ID

44744

Beskrivning

Gastrointestinal Tolerability Study Of Dimethyl Fumarate (DMF) In Participants With Relapsing-Remitting Multiple Sclerosis In Germany; ODM derived from: https://clinicaltrials.gov/show/NCT02125604

Länk

https://clinicaltrials.gov/show/NCT02125604

Nyckelord

Versioner (1)
  1. 2021-11-10 2021-11-10 -
Rättsinnehavare

Biogen

Uppladdad den

10 november 2021

DOI

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Creative Commons BY-NC 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT02125604

Engelsk

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02125604

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI [1]
C1512693
have a confirmed diagnosis of relapsing-remitting multiple sclerosis (rrms) according to the current mcdonald criteria and satisfy the therapeutic indication as described in the official local registration for tecfidera (dimethyl fumarate).
Beskrivning

relapsing-remitting multiple sclerosis according to mcdonald criteria with therapeutic indication as described in the official local registration for tecfidera

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0751967
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C1698061
UMLS CUI [1,5]
C3556178
naïve to dimethyl fumarate (dmf) and fumaric acid esters.
Beskrivning

naïve to dimethyl fumarate and fumaric acid esters

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0058218
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0060825
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI [1]
C0680251
female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study
Beskrivning

female subjects who are currently pregnant or breastfeeding or planned pregnancy while in the study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0549206
UMLS CUI [2,1]
C0086287
UMLS CUI [2,2]
C0006147
UMLS CUI [2,3]
C0521116
UMLS CUI [3,1]
C0086287
UMLS CUI [3,2]
C0032992
UMLS CUI [3,3]
C0489652
history of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal -related symptomatic therapy as determined by the investigator (or ≥7 consecutive days of gastrointestinal -related symptomatic therapy
Beskrivning

history of gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries) or chronic use of gastrointestinal-related symptomatic therapy as determined by the investigator (or ≥7 consecutive days)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0017178
UMLS CUI [1,3]
C0022104
UMLS CUI [1,4]
C0030920
UMLS CUI [1,5]
C0524722
UMLS CUI [2,1]
C0420257
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0521362
UMLS CUI [2,4]
C1707491
UMLS CUI [2,5]
C0439228
known active malignancies
Beskrivning

active malignancies

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205177
history of anaphylaxis or severe allergic reactions or known drug hypersensitivity
Beskrivning

history of anaphylaxis or severe allergic reactions or known drug hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C2220378
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C0262926
current use of b vitamin supplements
Beskrivning

current use of b vitamin supplements

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704763
UMLS CUI [1,2]
C0242297
UMLS CUI [1,3]
C0521116
in the opinion of the investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use.
Beskrivning

blood test values suggestive of a low lymphocyte count or renal or hepatic impairment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0854146
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0200635
UMLS CUI [1,4]
C0205251
UMLS CUI [2,1]
C0854146
UMLS CUI [2,2]
C1522609
UMLS CUI [2,3]
C0948807
UMLS CUI [3,1]
C0854146
UMLS CUI [3,2]
C1522609
UMLS CUI [3,3]
C1565489
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02125604

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI [1])
relapsing-remitting multiple sclerosis according to mcdonald criteria with therapeutic indication as described in the official local registration for tecfidera
Item
have a confirmed diagnosis of relapsing-remitting multiple sclerosis (rrms) according to the current mcdonald criteria and satisfy the therapeutic indication as described in the official local registration for tecfidera (dimethyl fumarate).
boolean
C0751967 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C1698061 (UMLS CUI [1,4])
C3556178 (UMLS CUI [1,5])
naïve to dimethyl fumarate and fumaric acid esters
Item
naïve to dimethyl fumarate (dmf) and fumaric acid esters.
boolean
C0919936 (UMLS CUI [1,1])
C0058218 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C0060825 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI [1])
female subjects who are currently pregnant or breastfeeding or planned pregnancy while in the study
Item
female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study
boolean
C0086287 (UMLS CUI [1,1])
C0549206 (UMLS CUI [1,2])
C0086287 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C0086287 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
C0489652 (UMLS CUI [3,3])
history of gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries) or chronic use of gastrointestinal-related symptomatic therapy as determined by the investigator (or ≥7 consecutive days)
Item
history of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal -related symptomatic therapy as determined by the investigator (or ≥7 consecutive days of gastrointestinal -related symptomatic therapy
boolean
C0262926 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0022104 (UMLS CUI [1,3])
C0030920 (UMLS CUI [1,4])
C0524722 (UMLS CUI [1,5])
C0420257 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0521362 (UMLS CUI [2,3])
C1707491 (UMLS CUI [2,4])
C0439228 (UMLS CUI [2,5])
active malignancies
Item
known active malignancies
boolean
C0006826 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
history of anaphylaxis or severe allergic reactions or known drug hypersensitivity
Item
history of anaphylaxis or severe allergic reactions or known drug hypersensitivity
boolean
C0002792 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C2220378 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
current use of b vitamin supplements
Item
current use of b vitamin supplements
boolean
C1704763 (UMLS CUI [1,1])
C0242297 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
blood test values suggestive of a low lymphocyte count or renal or hepatic impairment
Item
in the opinion of the investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use.
boolean
C0854146 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0200635 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0854146 (UMLS CUI [2,1])
C1522609 (UMLS CUI [2,2])
C0948807 (UMLS CUI [2,3])
C0854146 (UMLS CUI [3,1])
C1522609 (UMLS CUI [3,2])
C1565489 (UMLS CUI [3,3])
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