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| ID | Type | Description | Link |
|---|---|---|---|
| RDC-MI&A-01-2007 |
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This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Control Group (ACG) | Other | Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes. |
|
| Structured Testing Group (STG) | Experimental | Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek 360° View Blood Glucose Analysis Tool | Device |
| ||
| Accu-Chek Aviva Glucose Meter |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 | Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations | Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.) | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Petersen | Roche Diagnostics GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | AL 36608 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21916532 | Derived | Fisher L, Polonsky W, Parkin CG, Jelsovsky Z, Amstutz L, Wagner RS. The impact of blood glucose monitoring on depression and distress in insulin-naive patients with type 2 diabetes. Curr Med Res Opin. 2011 Nov;27 Suppl 3:39-46. doi: 10.1185/03007995.2011.619176. Epub 2011 Sep 14. | |
| 21270183 | Derived | Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care. 2011 Feb;34(2):262-7. doi: 10.2337/dc10-1732. |
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770 patients were screened. 522 patients were enrolled in the study. 23 patients at 1 site used the incorrect self monitored blood glucose device and were excluded. 499 patients met inclusion/exclusion criteria and were included in the analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Control Group (ACG) | Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes. |
| FG001 | Structured Testing Group (STG) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
|
| Change From Baseline in Depression Severity (PHQ-8) |
The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. |
| Baseline, Month 12 |
| Change From Baseline in the Diabetes Distress Scale (DDS) | Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. | Baseline, Month 12 |
| Change From Baseline in the World Health Organization (WHO-5) Well-being Index | Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement. | Baseline, Month 12 |
| Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) | Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement. | Baseline, Month 12 |
| Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day | SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period. | 12 Months |
| Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion. The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects. | Month 1, Month 12 |
| Pell City |
| Alabama |
| AL 35125 |
| United States |
| Chipley | Florida | 32428 | United States |
| Marianna | Florida | 32446 | United States |
| Pembroke Pines | Florida | FL 33028 | United States |
| Tampa | Florida | 33613 | United States |
| Tampa | Florida | 33624 | United States |
| Atlanta | Georgia | GA 30312 | United States |
| Atlanta | Georgia | GA 30342 | United States |
| Chicago | Illinois | 60616 | United States |
| O'Fallon | Illinois | IL 62269 | United States |
| Fishers | Indiana | IN 46038 | United States |
| Indianapolis | Indiana | 46256 | United States |
| Indianapolis | Indiana | In 46217 | United States |
| Flint | Michigan | 48504 | United States |
| Hickory | North Carolina | NC 28602 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cuyahoga Falls | Ohio | OH 44223 | United States |
| Zanesville | Ohio | OH 43701 | United States |
| Pottstown | Pennsylvania | 19468 | United States |
| Pottstown | Pennsylvania | PA 19464 | United States |
| High Point | South Carolina | SC 29720 | United States |
| Lancaster | South Carolina | SC 29720 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Bristol | Tennessee | 37620 | United States |
| Crossville | Tennessee | TN 38555 | United States |
| Abingdon | Virginia | VA 24210 | United States |
| 20482765 | Derived | Polonsky W, Fisher L, Schikman C, Hinnen D, Parkin C, Jelsovsky Z, Amstutz L, Schweitzer M, Wagner R. The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial [NCT00674986]. BMC Fam Pract. 2010 May 18;11:37. doi: 10.1186/1471-2296-11-37. |
Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly. |
| Intent to Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat population included all enrolled participants who completed the baseline training visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Control Group (ACG) | Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes. |
| BG001 | Structured Testing Group (STG) | Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly. |
| 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 |
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| 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 | Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 | Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. | Intent to treat population included all enrolled participants who completed the baseline training visit. | Posted | Least Squares Mean | Standard Error | Percent | Baseline, Month 12 |
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| Secondary | Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations | Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.) | Intent to treat population included all enrolled participants who completed the Baseline training visit. Participants who dropped out before Month 1 visit were not included in the analysis. | Posted | Mean | Standard Deviation | Visits | 12 Months |
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| Secondary | Change From Baseline in Depression Severity (PHQ-8) | The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. | Intent to treat population included all enrolled participants who completed the baseline training visit. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Month 12 |
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| Secondary | Change From Baseline in the Diabetes Distress Scale (DDS) | Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement. | Intent to treat population included all enrolled participants who completed the baseline training visit. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Month 12 |
