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Table 1 Definitions and criteria for post hoc analysis of clinical response and symptomatic remission[12, 18]

From: Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder

Terms

Definitions and Criteria

Clinical response

≥30% reduction in ADHD-RS-IV with adult prompts total scorea and a CGI-I rating of 1 or 2

Symptomatic remission

ADHD-RS-IV total score ≤18 (average per-item score ≤1)

Time to median clinical response or symptomatic remission

Time by which half the original sample achieves criteria for clinical response or symptomatic remission

Loss of clinical response or symptomatic remission status

Failure to meet criteria for clinical response or symptomatic remission after having achieved that status at a previous visit

Maintenance of clinical response or symptomatic remission at endpoint

4-week trial:

Participants meeting criteria for clinical response or symptomatic remission at postbaseline visits, enrolled at endpoint, and meeting criteria without interruption

Long-term trial:

Participants meeting criteria for clinical response or symptomatic remission at postbaseline visits and meeting the criteria without interruption up to endpoint

  1. aRelative to baseline ADHD-RS-IV total score in the 4-week trial.
  2. Abbreviations: ADHD-RS-IV = Attention-Deficit/Hyperactivity Disorder Rating Scale IV; CGI-I=Clinical Global Impressions-Improvement.