Adverse Events According to System-Organ Classes
| System-organ classes | Symptom | 2-6 weeks | 10-14 weeks |
|---|---|---|---|
| Central & peripheral nervous system disorders | Dizziness | 5 | 2 |
| Headache | 2 | 0 | |
| Tremor | 2 | 2 | |
| Paresthesia | 1 | 2 | |
| Eyelid fluttering | 1 | 0 | |
| Subtotal | 11 | 6 | |
| Gastro-intestinal system disorders | Constipation | 1 | 4 |
| Flatulence | 1 | 0 | |
| Heartburn | 1 | 0 | |
| Dyspepsia | 1 | 0 | |
| Nausea | 0 | 2 | |
| Abdominal pain | 0 | 1 | |
| Vomiting | 0 | 1 | |
| Subtotal | 4 | 8 | |
| Autonomic nervous system disorders | Palpitation | 4 | 2 |
| Dry mouth | 2 | 1 | |
| Sweating increased | 2 | 0 | |
| Subtotal | 8 | 3 | |
| Psychiatric disorders | Insomnia | 1 | 2 |
| Subtotal | 1 | 2 | |
| Body as a whole - general disorders | Sensation of cold | 1 | 0 |
| Sensation of warmth | 1 | 0 | |
| Halitosis | 1 | 0 | |
| Feeling unwell | 0 | 1 | |
| Subtotal | 3 | 1 | |
| Reproductive disorders, female | Menstrual irregularity | 1 | 0 |
| Menses onset delayed | 1 | 0 | |
| Hypomenorrhea | 0 | 2 | |
| Subtotal | 2 | 2 | |
| Musculo-skeletal system disorders | Body aching | 1 | 0 |
| Muscle cramp | 1 | 0 | |
| Joint pain | 0 | 1 | |
| Subtotal | 2 | 1 | |
| Skin and appendages disorders | Alopecia | 0 | 2 |
| Subtotal | 0 | 2 | |
| Vision disorders | Xerophthalmia | 0 | 1 |
| Subtotal | 0 | 1 | |
| Total | 31 | 26 |
Data are expressed number.
