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ID
15376
Beschrijving
Study documentation part: Discontinuation of Study medication Study short name: DIMAT MS Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.: NCT02461069.
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Versies (1)
- 28-05-16 28-05-16 -
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28 mei 2016
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Creative Commons BY-NC 3.0
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Discontinuation of Study medication, DIMAT-MS Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069
Discontinuation of Study medication, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069
Similar models
Discontinuation of Study medication, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Primary reason for discontinuation of study medication
Patient requests discontinuation of Study Medication
Item
Patient requests discontinuation of Study Medication
boolean
C0332153 (UMLS CUI [1,1])
C0558681 (UMLS CUI [1,2])
C0558681 (UMLS CUI [1,2])
Investigator determines that continuing it would result in a significant risk for that patient
Item
Investigator determines that continuing it would result in a significant risk for that patient
boolean
C0420243 (UMLS CUI [1])
Patient becomes pregnant
Item
Patient becomes pregnant
boolean
C0549206 (UMLS CUI [1])
Patient withdraws informed consent
Item
Patient withdraws informed consent
boolean
C1707492 (UMLS CUI [1])
Lymphocyte count is < 500/μl, confirmed by two independent measurements 2 weeks apart
Item
Lymphocyte count is < 500/μl, confirmed by two independent measurements 2 weeks apart
boolean
C1845611 (UMLS CUI [1])
Leukocyte count is < 3,000/μl, confirmed by two independent measurements 2 weeks apart
Item
Leukocyte count is < 3,000/μl, confirmed by two independent measurements 2 weeks apart
boolean
C0948695 (UMLS CUI [1])
Suspicion of a PML (progressive multifocal leukoencephalopathy)
Item
Suspicion of a PML (progressive multifocal leukoencephalopathy)
boolean
C0023524 (UMLS CUI [1])
Adverse event
Item
Adverse event
boolean
C0877248 (UMLS CUI [1])
Serious adverse event
Item
Serious adverse event (e.g. cardiac failure, diagnosed malignancy, serious infections)
boolean
C1519255 (UMLS CUI [1])
Abnormal laboratory value(s) including liver function tests or abnormal test result(s)
Item
Abnormal laboratory value(s) including liver function tests or abnormal test result(s)
boolean
C0438215 (UMLS CUI [1])
C0151766 (UMLS CUI [2])
C0151766 (UMLS CUI [2])
Use of prohibited medications
Item
Use of prohibited medications
boolean
C0013227 (UMLS CUI [1,1])
C0138547 (UMLS CUI [1,2])
C0138547 (UMLS CUI [1,2])
Protocol deviation(s)
Item
Protocol deviation(s)
boolean
C1705236 (UMLS CUI [1])
Unsatisfactory therapeutic effect
Item
Unsatisfactory therapeutic effect
boolean
C1527144 (UMLS CUI [1,1])
C0439856 (UMLS CUI [1,2])
C0439856 (UMLS CUI [1,2])
Patient's condition no longer requires study treatment
Item
Patient's condition no longer requires study treatment
boolean
C1318598 (UMLS CUI [1,1])
C0683521 (UMLS CUI [1,2])
C0683521 (UMLS CUI [1,2])
Administrative problems (e.g. patient's non-compliance)
Item
Administrative problems (e.g. patient's non-compliance)
boolean
C3469597 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,2])
Other reason
Item
Other reason:
text
C3840932 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Signature Investigator
Item
Signature Investigator
text
C2346576 (UMLS CUI [1])