| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS049639-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of the study is to obtain preliminary data regarding the safety and tolerability of etanercept in DM. In addition, we will use the study to assess the variability, reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The study will be performed under the aegis of the Muscle Study Group (MSG), consisting of experienced investigators with an avid interest in myopathies. The ultimate goal of this pilot study will be to obtain necessary, prerequisite information important in designing future therapeutic trials of etanercept and other agents in patients with DM. The specific aims of the study are:
Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM.
Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose to use.
Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability, reliability, and responsiveness in order to facilitate the design of future therapeutic trials in the inflammatory myopathies.
Dermatomyositis (DM) is one of the major subtypes of idiopathic inflammatory myopathy. Prednisone is the initial treatment of choice in most patients with DM. However, because of the high rate of patients with disabling weakness despite treatment with prednisone, the long-term side effects of prednisone, and the many side effects associated with other second-line immunosuppressive agents (e.g., methotrexate, azathioprine), better treatment options are needed. There is evidence that tumor necrosis factor-a (TNF-a) plays a role in the pathogenesis of DM. Thus, etanercept, which blocks TNF-a, is a logical drug to assess in DM. Etanercept has been associated with a number of side effects including an increased risk of infection, inducing other autoimmune diseases, and perhaps cancer. These risks may be further enhanced in DM in which the frequency of other autoimmune disorders (e.g., connective tissue disease) and malignancy are already increased.
The goal of this pilot study will be to assess the safety and tolerability of etanercept in DM.We will perform a double-blind, placebo-controlled pilot study of etanercept in 40 patients with DM randomized in a 3:1 ratio to receive etanercept or placebo. All newly diagnosed and untreated patients will be started on a standard dose of prednisone and tapering schedule. Refractory patients who have been or are currently being treated with prednisone, IVIG, or methotrexate can also participate. Subjects will be followed for 1 year and we will assess various outcome variables recommended by the The International Myositis Assessment Clinical Study Group (IMACS). The primary aim of the study is to preliminarily assess the safety and tolerability of etanercept in patients with DM. We hypothesize that etanercept will be safe and well tolerated in this population. The second aim is to assess the safety and tolerability of prednisone in the dosing schedule we propose to use. We hypothesize that most patients will be able to tolerate the reduction of the prednisone dosage but most will not be able to be completely weaned off the medication. We believe we will find a relationship between prednisone dosage and its related side effects. The third aim of the study is to assess the variability, reliability, and responsiveness of the outcome measures recommended by IMACS using this pilot study of etanercept as the vehicle. The information gained from this study is necessary in order to design larger therapeutic trials of etanercept and other drugs in dermatomyositis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Active Comparator | Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected subcutaneously once a week for 52 weeks. |
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| Placebo | Placebo Comparator | Subjects will be given syringes containing placebo. Injections will be given subcutaneously, one time per week for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept 50 mg will be injected subcutaneously once per week for 52 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of at Least One Adverse Event | Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of "mild", "moderate" or "severe" matches with the descriptions from the CTCAE dictionary. In general, a "Mild" AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated. A "Moderate" AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living. A "Severe" AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; | at each visit during the 12 month study |
| Tolerability | The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment. | At any point between Baseline (week 0) and the end of the study (Week 52) |
| Average Change in Oral Temperature From Baseline to Week 52 | The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. | At Baseline (Week 0) and Week 52 |
| Average Change in Respiration Rate From Baseline to Week 52 | The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. | At Baseline (Week0) and Week 52 |
| Average Change in Systolic Blood Pressure From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Prednisone Dosage After Week 24 | We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52). | from week 24 to 52 |
| Average Daily Dose of Prednisone From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Were Classified as Treatment Failures | Treatment failures were determined based on criteria from the study protocol using objective and subjective ratings from the study physician. If the study physician felt that the rate of prednisone taper needed to be reduced, the prednisone dose needed to be increased or restarted, or a second-line agent added, the patient will be considered to be a treatment failure. |
Inclusion Criteria:
Study subjects must meet the following criteria:
Meet the diagnostic criteria for DM (a-c; a,b,d; or a,c,d)
Newly diagnosed subjects should be able to walk independently 30 feet (cane, walkers, orthoses allowed). However, subjects with refractory dermatomyositis may be non-ambulatory.
Age > 18 years
Patients must not use topical skin ointments for treatment of the dermatological manifestations as it will interfere with skin assessment.
Men and women of childbearing age must be willing to use a method of birth control.
Able to give informed consent
Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections
Exclusion Criteria
The presence of any of the following excludes subject participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony A Amato, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21688301 | Derived | Muscle Study Group. A randomized, pilot trial of etanercept in dermatomyositis. Ann Neurol. 2011 Sep;70(3):427-36. doi: 10.1002/ana.22477. Epub 2011 Jun 17. |
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Most patient were initially ineligible because they were not new dermatomyositis patients.
