Adverse Events according to System-Organ Classes
| System-organ classes | Symptom | 1-6 weeks | 6-10 weeks | 10-14 weeks |
|---|---|---|---|---|
| Gastro-intestinal system disorders | Constipation | 5 | 4 | 4 |
| Dyspepsia | 2 | 1 | 0 | |
| Nausea | 2 | 1 | 0 | |
| Diarrhea | 1 | 1 | 0 | |
| Stools loose | 1 | 0 | 0 | |
| Vomiting | 1 | 0 | 0 | |
| Heartburn | 0 | 2 | 1 | |
| Tenesmus | 0 | 1 | 1 | |
| Abdominal pain | 0 | 1 | 0 | |
| Subtotal | 12 | 11 | 6 | |
| Central & peripheral nervous system disorders | Dizziness | 4 | 4 | 4 |
| Headache | 2 | 0 | 2 | |
| Tremor | 1 | 1 | 1 | |
| Head tightness | 1 | 1 | 0 | |
| wooziness | 1 | 1 | 0 | |
| Coldness local | 0 | 1 | 0 | |
| Subtotal | 9 | 8 | 7 | |
| Psychiatric disorders | Insomnia | 4 | 3 | 2 |
| Depression | 1 | 0 | 0 | |
| Subtotal | 5 | 3 | 2 | |
| Urinary system disorders | Dysuria | 2 | 1 | 1 |
| Urine discolouration | 1 | 0 | 0 | |
| Urinary frequency | 1 | 0 | 0 | |
| Nocturia | 0 | 1 | 0 | |
| Urine volume deficient | 0 | 1 | 0 | |
| Subtotal | 4 | 3 | 1 | |
| Autonomic nervous system disorders | Dry mouth | 2 | 0 | 1 |
| Palpitation | 1 | 0 | 0 | |
| Throat dry | 1 | 0 | 0 | |
| Impotence | 0 | 1 | 0 | |
| Male sexual dysfunction | 0 | 0 | 1 | |
| Subtotal | 4 | 1 | 2 | |
| Body as a whole–general disorders | Feeling of warmth | 1 | 1 | 0 |
| Chest discomfort | 1 | 0 | 1 | |
| Feeling unwell | 1 | 0 | 0 | |
| Fatigue | 0 | 1 | 1 | |
| Subtotal | 3 | 2 | 2 | |
| Metabolic and nutritional disorders | Hypoglycaemic reaction | 1 | 0 | 0 |
| Thirst | 1 | 0 | 0 | |
| Subtotal | 2 | 0 | 0 | |
| Hearing and vestibular disorders | Tinnitus | 1 | 0 | 0 |
| Subtotal | 1 | 0 | 0 | |
| Respiratory system disorders | Throat pain | 1 | 0 | 0 |
| Subtotal | 1 | 0 | 0 | |
| Total | 41 | 28 | 20 |
