Table 3.
Serious adverse events recorded during the clinical trial
| HaRT-A + XR-NTX | HaRT-A + Placebo | HaRT-A alone | TAU | |
|---|---|---|---|---|
| Deathsa | 0 | 0 | 0 | 3 |
| Hospitalizationsb | 25% | 29% | 24% | 20% |
| ED visitsb | 62% | 67% | 62% | 59% |
| Suicide attemptsb | 1 | 1 | 1 | 0 |
Notes.
a
Deaths, ER visits and suicide attempts were determined to be unrelated to study procedures; notes regarding 1 study-related hospitalization are discussed in text.
b
Self-report data informing table statistics were available for 269 participants. Chi-square tests of independence indicated the impact of treatment arm on hospitalizations, χ2(3)=1.28, p=.73, and emergency department (ED) visits, χ2(3)=0.78, p=.85, was not statistically significant. Given the low cell size, we were unable to test for treatment arm differences on suicide attempts and deaths.