Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-2990 | Experimental | MT-2990, over 16 weeks |
|
| Placebo | Placebo Comparator | Placebo, over 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-2990 | Drug | over 16 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 | |
| Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Science | Tanabe Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Precision Trials | Phoenix | Arizona | 85032 | United States | ||
| Northern California Research Corporation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo, over 16 weeks |
| FG001 | MT-2990 | MT-2990, over 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2020 | Apr 19, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
over 16 weeks |
|
| Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain) | Baseline to Week 16 |
| Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain) | Baseline to Week 16 |
| Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain) | Baseline to Week 16 |
| Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used | Baseline to Week 16 |
| Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used | Baseline to Week 16 |
| Time to Use of Rescue Medication (Analgesic) | Baseline to Week 16 |
| Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 |
| Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 |
| Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe) | Baseline to Week 16 |
| Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 |
| Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 |
| Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Baseline to Week 16 |
| Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Baseline to Week 16 |
| Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Baseline to Week 16 |
| Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Baseline to Week 16 |
| Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Baseline to Week 16 |
| Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Baseline to Week 16 |
| Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Baseline to Week 16 |
| Number of Responders Using Global 7-point Scale | Baseline to Week 16 |
| Percentage of Responders Using Global 7-point Scale | Baseline to Week 16 |
| Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | From Baseline to Weeks 4, 8, 12, and 16 |
| Number of Responders Using Endometriosis Specific 7-point Scale | Baseline to Week 16 |
| Percentage of Responders Using Endometriosis Specific 7-point Scale | Baseline to Week 16 |
| Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | From Baseline to Weeks 4, 8, 12, and 16 |
| Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | From Baseline to Weeks 4, 8, 12, and 16 |
| Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | From Baseline to Weeks 4, 8, 12, and 16 |
| Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | From Baseline to Weeks 4, 8, 12, and 16 |
| Sacramento |
| California |
| 95821 |
| United States |
| Ageless and Beautiful Medical Spa | San Diego | California | 92103 | United States |
| Precision Research Institute | San Diego | California | 92114 | United States |
| The Lundquist Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Clinical Physiology Associates - Fort Myers | Fort Myers | Florida | 33912 | United States |
| AGA Clinical Trials | Hialeah | Florida | 33012 | United States |
| Kendall South Medical Center | Hialeah | Florida | 33012 | United States |
| South Florida Clinical Trials | Hialeah | Florida | 33016 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | United States |
| Health and Life Research Institute | Miami | Florida | 33155 | United States |
| Ivetmar Medical Group | Miami | Florida | 33155 | United States |
| Future Care Solution | Miami | Florida | 33165 | United States |
| Advanced Medical Research Institute | Miami | Florida | 33174 | United States |
| South Florida Research Phase I-IV | Miami Springs | Florida | 33166 | United States |
| American Research Centers of Florida | Pembroke Pines | Florida | 33027 | United States |
| Agile Clinical Research Trials | Alpharetta | Georgia | 30005 | United States |
| Medi-Sense | Atlanta | Georgia | 30363 | United States |
| NuDirections Clinical Research | Dunwoody | Georgia | 30338 | United States |
| Drug Studies America - Marietta | Marietta | Georgia | 30060 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | United States |
| Advanced Clinical Research - Idaho | Meridian | Idaho | 83642 | United States |
| The Advanced Gynecologic Surgery Institute | Park Ridge | Illinois | 60068 | United States |
| GTC Research | Shawnee Mission | Kansas | 66218 | United States |
| Clinical Trials Management - Covington Northshore Office | Covington | Louisiana | 70433 | United States |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | United States |
| Omni Fertility and Laser Institute | Shreveport | Louisiana | 71118 | United States |
| Continental Clinical Solutions | Towson | Maryland | 21204 | United States |
| Saginaw Valley Medical Research Group/Women's OB-GYN | Saginaw | Michigan | 48604 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| Carolina Women's Research and Wellness Clinic | Durham | North Carolina | 27713 | United States |
| Unified Women's Clinical Research - Raleigh | Raleigh | North Carolina | 27607 | United States |
| PMG Research of Rocky Mount | Rocky Mount | North Carolina | 27804 | United States |
| Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Aventive Research - Colombus | Columbus | Ohio | 43213 | United States |
| North Star Medical Research | Middleburg Heights | Ohio | 44130 | United States |
| ClinEdge - Fusion Clinical Research of Spartanburg | Spartanburg | South Carolina | 29301 | United States |
| Wake Research Associates | Chattanooga | Tennessee | 37421 | United States |
| Precision Research Institute - Houston | Houston | Texas | 77036 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| Biopharma Informatic - Houston | Houston | Texas | 77084 | United States |
| Discovery Clinical Trials | San Antonio | Texas | 78258 | United States |
| Physician's Research Options (PRO) | Draper | Utah | 84020 | United States |
| Physician's Research Options (PRO) | Pleasant Grove | Utah | 84062 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Health Research of Hampton Roads | Newport News | Virginia | 23606 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo, over 16 weeks |
| BG001 | MT-2990 | MT-2990, over 16 weeks |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | pills | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | Pills | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Use of Rescue Medication (Analgesic) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Median | Inter-Quartile Range | days | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | percentage of NMPP responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | percentage of dysmenorrhea responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | percentage of dyspareunia responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | mean percentage change | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | Mean percentage change | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | Mean percentage change | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | percentage of NMPP responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | percentage of dysmenorrhea responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | percentage of dyspareunia responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | Mean percentage change | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | Mean percentage change | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | Mean percentage change | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Responders Using Global 7-point Scale | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Count of Participants | Participants | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders Using Global 7-point Scale | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | Percentage of responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Weeks 4, 8, 12, and 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Responders Using Endometriosis Specific 7-point Scale | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Count of Participants | Participants | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders Using Endometriosis Specific 7-point Scale | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Number | percentage of responders | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Weeks 4, 8, 12, and 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Weeks 4, 8, 12, and 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Weeks 4, 8, 12, and 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best) | Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Weeks 4, 8, 12, and 16 |
|
|
Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo, over 16 weeks | 0 | 39 | 0 | 39 | 22 | 39 |
| EG001 | MT-2990 | MT-2990, over 16 weeks | 0 | 37 | 1 | 37 | 23 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion induced | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Coronavirus test positive | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Clonic convulsion | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Meralgia paraesthetica | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Urge incontinence | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hydrosalpinx | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma America, Inc. | Please email | information.US@mb.tanabe-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2021 | Apr 19, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|