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This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine ER | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine ER | Drug | Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| Number of Participants With Clinical Significant Vital Changes | Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP >= 90 mmHg with change from the baseline >= 10 mmHg; SBP >= 140 mmHg with change from the baseline >= 20 mmHg; PR >= 100 bpm with change from the baseline >= 15 bpm. | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| Number of Participants With Clinical Significant Laboratory Tests Changes | Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count <0.8 x lower limit normal (LLN); Lymphocytes (%) <0.8 x LLN; Eosinophils (%) >1.2 x upper limit normal (ULN); Total Bilirubin >1.5 x ULN; Alanine Aminotransferase (ALT) >3.0 x ULN; Gamma glutamyl transferase (GGT) >3.0 x ULN; Uric Acid >1.2 x ULN; Cholesterol >1.3 x ULN; Low density lipoprotein (LDL) cholesterol >1.2 x ULN; Triglycerides >1.3 x ULN; Glucose >1.5 x ULN; Urine Glucose [qualitative (Qual)] >=1; Urine Protein (Qual) >=1; Urine Blood/Hemoglobin (Hgb) (Qual) >=1. | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Medical School Chiba Hokusoh Hospital | Inzai | Chiba | 270-1694 | Japan | ||
| Nakamoto Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26513202 | Derived | Higuchi T, Kamijima K, Nakagome K, Itamura R, Asami Y, Kuribayashi K, Imaeda T. A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan. Int Clin Psychopharmacol. 2016 Jan;31(1):8-19. doi: 10.1097/YIC.0000000000000105. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants who have completed the week 8 visit in the preceding double-blind study B2411263 (NCT01441440) were eligible to participate in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Venlafaxine ER 75-225 mg/Day Flexible | Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)> 450 millisecond (ms), >480 ms, and >500 ms respsctively, change from baseline in QTc, QTcB, and QTcF >= 30 ms, and >= 60 ms, respectively. |
| Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category. | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point | CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline. | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 |
| Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point | CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. | Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 |
| Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point | QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline. | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44 |
| Noda |
| Chiba |
| 278-0033 |
| Japan |
| Stress Care Yoshimura Clinic | Fukuoka | Fukuoka | 810-0041 | Japan |
| Hatakeyama Clinic | Kitakyushu | Fukuoka | 802-0064 | Japan |
| Shiranui Hospital | Omuta | Fukuoka | 836-0004 | Japan |
| Fujikawa Clinic | Hatsukaichi | Hiroshima | 738-0023 | Japan |
| Takahashi Psychiatric Clinic | Ashiya | Hyōgo | 659-0093 | Japan |
| Ikeuchi Psycho Induced Internal Med.Clinic | Kobe | Hyōgo | 655-0037 | Japan |
| National Hospital Organization Kanazawa Medical Center | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Medical Corporation Seishinkai Kishiro Mental Clinic | Kawasaki | Kanagawa | 214-0014 | Japan |
| Yutaka Clinic | Sagamihara-shi | Kanagawa | 252-0303 | Japan |
| Tawara Clinic | Yokohama | Kanagawa | 221-0835 | Japan |
| Shioiri Mental Clinic | Yokosuka | Kanagawa | 238-0042 | Japan |
| Shibamoto Clinic | Osakasayama-shi | Osaka | 589-0011 | Japan |
| Suzuki Hospital | Adachi-ku | Tokyo | 120-0033 | Japan |
| Sangenjaya Nakamura Mental Clinic | Setagaya-ku | Tokyo | 154-0004 | Japan |
| Omotesando Mental Clinic | Shibuya-ku | Tokyo | 150-0001 | Japan |
| Maynds Tower Mental Clinic | Shibuya-ku | Tokyo | 151-0053 | Japan |
| Tokyo Kosei Nenkin Hospital | Shinjuku-ku | Tokyo | 162-8543 | Japan |
| Himorogi Psychiatric Institute | Toshima-ku | Tokyo | 170-0002 | Japan |
| Tenjin Mental Clinic | Fukuoka | 810-0004 | Japan |
| Stress Care Yoshimura Clinic | Fukuoka | 810-0041 | Japan |
| Kuranari Psychiatry Clinic | Fukuoka | 810-0801 | Japan |
| Medical Corporation Toyokokai Tawara Clinic | Kanagawa | 221-0835 | Japan |
| Sagaarashiyama-Tanaka Clinic | Kyoto | 616-8421 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venlafaxine ER 75-225 mg/Day Flexible | Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. | Participants who recieved at least one dose of the study drug. | Posted | Number | Participants | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Significant Vital Changes | Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP >= 90 mmHg with change from the baseline >= 10 mmHg; SBP >= 140 mmHg with change from the baseline >= 20 mmHg; PR >= 100 bpm with change from the baseline >= 15 bpm. | Participants who received at least one dose of the study drug. | Posted | Number | Participants | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Significant Laboratory Tests Changes | Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count <0.8 x lower limit normal (LLN); Lymphocytes (%) <0.8 x LLN; Eosinophils (%) >1.2 x upper limit normal (ULN); Total Bilirubin >1.5 x ULN; Alanine Aminotransferase (ALT) >3.0 x ULN; Gamma glutamyl transferase (GGT) >3.0 x ULN; Uric Acid >1.2 x ULN; Cholesterol >1.3 x ULN; Low density lipoprotein (LDL) cholesterol >1.2 x ULN; Triglycerides >1.3 x ULN; Glucose >1.5 x ULN; Urine Glucose [qualitative (Qual)] >=1; Urine Protein (Qual) >=1; Urine Blood/Hemoglobin (Hgb) (Qual) >=1. | Participants with at least one observation of the given laboratory test while on study treatment or during lag time. | Posted | Number | Participants | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes | Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)> 450 millisecond (ms), >480 ms, and >500 ms respsctively, change from baseline in QTc, QTcB, and QTcF >= 30 ms, and >= 60 ms, respectively. | Participants with at least one observation of the electrocardiogram while on study treatment. | Posted | Number | Participants | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category. | Participants who received at least one dose of the study drug. | Posted | Number | Participants | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline. | Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point | CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline. | Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point | CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. | Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point | QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline. | Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score and QIDS16-SR-J score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44 |
|
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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 | Venlafaxine ER 75-225 mg/Day Flexible | Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation. | 2 | 50 | 49 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Crime | Social circumstances | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperacusis | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Retrograde amnesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tethered cord syndrome | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Loss of libido | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
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