Adverse Events According to System-Organ Classes
| System-organ classes | Symptom | 2-6 weeks | 10-14 weeks |
|---|---|---|---|
| Gastro-intestinal system disorders | Constipation | 8 (14.8) | 9 (23.7) |
| Nausea | 5 (9.3) | 4 (10.5) | |
| Dry mouth | 3 (5.6) | 0 (0.0) | |
| Dyspepsia | 3 (5.6) | 1 (2.6) | |
| Heartburn | 2 (3.7) | 0 (0.0) | |
| Diarrhea | 1 (1.9) | 0 (0.0) | |
| Abdominal pain | 1 (1.9) | 0 (0.0) | |
| Subtotal | 23 (42.6) | 14 (36.8) | |
| Central & peripheral nervous system Disorders | Dizziness | 5 (9.3) | 1 (2.6) |
| Shakiness | 4 (7.4) | 1 (2.6) | |
| Paresthesia | 1 (1.9) | 0 (0.0) | |
| Headache | 0 (0.0) | 3 (7.9) | |
| Tingling | 0 (0.0) | 1 (2.6) | |
| Subtotal | 10 (18.5) | 6 (15.8) | |
| Psychiatric disorders | Insomnia | 7 (13.0) | 4 (10.5) |
| Memory impairment | 1 (1.9) | 0 (0.0) | |
| subtotal | 8 (14.8) | 4 (10.5) | |
| Autonomic nervous system disorders | Palpitation | 7 (13.0) | 1 (2.6) |
| Body as a whole - general disorders | Coldness | 2 (3.7) | 3 (7.9) |
| Hot flushes | 1 (1.9) | 1 (2.6) | |
| Flank pain | 1 (1.9) | 0 (0.0) | |
| Fatigue | 0 (0.0) | 1 (2.6) | |
| Subtotal | 4 (7.4) | 5 (13.2) | |
| Skin and appendages disorders | Alopepsia | 1 (1.9) | 0 (0.0) |
| Dermatitis | 0 (0.0) | 2 (5.3) | |
| Sweating increased | 0 (0.0) | 2 (5.3) | |
| Subtotal | 1 (1.9) | 4 (10.5) | |
| Reproductive disorders, female | Metrorrhagia | 1 (1.9) | 0 (0.0) |
| Menses onset delayed | 0 (0.0) | 1 (2.6) | |
| Subtotal | 1 (1.9) | 1 (2.6) | |
| Urinary system disorders | Bladder retention | 0 (0.0) | 1 (2.6) |
| Nocturnal enuresis | 0 (0.0) | 1 (2.6) | |
| Subtotal | 0 (0.0) | 2 (5.3) | |
| Vision disorders | Hordeolum | 0 (0.0) | 1 (2.6) |
| Total | 54 (100.0) | 38 (100.0) |
Data are expressed number (%).
