Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients

Pfizer13 enrolled

Overview

This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.

post marketing surveillance none

Study Type

OBSERVATIONAL

Enrollment

Conditions

Major Depressive Disorder Vasomotor Symptoms

Interventions

desvenlafaxine succinateDRUG

50 mg tablet once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate Exclusion Criteria: Hypersensitivity to desvenlafaxine succinate

Locations (3)

Private Clinic

Las Piñas, Philippines

Private Clinic

Manila, Philippines

Private Clinic

Pasay, Philippines

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Week 4 to Week 8

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.

Time frame: Week 4

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.

Time frame: Week 8

Change From Baseline in Heart Rate at Week 4.

Time frame: Week 4

Change From Baseline in Heart Rate at Week 8.

Time frame: Week 8

Change From Baseline in Weight at Week 4.

Time frame: Week 4

Change From Baseline in Weight at Week 8.

Time frame: Week 8

Data from ClinicalTrials.gov

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