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ID
41783
Description
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.; ODM derived from: https://clinicaltrials.gov/show/NCT01197534
Link
https://clinicaltrials.gov/show/NCT01197534
Keywords
Versions (3)
- 1/20/21 1/20/21 - Ahmed Rafee, MD
- 1/21/21 1/21/21 - Ahmed Rafee, MD
- 1/22/21 1/22/21 - Sarah Riepenhausen
Copyright Holder
AstraZeneca
Uploaded on
January 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01197534
Eligibility Rheumatoid Arthritis NCT01197534
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT01197534
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Active Rheumatoid Arthritis | Age at Diagnosis
Item
Active Rheumatoid Arthritis (RA) diagnosed after the age of 16?
boolean
C0003873 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
Methotrexat | Sulfasalazine | Hydroxychloroquine | Choloroquine
Item
Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, Sulfasalazine, Hydroxychloroquine or Chloroquine?
boolean
C0025677 (UMLS CUI [1])
C0036078 (UMLS CUI [2])
C0020336 (UMLS CUI [3])
C0008269 (UMLS CUI [4])
C0036078 (UMLS CUI [2])
C0020336 (UMLS CUI [3])
C0008269 (UMLS CUI [4])
Joint Swelling; count | Joint Tenderness | Joint Pain | ESR | CRP
Item
4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either erythrocyte sedimentation rate (esr) blood result of 28mm/h or more, or c-reactive protein (crp) blood result of 10mg/l or more?
boolean
C0152031 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C0003862 (UMLS CUI [3])
C1176468 (UMLS CUI [4])
C0201657 (UMLS CUI [5])
C0449788 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C0003862 (UMLS CUI [3])
C1176468 (UMLS CUI [4])
C0201657 (UMLS CUI [5])
History of Rheumatoid Factor | Current positive Rheumatoid Factor | Radiographic Bone Erosion | Anti-Cyclic Citrullinated Peptide Antibodies
Item
at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)?
boolean
C0151379 (UMLS CUI [1])
C0151379 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0444708 (UMLS CUI [3,1])
C0587240 (UMLS CUI [3,2])
C2609056 (UMLS CUI [4])
C0151379 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0444708 (UMLS CUI [3,1])
C0587240 (UMLS CUI [3,2])
C2609056 (UMLS CUI [4])
Pregnant | Breast Feeding
Item
Pregnant or breastfeeding (applicable for females)?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Poorly controlled Hypertension
Item
Poorly controlled hypertension?
boolean
C0020538 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,2])
Abnormal liver functions tests
Item
liver disease or significant liver function test abnormalities?
boolean
C0023901 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
Inflammatory Disorder other than Rheumatoid Arthritis | Connective Tissue Disease | Chronic Pain Syndrome
Item
certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders?
boolean
C1290884 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0009782 (UMLS CUI [3])
C1298685 (UMLS CUI [4])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0009782 (UMLS CUI [3])
C1298685 (UMLS CUI [4])
Recent severe Cariovascular Disease
Item
recent or significant cardiovascular disease?
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Severe active infection | severe recent infection | Tuberculosis
Item
significant active or recent infection including tuberculosis?
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C2169571 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0041296 (UMLS CUI [3])
C0205177 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C2169571 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0041296 (UMLS CUI [3])
Unresposive Therapy with TNF-Alpha Inhibitors | Unresponsive Therapy with Anakinra | Unresponsive Therapy with Biological Agents
Item
previous failure to respond to a tnf alpha antagonist, anakinra or previous treatment with other biological agent?
boolean
C3537192 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0245109 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0005515 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0205269 (UMLS CUI [1,2])
C0245109 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0005515 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Severe renal insufficiency
Item
severe renal impairment?
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Neutropenia
Item
neutropenia?
boolean
C0027947 (UMLS CUI [1])