Table 6.
Summary of total adverse events during 2 months treatment with the transdermal fentanyl (Fentavera) patch.
| n | |
|---|---|
| Preferred terms (MedDRA) | |
| Nausea | 6 |
| Vomiting | 3 |
| Vertigo | 2 |
| Restlessness | 2 |
| Abdominal pain upper | 2 |
| Fatigue | 1 |
| Sedation | 1 |
| Dysphoria | 1 |
| Retching | 1 |
| Feeling abnormal | 1 |
| Dyspnoea | 1 |
| Confusional state | 1 |
| Rash | 1 |
| Death | 1 |
| Dermatitis allergic | 1 |
| Pain | 1 |
| Diarrhoea | 1 |
| Swelling | 1 |
| Headache | 1 |
| Depressive symptom | 1 |
| System-Organ-Class (SOC) (MedDRA) | |
| Gastrointestinal disorders | 13 |
| General disorders and administration site conditions | 5 |
| Psychiatric disorders | 5 |
| Ear and labyrinth disorders | 2 |
| Nervous system disorders | 2 |
| Skin and subcutaneous tissue disorders | 2 |
| Respiratory, thoracic, and mediastinal disorders | 1 |
| Outcome | |
| Recovered | 16 |
| Unknown | 1 |
| Fatal | 1 |
| Life-threatening | 3 |
| Causality assessment | |
| Certain | 4 |
| Probable | 9 |
| Possible | 2 |
| Unlikely | 3 |