N/A N=2,272

Drug Use Investigation of Jzoloft.

Panic Disorder · Depression

Bottom Line

View on ClinicalTrials.gov: NCT00605865 ↗

Enrolled (actual)

2,272

Serious AEs

0.4%

Results posted

Oct 2012

Primary outcome: Primary: Number of Participants of Treatment Related Adverse Events (TRAEs) — 263 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Sertraline hydrochloride (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants of Treatment Related Adverse Events (TRAEs)	263	—
PRIMARY Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert	3; 3; 2; 2	—
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications	129; 134	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug	238; 25	0.039 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction	7; 256	0.011 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness	57; 206	0.010 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose	6; 175; 61; 20; 1	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)	73; 182	0.014 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not	261; 2	0.021 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity	416; 1000; 93	<0.001 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride	398; 1046	0.003 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient	99; 1410	0.012 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.	528; 981	0.019 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not	1508; 1	0.010 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Age	23; 829; 412; 245	0.015 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)	319; 1136	<0.001 sig

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.

Eligibility Criteria

Inclusion Criteria

Patients need to be taking Sertraline hydrochloride in order to be enrolled in the surveillance.

Exclusion Criteria

Patients not taking Sertraline hydrochloride.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00605865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.