CDE Detailed Report

Disease: Duchenne Muscular Dystrophy/Becker Muscular Dystrophy
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 19 of 19
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
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 category Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Alphanumeric

Supplemental - Highly Recommended

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 Adult;Pediatric Supplemental-Highly Recommended 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
C18241 Diagnosis age type DiagnosAgeTyp Type of age of the participant/subject when initially diagnosed with disease/disorder Type of age of the participant/subject when initially diagnosed with disease/disorder Age at diagnosis years;Months;Weeks;Days;Hours years;Months;Weeks;Days;Hours Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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 SNOMED CT code Alphanumeric

Code each of the medical history conditions using SNOMED CT

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

C18242 Symptoms first appeared age value SymptmFrstApprAgVal Value of the age at which the participant/subject first noted a neuromuscular symptom Value of the age at which the participant/subject first noted a neuromuscular symptom Age at first symptom Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Medical History General Health History Participant History and Family History

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

Supplemental - Highly Recommended
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-Highly Recommended 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2179659
C18243 Symptom first appear age type SymptmFrstApprAgTyp Type of age of the participant/subject at first symptom appearance Type of age of the participant/subject at first symptom appearance Age at first symptom years;Months;Weeks;Days;Hours years;Months;Weeks;Days;Hours Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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 Yes;No Yes;No Alphanumeric

Supplemental - Highly Recommended

Adult;Pediatric Supplemental-Highly Recommended 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
C18246 Medical history condition start age value MedHistCondStrtAgeVal Value of the age, approximated, when the specific medical condition began Value of the age, approximated, when the specific medical condition began Start Date or Age (approximate) Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Medical History General Health History Participant History and Family History

Free-Form Entry

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

Supplemental - Highly Recommended
Recordthe date the medical condition/disease ended. 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.) and in the format acceptable to the study database.

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

Free-Form Entry

3145557
C18253 Clinical trial previous participation indicator ClinTrialPrevPrtpInd Indicator of whether the participant/subject participated in any prior clinical trials Indicator of whether the participant/subject participated in any prior clinical trials Has participant participated in prior clinical trials? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Supplemental - Highly Recommended
Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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 the medical condition/disease started. 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.) and in the format acceptable to the study database.
Supplemental - Highly Recommended

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

Free-Form Entry

2543596
C18254 Medical history assessment indicator MedclHistAssmtInd Whether the participant/subject has a history of any medical problems/conditions Whether the participant/subject has a history of any medical problems/conditions History of any medical problems or conditions? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Supplemental - Highly Recommended

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-21 12:11:21.037 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

3145578
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 Continuing? Yes;No;Unknown Yes;No;Unknown Alphanumeric

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

No references available Adult;Pediatric Supplemental-Highly Recommended 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
C18256 Medical history condition end age value MedHistCondEndAgeVal Value of the age, approximated, when the specific medical condition ended Value of the age, approximated, when the specific medical condition ended If no, indicate End Date or Age (approximate) Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-21 12:11:21.037 Medical History General Health History Participant History and Family History

Free-Form Entry

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 Medical Condition Alphanumeric

Supplemental - Highly Recommended

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Supplemental-Highly Recommended 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

Supplemental - Highly Recommended

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 Adult;Pediatric Supplemental-Highly Recommended 1.00 2014-05-27 13:34:46.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
C08006 Symptoms first appeared date and time SymptmFirstAppearDateTime Date (and time if applicable and known) the symptoms for the disease or disorder first appeared as confirmed by the participant's/subject's medical history obtained by a physician Date (and time if applicable and known) the symptoms for the disease or disorder first appeared as confirmed by the participant's/subject's medical history obtained by a physician Date of first symptom Date or Date & Time Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-24 21:00:23.88 Medical History General Health History Participant History and Family History

Free-Form Entry

C08007 Diagnosis first given date and time DiagnosFirstGivnDateTime Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Date at diagnosis Date or Date & Time Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Free-Form Entry

C10501 Diagnosis initial age value DiagnosAgeVal Age of the participant/subject when initially diagnosed with disease/disorder Age of the participant/subject when initially diagnosed with disease/disorder Age at diagnosis Numeric Values

Answer should be recorded in years. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 16:29:10.887 Medical History General Health History Participant History and Family History

Free-Form Entry

year
CSV