Table 2.
Safety of the patch: most affected organ systems and most frequent AEs (incidence ≥ 0.5%)
| MedDRA | All | Non-serious | Serious | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| System organ class | Preferred term | Unrelated | Related | Unrelated | Related | ||||||
| n* | % | n* | % | n* | % | n* | % | n* | % | ||
| Total | 1104 | 100 | 1104 | 100 | 1104 | 100 | 1104 | 100 | 1104 | 100 | |
| Gastrointestinal disorders | Total | 21 | 1.9 | 5 | 0.5 | 13 | 1.2 | 1 | 0.1 | 2 | 0.2 |
| Nausea | 8 | 0.7 | 2 | 0.2 | 5 | 0.5 | 0 | – | 1 | 0.1 | |
| Vomiting | 6 | 0.5 | 1 | 0.1 | 5 | 0.5 | 0 | – | 0 | – | |
| General and administration site | Total | 15 | 1.4 | 8 | 0.7 | 5 | 0.5 | 2 | 0.2 | 0 | – |
| Nervous system | Total | 19 | 1.7 | 7 | 0.6 | 8 | 0.7 | 3 | 0.3 | 1 | 0.1 |
| Cognitive disorder | 6 | 0.5 | 4 | 0.4 | 1 | 0.1 | 0 | – | 1 | 0.1 | |
| Psychiatric disorders | Total | 28 | 2.5 | 8 | 0.7 | 15 | 1.4 | 1 | 0.1 | 5 | 0.5 |
| Confusional state | 5 | 0.5 | 2 | 0.2 | 2 | 0.2 | 0 | – | 1 | 0.1 | |
| Restlessness | 7 | 0.6 | 1 | 0.1 | 5 | 0.5 | 0 | – | 1 | 0.1 | |
| Skin and subcutaneous tissue | Total | 72 | 6.5 | 1 | 0.1 | 71 | 6.4 | 0 | – | 0 | – |
| Dermatitis allergic | 10 | 0.9 | 0 | – | 10 | 0.9 | 0 | – | 0 | – | |
| Dermatitis contact | 12 | 1.1 | 0 | – | 12 | 1.1 | 0 | – | 0 | – | |
| Erythema | 19 | 1.7 | 0 | – | 19 | 1.7 | 0 | – | 0 | – | |
| Pruritus | 8 | 0.7 | 0 | – | 8 | 0.7 | 0 | – | 0 | – | |
| Skin reaction | 9 | 0.8 | 0 | – | 9 | 0.8 | 0 | – | 0 | – | |
*
n, number of patients.