Drug Use Investigation of Jzoloft.
- Registration Number
- NCT00605865
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The objective of this surveillance is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
- Detailed Description
All the patients whom an investigator prescribes the first Sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2272
Patients need to be taking Sertraline hydrochloride in order to be enrolled in the surveillance.
Patients not taking Sertraline hydrochloride.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sertraline hydrochloride. Sertraline hydrochloride Patients taking Sertraline hydrochloride.
- Primary Outcome Measures
Name Time Method Number of Participants of Treatment Related Adverse Events (TRAEs) Baseline up to 16 weeks All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Baseline up to 16 weeks
- Secondary Outcome Measures
Name Time Method Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose Baseline up to 16 weeks Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor
Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity Baseline up to 16 weeks Number of participants with responders of Sertraline to determine whether target disease severity is significant factor
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug Baseline up to 16 weeks Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications Baseline up to 16 weeks Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not Baseline up to 16 weeks Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction Baseline up to 16 weeks Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) Baseline up to 16 weeks Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor
Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient Baseline up to 16 weeks Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness Baseline up to 16 weeks Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor
Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride Baseline up to 16 weeks Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor
Factors 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 weeks Number of participants with responders of Sertraline to determine whether with or without complication is significant factor
Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not Baseline up to 16 weeks Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor
Factors Considered to Affect the Efficacy of Sertraline: Age Baseline up to 16 weeks Number of participants with responders of Sertraline to determine whether age is significant factor
Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) Baseline up to 16 weeks Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor