Table 4 |
||||||||
| Incidence and severity of hypersensitivity adverse events, all causality | ||||||||
| Pegaptanib 0.3 mg | ||||||||
| Number of Subjects | With Diabetes | Without Diabetes | ||||||
| (N = 165) | (N = 1421) | |||||||
| Preferred Term1 | n | (%) | Severe | LT | n | (%) | Severe | LT |
| Blepharitis, allergic | 0 | 0 | 0 | 0 | 1 | (0.1) | 0 | 0 |
| Dermatitis, allergic | 0 | 0 | 0 | 0 | 1 | (0.1) | 0 | 0 |
| Dermatitis, contact | 0 | 0 | 0 | 0 | 7 | (0.5) | 0 | 0 |
| Drug hypersensitivity | 0 | 0 | 0 | 0 | 6 | (0.4) | 0 | 0 |
| Erythema | 0 | 0 | 0 | 0 | 2 | (0.1) | 0 | 0 |
| Hypersensitivity | 0 | 0 | 0 | 0 | 2 | (0.1) | 0 | 0 |
| Hypersensitivity NOS | 0 | 0 | 0 | 0 | 5 | (0.4) | 0 | 0 |
| Rash | 0 | 0 | 0 | 0 | 2 | (0.1) | 0 | 0 |
| Rash NOS | 2 | (1.2) | 0 | 0 | 12 | (0.8) | 0 | 0 |
| Toxic skin eruption | 0 | 0 | 0 | 0 | 1 | (0.1) | 0 | 0 |
| Urticaria | 0 | 0 | 0 | 0 | 1 | (0.1) | 0 | 0 |
1Preferred terms are from MedDRA [Medical Dictionary for Regulatory Activities, version 12.1].
LT: life-threatening.
NOS: not otherwise specified.
Dombi et al. BMC Ophthalmology 2012 12:37 doi:10.1186/1471-2415-12-37
