ID

15376

Description

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.

Keywords

Versions (1)
  1. 5/28/16 5/28/16 -
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May 28, 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

English

Discontinuation of Study medication, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069

1 forms  
Discontinuation of Study Medication
Description

Discontinuation of Study Medication

Date
Description

Date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Primary reason for discontinuation of study medication
Description

Primary reason for discontinuation of study medication

Patient requests discontinuation of Study Medication
Description

Patient requests discontinuation of Study Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0332153
UMLS CUI [1,2]
C0558681
Investigator determines that continuing it would result in a significant risk for that patient
Description

Investigator determines that continuing it would result in a significant risk for that patient

Data type

boolean

Alias
UMLS CUI [1]
C0420243
Patient becomes pregnant
Description

Patient becomes pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0549206
Patient withdraws informed consent
Description

Patient withdraws informed consent

Data type

boolean

Alias
UMLS CUI [1]
C1707492
Lymphocyte count is < 500/μl, confirmed by two independent measurements 2 weeks apart
Description

Lymphocyte count is < 500/μl, confirmed by two independent measurements 2 weeks apart

Data type

boolean

Alias
UMLS CUI [1]
C1845611
Leukocyte count is < 3,000/μl, confirmed by two independent measurements 2 weeks apart
Description

Leukocyte count is < 3,000/μl, confirmed by two independent measurements 2 weeks apart

Data type

boolean

Alias
UMLS CUI [1]
C0948695
Suspicion of a PML (progressive multifocal leukoencephalopathy)
Description

Suspicion of a PML (progressive multifocal leukoencephalopathy)

Data type

boolean

Alias
UMLS CUI [1]
C0023524
Adverse event
Description

Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Serious adverse event (e.g. cardiac failure, diagnosed malignancy, serious infections)
Description

Serious adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Abnormal laboratory value(s) including liver function tests or abnormal test result(s)
Description

Abnormal laboratory value(s) including liver function tests or abnormal test result(s)

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0151766
Use of prohibited medications
Description

Use of prohibited medications

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0138547
Protocol deviation(s)
Description

Protocol deviation(s)

Data type

boolean

Alias
UMLS CUI [1]
C1705236
Unsatisfactory therapeutic effect
Description

Unsatisfactory therapeutic effect

Data type

boolean

Alias
UMLS CUI [1,1]
C1527144
UMLS CUI [1,2]
C0439856
Patient's condition no longer requires study treatment
Description

Patient's condition no longer requires study treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1318598
UMLS CUI [1,2]
C0683521
Administrative problems (e.g. patient's non-compliance)
Description

Administrative problems (e.g. patient's non-compliance)

Data type

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0033213
Other reason:
Description

Other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
Signature
Description

Signature

Date
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Signature Investigator
Description

Signature Investigator

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Discontinuation of Study medication, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Discontinuation of Study Medication
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])
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])
Use of prohibited medications
Item
Use of prohibited medications
boolean
C0013227 (UMLS CUI [1,1])
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])
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])
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])
Other reason
Item
Other reason:
text
C3840932 (UMLS CUI [1])
Item Group
Signature
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature Investigator
Item
Signature Investigator
text
C2346576 (UMLS CUI [1])
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