N/A
Completed N=2,272
Drug Use Investigation of Jzoloft.
Source: ClinicalTrials.gov NCT00605865 ↗Enrolled (actual)
2,272
Serious AEs
0.4%
Results posted
Oct 2012
Primary outcomePrimary: Number of Participants of Treatment Related Adverse Events (TRAEs) — 263 participants
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.
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 |
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.
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. Informational only — not medical advice.