ID
15376
Descripción
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.
Palabras clave
Versiones (1)
- 28/5/16 28/5/16 -
Subido en
28 de mayo de 2016
DOI
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Licencia
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
Descripción
Primary reason for discontinuation of study medication
Descripción
Patient requests discontinuation of Study Medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332153
- UMLS CUI [1,2]
- C0558681
Descripción
Investigator determines that continuing it would result in a significant risk for that patient
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0420243
Descripción
Patient becomes pregnant
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0549206
Descripción
Patient withdraws informed consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1707492
Descripción
Lymphocyte count is < 500/μl, confirmed by two independent measurements 2 weeks apart
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1845611
Descripción
Leukocyte count is < 3,000/μl, confirmed by two independent measurements 2 weeks apart
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0948695
Descripción
Suspicion of a PML (progressive multifocal leukoencephalopathy)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0023524
Descripción
Adverse event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0877248
Descripción
Serious adverse event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Abnormal laboratory value(s) including liver function tests or abnormal test result(s)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0438215
- UMLS CUI [2]
- C0151766
Descripción
Use of prohibited medications
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0138547
Descripción
Protocol deviation(s)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1705236
Descripción
Unsatisfactory therapeutic effect
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1527144
- UMLS CUI [1,2]
- C0439856
Descripción
Patient's condition no longer requires study treatment
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1318598
- UMLS CUI [1,2]
- C0683521
Descripción
Administrative problems (e.g. patient's non-compliance)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0033213
Descripción
Other reason
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3840932
Descripción
Signature
Similar models
Discontinuation of Study medication, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069
C0558681 (UMLS CUI [1,2])
C0151766 (UMLS CUI [2])
C0138547 (UMLS CUI [1,2])
C0439856 (UMLS CUI [1,2])
C0683521 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])