N/A N=987

Special Investigation Of J Zoloft For Panic Disorder Patients

Panic Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00605917 ↗

Enrolled (actual)

987

Serious AEs

0.1%

Results posted

Sep 2012

Primary outcome: Primary: Number of Participants of Treatment Related Adverse Events (TRAEs) — 110 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)	110	—
PRIMARY Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert	3; 2; 1; 1	—
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	101; 6; 0; 0; 3	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug	94; 16	0.002 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder	11; 78	0.032 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status	57; 9; 30	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness	25; 85	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies	65; 45	0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline	33; 73	0.028 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose	2; 92; 14; 2; 0	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications	47; 63	0.030 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug	565; 216	0.013 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Complication	246; 535	0.004 sig
SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Drinking Status	171; 312; 23; 118; 53	0.004 sig

Summary

The objective of this surveillance is to collect information for panic disorder patients 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 with panic disorder 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 (NCT00605917). 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.