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The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin 10 mg BID | Experimental | Lorcaserin 10 mg tablet each morning and evening |
|
| Matching Placebo BID | Placebo Comparator | Matching placebo tablet each morning and evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin 10 mg BID | Drug | Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1. | 52 weeks |
| Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2. | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Year 1: Percent Change in Body Weight From Baseline to Week 52 | Year 1: The % change in body weight (kg) from baseline to week 52. | 52 weeks |
| Year 2: Percent Change in Body Weight From Week 52 to Week 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arena Pharmaceuticals, Inc. | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27888609 | Derived | Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26. | |
| 27659698 | Derived | Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19. |
| Label | URL |
|---|---|
| Arena Pharmaceuticals, Inc. Home Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Year 1 - Lorcaserin 10 mg BID | lorcaserin 10 mg BID tablets |
| FG001 | Year 1 - Matching Placebo BID | matching placebo tablets |
| FG002 | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2. |
| FG003 | Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2) | Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2. |
| FG004 | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
| |||||||||||||
| Year 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Year 1 - Lorcaserin 10 mg BID | lorcaserin 10 mg BID tablets |
| BG001 | Year 1 - Matching Placebo BID | matching placebo tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1. | MITT with LOCF | Posted | Apr 2011 | Number | percentage of participants | 52 weeks |
|
Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
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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 | Year 1 - Lorcaserin 10 mg BID | lorcaserin 10 mg BID tablets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | +1-888-274-2378 | esi_medinfo@eisai.com |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D012891 | Sleep Apnea Syndromes |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
| C494814 | BID protein, human |
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| Matching Placebo BID | Drug | Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks. |
|
Year 2: The % change in body weight (kg) from week 52 to week 104.
| 52 weeks |
| 27206567 | Derived | Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17. |
| 27116910 | Derived | Nesto R, Fain R, Li Y, Shanahan W. Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia. Postgrad Med. 2016 May;128(4):364-70. doi: 10.1080/00325481.2016.1178590. |
| 23661689 | Derived | Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9. |
| 20647200 | Derived | Smith SR, Weissman NJ, Anderson CM, Sanchez M, Chuang E, Stubbe S, Bays H, Shanahan WR; Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) Study Group. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010 Jul 15;363(3):245-56. doi: 10.1056/NEJMoa0909809. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2. | MITT with LOCF | Posted | Apr 2011 | Number | percentage of participants | 104 weeks |
|
|
|
| Secondary | Year 1: Percent Change in Body Weight From Baseline to Week 52 | Year 1: The % change in body weight (kg) from baseline to week 52. | MITT with LOCF | Posted | Least Squares Mean | Standard Error | % change from baseline: body wt (kg) | 52 weeks |
|
|
|
|
| Secondary | Year 2: Percent Change in Body Weight From Week 52 to Week 104 | Year 2: The % change in body weight (kg) from week 52 to week 104. | MITT with LOCF | Posted | Least Squares Mean | Standard Error | % change from baseline: body wt (kg) | 52 weeks |
|
|
|
|
| 38 |
| 1,593 |
| 1,324 |
| 1,593 |
| EG001 | Year 1 - Matching Placebo BID | matching placebo tablets | 37 | 1,584 | 1,203 | 1,584 |
| EG002 | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | lorcaserin 10 mg BID tablets | 15 | 573 | 450 | 573 |
| EG003 | Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2) | lorcaserin 10 mg BID tablets, matching placebo tablets | 6 | 283 | 210 | 283 |
| EG004 | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | matching placebo tablets | 24 | 697 | 515 | 697 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 9.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dysphasia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Enterocele | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Giardiasis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Intervertebral disc protusion | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Multiple congenital abnormalities | Congenital, familial and genetic disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Radiculitis | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Rectocele | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Retinal exudates | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Uterine malposition | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
Publication of study results are only allowed with prior written consent from Arena Pharmaceuticals, Inc.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Difference in proportion (%) |
| 1.64 |
| 2-Sided |
| 95 |
| 1.10 |
| 2.19 |
| Superiority or Other (legacy) |