Table 3.
Adverse events
Adverse events | DLBS3233 (n=40) |
Placebo (n=40) |
---|---|---|
| ||
Number of events (number of subjects with event) | ||
Central/peripheral nervous system | ||
Anxiety | 3 (2) | 0 |
Appetite exaggerated | 9 (7) | 10 (7) |
Dizziness | 16 (10) | 10 (7) |
Drowsiness | 0 | 1 (1) |
Headache | 8 (6) | 2 (2) |
Insomnia | 1 (1) | 1 (1) |
Local coldness | 1 (1) | 0 |
Tremor | 9 (5) | 2 (2) |
Vertigo | 2 (1) | 0 |
Cardiovascular system | ||
Increased blood pressure | 0 | 3 (3) |
Palpitation | 11 (6) | 4 (4) |
Ophthalmologic system | ||
Blurred vision | 1 (1) | 0 |
Ear, nose, and throat system | ||
Ear ache | 1 (1) | 0 |
Respiratory system | ||
Coughing | 0 | 1 (1) |
Dyspnea | 1 (1) | 0 |
Laryngitis | 1 (1) | 0 |
Pharyngitis | 0 | 1 (1) |
Gastrointestinal system | ||
Abdominal pain | 0 | 2 (2) |
Appendicitis | 1 (1) | 0 |
Constipation | 1 (1) | 1 (1) |
Diarrhea | 2 (2) | 0 |
Gastritis | 0 | 1 (1) |
Nausea | 2 (2) | 1 (1) |
Reproductive system | ||
Menstrual disorder | 3 (2) | 0 |
Urinary system | ||
Polyuria | 0 | 2 (1) |
Oliguria | 0 | 1 (1) |
Musculoskeletal system | ||
Myalgia | 4 (4) | 4 (4) |
Skin and appendages system | ||
Acne | 1 (1) | 1 (1) |
Dermatitis | 0 | 2 (1) |
Pruritus | 2 (2) | 2 (2) |
Hyperpigmentation | 0 | 1 (1) |
Body as whole – general | ||
Feeling unwell | 1 (1) | 0 |
Fever | 1 (1) | 3 (3) |
General weakness | 15 (9) | 8 (6) |
Influenza-like symptoms | 1 (1) | 0 |
Leg pain | 2 (2) | 1 (1) |
Pain | 1 (1) | 0 |
Diaphoresis | 7 (4) | 5 (4) |
Total | 108 (20) | 70 (19) |
Note: One subject might have more than one adverse event.