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Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIB® | Experimental | Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. |
|
| Control | Other | Control arm receives the Behavioral modification intervention only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioEnterics® Intragastric Balloon | Device | Inflatable balloon inserted into the stomach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Excess Weight Loss (%EWL) | The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight. | 9 months |
| Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group | The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Comorbid Conditions | The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline. Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL. Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic. Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Eaton, RN, BSN | Apollo Endosurgery, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apollo Endosurgery | Austin | Texas | 78746 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27465076 | Derived | Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28. |
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448 subjects were enrolled (defined as signing the informed consent), 44 of which were run-in subjects. Prior to randomization, 131 subjects were screen failures. 273 subjects were randomized to the BIB (137) and control groups (136). 12 BIB and 6 control subjects discontinued prior to treatment. 125 BIB and 130 control subjects began treatment.
Patients were enrolled at 15 investigational sites across the US, between 6/20/2008 and 10/10/2010. Patients were either enrolled as run-in subjects (mentored cases which were enrolled prior to randomized subjects in order for physicians to gain experience with placing and removing the device) or as subjects for randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIB® | Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise |
| FG001 | Control | Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population consisted of the Intent-to-Treat (ITT) population. All baseline characteristics were calculated at the screening visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | BIB® | Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Percent Excess Weight Loss (%EWL) | The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight. | Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward). | Posted | Mean | Standard Deviation | percentage of EWL | 9 months |
|
Adverse event (AE) data was collected over a period of 12 months.
AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
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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 | BIB® | Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic myelogenous leukemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Eaton, Study Director, RN, BSN, CCRN-R, | Apollo Endosurgery | 949-468-9301 | laura.eaton@apolloendo.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral modification | Other | Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise |
|
| Baseline, Week 26, Week 39, Week 52 |
| Change in Quality of Life (SF-36) | The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores. | Baseline, Week 39 |
| Change in Quality of Life (IWQOL-Lite) | The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints. | Baseline, Week 26, Week 39, Week 52 |
| Change in Participant Depression (Beck Depression Inventory II) | Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion). | Baseline, Week 26, Week 39, Week 52 |
| Withdrawal by Subject |
|
| Subject withdrew (reason not specified) |
|
| Control |
Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| BMI | Subject BMI (kg/m²) was calculated using their baseline weight at screening. Subjects with BMI<30 or >40 were major protocol deviations | Number | participants |
|
| Number of Years Obese | Number | participants |
|
| OG001 | Control | Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise |
|
|
| Primary | Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group | The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table. | Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward). | Posted | Number | 95% Confidence Interval | percentage of BIB participants | 9 months |
|
|
|
| Secondary | Percent of Participants With Comorbid Conditions | The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline. Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL. Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic. Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female). | Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit). | Posted | Number | percentage of participants | Baseline, Week 26, Week 39, Week 52 |
|
|
|
| Secondary | Change in Quality of Life (SF-36) | The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores. | Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 39 |
|
|
|
| Secondary | Change in Quality of Life (IWQOL-Lite) | The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints. | Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 26, Week 39, Week 52 |
|
|
|
| Secondary | Change in Participant Depression (Beck Depression Inventory II) | Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion). | Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 26, Week 39, Week 52 |
|
|
|
| Post-Hoc | Change in BMI | Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion). | Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint). | Posted | Mean | Standard Deviation | kg/m² | Baseline, Week 26, Week 39, Week 52 |
|
|
|
| Post-Hoc | Percent EWL (Using BMI=25 kg/m²) | Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion). Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25. | Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint) | Posted | Mean | Standard Deviation | percentage of EWL | Baseline, Week 26, Week 39, Week 52 |
|
|
|
| Post-Hoc | Percent Total Body Weight Loss (%TBWL) | Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion). | Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint). | Posted | Mean | 95% Confidence Interval | percentage of TBWL | Baseline, Week 26, Week 39, Week 52 |
|
|
|
| 19 |
| 125 |
| 124 |
| 125 |
| EG001 | Control | Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise | 8 | 130 | 92 | 130 |
|
| Syncope | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Ventral hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Device Intolerance | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Gastric outlet obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Defective device | General disorders | MedDRA 10.0 | Systematic Assessment | Abdominal cramping due to defective device (bacterial overgrowth). |
|
| Choledocholithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Giardia lamblia infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Viral gastroparesis | Infections and infestations | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Osteoarthritis of the hip | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Breast abscess | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment | Event determined to be not-device related for BIB group. |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | Laryngospasm during BIB placement (procedure-related) |
|
| Hemithyroidectomy | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sphincter of Oddi dysfunction | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Motor vehicle accident with nasal fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Herniated lumbar disc | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal cell carcinoma with nephrectomy | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bilateral vertebral artery hypoplasia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastroesophageal Reflux Disease (GERD) | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Post procedural pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Vitamin B1 decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Diabetes-Week 39 (BIB n=102, Control n=94) |
|
| Diabetes-Week 52 (BIB n=95, Control n=94) |
|
| Hypertension-Baseline (BIB n=125, Control n=130) |
|
| Hypertension-Week 26 (BIB n=124, Control n=91) |
|
| Hypertension-Week 39 (BIB n=91, Control n=95) |
|
| Hypertension-Week 52 (BIB n=98, Control n=92) |
|
| Dyslipidemia-Baseline (BIB n=125, Control n=130) |
|
| Dyslipidemia-Week 26 (BIB n=102, Control n=94) |
|
| Dyslipidemia-Week 39 (BIB n=102, Control n=95) |
|
| Dyslipidemia-Week 52 (BIB n=96, Control n=94) |
|
| Role Physical-Baseline (BIB n=123, Control n=130) |
|
| Role Physical-Week 39 (BIB n=98, Control n=93) |
|
| Bodily Pain-Baseline (BIB n=123, Control n=130) |
|
| Bodily Pain-Week 39 (BIB n=99, Control n=93) |
|
| General Health-Baseline (BIB n=123, Control n=128) |
|
| General Health-Week 39 (BIB n=99, Control n=93) |
|
| Vitality-Baseline (BIB n=123, Control n=130) |
|
| Vitality-Week 39 (BIB n=99, Control n=93) |
|
| Social Func-Baseline (BIB n=123, Control n=130) |
|
| Social Func-Week 39 (BIB n=99, Control n=93) |
|
| Role Emotional-Baseline (BIB n=123, Control n=130) |
|
| Role Emotional-Week 39 (BIB n=98, Control n=93) |
|
| Mental Health-Baseline (BIB n=123, Control n=130) |
|
| Mental Health-Week 39 (BIB n=99, Control n=93) |
|
| Week 39 (BIB n=99, Control n=93) |
|
| Week 52 (BIB n=97, Control n=94) |
|
| Week 39 (BIB n=99, Control n=93) |
|
| Week 52 (BIB n=97, Control n=95) |
|
| Week 39 (BIB n=91, Control n=95) |
|
| Week 52 (BIB n=98, Control n=92) |
|
| Week 52 (BIB n=98, Control n=92) |
|
| Week 52 (BIB n=98, Control n=92) |
|