
Adverse Events According to System-Organ Classes
System-organ classes | Symptom | Week 2-4 | Week 6-8 | Week 10-14 | Total |
---|---|---|---|---|---|
Gastro-intestinal system disorders | Constipation | 9 (13.2) | 13 (26.0) | 17 (21.3) | 39 (19.7) |
Dyspepsia | 5 (7.4) | 1 (2.0) | 5 (6.3) | 11 (5.6) | |
Nausea | 3 (4.4) | 4 (8.0) | 3 (3.8) | 10 (5.1) | |
Vomiting | 0 (0) | 0 (0) | 2 (2.5) | 2 (1.0) | |
Abdominal pain | 1 (1.5) | 0 (0) | 1 (1.3) | 2 (1.0) | |
Diarrhea | 0 (0) | 1 (2.0) | 0 (0) | 1 (0.5) | |
Lip Soreness | 1 (1.5) | 0 (0) | 0 (0) | 1 (0.5) | |
Blood in stool | 0 (0) | 0 (0) | 1 (1.3) | 1 (0.5) | |
Subtotal | 19 (27.9) | 19 (38.0) | 29 (36.3) | 67 (33.8) | |
Psychiatric disorders | Insomnia | 20 (29.4) | 13 (26.0) | 22 (27.5) | 55 (27.8) |
Central & peripheral nervous system disorders | Dizziness | 3 (4.4) | 3 (6.0) | 9 (11.3) | 15 (7.6) |
Diaphoresis | 6 (8.8) | 4 (8.0) | 2 (2.5) | 12 (6.1) | |
Headache | 3 (4.4) | 2 (4.0) | 1 (1.3) | 6 (3.0) | |
Limpness body | 2 (2.9) | 0 (0) | 1 (1.3) | 3 (1.5) | |
Subtotal | 14 (20.6) | 10 (20.0) | 14 (17.5) | 38 (19.2) | |
Autonomic nervous system disorders | Mouth dry | 5 (7.4) | 3 (6.0) | 4 (5.0) | 12 (6.1) |
Palpitation | 1 (1.5) | 2 (4.0) | 0 (0) | 3 (1.5) | |
Throat dry | 1 (1.5) | 0 (0) | 0 (0) | 1 (0.5) | |
Subtotal | 7 (10.3) | 5 (10.0) | 4 (5.0) | 16 (8.1) | |
Musculo-skeletal system disorders | Muscle cramp | 3 (4.4) | 2 (4.0) | 5 (6.3) | 10 (5.1) |
Muscle pain | 0 (0) | 0 (0) | 1 (1.3) | 1 (0.5) | |
Subtotal | 3 (4.4) | 2 (4.0) | 6 (7.5) | 11 (5.6) | |
Skin and appendages disorders | Pruritus | 0 (0) | 0 (0) | 2 (2.5) | 2 (1.0) |
Hair loss | 1 (1.5) | 0 (0) | 1 (1.3) | 2 (1.0) | |
Rash | 1 (1.5) | 0 (0) | 0 (0) | 1 (0.5) | |
Subtotal | 2 (2.9) | 0 (0) | 3 (3.8) | 5 (2.5) | |
Body as a whole-general disorders | Chest discomfort | 0 (0) | 0 (0) | 1 (1.3) | 1 (0.5) |
Oedema | 0 (0) | 1 (2.0) | 0 (0) | 1 (0.5) | |
Halitosis | 0 (0) | 0 (0) | 1 (1.3) | 1 (0.5) | |
Fever | 1 (1.5) | 0 (0) | 0 (0) | 1 (0.5) | |
Subtotal | 1 (1.5) | 1 (2.0) | 2 (2.5) | 4 (2.0) | |
Urinary system disorders | Dysuria | 1 (1.5) | 0 (0) | 0 (0) | 1 (0.5) |
Respiratory system disorders | Throat irritation | 1 (1.5) | 0 (0) | 0 (0) | 1 (0.5) |
The data was expressed as a number (%).