Table 6.
Adverse events up to one year: bevacizumab vs. ranibizumab
| Serious ocular adverse event | Studies reporting adverse event* | Bevacizumab | Ranibizumab | RR [95% CI] Bevacizumab vs. ranibizumab |
||
|---|---|---|---|---|---|---|
| Number with event | Total participants | Number with event | Total participants | |||
| Endophthalmitis | CATT 2011; GEFAL 2013 | 4 (< 1%) | 832 | 3 (< 1%) | 838 | 1.34 [0.30, 5.98] |
| Retinal detachment | CATT 2011; GEFAL 2013 | 3 (< 1%) | 832 | 0 | 838 | 7.05 [0.36, 136. 28] |
| Retinal pigment epithelial tear | CATT 2011; IVAN 2013 | 3 (< 1%) | 882 | 3 (< 1%) | 913 | 1.04 [0.21, 5.11] |
| Traumatic cataract | CATT 2011; GEFAL 2013; IVAN 2013 | 1 (< 1%) | 1128 | 2 (< 1%) | 1152 | 0.51 [0.05, 5.62] |
| Severe uveitis | CATT 2011; IVAN 2013 | 4 (< 1%) | 882 | 1 (< 1%) | 913 | 4.14 [0.46, 36. 97] |
| Non-ocular adverse event | Studies reporting adverse event** | Bevacizumab | Ranibizumab | RR [95% CI] Bevacizumab vs. ranibizumab |
||
|---|---|---|---|---|---|---|
| Number with event | Total participants | Number with event | Total participants | |||
| At least 1 serious adverse event | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 227 (18%) | 1282 | 183 (14%) | 1315 | 1.27 [1.06, 1.52] |
| Death | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 25 (2%) | 1282 | 20 (2%) | 1315 | 1.28 [0.72, 2.30] |
| Myocardial infarction | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 8 (< 1%) | 1282 | 10 (< 1%) | 1315 | 0.82 [0.32, 2.07] |
| Stroke or cerebral infarction | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 5 (< 1%) | 1282 | 8 (< 1%) | 1315 | 0.64 [0.21, 1.95] |
| Transient ischemic attack | CATT 2011; GEFAL 2013; IVAN 2013 | 4 (< 1%) | 1128 | 4 (< 1%) | 1152 | 1.02 [0.26, 4.07] |
| Venous thrombotic event | CATT 2011; GEFAL 2013; IVAN 2013 | 8 (< 1%) | 1128 | 2 (< 1%) | 1152 | 4.09 [0.87, 19. 20] |
| Cardiac disorders | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 37 (3%) | 1282 | 36 (3%) | 1315 | 1.05 [0.67, 1.66] |
| Gastrointestinal disorders | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 24 (2%) | 1282 | 11 (< 1%) | 1315 | 2.24 [1.10, 4.55] |
| Infections | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 42 (3%) | 1282 | 27 (2%) | 1315 | 1.60 [0.99, 2.57] |
| Injury and procedural complications | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 30 (2%) | 1282 | 21 (2%) | 1315 | 1.47 [0.84, 2.55] |
| Neoplasms (benign, malignant, unspecified) | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 20 (2%) | 1282 | 21 (2%) | 1315 | 0.98 [0.53, 1.79] |
| Nervous system disorders | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 25 (2%) | 1282 | 24 (2%) | 1315 | 1.07 [0.61, 1.86] |
| Surgical or medical procedure | CATT 2011; GEFAL 2013; IVAN 2013; MANTA 2013 | 26 (2%) | 1282 | 13 (1%) | 1315 | 2.05 [1.06, 3.97] |
CI: confidence interval
RR: risk ratio
*
CATT 2011 (n = 586 in bevacizumab group; n = 599 in ranibizumab group); GEFAL 2013 (n = 246 in bevacizumab group; n = 239 in ranibizumab group); IVAN 2013 (n = 296 in bevacizumab group; n = 314 in ranibizumab group)
**
CATT 2011 (n = 586 in bevacizumab group; n = 599 in ranibizumab group); GEFAL 2013 (n = 246 in bevacizumab group; n = 239 in ranibizumab group); IVAN 2013 (n = 296 in bevacizumab group; n = 314 in ranibizumab group); MANTA 2013 (n = 154 in bevacizumab group; n = 163 in ranibizumab group)