Table 3 Adverse events in safety population
Event | Cyclosporine–corticosteroids (N = 56) | Adalimumab–corticosteroids (N = 54) | ||
|---|---|---|---|---|
No. of events | Events/100 person-years | No. of events | Events/100 person-years | |
Any adverse event | 384 | 1573.8 | 372 | 1447.5 |
Serious adverse event | 17 | 69.7 | 31 | 120.6 |
Hospitalization for cataract surgery | 14 | 57.4 | 12 | 46.7 |
Hospitalization for ocular hypertension | 2 | 8.2 | 14 | 54.5 |
Glaucoma | 0 | 0.0 | 3 | 11.7 |
Pneumonitis | 1 | 4.1 | 0 | 0.0 |
Shingles | 0 | 0.0 | 1 | 3.9 |
Corneal ulcer | 0 | 0.0 | 1 | 3.9 |
Adverse event leading to discontinuation of trial drugs | 3 | 12.3 | 2 | 7.8 |
Adverse event possibly associated with trial drugs | 314 | 1286.9 | 257 | 1000.0 |
Adverse event possibly associated with VKH disease | 70 | 286.9 | 115 | 447.5 |
Adverse event that occurred in ≥10% of total participants | ||||
Alanine aminotransferse increased | 9 | 36.9 | 8 | 31.1 |
Arthragia | 13 | 53.3 | 0 | 0.0 |
Blood bilirubin increased | 17 | 69.7 | 9 | 35.0 |
Blood lactate dehydrogenase increased | 9 | 36.9 | 3 | 11.7 |
Blood urea nitrogen increased | 13 | 53.3 | 9 | 35.0 |
Cataract | 15 | 61.5 | 14 | 54.5 |
Creatinine increased | 13 | 53.3 | 7 | 27.2 |
Erythrocytes sedimentation rate increased | 10 | 41.0 | 9 | 35.0 |
Glomerular filteration rate decreased | 11 | 45.1 | 6 | 23.3 |
Hemoglobin increased | 8 | 32.8 | 7 | 27.2 |
Hyperglycemia | 15 | 61.5 | 12 | 46.7 |
Hypertensiona | 20 | 82.0 | 17 | 66.1 |
Hyperuricemia | 19 | 77.9 | 16 | 62.3 |
Lymphocyte count increased | 25 | 102.5 | 37 | 144.0 |
Leukocytosis | 37 | 151.6 | 38 | 147.9 |
Iris synechiae | 4 | 16.4 | 16 | 62.3 |
Ocular hypertension | 31 | 127.0 | 61 | 237.4 |
