Table 7.
Adverse Events
| Injection Number | Temporal relationship to injection | Description | Status |
|---|---|---|---|
| Ocular · Related to Injection/Investigational Product | |||
| 3 | 29 d | Small asymptomatic vitreous condensation | No treatment, Ongoing |
| 5 | Same day | Intraocular pressure >50mmHg, lightheadedness | Resolved same day |
| 5 | Same day | Corneal abrasion | Resolved next day |
| 6 | 2 m | Mild uveitis | No treatment, Resolved spontaneously |
| 9 | 2 m | Uveitis | No treatment, Resolved spontaneously |
| Reported by most patients | Same day | Burning sensation after anesthesia wore off | Resolved same or next day |
| 11 | 18 d | Occasional mild stinging, possibly related to injection | Resolved |
| 14 | 1 d | Decreased vision in injected eye of unilateral patient | Resolved spontaneously within 7 days with return to pre-injection acuity which is maintained through 6 month follow up |
| Systemic · Possibly related to Injection/Investigational Product | |||
| 4 | 2 d | Sore throat (possibly due to seasonal allergies) | Resolved by 14 days |
| 10 | 2 d | Cough and sore throat | Resolved within 10 days But recurred 3m later and are ongoing |
| 9 | 1.1 m | Elevated ALT | Resolved by month 2 |
| Ocular · Likely Unrelated to Injection/Investigational Product | |||
| 2 | 2.1 m | Small afferent pupillary defect | Resolved within 1 month |
| 7 | 2.7 m | Irritation | Resolved in 1 day |
| 6 | 1.6 m | Pain discomfort in both eyes | Resolved in one month |
| 6 | 2.2 m | Fellow eye red and twitching | Resolved spontaneously |
| 6 | 2.3 m | Complains of decreased acuity in both eyes. This decrease was not manifest upon study vision testing in which the patient read more letters than at either baseline 1 or baseline 2. Visual field tests | Ongoing |
| did not show worsening from baseline | |||
| 12 | 3.4 m | Decreased acuity in injected eye of unilateral patient attributed to natural course of LHON despite injection | Ongoing |
| Systemic · Likely unrelated to Injection/Investigational Product † | |||
| 6 | 3.8 m | Mucocele on MRI | Ongoing |
| 6 | 9.5 m | Tingling in legs | Ongoing |
| 7 | 1 d prior | Lightheaded during blood draw | Resolved by time of injection |
| 7 | 1.3 m | Headaches attributed to enlarged cisterna magna, unchanged from pre-injection MRI | Headaches stopped within 4 months |
| 2 | 5.2 m | Hospitalization to treat pre-existing parathyroid gland condition | Resolved post treatment |
| 4 | 17.1 m | Headaches, motion sickness | Ongoing |
| 12 | 5.2 m | Headaches | Resolved within 2 days |
| 12 | 3 d prior | Occasional bloody nose | Ongoing |
| 13 | 29 d | Exacerbation of numbness in feet | Ongoing |
| 5 | 8 m | Mild chest pain | Resolved within 5 weeks |
†
Other systemic unrelated adverse events [ref #] which resolved included: GI upset [8], sprained ankle [19], allergic reaction to energy drink [23], common cold [27], Flu symptoms [31], and rash on face [32]