Table 5.
Serious Medical Events between Year 2 and the Follow-up Study Visit by Drug Assigned in the Clinical Trial
| All (N=1090) | Drug Assigned in the Clinical Trial | ||||||
|---|---|---|---|---|---|---|---|
| Ranibizumab (N=555) | Bevacizumab (N=535) | ||||||
|
| |||||||
| Serious Medical Event | n | (%) | n | (%) | n | (%) | P§ |
| Death-all causes | 203 | (18.6) | 101 | (18.2) | 102 | (19.1) | 0.76 |
| Arteriothrombotic events | 66 | (6.1) | 42 | (7.6) | 24 | (4.5) | 0.04 |
| Venous thrombotic events | 9 | (0.8) | 4 | (0.7) | 5 | (0.9) | 0.75 |
| Hypertension | 27 | (2.5) | 13 | (2.3) | 14 | (2.6) | 0.85 |
| One or more serious medical events | 533 | (48.9) | 273 | (49.2) | 260 | (48.6) | 0.86 |
| Previously associated with anti-VEGF treatment‡ | 177 | (16.2) | 90 | (16.2) | 77 | (14.4) | 0.15 |
| MedDRA† system organ class** | |||||||
| Cardiac disorders | 120 | (11.0) | 62 | (11.2) | 58 | (10.8) | 0.92 |
| Infections | 75 | (6.9) | 32 | (5.8) | 43 | (8.0) | 0.15 |
| Nervous system disorders | 82 | (7.5) | 44 | (7.9) | 38 | (7.1) | 0.65 |
| Injury and procedural complications | 57 | (5.2) | 33 | (5.9) | 24 | (4.5) | 0.34 |
| Neoplasms benign and malignant | 97 | (8.9) | 48 | (8.6) | 49 | (9.2) | 0.83 |
| Gastrointestinal disorders | 36 | (3.3) | 20 | (3.6) | 16 | (3.0) | 0.61 |
§
Fisher’s exact test
‡
Arteriothrombotic events, systemic hemorrhage, congestive heart failure, venous thrombotic events, hypertension, vascular death
†
Medical Dictionary for Regulatory Activities