ID

12439

Description

Study documentation part: Relapse Evaluation 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. EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069. Please document clinically significant symptoms as Adverse Events on form Adverse Events. (and also additionally as SAE if a seriousness criterion is fulfilled). Please document all Medications which are administered to treat the relapse on form concomitant medication. Please document all Study Medication dose adjustments and interruptions on form study medication.

Keywords

Versions (4)
  1. 11/17/15 11/17/15 - Julian Varghese
  2. 11/17/15 11/17/15 - Julian Varghese
  3. 5/28/16 5/28/16 -
  4. 5/28/16 5/28/16 -
Uploaded on

November 17, 2015

DOI

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License

Creative Commons BY-NC 3.0
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Relapse Evaluation DIMAT MS Multiple Sclerosis NCT02461069

English

Relapse Evaluation

1 forms  
  1. StudyEvent: ODM
    1. Relapse Evaluation
Confirmation of Relapse
Description

Confirmation of Relapse

Start date of relapse symptoms
Description

Start date of relapse symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0808070
Confirmation of the relapse?
Description

Confirmation of the relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0521091
If yes, date of relapse confirmation:
Description

If relapse confirmed, date of relapse confirmation:

Data type

text

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0521091
UMLS CUI [1,3]
C0011008
Treatment of Relapse
Description

Treatment of Relapse

no treatment
Description

no treatment

Data type

boolean

Plasmapheresis / Immunoadsorption
Description

Plasmapheresis / Immunoadsorption

Data type

boolean

Alias
UMLS CUI [1]
C0398341
UMLS CUI [2]
C0032134
If Plasmapheresis / Immunoadsorption= yes, enter number of cycles
Description

enter number of cycles

Data type

integer

other treatment
Description

other treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Intravenous Steroid Treatment
Description

Intravenous Steroid Treatment

Alias
UMLS CUI-1
C0149783
Treatment Start Date
Description

Treatment Begin Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date
Description

Treatment End Date

Data type

date

Alias
UMLS CUI [1]
C1531784
Dose
Description

Medication Dose

Data type

float

Measurement units
  • g/day
Alias
UMLS CUI [1]
C3174092
g/day
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Similar models

Relapse Evaluation

1 forms
  1. StudyEvent: ODM
    1. Relapse Evaluation
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Confirmation of Relapse
Start date of relapse symptoms
Item
Start date of relapse symptoms
date
C0035020 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Confirmation of the relapse
Item
Confirmation of the relapse?
boolean
C0035020 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
date of relapse confirmation
Item
If yes, date of relapse confirmation:
text
C0035020 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
no treatment
Item
no treatment
boolean
Plasmapheresis / Immunoadsorption
Item
Plasmapheresis / Immunoadsorption
boolean
C0398341 (UMLS CUI [1])
C0032134 (UMLS CUI [2])
enter number of cycles
Item
If Plasmapheresis / Immunoadsorption= yes, enter number of cycles
integer
other treatment
Item
other treatment
text
C0087111 (UMLS CUI [1])
Item Group
Intravenous Steroid Treatment
C0149783 (UMLS CUI-1)
Treatment Begin Date
Item
Treatment Start Date
date
C3173309 (UMLS CUI [1])
Treatment End Date
Item
Treatment End Date
date
C1531784 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
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