CDE Detailed Report

Disease: Mitochondrial Disease
Sub-Domain: General Health History
CRF: Dietary Supplements

Displaying 1 - 8 of 8
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C19716 Dietary supplement compounded formulation ingredient text DietrSupplCompFormlIngTxt List of ingredients used to make a specially compounded formulation. List of ingredients used to make a specially compounded formulation. Specially Compounded Formulations (list ingredients) Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History 255

Free-Form Entry

C19717 Dietary supplement brand formulation name DietrSupplBrandFormNam Name of the brand or formulation subject took. Name of the brand or formulation subject took. Brand/formulation Alphanumeric

Record the brand name and chemical form. For example, for calcium, indicate if it is calcium carbonate, calcium citrate, etc. For coenzyme Q10, note if it is ubiquinol, ubiquinone, idebenone, MitoQ, etc.

Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History 255

Free-Form Entry

C19718 Dietary supplement indication reason DietrSupplIndicatnRsn Reason the participant is taking the drug. Reason the participant is taking the drug. Indication Alphanumeric

Record the reason the participant/subject gives for taking the dietary supplement.

Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History 255

Free-Form Entry

C19719 Dietary supplement dose value DietrSupplDoseVal Strength of the dietary supplement the participant/subject is taking. Strength of the dietary supplement the participant/subject is taking. Dose Numeric Values

Record the strength and units of the dietary supplement the participant/subject is taking.

Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History

Free-Form Entry

C19720 Dietary supplement administered count DietrSupplAdminCt Numerical number of how many times the supplement was taken. Numerical number of how many times the supplement was taken. Frequency Numeric Values

Record how often the medication is being taken.

Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History

Free-Form Entry

C19721 Dietary supplement route administered anatomic site DietrSupplRouteAdminAnatSite Anatomic site for supplement entry being administered. Anatomic site for supplement entry being administered. Route Buccal;Inhaled;Intramuscular;Intravenous / Parenteral;Nasal;By mouth;Enteral (via tube);Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Buccal;Inhaled;Intramuscular;Intravenous / Parenteral;Nasal;By mouth;Enteral (via tube);Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Alphanumeric

Select from the following for dietary supplement route of administration:

Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19714 Dietary supplement study use indicator DietrSupplStdyUseInd Indicator to whether the participant/subject took dietary supplements before or during the study. Indicator to whether the participant/subject took dietary supplements before or during the study. Did the participant/subject take any dietary supplements before or during the study? No;Yes No;Yes Alphanumeric

Choose one. If this question is answered YES then at least one prior/concomitant dietary supplement record needs to be recorded. Do NOT record study dietary supplements taken (if study has a dietary supplement intervention) on this form.

Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19715 Dietary supplement generic name DietrSupplGenrNam Generic name for the supplement taken. Generic name for the supplement taken. Dietary Supplement Generic Name Biotin;Folic Acid;Folinic acid;Vitamin B1 (thiamin);Vitamin B2 (riboflavin);Vitamin B3 (niacin);Vitamin B6 (pyridoxine);Vitamin C (ascorbic acid);Vitamin D2 (ergocalciferol);Vitamin D3 (cholecalciferol);Calcium;Magnesium;Phosphorous;Selenium;Arginine;Carnitine;Citrate;Citrulline;Coenzyme Q10;Creatinine;Lipoic acid (thioctic acid);N-acetyl cysteine;Succinate;Uridine;Other Biotin;Folic Acid;Folinic acid;Vitamin B1 (thiamin);Vitamin B2 (riboflavin);Vitamin B3 (niacin);Vitamin B6 (pyridoxine);Vitamin C (ascorbic acid);Vitamin D2 (ergocalciferol);Vitamin D3 (cholecalciferol);Calcium;Magnesium;Phosphorous;Selenium;Arginine;Carnitine;Citrate;Citrulline;Coenzyme Q10;Creatinine;Lipoic acid (thioctic acid);N-acetyl cysteine;Succinate;Uridine;Other Alphanumeric

Record the verbatim name (generic or trade name) of the dietary supplement(s) the participant/subject reports taking. Dietary supplements may be taken as a commercial multivitamin or multivitamin/mineral preparation (e.g. a children's chewable multivitami

Adult;Pediatric Supplemental 1.00 2015-02-02 00:00:00.0 Dietary Supplements General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

CSV