Summary of toxicity grades 3 and 4 according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
| MedDRA System Organ Class preferred term . | No. of patients (%) . | No. of events . |
|---|---|---|
| Total no. of subjects with grade 3 or 4 adverse events | 10 (30) | 18 |
| Blood and lymphatic system disorders | 4 (12) | 7 |
| Thrombocytopenia | 3 (9) | 4 |
| Neutropenia | 2 (6) | 2 |
| Anemia NOS | 1 (3) | 1 |
| Infections and infestations | 3 (9) | 3 |
| Herpes zoster | 1 (3) | 1 |
| Nasopharyngitis | 1 (3) | 1 |
| Pneumonia NOS | 1 (3) | 1 |
| General disorders and administration site conditions | 2 (6) | 3 |
| Pyrexia | 2 (6) | 2 |
| Pain NOS | 1 (3) | 1 |
| Nervous system disorders | 2 (6) | 2 |
| Carotid artery stenosis | 1 (3) | 1 |
| Dizziness | 1 (3) | 1 |
| Cardiac disorders: angina pectoris | 1 (3) | 1 |
| 1 (3) | 1 | |
| Hepatobiliary disorders: cytolytic hepatitis | 1 (3) | 1 |
| 1 (3) | 1 | |
| Respiratory, thoracic, and mediastinal disorders: hypoxia | 1 (3) | 1 |
| 1 (3) | 1 |
| MedDRA System Organ Class preferred term . | No. of patients (%) . | No. of events . |
|---|---|---|
| Total no. of subjects with grade 3 or 4 adverse events | 10 (30) | 18 |
| Blood and lymphatic system disorders | 4 (12) | 7 |
| Thrombocytopenia | 3 (9) | 4 |
| Neutropenia | 2 (6) | 2 |
| Anemia NOS | 1 (3) | 1 |
| Infections and infestations | 3 (9) | 3 |
| Herpes zoster | 1 (3) | 1 |
| Nasopharyngitis | 1 (3) | 1 |
| Pneumonia NOS | 1 (3) | 1 |
| General disorders and administration site conditions | 2 (6) | 3 |
| Pyrexia | 2 (6) | 2 |
| Pain NOS | 1 (3) | 1 |
| Nervous system disorders | 2 (6) | 2 |
| Carotid artery stenosis | 1 (3) | 1 |
| Dizziness | 1 (3) | 1 |
| Cardiac disorders: angina pectoris | 1 (3) | 1 |
| 1 (3) | 1 | |
| Hepatobiliary disorders: cytolytic hepatitis | 1 (3) | 1 |
| 1 (3) | 1 | |
| Respiratory, thoracic, and mediastinal disorders: hypoxia | 1 (3) | 1 |
| 1 (3) | 1 |