TABLE II.
Adverse events by system
| Body system |
Events |
|
|---|---|---|
| (n) | (%) | |
| Cardiac disorders | 0 | 0 |
| Ear and labyrinth disorders | 1 | 2.2 |
| Eye disorders | 1 | 2.2 |
| Gastrointestinal disorders [oral hypoesthesia (23%), nausea (8%), vomiting (3%), oral pain (1%)] | 16 | 35.6 |
| General disorders and administration-site conditions (for example, local injection pain) | 20 | 44.4 |
| Infections and infestations | 2 | 4.4 |
| Investigations | 3 | 6.7 |
| Metabolism and nutrition disorders | 1 | 2.2 |
| Musculoskeletal and connective tissue disorders | 7 | 15.6 |
| Nervous system disorders [oral paresthesia (18%), hypoesthesia (15%), dizziness (3%), dysgeusia (4%), somnolence (8%), vertigo (4%)] | 21 | 46.7 |
| Psychiatric disorders | 4 | 8.9 |
| Respiratory, thoracic and mediastinal disorders | 6 | 13.3 |
| Skin and subcutaneous tissue disorders | 11 | 24.4 |
| Vascular disorders | 4 | 8.9 |
| TOTAL | 45 | 100 |