ID

34523

Description

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT01242514

Link

https://clinicaltrials.gov/show/NCT01242514

Keywords

Versions (1)
  1. 1/18/19 1/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01242514

English

Eligibility Rheumatoid Arthritis NCT01242514

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have successfully completed a qualifying study (d4300c00001, d4300c00002, d4300c00003 or d4300c00004) with fostamatinib
Description

Completion of clinical trial Specified Successful | fostamatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C2732579
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1272703
UMLS CUI [2]
C2713632
patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at week 12 (d4300c00001, d4300c00002, d4300c00003).
Description

Participation Clinical Trials Specified | Therapy non-responder Due to Lack of Efficacy

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0235828
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
premature withdrawal from the qualifying study (d4300c00001, d4300c00002, d4300c00003 and d4300c00004)
Description

Patient withdrawn from trial specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205369
females who are pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
poorly controlled hypertension
Description

Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1]
C0421190
significant liver function test abnormalities or physical symptoms of hepatotoxicity
Description

Liver function tests abnormal | Physical symptom Hepatotoxicity

Data type

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2,1]
C0679309
UMLS CUI [2,2]
C0235378
significant infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
gastrointestinal intolerance
Description

Gastrointestinal sensitivity (hyper)

Data type

boolean

Alias
UMLS CUI [1]
C1533260
cancer
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Rheumatoid Arthritis NCT01242514

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Completion of clinical trial Specified Successful | fostamatinib
Item
patients who have successfully completed a qualifying study (d4300c00001, d4300c00002, d4300c00003 or d4300c00004) with fostamatinib
boolean
C2732579 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1272703 (UMLS CUI [1,3])
C2713632 (UMLS CUI [2])
Participation Clinical Trials Specified | Therapy non-responder Due to Lack of Efficacy
Item
patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at week 12 (d4300c00001, d4300c00002, d4300c00003).
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0919875 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0235828 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Patient withdrawn from trial specified
Item
premature withdrawal from the qualifying study (d4300c00001, d4300c00002, d4300c00003 and d4300c00004)
boolean
C0422727 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
females who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Poor hypertension control
Item
poorly controlled hypertension
boolean
C0421190 (UMLS CUI [1])
Liver function tests abnormal | Physical symptom Hepatotoxicity
Item
significant liver function test abnormalities or physical symptoms of hepatotoxicity
boolean
C0151766 (UMLS CUI [1])
C0679309 (UMLS CUI [2,1])
C0235378 (UMLS CUI [2,2])
Communicable Disease
Item
significant infection
boolean
C0009450 (UMLS CUI [1])
Gastrointestinal sensitivity (hyper)
Item
gastrointestinal intolerance
boolean
C1533260 (UMLS CUI [1])
Malignant Neoplasms
Item
cancer
boolean
C0006826 (UMLS CUI [1])
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