Table 6.
Adverse Events by Treatment Group
| Adverse Event | No.
|
P Valuea | ||
|---|---|---|---|---|
| Voriconazole | Natamycin | Total | ||
| Serious | ||||
| Corneal perforation | 15 | 10 | 25 | .31 |
| TPK | 29 | 13 | 42 | .01 |
| Corneal perforation and/or TPK | 34 | 18 | 52 | .02 |
| Endophthalmitis | 2 | 0 | 2 | .50 |
| Other serious ocular event thought to be related to study drug | 0 | 0 | 0 | NA |
| Death | 1 | 1 | 2 | >.99 |
| Nonelective surgery, hospitalization, or loss of function | 0 | 0 | 0 | NA |
| Myocardial infarction or stroke | 1 | 0 | 1 | >.99 |
| Nonserious | ||||
| Local allergic reaction | 0 | 0 | 0 | NA |
| >2-mm increase in hypopyon | 12 | 5 | 17 | .09 |
| >50% Increase in infiltrate size | 13 | 5 | 18 | .06 |
| Intraocular pressure ≥35 mm Hg for 1 wk despite therapy | 0 | 0 | 0 | NA |
| Progressive corneal thinning to ≤50% of thickness at enrollment | 2 | 0 | 2 | .25 |
| Other nonserious | 3 | 3 | 6 | >.99 |
Abbreviations: NA, not applicable; TPK, therapeutic penetrating keratoplasty.
Fisher exact test.