ID

15372

Beskrivning

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. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster 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.

Nyckelord

Versioner (4)
  1. 2015-11-17 2015-11-17 - Julian Varghese
  2. 2015-11-17 2015-11-17 - Julian Varghese
  3. 2016-05-28 2016-05-28 -
  4. 2016-05-28 2016-05-28 -
Uppladdad den

28 maj 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Relapse Evaluation DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Engelsk

Relapse Evaluation DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069Relapse Evaluation

1 Formulär  
Confirmation of Relapse
Beskrivning

Confirmation of Relapse

Start date of relapse symptoms
Beskrivning

Start date of relapse symptoms

Datatyp

date

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

Confirmation of the relapse

Datatyp

boolean

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

If relapse confirmed, date of relapse confirmation:

Datatyp

text

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

Treatment of Relapse

no treatment
Beskrivning

no treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0332155
Plasmapheresis / Immunoadsorption
Beskrivning

Plasmapheresis / Immunoadsorption

Datatyp

boolean

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

enter number of cycles

Datatyp

integer

other treatment
Beskrivning

other treatment

Datatyp

text

Alias
UMLS CUI [1]
C0087111
Intravenous Steroid Treatment
Beskrivning

Intravenous Steroid Treatment

Alias
UMLS CUI-1
C0149783
Treatment Start Date
Beskrivning

Treatment Begin Date

Datatyp

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date
Beskrivning

Treatment End Date

Datatyp

date

Alias
UMLS CUI [1]
C1531784
Dose
Beskrivning

Medication Dose

Datatyp

float

Måttenheter
  • g/day
Alias
UMLS CUI [1]
C3174092
g/day
Signature
Beskrivning

Signature

Date
Beskrivning

Investigator Signature Date

Datatyp

date

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

Signature Investigator

Datatyp

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Relapse Evaluation DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069Relapse Evaluation

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
C0035020 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
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])
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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