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| Secondary | Change From Baseline in the World Health Organization (WHO-5) Well-being Index | Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement. | Intent to treat population included all enrolled participants who completed the baseline training visit. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Month 12 |
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| Secondary | Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) | Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement. | Per protocol population included all enrolled participants who completed the baseline training visit, completed at least 4 of 5 clinical visits, and had evaluable HbA1c data at Month 12. The Structured Testing Group also had to have at least 80% of the blood glucose values. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Month 12 |
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| Secondary | Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day | SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period. | Intent to treat population included all enrolled participants who completed the baseline training visit. | Posted | Least Squares Mean | Standard Error | Tests/day | 12 Months |
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| Secondary | Glycemic Variability Pre and Post-Prandial Excursions at Each Meal | Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion. The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects. | Intent to treat population included all enrolled participants who completed the baseline training visit. | Posted | Least Squares Mean | Standard Error | mg/dL | Month 1, Month 12 |
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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 | Structured Testing Group (STG) | Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly. | 14 | 256 | 33 | 256 | ||
| EG001 | Active Control Group (ACG) | Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes. | 21 | 227 | 35 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| SVT (Supraventricular tachycardia) | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation/bradycardia | Cardiac disorders | Systematic Assessment |
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| Exacerbation of coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Emergency CABG x 5 (Coronary artery bypass graft) | Cardiac disorders | Systematic Assessment |
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| Artherosclerotic coronary disease | Cardiac disorders | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Blockage in left descending coronary artery | Cardiac disorders | Systematic Assessment |
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| MVA - high speed (Motor vehicle accident) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Abdominal pain | General disorders | Systematic Assessment |
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| Mid sternal chest pain, acute onset | General disorders | Systematic Assessment |
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| Chest pain associated with pulled muscle | General disorders | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | Systematic Assessment |
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| Anterior and epigastric chest pain | General disorders | Systematic Assessment |
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| Acute cholecystitus | Hepatobiliary disorders | Systematic Assessment |
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| Biliary pancreatitis | Hepatobiliary disorders | Systematic Assessment |
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| Acute bronchitis | Infections and infestations | Systematic Assessment |
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| Pneumonia/bronchitis | Infections and infestations | Systematic Assessment |
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| Influenza a | Infections and infestations | Systematic Assessment |
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| Arm and leg swelling | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Intractable pain status post lumbar fusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Recurrent colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Left breast mastectomy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Benign tumor on thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Vertigo/labyrinthitis/ataxia | Nervous system disorders | Systematic Assessment |
| ||
| Brain stem CVA (Cerebrovascular accident) | Nervous system disorders | Systematic Assessment |
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| Major depressive symptoms - emptiness, nervousness | Psychiatric disorders | Systematic Assessment |
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| Major depressive disorder, recurrent, severe and adjustment disorder | Psychiatric disorders | Systematic Assessment |
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| Complex fluid collection posterior to the operative site | Injury, poisoning and procedural complications | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Congestive heart failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Worsening chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cellulitis of leg, left lower extremity | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blister on right foot big toe | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Feeding tube placed problems eating | Surgical and medical procedures | Systematic Assessment |
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| Lower lumbar surgery | Surgical and medical procedures | Systematic Assessment |
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| Lower lumber decompression & laminectomy at L3-4, lumbar decompression, laminectomy, fusion at L4-5 | Surgical and medical procedures | Systematic Assessment |
| ||
| Possible RIND (Reversible ischemic neurologic deficit) | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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