TABLE 2.
Description of 64 adjudicated AEs occurring in 26 patients in the ADvance trial
| AE | No. of Patients |
|---|---|
| Dermatological | |
| Bruising, left forehead and cheek | 1 |
| Contact dermatitis | 1 |
| Rash | 1 |
| Fatigue | |
| Fatigue | 5 |
| Increased fatigue | 1 |
| Gastrointestinal | |
| Nausea | 2 |
| Nausea resulting in prolonged hospitalization* | 1 |
| Nausea and vomiting | 1 |
| Vomiting | 2 |
| Genitourinary | |
| Urinary retention | 3 |
| Headache or other pain | |
| Headache | 11 |
| Headache, nausea, and vomiting* | 1 |
| Left mastoid pain | 1 |
| Left neck discomfort | 1 |
| Neck/shoulder pain | 1 |
| Major surgical site | |
| Bilateral subacute & chronic subdural hematoma* | 1 |
| IPG infection | 3 |
| Left electrode lead misplacement* | 1 |
| Mental status change | |
| Confusion | 2 |
| Delirium | 2 |
| Depressed mood | 1 |
| Minor surgical site | |
| Fluid collection | 1 |
| Neck discomfort due to pulling of extensions | 1 |
| Redness of the left frontal incision w/o drainage or swelling | 1 |
| Right periorbital edema | 2 |
| Small pustule at right chest near surgical scar | 1 |
| Surgical site pain in right chest | 1 |
| Swelling at suture behind right ear w/ pain | 1 |
| Swelling of left eyelid | 1 |
| Bilateral eyelid swelling | 1 |
| Extraaxial collection | 1 |
| Inflammation at IPG site | 1 |
| Left cerebral convexity subdural hematoma | 1 |
| Pink skin behind right ear | 1 |
| Pinkish discharge | 1 |
| Possible infection at surgical site | 1 |
| Rash on right chest around incision | 1 |
| Small right intracerebral hemorrhage | 1 |
| Surgical pain | 1 |
| Swelling & redness | 1 |
| Trauma | |
| Fall | 1 |
*
SAE.