Table 1.
Adverse Events
| Subjects affected | aRelationship To surgery | aRelationship to Infusion | |
|---|---|---|---|
| Incisional tenderness | 8 | 8 | |
| Transient headache | 6 | 6 | |
| Facial edema | 5 | 5 | |
| Scalp numbness or paresthesia | 4 | 4 | |
| Anxiety | 4 | ||
| Transient increase in dyskinesia | 4 | 4 | |
| Transient nasal congestion | 3 | 3 | |
| Falling | 10 | ||
| Intracranial hemorrhageb | 3 | 3 | |
| Insomnia | 2 | ||
| Lower extremity numbness | 2 | ||
| Seizure disorderc | 1 | ||
| Prostatitis and urinary retention | 1 | ||
| Syncope | 1 | ||
| Upper respiratory infection | 1 |
a
Designation includes adverse events that were possibly, probably, or definitely related to the intervention.
b
Subject 9 suffered a hemorrhagic infarct (attributed to an arterial rupture). The other two events were asymptomatic and discovered incidentally on postoperative MRI. One subject had a small subdural and subarachnoid hemorrhage, and the other an intra-cerebral hemorrhage thought to be secondary to venous infarction. All hemorrhages were dorsal to the infusion site and were attributed to the surgical procedure.
c
Partial seizure disorder developed 4 months after surgery in the subject with an intra-cerebral arterial hemorrhage and resolved on treatment with phenytoin.