Table 4. Serious adverse events (MedDRA system organ classes) reported during follow-up.
| MedDRA system-organ class | Total number of “serious” reports | Number of reports suspected of being related to the treatment by the investigator |
|---|---|---|
| General disorders and administration site conditions | 24 | 1 |
| Neoplasms benign and malignant | 23 | 1 |
| Gastrointestinal disorders | 19 | 3 |
| Respiratory and thoracic disorders | 9 | 2 |
| Cardiac disorders | 7 | 0 |
| Infections and infestations | 7 | 0 |
| Surgical and medical procedures | 6 | 0 |
| Blood disorders | 7 | 0 |
| Injury, poisoning | 5 | 0 |
| Nervous system disorders | 4 | 0 |
| Skin disorders | 2 | 1 |
| Investigationsa | 2 | 0 |
| Psychiatric disorders | 2 | 0 |
| Reproductive system disorders | 2 | 0 |
| Renal and urinary disorders | 1 | 0 |
| Hepatobiliary disorders | 1 | 0 |
| Metabolism and nutrition disorders | 2 | 0 |
| Vascular disorders | 1 | 0 |
| Eye disorders | 1 | 0 |
| Endocrine disorders | 1 | 0 |
| Total | 126 | 8 |
a Investigations include biological examinations abnormalities, examinations (ECG, CT scan etc.) induced by abnormalities