Table 5 Summary of TE-ADEs by SOC and PT for Safety Population (N = 162) Adolescent

From: Two single arm trials of AKL-T01, a digital therapeutic for adolescents and adults with ADHD

 

All Subjects (N = 162)

 

n (%)

Events

Any TE-ADE

4 (2.5%)

4

 Nervous system disorders

 1 (0.6%)

 1

  Headache

  1 (0.6%)

  1

 Psychiatric disorders

 3 (1.9%)

 3

  Frustration tolerance decreased

  3 (1.9%)

  3

  1. TE-ADE treatment-emergent adverse device effect. SOC System Organ Class (categories), PT Preferred Term (indented; subcategories).