Due to slow recruitment, we modified the protocol. We allowed enrollment of refractory dermatomyositis patients receiving prednisone for greater than 2 months. These subjects could also receive second line agents, as long as they were on a stable dose.
153 patients were screened and we enrolled and randomized 16 subjects (F 10, M 6) from until February 2006 to May 2009. Of these, 5 were new DM patients and 11 were refractory dermatomyositis patients.
Etanercept: 11 subjects (New 3, Refractory 8) Placebo: 5 subjects (New 2, Refractory 3)
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks |
| FG001 | Placebo | Subjects will be given syringes containing placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks |
| BG001 | Placebo | Subjects will be given syringes containing placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | 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 | Occurrence of at Least One Adverse Event | Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of "mild", "moderate" or "severe" matches with the descriptions from the CTCAE dictionary. In general, a "Mild" AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated. A "Moderate" AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living. A "Severe" AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; | Intention- to -Treat (ITT) | Posted | Oct 2010 | Number | participants | at each visit during the 12 month study |
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from screening to one month after completion of the study (at least 56 wks)
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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 | Etanercept | Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partner Pregnant | Pregnancy, puerperium and perinatal conditions | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Ascites | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A Pilot Study of Etanercept in Dermatomyositis | Brigham and Women's Hospital | 617-732-8046 | aamato@partners.org |
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| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Placebo |
| Drug |
Placebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks. |
|
|
The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| At Baseline (Week0) and Week 52 |
| Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52. | The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. | At Baseline (Week0) and Week 52 |
| Average Change in Pulse Comparing Baseline to Week 52 | The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52. | The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline. Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit. | Screening visit and Week 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52. | At Screening, Week 12, 24, 40, and 52 |
| Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52. | Screening visit, Week 12, 24, 40, and 52 |
| Average Cumulative Dosage of Prednisone Over the One Year Study Period | The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group. | Baseline until week 52 |
The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.
| Baseline through Week 52 |
| At any point during the 52 week study |
| Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52 | The Manual Muscle Test (MMT) assesses 26 muscle groups. The muscle strength of each muscle group is graded. The score for each muscle group ranges from 0 (No contraction palpable) to 5 (normal strength). The minimum total MMT score is a 0. The maximum total MMT score is a 130. The average change in the average Manual Muscle Testing (MMT)from Baseline to Week 52 was calculated. The average score is composed of 26 muscle groups that were tested. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). | At Baseline (Week 0) and Week 52 |
| Average Change in Time to Rise From a Chair From Baseline to Week 52 | The Average change in time to rise from a chair comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52 | Average change in time to walk 30 feet comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52 | The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the femur from the Screening visit to the Week 52 visit was calculated. The average change was determined by subtracting the Screening Visit test results from the Week 52 results (Week 52- Screening visit). The Screening visit was conducted within 8 weeks of the Baseline visit. | Screening and Week 52 |
| Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52 | The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the lumbar spine was calculated comparing the results from the Screening visit to Week 52. The average change was determined by subtracting the Screening Visit (Week <8)test results from the Week 52 results (Week 52- screening Visit). The Screening visit occurred within 8 weeks of the Baseline visit. | Screening visit and Week 52. |
| Average Change in Physician Global Activity Assessment From Baseline to Week 52 | Average change in Physician Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Average Change in Patient Global Activity Assessment Score From Baseline to Week 52 | Average change in Patient Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline | Average change in Cutaneous Disease Activity and Severity Index (CDASI) score from Baseline to Week 52. The assessment graded the severity of the subject's rash. The rash was rated using a a 4-point scale with a score of 0 indicating no rash. The score was added together using all 13 anatomical locations included on the assessment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Change in Pruritis Rating From Baseline to Week 52 | This is the average change in pruritis score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived level of pruritis (itchiness). A score of 0 cm indicated "Not itchy at all". A score of 10.0 cm indicated "Extremely itchy". This assessment was also completed at Week 4, 8, 12, 16, 20, 24, 32 and 40. | At Baseline (Week0), and Week 52 |
| Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52 | The Health Assessment Questionnaire (HAQ)was completed by subjects to assess the affects of their illness on the ability to function in daily life. The HAQ consists of 8 sections. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).The 8 scores of the 8 sections are summed and divided by 8. A higher score indicates more impairment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40. | At Baseline (Week0) and Week 52 |
| Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52. | The average change in percent predicted Forced Vital Capacity (FVC) from the Screening Visit to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit. This assessment was also completed at the Week 24 visit. | Screening Visit and Week 52. |
| Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52 | The average change in percent predicted Forced Expiratory Volume in 1 second (FEV1) from Screening to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening visit). The Screening visit occurred within 8 weeks prior to the Baseline visit. This assessment was also completed during the Week 24 visit. | Screening Visit and Week 52 |
| Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52 | Average change in percent predicted Diffusion Capacity (DLCO)from the Screening Visit to Week 52 was calculate. The average change was determined by subtracting the Screening test results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit. This assessment was also completed during the Week 24 visit. | Screening visit and Week 52 |
| BG002 | Total | Total of all reporting groups |
| participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo | Subjects will be given syringes containing placebo |
