Table 3.
Adverse events up to one year: pegaptanib vs. control
| Ocular adverse event* | 0.3 mg pegaptanib n = 295 |
1.0 mg pegaptanib n = 301 |
3.0 mg pegaptanib n = 296 |
All doses pegaptanib n = 892 |
Control n = 298 |
RR [95% CI] All doses vs. control |
|---|---|---|---|---|---|---|
| Any eye disorder | 9 (3%) | 4 (1%) | 10 (3%) | 23 (3%) | 2 (< 1%) | 3.84 [0.91, 16. 20] |
| Endophthalmitis | 6 (2%) | 3 (1%) | 3 (1%) | 12 (1%) | 0 | 8.37 [0.50, 140. 95] |
| Retinal detachment | 1 (< 1%) | 2 (< 1%) | 2 (< 1%) | 5 (< 1%) | 0 | 3.68 [0.20, 66. 41] |
| Traumatic cataract | 1 (< 1%) | 2 (< 1%) | 2 (< 1%) | 5 (< 1%) | 0 | 3.68 [0.20, 66. 41] |
| Retinal hemorrhage | 1 (< 1%) | 0 | 1 (< 1%) | 2 (< 1%) | 0 | 1.67 [0.08, 34. 77] |
| Vitreous hemorrhage | 0 | 0 | 1 (< 1%) | 1 (< 1%) | 0 | 1.00 [0.04, 24. 59] |
| Uveitis | 0 | 0 | 1 (< 1%) | 1 (< 1%) | 0 | 1.00 [0.04, 24. 59] |
| Elevated intraocular pressure | 1 (< 1%) | 0 | 0 | 1 (< 1%) | 0 | 1.00 [0.04, 24. 59] |
| Papilledema | 0 | 0 | 0 | 0 | 1 (< 1%) | 0.11 [0.00, 2.73] |
| Non-ocular adverse event* | 0.3 mg pegaptanib n = 295 |
1.0 mg pegaptanib n = 301 |
3.0 mg pegaptanib n = 296 |
All doses pegaptanib n = 892 |
Control n = 298 |
RR [95% CI] All doses vs. control |
|---|---|---|---|---|---|---|
| At least 1 serious adverse event | 55 (19%) | 50 (17%) | 64 (22%) | 169 (19%) | 45 (15%) | 1.25 [0.93, 1.70] |
| Cardiac disorders | 11 (4%) | 4 (1%) | 10 (3%) | 25 (3%) | 14 (5%) | 0.60 [0.31, 1.13] |
| Neoplasms (benign, malignant, unspecified) | 11 (4%) | 7 (2%) | 8 (3%) | 26 (3%) | 12 (4%) | 0.72 [0.37, 1.42] |
| Injury and procedural complications, such as fractures (also includes traumatic cataracts) | 10 (3%) | 9 (3%) | 8 (3%) | 27 (3%) | 3 (1%) | 3.01 [0.92, 9.84] |
| Nervous system disorders | 10 (3%) | 5 (2%) | 10 (3%) | 25 (3%) | 7 (2%) | 1.19 [0.52, 2.73] |
| Infections and infestations | 2 (<1%) | 7 (2%) | 11 (4%) | 20 (2%) | 5 (2%) | 1.34 [0.51, 3.53] |
| Gastrointestinal disorders | 3 (1%) | 6 (2%) | 5 (2%) | 14 (2%) | 4 (1%) | 1.17 [0.39, 3.52] |
| Respiratory, thoracic, mediastinal disorders | 2 (< 1%) | 5 (2%) | 5 (2%) | 12 (1%) | 4 (1%) | 1.00 [0.33, 3.08] |
| Musculoskeletal and connective tissue | 1 (< 1%) | 5 (2%) | 3 (1%) | 9 (1%) | 2 (<1%) | 1.50 [0.33, 6.92] |
| Renal and urinary disorders | 2 (< 1%) | 3 (1%) | 2 (<1%) | 7 (<1%) | 3 (1%) | 0.78 [0.20, 3.00] |
| Vascular disorders | 3 (1%) | 2 (< 1%) | 2 (< 1%) | 7 (< 1%) | 3 (1%) | 0.78 [0.20, 3.00] |
CI: confidence interval
RR: risk ratio
*
Most frequent serious adverse events experienced by 1190 participants in the VISION 2004 study