Table 6.
TEAEs in 1% or more of subjects in any treatment group (safety population)
| TEAEsa,b System organ class, preferred term | Combination (n=305), n (%) | 0.1% dexamethasone (n=298), n (%) | 1% azithromycin (n=155), n (%) | Vehicle (n=149), n (%) |
|---|---|---|---|---|
| Subjects with ≥1 TEAE | 80 (26.2) | 81 (27.2) | 33 (21.3) | 39 (26.2) |
| Eye disorders | 36 (11.8) | 27 (9.1) | 14 (9) | 16 (10.7) |
| Vision blurred | 5 (1.6) | 1 (0.3) | 0 | 1 (0.7) |
| Chalazion | 4 (1.3) | 5 (1.7) | 0 | 2 (1.3) |
| Conjunctivitis | 2 (0.7) | 3 (1) | 2 (1.3) | 4 (2.7) |
| Eye irritation | 3 (1) | 3 (1) | 0 | 0 |
| Conjunctival hyperemia | 3 (1) | 1 (0.3) | 1 (0.6) | 0 |
| Ocular hypertension | 3 (1) | 0 | 0 | 0 |
| Eye pain | 0 | 1 (0.3) | 2 (1.3) | 0 |
| Eye irritation | 3 (1) | 3 (1) | 0 | 0 |
| Eyelid irritation | 0 | 1 (0.3) | 1 (0.6) | 2 (1.3) |
| Lacrimation increased | 0 | 1 (0.3) | 2 (1.3) | 0 |
| Visual acuity reduced | 1 (0.3) | 0 | 2 (1.3) | 0 |
| Infections and infestations | 22 (7.2) | 28 (9.4) | 8 (5.2) | 15 (10.1) |
| Bronchitis | 1 (0.3) | 4 (1.3) | 1 (0.6) | 1 (0.7) |
| Upper respiratory tract infection | 6 (2) | 3 (1) | 1 (0.6) | 2 (1.3) |
| Nasopharyngitis | 5 (1.6) | 2 (0.7) | 2 (1.3) | 2 (1.3) |
| Hordeolum | 3 (1) | 3 (1) | 0 | 1 (0.7) |
| Sinusitus | 2 (0.7) | 4 (1.3) | 3 (1.9) | 4 (2.7) |
| Influenza | 2 (0.7) | 3 (1) | 1 (0.6) | 0 |
| Urinary tract infection | 1 (0.3) | 4 (1.3) | 0 | 1 (0.7) |
| Ear infection | 0 | 2 (0.7) | 0 | 3 (2) |
| Pneumonia | 0 | 0 | 0 | 3 (2) |
| Gastrointestinal disorders | 9 (3) | 7 (2.3) | 1 (0.6) | 2 (1.3) |
| Abdominal pain, upper | 0 | 0 | 1 (0.6) | 2 (1.3) |
| Nervous system disorders | 5 (1.6) | 4 (1.3) | 2 (1.3) | 3 (2) |
| Headache | 3 (1) | 4 (1.3) | 1 (0.6) | 1 (0.7) |
| Investigations | 6 (2) | 3 (1) | 2 (1.3) | 0 |
| Intraocular pressure increased | 6 (2) | 3 (1) | 2 (1.3) | 0 |
| Vascular disorders | 3 (1) | 2 (0.7) | 1 (0.6) | 2 (1.3) |
| Deep vein thrombosis | 0 | 0 | 0 | 2 (1.3) |
| Immune-system disorders | 1 (0.3) | 3 (1) | 3 (1.9) | 4 (2.7) |
| Drug hypersensitivity | 0 | 0 | 1 (0.6) | 3 (2) |
Notes:
a
Any event not present prior to the initiation of treatment or that worsened relative to pretreatment baseline;
b
percentages based on the number of subjects in the safety population and subjects counted only once for the calculation if the same subject experienced multiple events. Combination =0.1% dexamethasone and 1% azithromycin.
Abbreviation: TEAEs, treatment-emergent adverse events.