TABLE 3.
Adverse Events
| Event type | Open shunt | Placebo group | Total |
|---|---|---|---|
| Adverse NPH-related events | |||
| Falls (requiring medical care) | 0 | 2 | 2 |
| Cognitive decline (by MoCA)a | 6 | 1 | 7 |
| Surgical complications | |||
| Subdural hematomas | 0 | 0 | 0 |
| Subdural hygromas | 1 | 0 | 1 |
| Shunt or incisional Infection | 0 | 0 | 0 |
| Cerebral hemorrhage | 0 | 0 | 0 |
| Unrelated morbidity | |||
| Urosepsis | 1 | 0 | 1 |
| Generalized muscular weakness | 1 | 0 | 1 |
| Coagulopathy | 1 | 0 | 1 |
| Crohn's disease (newly diagnosed) | 0 | 1 | 1 |
| Unrelated mortality | |||
| Contralateral stroke | 0 | 1 | 1 |
| Necrotic gallbladder | 1 | 0 | 1 |
MoCA, Montreal Cognitive Assessment; NPH, normal pressure hydrocephalus.
a
Cognitive decline was defined as a drop in MoCA score greater than or equal 2 points. Although not necessarily an adverse event, any decrease in MoCA score greater than 2 points was assessed by the site investigator for clinical significance. All drops in MoCA score during the study period were transient.
This table summarizes the adverse events and events of interest reported on the study.