CDE Detailed Report

Disease: Amyotrophic Lateral Sclerosis
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 18 of 18
CDE ID CDE Name Variable Name Definition Short Description 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
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;Unknown Yes;No;Unknown 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
C18818 Childbearing potential surgically sterile other text ChldbrngPotentSurgSterilOTH The free-text field related to 'Childbearing potential surgically sterile type' specifying other text. Type of surgical procedure that rendered the participant/subject sterile. The free-text field related to 'Childbearing potential surgically sterile type' specifying other text. Type of surgical procedure that rendered the participant/subject sterile. Other, specify Alphanumeric

Only answered if "Is the subject of childbearing potential?" is answered No, and "Surgically sterile" is checked as the reason. Choose one.

No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C00321 Medical history for body system indicator MedclHistBodySysInd Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. Does the participant/subject have a history of any medical problems/conditions in the following body systems? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for each body system.

No references available Adult;Pediatric Core 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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 History Term Alphanumeric

Record one Medical History term per line. See the data dictionary for additional information on coding the condition 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 4000

Free-Form Entry

2003874
C10980 Childbearing potential indicator ChldbrngPtntlInd Indicator of whether the participant/subject is of childbearing potential. Indicator of whether the participant/subject is of childbearing potential. Is the subject of childbearing potential? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. No should be chosen if the participant/subject is a male.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10981 Birth control method type BirthCntrlMethdTyp The female participant's/subject's method of birth control The female participant's/subject's method of birth control If yes, check box for birth control measure Oral contraceptives – combined pill;Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Implantable devices with hormone;Abstinence;Hormonal (e.g., oral, implanted, injected);Intrauterine device in place for greater than or equal to 3 months;Adequate barrier method in conjunction with spermicide;None of these;Other, specify: Oral contraceptives – combined pill;Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Implantable devices with hormone;Abstinence;Hormonal (e.g., oral, implanted, injected);Intrauterine device in place for greater than or equal to 3 months;Adequate barrier method in conjunction with spermicide;None of these;Other, specify: Alphanumeric

Only answered if "Is the subject of childbearing potential?" is answered Yes. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

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 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

Record the appropriate body system for each line of medical history. Each body system is pre-populated on the case report form.

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 Core 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
C10982 Childbearing potential sterile reason ChldbrngPotentSterilRsn Explanation of why the female participant/subject is not of childbearing potential. Explanation of why the female participant/subject is not of childbearing potential. If no, check appropriate box Surgically sterile;Non-surgically sterile;Post menopausal for at least one year Surgically sterile;Non-surgically sterile;Post menopausal for at least one year Alphanumeric

Only answered if "Is the subject of childbearing potential?" is answered No. Choose one.

No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 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 Medical History Term Alphanumeric

Record one Medical History term per line. See the data dictionary for additional information on coding the condition 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

C10983 Childbearing potential surgically sterile type ChldbrngPotentSurgSterilTyp Type of surgical procedure that rendered the participant/subject sterile. Type of surgical procedure that rendered the participant/subject sterile. If surgicially sterile, check one Hysterectomy;Tubal ligation;Other, specify Hysterectomy;Tubal ligation;Other, specify Alphanumeric

Only answered if "Is the subject of childbearing potential?" is answered No, and "Surgically sterile" is checked as the reason. Choose one.

No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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/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
C17770 Allergy diagnosis indicator AllergyDiagnInd Indicator of whether the participant/subject has allergies. Indicator of whether the participant/subject has allergies. Does the subject have any allergies? Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 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 Does the participant/subject have a history of any medical problems/conditions in the following body systems? Yes;No;Unknown Yes;No;Unknown 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
C17771 Allergy diagnosis type AllergyTyp Type of allergy the participant/subject experiences. Type of allergy the participant/subject experiences. If yes, check which type Seasonal;Food;Medication Seasonal;Food;Medication Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

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/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
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. Each body system is pre-populated on the case report form.

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 1.00 2014-05-27 13:34:46.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
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/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 Core 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2543596
C18817 Birth control method other text BirthCntrlMethdOTH The free-text field related to 'Birth control method type' specifying other text. The female participant's/subject's method of birth control The free-text field related to 'Birth control method type' specifying other text. The female participant's/subject's method of birth control Other, specify Alphanumeric

Only answered if "Is the subject of childbearing potential?" is answered Yes. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

CSV