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| Name | Class |
|---|---|
| Targacept Inc. | INDUSTRY |
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The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSRI/Serotonin/SNRI + TC-5214 1-4 mg | Experimental | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID |
|
| SSRI/Serotonin/SNRI + placebo | Placebo Comparator | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-5214 | Drug | Tablet, oral, twice daily for 52 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Patients Experiencing at Least One Adverse Event (AE) | The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated. | Randomization (Week 0) to end of the follow-up period (Week 54) |
| Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. | Randomization (Week 0) to end of the follow-up period (Week 54) |
| Frequency of Patients Experiencing Serious Adverse Events (SAEs) | The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated. | Randomization (Week 0) to end of the follow-up period (Week 54) |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24 | The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans A. Eriksson, MD, Ph.D, MBA | AstraZeneca | Study Director |
| Andrew . J Cutler, MD | Florida Clinical Research Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25514064 | Derived | Tummala R, Desai D, Szamosi J, Wilson E, Hosford D, Dunbar G, Eriksson H. Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study. J Clin Psychopharmacol. 2015 Feb;35(1):77-81. doi: 10.1097/JCP.0000000000000269. |
| Label | URL |
|---|---|
| CSR-D4130C00007.pdf | View source |
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The study had an up to 21-day screening/washout period, and an 6-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (a HAMD-17 total score of ≥10 and a CGI-S score ≥3).
This multicenter study was conducted in the US between 22 June 2010 and 07 February 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | TC-5214 | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID |
| FG001 | Placebo | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Tablet, oral, twice daily for 52 weeks |
|
| Week 12 to Week 24 |
| Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52 | The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. | Week 12 to Week 52 |
| Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52) | A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity. | Randomization (Week 0) to end of treatment (Week 52) |
| Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score | Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired). | Randomization (Week 0) to end of treatment (Week 52) |
| Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score | The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%. | Randomization (Week 0) to end of treatment (Week 52) |
| Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52) | A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state. | Randomization (Week 0) to end of treatment (Week 52) |
| Tuscaloosa |
| Alabama |
| United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Arcadia | California | United States |
| Research Site | Beverly Hills | California | United States |
| Research Site | Carson | California | United States |
| Research Site | Cerritos | California | United States |
| Research Site | Chino | California | United States |
| Research Site | Costa Mesa | California | United States |
| Research Site | Encino | California | United States |
| Research Site | Escondido | California | United States |
| Research Site | Garden Grove | California | United States |
| Research Site | Irvine | California | United States |
| Research Site | Los Alamitos | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Newport Beach | California | United States |
| Research Site | Pico Rivera | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Sherman Oaks | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | Upland | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Norwalk | Connecticut | United States |
| Research Site | Norwich | Connecticut | United States |
| Research Site | Bradenton | Florida | United States |
| Research Site | Coral Springs | Florida | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Gainsville | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | North Miami | Florida | United States |
| Research Site | Orange City | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Pinecrest | Florida | United States |
| Research Site | Plantation | Florida | United States |
| Research Site | St. Petersburg | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Roswell | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Joliet | Illinois | United States |
| Research Site | Schaumburg | Illinois | United States |
| Research Site | Skokie | Illinois | United States |
| Research Site | Lafayette | Indiana | United States |
| Research Site | Valparaiso | Indiana | United States |
| Research Site | Prairie Village | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Florence | Kentucky | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Gaithersburg | Maryland | United States |
| Research Site | Glen Burnie | Maryland | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | Weymouth | Massachusetts | United States |
| Research Site | Flowood | Mississippi | United States |
| Research Site | Creve Coeur | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Lincoln | Nebraska | United States |
| Research Site | Toms River | New Jersey | United States |
| Research Site | Willingboro | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Fresh Meadows | New York | United States |
| Research Site | Mount Kisco | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Wilmington | North Carolina | United States |
| Research Site | Beechwood | Ohio | United States |
| Research Site | Canton | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Dublin | Ohio | United States |
| Research Site | Mason | Ohio | United States |
| Research Site | Middleburg Heights | Ohio | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Salem | Oregon | United States |
| Research Site | Jenkintown | Pennsylvania | United States |
| Research Site | Norristown | Pennsylvania | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Friendswood | Texas | United States |
| Research Site | Irving | Texas | United States |
| Research Site | Lake Jackson | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Woodstock | Vermont | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | South Kirkland | Washington | United States |
| Research Site | Middleton | Wisconsin | United States |
| Research Site | San Juan | Puerto Rico |
| D4130C00007/Clinical Study Protocol | View source |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TC-5214 | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID |
| BG001 | Placebo | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization | A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization | A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. | Mean | Standard Deviation | Scores on a scale |
|
| 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 | Frequency of Patients Experiencing at Least One Adverse Event (AE) | The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated. | Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available. | Posted | Number | percentage of participants analyzed | Randomization (Week 0) to end of the follow-up period (Week 54) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. | Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available. | Posted | Number | percentage of participants analyzed | Randomization (Week 0) to end of the follow-up period (Week 54) |
|
| ||||||||||||||||||||||||||||||
| Primary | Frequency of Patients Experiencing Serious Adverse Events (SAEs) | The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated. | Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available. | Posted | Number | percentage of participants analyzed | Randomization (Week 0) to end of the follow-up period (Week 54) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24 | The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | Posted | Number | percentage of participants analyzed | Week 12 to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52 | The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms. | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | Posted | Number | percentage of patients analyzed | Week 12 to Week 52 |
| |||||||||||||||||||||||||||||||
| Secondary | Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52) | A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity. | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | Posted | Mean | Standard Deviation | units on a scale | Randomization (Week 0) to end of treatment (Week 52) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score | Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired). | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | Posted | Mean | Standard Deviation | units on a scale | Randomization (Week 0) to end of treatment (Week 52) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score | The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%. | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | Posted | Mean | Standard Deviation | units on a scale | Randomization (Week 0) to end of treatment (Week 52) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52) | A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state. | Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization. | Posted | Mean | Standard Deviation | units on a scale | Randomization (Week 0) to end of treatment (Week 52) |
|
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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 | Placebo | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo | 5 | 201 | 151 | 201 | ||
| EG001 | TC-5214 | Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID | 22 | 607 | 451 | 607 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Oral Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Brain Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 14.1 | Systematic Assessment |
| |
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ovarian Torsion | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Weight Increased | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Blood Pressure Increased | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Increased Appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abnormal Dreams | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| Male |
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| Black or African American |
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| Asian |
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| Native Hawaiian or other Pacific Islander |
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| American Indian or Alaska Native |
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| Other |
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