CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 11 of 11
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
C00316 Medical history condition end date and time MedclHistCondEndDateTime Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history End Date Date or Date & Time

Record the date (and time) the medical condition/disease stopped. For surgeries, start and stop dates will most likely be the same date. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

3145557
C00317 Medical history condition start date and time MedclHistCondStrtDateTime Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Start Date Date or Date & Time

Record the date (and time) the medical condition/disease started. At a minimum the start year (YYYY) should be recorded. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2543596
C00319 Medical history condition ongoing indicator MedclHistCondOngoingInd Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Ongoing? Yes;No Yes;No Alphanumeric

Check Yes or No to indicate if the medical condition/disease is still present.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2736881
C00322 Medical history condition text MedclHistCondTxt Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Description Alphanumeric

Record one Medical History term per line. Document the specific diagnosis for each pre-existing neuro-musculoskeletal condition and document the location/anatomic site if not obvious. Previous surgeries due to any of the conditions should also be documented with this element. Record each condition or surgery on separate lines. Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2003874
C18666 Body system other text BodySysOTH The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured Free-text category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Other, specify Alphanumeric

Record the appropriate body system for each line of medical history. Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. For TBI: Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history. For SCI: Record all pulmonary conditions present before spinal cord lesion. For ALS: Each body system is pre-populated on the case report form. Record the physical exam results for each. The 'Neurological' body system should only be used to record physical examination findings separate from the ALS exam.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
C00001 Gestational age value GestatnlAgeVal Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject. Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject. Gestational age at birth Numeric Values

Answer should be recorded in weeks

Stroke Reference: Govaert P, Ramenghi L, Taal R, de Vries L, Deveber G. Diagnosis of perinatal stroke I: definitions, differential diagnosis and registration. Acta Paediatr. 2009 Oct;98(10):1556-67. Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

0 52 week 3192017
C00311 Birth weight value BirthWgtVal Birth weight according to the participant's/subject's medical report or reported by the parent or legal guardian Birth weight according to the participant's/subject's medical report or reported by the parent or legal guardian Birth weight Numeric Values

Record the birth weight of the participant/ subject in pounds (lb) and ounces (oz) or kilograms (kg).

Pediatric Reference: Govaert P, Ramenghi L, Taal R, de Vries L, Deveber G. Diagnosis of perinatal stroke I: definitions, differential diagnosis and registration. Acta Paediatr. 2009 Oct;98(10):1556-67. Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History General Health History Participant History and Family History

Free-Form Entry

0 9000 gram 3201400;2179689
C00312 Body system category BodySysCat Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Body System Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Hepatobiliary;Musculoskeletal;Integumentary (skin and/or breast);Neurological;Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Hepatobiliary;Musculoskeletal;Integumentary (skin and/or breast);Neurological;Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic Alphanumeric

Record the appropriate body system for each line of medical history. Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. For TBI: Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history. For SCI: Record all pulmonary conditions present before spinal cord lesion. For ALS: Each body system is pre-populated on the case report form. Record the physical exam results for each. The 'Neurological' body system should only be used to record physical examination findings separate from the ALS exam.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2002895
C00313 Medical history condition SNOMED CT code MedclHistCondSNOMEDCTCode Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Medical History Term Alphanumeric

The code related to the medical condition or disease reported using SNOMED CT codes (owned and administered by the International Health Terminology Standards Development Organisation) to enable data aggregation or sharing.

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C00314 Medical history taken date and time MedclHistTakenDateTime Date (and time, if applicable and known) the participant/subject's medical history was taken Date (and time, if applicable and known) the participant/subject's medical history was taken Date medical history taken Date or Date & Time

Record the date (and time) the medical history was taken. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2179659
C00315 Medical history global assessment indicator MedclHistGlobalAssmtInd Indicator of whether the participant/subject has a history of any medical problems/conditions Indicator of whether the participant/subject has a history of any medical problems/conditions Does the participant/subject have a history of any medical problems/conditions in the following body systems Yes;No Yes;No Alphanumeric

Choose one. If this question is answered NO then the rest of the form is blank. If the question is answered YES then the medical history for at least one body system should be recorded.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

3145578
CSV