Table 3.
Summary of all adverse events for adolescents and family members by subject and safety population
| TAU
|
BSFT™ |
All
|
||||
|---|---|---|---|---|---|---|
| Adolescent (N = 235) | Family member (N = 617) | Adolescent (N = 246) | Family member (N = 721) | Adolescent (N = 481) | Family member (N = 1338) | |
| Any AEs | 133/235 (56.6%) | 17/617 (2.8%) | 144/246 (58.5%) | 44/721 (6.1%) | 277/481 (57.5%) | 61/1338 (4.5%) |
| Any related AEs | 1/235 (0.4%) | 0/617 (0.0%) | 4/246 (1.6%) | 6/721 (0.8%) | 5/481 (1.0%) | 6/1338 (0.4%) |
| Any SAEs | 16/235 (6.8%) | 4/617 (0.6%) | 16/246 (6.5%) | 10/721 (1.4%) | 32/481 (6.6%) | 14/1338 (1.0%) |
| Any related SAEs | 0/235 (0.0%) | 0/617 (0.0%) | 0/246 (0.0%) | 0/721 (0.0%) | 0/481 (0.0%) | 0/1338 (0.0%) |
| Non serious adverse events* | ||||||
| Arrest | 79/133 (59.4%) | 4/17 (23.5%) | 85/144 (59.0%) | 9/44 (20.5%) | 164/277 (59.2%) | 13/61 (21.3%) |
| Runaway | 45/133 (33.8%) | 2/17 (11.8%) | 34/144 (23.6%) | 5/44 (11.4%) | 79/277 (28.5%) | 7/61 (11.4%) |
| Kicked out of home | 4/133 (3.0%) | 0/17 (0.0%) | 6/144 (4.2%) | 5/44 (11.4%) | 10/277 (3.6%) | 5/61 (8.1%) |
| School suspension | 71/133 (53.4%) | 1/17 (5.9%) | 72/144 (50.0%) | 4/44 (9.1%) | 143/277 (51.6%) | 5/61 (8.1%) |
| Violence | 23/133 (17.3%) | 11/17 (64.7%) | 31/144 (21.5%) | 14/44 (31.8%) | 54/277 (19.4%) | 25/61 (40.9%) |
| Unexpected AE other | 3/133 (2.3%) | 0/17 (0.0%) | 12/144 (8.3%) | 4/44 (9.1%) | 15/277 (5.4%) | 4/61 (6.5%) |
| Serious adverse events* | ||||||
| Physical/sexual abuse | 2/133 (1.5%) | 0/17 (0.0%) | 2/144 (1.4%) | 0/44 (0.0%) | 4/277 (1.4%) | 0/61 (0.0%) |
| Suicidal behavior | 5/133 (3.8%) | 1/17 (5.9%) | 8/144 (5.6%) | 4/44 (9.1%) | 13/277 (4.6%) | 5/61 (8.1%) |
| Homicidal behavior | 4/133 (3.0%) | 1/17 (5.9%) | 3/144 (2.1%) | 0/44 (0.0%) | 7/277 (2.5%) | 1/61 (1.6%) |
| Hospitalization | 8/133 (6.0%) | 2/17 (11.8%) | 8/144 (5.6%) | 5/44 (11.4%) | 16/277 (5.7%) | 7/61 (11.4%) |
| Death | 1/133 (0.8%) | 2/17 (11.8%) | 0/144 (0.0%) | 3/44 (6.8%) | 1/277 (0.3%) | 5/61 (8.1%) |
| Unexpected SAE other | 1/133 (0.8%) | 0/17 (0.0%) | 0/144 (0.0%) | 0/44 (0.0%) | 1/277 (0.3%) | 0/61 (0.0%) |
*
A participant could be represented in more than one category.