
Adverse Events According to System Organ Classes
System-organ classes | Symptom | 0-4 weeks | 4-8 weeks | 8-14 weeks | Total |
---|---|---|---|---|---|
Gastro-intestinal system disorders | Dry mouth or thirst | 11 (17.74) | 1 (4.17) | 2 (11.76) | 14 (13.59) |
Constipation | 1 (1.61) | 6 (25.00) | 2 (11.76) | 9 (8.74) | |
Nausea | 3 (4.84) | 2 (8.33) | 0 (0) | 5 (4.85) | |
Dyspepsia | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Vomit | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Esophageal pain | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Diarrhea | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Abdominal distension | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Subtotal | 20 (32.26) | 9 (37.50) | 4 (23.53) | 33 (32.04) | |
Central & peripheral nervous system disorders | Dizziness | 11 (17.74) | 2 (8.33) | 1 (5.88) | 14 (13.59) |
Headache | 2 (3.23) | 4 (16.67) | 2 (11.76) | 8 (7.77) | |
Coldness of hands and feet | 1 (1.61) | 0 (0) | 1 (5.88) | 2 (1.94) | |
Shakiness | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Paresthesia | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Subtotal | 16 (25.81) | 6 (25.00) | 4 (23.53) | 26 (25.24) | |
Psychiatric disorders | Insomnia | 6 (9.68) | 4 (16.67) | 1 (5.88) | 11 (10.68) |
Irritability | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Subtotal | 7 (11.29) | 4 (16.67) | 1 (5.88) | 12 (11.65) | |
Urinary system disorders | Dysuria | 3 (4.84) | 0 (0) | 2 (11.76) | 5 (4.85) |
Residual urine sense | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Subtotal | 4 (6.45) | 0 (0) | 2 (11.76) | 6 (5.83) | |
Skin and appendages disorders | Alopecia | 1 (1.61) | 0 (0) | 1 (5.88) | 2 (1.94) |
Itching | 2 (3.23) | 0 (0) | 0 (0) | 2 (1.94) | |
Urticaria | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Folliculitis | 0 (0) | 0 (0) | 1 (5.88) | 1 (0.97) | |
Subtotal | 4 (6.45) | 0 (0) | 2 (11.76) | 6 (5.83) | |
Autonomic nervous system disorders | Hyperhidrosis | 3 (4.84) | 0 (0) | 0 (0) | 3 (2.91) |
Heat intolerance | 1 (1.61) | 0 (0) | 1 (5.88) | 2 (1.94) | |
Subtotal | 4 (6.45) | 0 (0) | 1 (5.88) | 5 (4.85) | |
Reproductive disorders | Erectile dysfunction | 3 (4.84) | 0 (0) | 0 (0) | 3 (2.91) |
Abnormal uterine bleeding | 0 (0) | 0 (0) | 1 (5.88) | 1 (0.97) | |
Subtotal | 3 (4.84) | 0 (0) | 1 (5.88) | 4 (3.88) | |
Eye disorders | Ocular pain | 0 (0) | 2 (8.33) | 0 (0) | 2 (1.94) |
Eyelid myokymia | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Visual disturbance | 0 (0) | 1 (4.17) | 0 (0) | 1 (0.97) | |
Subtotal | 1 (1.61) | 3 (12.50) | 0 (0) | 4 (3.88) | |
Musculo-skeletal and connective tissue system disorders | Acute gout attack | 1 (1.61) | 0 (0) | 1 (5.88) | 2 (1.94) |
Dorsal foot pain | 1 (1.61) | 0 (0) | 0 (0) | 1 (0.97) | |
Subtotal | 2 (3.23) | 0 (0) | 1 (5.88) | 3 (2.91) | |
Body as a whole- general disorders | Fatigue | 1 (1.61) | 1 (4.17) | 1 (5.88) | 3 (2.91) |
Respiratory system disorders | COVID-19 infection | 0 (0) | 1 (4.17) | 0 (0) | 1 (0.97) |
Total | 62 (100) | 24 (100) | 17 (100) | 103 (100) |
Data presented as n (%) for categorical variables.
COVID-19: corona virus disease 19.