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| Other Pre-specified | The Number of Participants Who Were Classified as Treatment Failures | Treatment failures were determined based on criteria from the study protocol using objective and subjective ratings from the study physician. If the study physician felt that the rate of prednisone taper needed to be reduced, the prednisone dose needed to be increased or restarted, or a second-line agent added, the patient will be considered to be a treatment failure. | Posted | Oct 2010 | Number | participants | At any point during the 52 week study |
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| Secondary | Average Prednisone Dosage After Week 24 | We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52). | Posted | Oct 2010 | Median | Inter-Quartile Range | mg | from week 24 to 52 |
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| Other Pre-specified | Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52 | The Manual Muscle Test (MMT) assesses 26 muscle groups. The muscle strength of each muscle group is graded. The score for each muscle group ranges from 0 (No contraction palpable) to 5 (normal strength). The minimum total MMT score is a 0. The maximum total MMT score is a 130. The average change in the average Manual Muscle Testing (MMT)from Baseline to Week 52 was calculated. The average score is composed of 26 muscle groups that were tested. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Oct 2010 | Mean | Standard Deviation | Units on a scale | At Baseline (Week 0) and Week 52 |
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| Primary | Tolerability | The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment. | Posted | Jan 2011 | Number | Participants | At any point between Baseline (week 0) and the end of the study (Week 52) |
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| Other Pre-specified | Average Change in Time to Rise From a Chair From Baseline to Week 52 | The Average change in time to rise from a chair comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | Seconds | At Baseline (Week0) and Week 52 |
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| Other Pre-specified | Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52 | Average change in time to walk 30 feet comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | Seconds | At Baseline (Week0) and Week 52 |
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| Other Pre-specified | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52 | The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the femur from the Screening visit to the Week 52 visit was calculated. The average change was determined by subtracting the Screening Visit test results from the Week 52 results (Week 52- Screening visit). The Screening visit was conducted within 8 weeks of the Baseline visit. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Jan 2011 | Mean | Standard Deviation | Z-score | Screening and Week 52 |
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| Other Pre-specified | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52 | The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the lumbar spine was calculated comparing the results from the Screening visit to Week 52. The average change was determined by subtracting the Screening Visit (Week <8)test results from the Week 52 results (Week 52- screening Visit). The Screening visit occurred within 8 weeks of the Baseline visit. | Data for all subjects enrolled in the trial are not available for this assessment. One subject left the study early and one subject was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Jan 2011 | Mean | Standard Deviation | Z-Score | Screening visit and Week 52. |
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| Other Pre-specified | Average Change in Physician Global Activity Assessment From Baseline to Week 52 | Average change in Physician Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | cm | At Baseline (Week0) and Week 52 |
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| Other Pre-specified | Average Change in Patient Global Activity Assessment Score From Baseline to Week 52 | Average change in Patient Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | cm | At Baseline (Week0) and Week 52 |
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| Other Pre-specified | Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline | Average change in Cutaneous Disease Activity and Severity Index (CDASI) score from Baseline to Week 52. The assessment graded the severity of the subject's rash. The rash was rated using a a 4-point scale with a score of 0 indicating no rash. The score was added together using all 13 anatomical locations included on the assessment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | Units on a scale | At Baseline (Week0) and Week 52 |
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| Other Pre-specified | Change in Pruritis Rating From Baseline to Week 52 | This is the average change in pruritis score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived level of pruritis (itchiness). A score of 0 cm indicated "Not itchy at all". A score of 10.0 cm indicated "Extremely itchy". This assessment was also completed at Week 4, 8, 12, 16, 20, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | cm | At Baseline (Week0), and Week 52 |
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| Other Pre-specified | Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52 | The Health Assessment Questionnaire (HAQ)was completed by subjects to assess the affects of their illness on the ability to function in daily life. The HAQ consists of 8 sections. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).The 8 scores of the 8 sections are summed and divided by 8. A higher score indicates more impairment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline). This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | Units on a scale | At Baseline (Week0) and Week 52 |
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| Other Pre-specified | Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52. | The average change in percent predicted Forced Vital Capacity (FVC) from the Screening Visit to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit. This assessment was also completed at the Week 24 visit. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Jan 2011 | Mean | Standard Deviation | Percent predicted | Screening Visit and Week 52. |
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| Other Pre-specified | Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52 | The average change in percent predicted Forced Expiratory Volume in 1 second (FEV1) from Screening to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening visit). The Screening visit occurred within 8 weeks prior to the Baseline visit. This assessment was also completed during the Week 24 visit. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Jan 2011 | Mean | Standard Deviation | Percent predicted | Screening Visit and Week 52 |
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| Other Pre-specified | Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52 | Average change in percent predicted Diffusion Capacity (DLCO)from the Screening Visit to Week 52 was calculate. The average change was determined by subtracting the Screening test results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit. This assessment was also completed during the Week 24 visit. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Jan 2011 | Mean | Standard Deviation | Percent predicted | Screening visit and Week 52 |
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| Primary | Average Change in Oral Temperature From Baseline to Week 52 | The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Jan 2011 | Mean | Standard Deviation | degrees Celsius | At Baseline (Week 0) and Week 52 |
