N/A
Completed N=542
Special Investigation Of Long Term Use Of Sertraline.
Source: ClinicalTrials.gov NCT00605813 ↗Enrolled (actual)
542
Serious AEs
0.4%
Results posted
Sep 2012
Primary outcomePrimary: Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert — 2; 1; 1 events
Summary
Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" 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 regarding long time use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert |
2; 1; 1 | — |
| PRIMARY Number of Participants of Treatment Related Adverse Events (TRAEs) |
44 | — |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction |
42; 2 | 0.003 sig |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness |
28; 16 | <0.001 sig |
| SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies |
141; 255 | 0.040 sig |
| SECONDARY Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt) |
29; 63 | 0.004 sig |
Eligibility Criteria
Inclusion Criteria
The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).
Exclusion Criteria
Patients not taking sertraline hydrochloride.
Data sourced from ClinicalTrials.gov (NCT00605813). 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.