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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