Table 2.
Adverse Events
| Patient | Description | Infection | Related to Agent | Severity | Treatment Required | Hospitalized | Outcome |
|---|---|---|---|---|---|---|---|
| 001 | Pterygium | No | No | Mild | No | No | Monitored |
| Dry eye | No | No | Mild | ATs | No | Monitored | |
| Neutropenia | No | Possibly | Mild | No | No | Recovered, no residual effects | |
| Decrease in VA | No | Possibly | Moderate | No | No | Recovered, no residual effects | |
| 002 | Pain with eye movements | No | Remotely | Mild | No | No | Recovered, no residual effects |
| Skin rash | No | Remotely | Mild | No | No | Recovered, no residual effects | |
| 003 | Lymphocytosis | Possible | Remotely | Moderate | No | No | Recovered, no residual effects |
| URI | Possible | Remotely | Mild | No | No | Recovered, no residual effects | |
| Sore Throat | Possible | Remotely | Mild | No | No | Recovered, no residual effects | |
| Headache | No | Possibly | Mild | OTC med | No | Recovered, no residual effects | |
| 004 | Hot flashes | No | Possibly | Mild | No | No | Recovered, no residual effects |
| Neck and back pain | No | Not related | Mild | No | No | Chronic disorder, not resolved | |
| Depression | No | Not related | Moderate | Rx med | No | Recovered, no residual effects | |
| Headache | No | Not related | Mild | OTC med | No | Recovered, no residual effects | |
| Ocular Discomfort | No | Not related | Moderate | ATs | No | Recovered, no residual effects | |
| 005 | Skin rash | No | Not related | Moderate | Benedryl | No | Recovered, no residual effects |
| Headache | No | Probably | Mild | OTC med | No | Recovered, no residual effects | |
| Sinusitis | No | Not related | Mild | No | No | Recovered, no residual effects | |
| Lymphocytosis | No | Probably | Mild | No | No | Recovered, no residual effects | |
| Fatigue | No | Possibly | Mild | No | No | Recovered, no residual effects | |
| 006 | Lymphocytosis | No | Possibly | Mild | No | No | Recovered, no residual effects |
| Ocular discomfort | No | Remotely | Mild | No | No | Recovered, no residual effects | |
| Dizziness and nausea | No | Remotely | Mild | No | No | Recovered, no residual effects |
All adverse events associated with the study medication were classified as not related, remotely related, possibly related, probably related or related. All events were transient and resolved spontaneously or with minimum treatment.