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Trial · NCT01387607

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
SECONDARYChange From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale ScoreBaseline, Week 14The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.Units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale ScoreBaseline, Week 14The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.Units on a scaleLEAST_SQUARES_MEAN
SECONDARYNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEsBaseline to Follow up (Day 105)The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.ParticipantsNUMBER
SECONDARYNumber of Treatment-Emergent Adverse Events (TEAEs) Categorized by SeverityBaseline to Follow up (Day 105)The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.EventsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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