TABLE 7.
Adverse events associated with Golden-Antrodia Camphorata consumption (Safety Set).
| System organ class | Test (N = 53) | Placebo (N = 51) | Total (N = 104) | |||
|---|---|---|---|---|---|---|
| Preferred term | N (%) | Case number | N (%) | Case number | N (%) | Case number |
| Gastrointestinal disorders | 2 (3.77) | 4 | 0 (0.00) | 0 | 2 (1.92) | 4 |
| Abdominal pain | 1 (1.89) | 2 | 0 (0.00) | 0 | 1 (0.96) | 2 |
| Diarrhea | 2 (3.77) | 2 | 0 (0.00) | 0 | 2 (1.92) | 2 |
| General disorders and administration site conditions | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Fatigue | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Infections and infestations | 1 (1.89) | 1 | 1 (1.96) | 1 | 2 (1.92) | 2 |
| Bronchitis | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Nasopharyngitis | 0 (0.00) | 0 | 1 (1.96) | 1 | 1 (0.96) | 1 |
| Injury, poisoning and procedural complications | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Lip injury | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Musculoskeletal and connective tissue disorders | 0 (0.00) | 0 | 1 (1.96) | 1 | 1 (0.96) | 1 |
| Back pain | 0 (0.00) | 0 | 1 (1.96) | 1 | 1 (0.96) | 1 |
| Nervous system disorders | 2 (3.77) | 2 | 0 (0.00) | 0 | 2 (1.92) | 2 |
| Headache | 2 (3.77) | 2 | 0 (0.00) | 0 | 2 (1.92) | 2 |
| Respiratory, thoracic and mediastinal disorders | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Rhinitis allergic | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Skin and subcutaneous tissue disorders | 2 (3.77) | 2 | 1 (1.96) | 1 | 3 (2.88) | 3 |
| Eczema | 1 (1.89) | 1 | 1 (1.96) | 1.96 | 2 | 1.92 |
| Urticaria | 1 (1.89) | 1 | 0 (0.00) | 0 | 1 (0.96) | 1 |
| Totoal a | 9 (16.98) | 12 | 3 (5.88) | 3 | 12 (11.54) | 15 |
Accumulated total (number of cases).