2) 3 (23.1) 1 (33.0) 1 (100.0)
 Headache 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
 Disturbance in attention 2 (6.1) 1 (6.2) 1 (7.7) 0 (0.0) 0 (0.0)
 Somnolence 1 (3.0) 0 (0.0) 1 (7.7) 0 (0.0) 0 (0.0)
Gastrointestinal disorders 11 (33.3) 6 (37.5) 4 (30.8) 1 (33.0) 0 (0.0)
 Nausea 3 (9.1) 1 (6.2) 1 (7.7) 1 (33.0) 0 (0.0)
 Dry mouth 3 (9.1) 1 (6.2) 2 (15.4) 0 (0.0) 0 (0.0)
 Diarrhea 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
 Dyspepsia 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
 Gastrooesophageal reflux disease 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
 Mouth ulceration 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
 Reflux gastritis 1 (3.0) 0 (0.0) 1 (7.7) 0 (0.0) 0 (0.0)
Psychiatric disorders 5 (15.2) 2 (12.5) 2 (15.4) 1 (33.0) 0 (0.0)
 Anxiety 2 (6.1) 1 (6.2) 0 (0.0) 1 (33.0) 0 (0.0)
 Mood change 1 (3.0) 0 (0.0) 1 (7.7) 0 (0.0) 0 (0.0)
 Aggression 1 (3.0) 0 (0.0) 1 (7.7) 0 (0.0) 0 (0.0)
 Insomnia 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
Ear and labyrinth disorders 3 (9.1) 2 (12.5) 1 (7.7) 0 (0.0) 0 (0.0)
 Tinnitus 3 (9.1) 2 (12.5) 1 (7.7) 0 (0.0) 0 (0.0)
Respiratory, thoracic, and mediastinal disorders 2 (6.1) 2 (12.5) 0 (0.0) 0 (0.0) 0 (0.0)
 Cough 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
 Dyspnea 1 (3.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0)
Metabolism and nutrition disorders 1 (3.0) 0 (0.0) 1 (7.7) 0 (0.0) 0 (0.0)
 Increased appetite 1 (3.0) 0 (0.0) 1 (7.7) 0 (0.0) 0 (0.0)
Total 32 15 13 3 1
  1. MedDRA Medical Dictionary for Regulatory Activities, PT Preferred Term, SOC System Organ Class
  2. There were no significant differences across product profiles