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Trial · NCT00605865

Outcomes16

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants of Treatment Related Adverse Events (TRAEs)Baseline up to 16 weeksSafety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.participantsNUMBER
PRIMARYNumber of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package InsertBaseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.eventsNUMBER
SECONDARYRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: ComplicationsBaseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.participantsNUMBER
SECONDARYRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant DrugBaseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.participantsNUMBER
SECONDARYRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal DysfunctionBaseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.participantsNUMBER
SECONDARYRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other IllnessBaseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.participantsNUMBER
SECONDARYRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily DoseBaseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.participantsNUMBER
SECONDARYRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)Baseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.participantsNUMBER
SECONDARYRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or NotBaseline up to 16 weeksThe safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.participantsNUMBER
SECONDARYFactors Considered to Affect the Efficacy of Sertraline: Target Disease SeverityBaseline up to 16 weeksThe efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).participantsNUMBER
SECONDARYFactors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline HydrochlorideBaseline up to 16 weeksThe efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).participantsNUMBER
SECONDARYFactors Considered to Affect the Efficacy of Sertraline: Outpatient/InpatientBaseline up to 16 weeksThe efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).participantsNUMBER
SECONDARYFactors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.Baseline up to 16 weeksThe efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).participantsNUMBER
SECONDARYFactors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or NotBaseline up to 16 weeksThe efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).participantsNUMBER
SECONDARYFactors Considered to Affect the Efficacy of Sertraline: AgeBaseline up to 16 weeksThe efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).participantsNUMBER
SECONDARYFactors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)Baseline up to 16 weeksThe efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).participantsNUMBER

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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