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| Primary | Average Change in Respiration Rate From Baseline to Week 52 | The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Jan 2011 | Mean | Standard Deviation | breaths per minute | At Baseline (Week0) and Week 52 |
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| Primary | Average Change in Systolic Blood Pressure From Baseline to Week 52 | The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | mmHg | At Baseline (Week0) and Week 52 |
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| Primary | Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52. | The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | mmHg | At Baseline (Week0) and Week 52 |
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| Primary | Average Change in Pulse Comparing Baseline to Week 52 | The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | beats per minute | At Baseline (Week0) and Week 52 |
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| Primary | Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52. | The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Posted | Jan 2011 | Mean | Standard Deviation | Kilograms | At Baseline (Week0) and Week 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Feb 2011 | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline. Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | Screening visit and Week 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | At Screening, Week 12, 24, 40, and 52 |
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| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52. | Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit. Data may also be missing due to the subject's refusal to complete an assessment or examiner error. | Posted | Number | participants | Screening visit, Week 12, 24, 40, and 52 |
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| Primary | Average Cumulative Dosage of Prednisone Over the One Year Study Period | The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group. | Posted | Jan 2011 | Mean | Standard Deviation | mg | Baseline until week 52 |
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| Secondary | Average Daily Dose of Prednisone From Baseline to Week 52 | The average daily dose of prednisone from baseline to week 52 was calculated by treatment group. | Posted | Mean | Standard Deviation | mg | Baseline through Week 52 |
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| 3 |
| 11 |
| 11 |
| 11 |
| EG001 | Placebo | Subjects will be given syringes containing placebo | 3 | 5 | 5 | 5 |
| Urinary Tract Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Post Herpetic Neuralgia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Acute Psychosis | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Viral Gastroenteritis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Dermatomyositis Flare | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
|
| Abdominal Distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anxiety/Mood Alternation | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Auditory/Ear-Other- Tingling in ear | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Bladder Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Bleeding- Vaginal | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Burning sensation right foot | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cataracts | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Chest tightness | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Chest tightness | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cholesterol High | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dental/Teeth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Difficulty Swallowing | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dryness inner eyelids | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Edema: Left Knee Swelling | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated Aldolase | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated ALT | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated AST | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated CK | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated GGT | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated Glucose | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated WBC | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fall; Right Scalp Abrasion & Hematoma, R Chest Wall Bruising | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fatty liver | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fecal Urgency | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Increased Edema | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Increased Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Increased weakness right lower leg | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection- Sacral area | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection NOS (Viral Syndrome) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection Upper Airway | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection with Normal ANC - Conjunctiva | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection with Normal - ANC - UTI | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection- Conjuctiva | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection - Lip | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection - Other (Gastrointestinal) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Injection Site Reaction | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Interstital Lung Disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Laboratory/Other- Abnormal PAP Smear | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Left Antecubital Fossa Scab- Wound Complication - Noninfectious | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Left Kidney Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
|
| Low WBC Count | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Mechanics Hand on Right Index Finger- Hand/Foot | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Musculoskeletal Pains | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Replacement of pacemaker | Surgical and medical procedures | CTCAE (3.0) | Non-systematic Assessment |
|
| Ear numbness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Endometrial polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
|
| Increased Vit D Level | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain- Ear | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain- Throat/Pharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Periungal Finger Infections | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Skin Burn Left Forearm Vent Surface | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Skin/Cellulitus Right Great Toe | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Spinal Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Stomach Cramps | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Subconjuctival haemorrhage | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Syndromes- Other (Sicca) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Transient Cardiac Arrhythmia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Urine Glucose Pos. | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Urine Protein Pos. | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| UTI | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Viral Gastroenteritis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Viral Hepatitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Vitamin D Low | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Worsening of Dermato | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Worsening Skin Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D009468 |
| Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |