Table 5.
Summary of all adverse drug reactions for the period June 2005 to December 2011, sorted by MedDRA system organ classes
| MedDRA system organ class | MedDRA preferred term | No. of symptoms |
Main events | Secondary events |
|---|---|---|---|---|
| Gastrointestinal disorders | 16* | 8 | 8 | |
| Abdominal discomfort | 1 | 0 | 1 | |
| Abdominal pain | 2 | 1 | 1 | |
| Abdominal pain upper | 1 | 0 | 1 | |
| Diarrhea | 3 | 1 | 2 | |
| Flatulence | 1 | 1 | 0 | |
| Gingival bleeding | 1 | 1 | 0 | |
| Glossodynia | 1 | 0 | 1 | |
| Lip swelling | 1 | 0 | 1 | |
| Nausea | 4 | 4 | 0 | |
| Swollen tongue | 1 | 0 | 1 | |
| General disorders and administration site conditions | 2 | 1 | 1 | |
| Drug intolerance | 1 | 1 | 0 | |
| Pyrexia | 1 | 0 | 1 | |
| Immune system disorders | 1 | 1 | 0 | |
| Hypersensitivity | 1 | 1 | 0 | |
| Nervous system disorders | 4 | 2 | 2 | |
| Ageusia | 1 | 0 | 1 | |
| Anosmia | 1 | 1 | 0 | |
| Burning sensation mucosal | 1 | 0 | 1 | |
| Headache | 1 | 1 | 0 | |
| Psychiatric disorders | 2 | 0 | 2 | |
| Agitation | 1 | 0 | 1 | |
| Sleep disorder | 1 | 0 | 1 | |
| Respiratory, thoracic and mediastinal disorders | 1 | 1 | 0 | |
| Dyspnoea | 1 | 1 | 0 | |
| Skin and subcutaneous tissue disorders | 4 | 4 | 0 | |
| Acne | 1 | 1 | 0 | |
| Angioedema | 1 | 1 | 0 | |
| Rash | 1 | 1 | 0 | |
| Rosacea | 1 | 1 | 0 | |
| Total | 30 | 17 | 13 | |
| *The numbers of reported adverse reactions for each MedDRA system organ class (shown in bold) are further subdivided into the MedDRA preferred terms | ||||