Table 4.
Ocular treatment-emergent adverse events (safety analysis set)
| Molidustat (n = 153) | Darbepoetin (n = 76) | Total (N = 229) | |
|---|---|---|---|
| Any ocular adverse events, n (%) | 46 (30.1) | 14 (18.4) | 60 (26.2) |
| Eye disorders, n (%) | 41 (26.8) | 12 (15.8) | 53 (23.1) |
| Angle closure glaucoma | 1 (0.7) | 0 | 1 (0.4) |
| Blepharitis | 1 (0.7) | 0 | 1 (0.4) |
| Borderline glaucoma | 0 | 1 (1.3) | 1 (0.4) |
| Cataract | 5 (3.3) | 0 | 5 (2.2) |
| Chalazion | 1 (0.7) | 0 | 1 (0.4) |
| Conjunctival deposit | 1 (0.7) | 0 | 1 (0.4) |
| Conjunctival hemorrhagea | 4 (2.6) | 2 (2.6) | 6 (2.6) |
| Conjunctivitis allergic | 3 (2.0) | 0 | 3 (1.3) |
| Corneal erosion | 1 (0.7) | 0 | 1 (0.4) |
| Corneal opacity | 1 (0.7) | 0 | 1 (0.4) |
| Diabetic retinal edemaa | 0 | 1 (1.3) | 1 (0.4) |
| Diabetic retinopathya | 4 (2.6) | 1 (1.3) | 5 (2.2) |
| Dry eye | 5 (3.3) | 1 (1.3) | 6 (2.6) |
| Entropion | 1 (0.7) | 0 | 1 (0.4) |
| Eye allergy | 1 (0.7) | 0 | 1 (0.4) |
| Eye pain | 0 | 1 (1.3) | 1 (0.4) |
| Eyelid edema | 1 (0.7) | 0 | 1 (0.4) |
| Eyelid rash | 1 (0.7) | 0 | 1 (0.4) |
| Foreign body sensation in eyes | 0 | 1 (1.3) | 1 (1.4) |
| Glaucoma | 2 (1.3) | 1 (1.3) | 3 (1.3) |
| Keratitis | 1 (0.7) | 0 | 1 (0.4) |
| Lenticular opacities | 1 (0.7) | 0 | 1 (0.4) |
| Ocular hyperemia | 3 (2.0) | 2 (2.6) | 5 (2.2) |
| Periorbital inflammation | 1 (0.7) | 0 | 1 (0.4) |
| Posterior capsule opacification | 0 | 1 (1.3) | 1 (0.4) |
| Retinal artery stenosisa | 1 (0.7) | 0 | 1 (0.4) |
| Retinal detachment | 1 (0.7) | 0 | 1 (0.4) |
| Retinal exudatesa | 1 (0.7) | 0 | 1 (0.4) |
| Retinal hemorrhagea | 3 (2.0) | 0 | 3 (1.3) |
| Retinal tear | 0 | 1 (1.3) | 1 (0.4) |
| Retinopathy hypertensivea | 2 (1.3) | 0 | 2 (0.9) |
| Rhegmatogenous retinal detachment | 0 | 1 (1.3) | 1 (0.4) |
| Trichiasis | 1 (0.7) | 0 | 1 (0.4) |
| Visual acuity reduced | 2 (1.3) | 0 | 2 (0.9) |
| Vitreous floaters | 0 | 1 (1.3) | 1 (0.4) |
| Immune system disorders, n (%) | 1 (0.7) | 0 | 1 (0.4) |
| Drug hypersensitivity | 1 (0.7) | 0 | 1 (0.4) |
| Infections and infestations, n (%) | 6 (3.9) | 1 (1.3) | 7 (3.1) |
| Conjunctivitis | 5 (3.3) | 0 | 5 (2.2) |
| Hordeolum | 1 (0.7) | 1 (1.3) | 2 (0.9) |
| Injury, poisoning and procedural complications, n (%) | 2 (1.3) | 1 (1.3) | 3 (1.3) |
| Eye contusion | 1 (0.7) | 0 | 1 (0.4) |
| Eye injury | 0 | 1 (1.3) | 1 (0.4) |
| Injury corneal | 1 (0.7) | 0 | 1 (0.4) |
| Product issues, n (%) | 0 | 1 (1.3) | 1 (0.4) |
| Device dislocation | 0 | 1 (1.3) | 1 (0.4) |
| Surgical and medical procedures, n (%) | 1 (0.7) | 1 (1.3) | 2 (0.9) |
| Cataract operation | 1 (0.7) | 1 (1.3) | 2 (0.9) |
A patient is counted only once within each preferred term or any primary system organ class.
a
Vascular-related events.