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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desvenlafaxine succinate | Drug | 50 mg tablet once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 to Week 8 |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. | Week 4 | |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. | Week 8 | |
| Change From Baseline in Heart Rate at Week 4. | Week 4 | |
| Change From Baseline in Heart Rate at Week 8. | Week 8 | |
| Change From Baseline in Weight at Week 4. | Week 4 | |
| Change From Baseline in Weight at Week 8. | Week 8 |
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Inclusion Criteria:
Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate
Exclusion Criteria:
Hypersensitivity to desvenlafaxine succinate
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Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Clinic | Las Piñas | Philippines | ||||
| Private Clinic |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desvenlafaxine Succinate | Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least 1 dose of study medication during the observation period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Desvenlafaxine Succinate | Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Number | Participants | Week 4 to Week 8 |
|
Week 4 to Week 8
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Desvenlafaxine Succinate | Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Libido decreased | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
Due to the low number of subjects with data available, only descriptive summaries have been presented. The outcomes measures were prioritized as per study team's discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Manila |
| Philippines |
| Private Clinic | Pasay | Philippines |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity. |
|
|
| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. | Safety population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Week 4 |
|
|
|
| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. | Safety population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Week 8 |
|
|
|
| Primary | Change From Baseline in Heart Rate at Week 4. | Safety population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Week 4 |
|
|
|
| Primary | Change From Baseline in Heart Rate at Week 8. | Safety population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Mean | Standard Deviation | bpm | Week 8 |
|
|
|
| Primary | Change From Baseline in Weight at Week 4. | Safety population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Mean | Standard Deviation | kilogram (kg) | Week 4 |
|
|
|
| Primary | Change From Baseline in Weight at Week 8. | Safety population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Mean | Standard Deviation | kg | Week 8 |
|
|
|
| 0 |
| 13 |
| 5 |
| 13 |
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |