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])
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])