Table 2.
Treatment-emergent adverse events (TEAEs) by dose
| TEAE | Study 1 (n =40)
|
Study 2 (n= 30)
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=8) |
Asenapine
|
Asenapine
|
||||||||
| Cohort 1, 1 mg (n=8) |
Cohort 2, 3 mg (n=8) |
Cohort 3, 5 mg (n=16)a |
Cohort 4, 10 mg (n=8) |
Cohort 1, 2.5 mg (n=6) |
Cohort 2, 5 mg (n=6) |
Cohort 3, 10 mg (n=6)a |
Cohort 3, 10 mg (n=12)b–d |
Cohort 3, 10 mg (n=18)b |
||
| Any TEAE, n (%) | 6 (75) | 5 (62.5) | 8 (100) | 14 (87.5) | 8 (100) | 3 (50) | 4 (67) | 1 (16.7) | 10 (83.3) | 11 (61) |
| TEAEs by preferred term in ≥2 patients in any cohort, n (%) | ||||||||||
| Dysgeusia | 1 (12.5) | 2 (25) | 4 (50) | 3 (18.8) | 2 (25) | 1 (17) | 0 | 0 | 7 (58.3) | 7 (39) |
| Sedation | 0 | 2 (25) | 4 (50) | 7 (43.8) | 0 | 2 (33) | 2 (33) | 0 | 1 (8.3) | 1 (6) |
| Hypoesthesia, oral | 1 (12.5) | 1 (12.5) | 4 (50) | 1 (6.3) | 0 | 1 (17) | 0 | 0 | 9 (75) | 9 (50) |
| Somnolence | 1 (12.5) | 0 | 0 | 1 (6.3) | 4 (50) | 1 (17) | 0 | 0 | 5 (41.7) | 7 (39) |
| Dizziness | 1 (12.5) | 0 | 1 (12.5) | 1 (6.3) | 1 (12.5) | 0 | 2 (33) | 0 | 7 (58.3) | 7 (39) |
| Headache | 1 (12.5) | 0 | 2 (25) | 2 (12.5) | 1 (12.5) | 0 | 1 (17) | 0 | 2 (16.7) | 2 (11) |
| Glossalgia | 1 (12.5) | 0 | 0 | 6 (37.5) | 1 (12.5) | 0 | 0 | 0 | 0 | 0 |
| Nausea | 1 (12.5) | 1 (12.5) | 0 | 1 (6.3) | 0 | 0 | 2 (33) | 1 (16.7) | 1 (8.3) | 2 (11) |
| Dystonia | 0 | 0 | 0 | 0 | 0 | 0 | 4 (67) | 0 | 3 (25) | 3 (17) |
| Paresthesia, oral | 0 | 0 | 0 | 2 (12.5) | 4 (50) | 0 | 0 | 0 | 0 | 0 |
| Fatigue | 1 (12.5) | 0 | 1 (12.5) | 0 | 2 (25) | 0 | 0 | 0 | 0 | 0 |
| Contusion | 0 | 0 | 2 (25) | 2 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 0 | 1 (6.3) | 0 | 0 | 2 (33) | 0 | 0 | 0 |
| Extrapyramidal disorder | 1 (12.5) | 0 | 0 | 0 | 2 (25) | 0 | 0 | 0 | 0 | 0 |
| Salivary hypersecretion | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33) | 0 | 0 | 0 |
| Hostility | 0 | 0 | 0 | 0 | 2 (25) | 0 | 0 | 0 | 0 | 0 |
Notes: TEAEs in descending order across both studies.
a
Eight patients received 5 mg for 10 days (study 1, cohort 3) and another eight received 5 mg for 1 day as the titration step to subsequent 10 mg for 10 days (cohort 4);
b
cohort three includes cohort 3a, which consisted of patients aged 10–11 years who received a slower uptitration regimen, as well as cohorts 3b–3d (see Figure 1).