CDE Detailed Report
Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: General Health History
CRF: Medical History
Displaying 1 - 18 of 18
Subdomain Name: 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 / Guidance) | Subdomain 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 system | 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 potentia | 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 |
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| 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 |
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| 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 steril | 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 |
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| C00314 | Medical history taken date and time | MedclHistTakenDateTime | Date (and time, if applicable and known) the participant's medical history was taken | Date (and time, if applicable and known) the participant '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 | 3.20 | 2024-02-29 15:42:39.0 | 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 allergie | 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 |
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| C00315 | Medical history global assessment indicator | MedclHistGlobalAssmtInd | Indicator of whether the participant has a history of any medical problems/conditions | Indicator of whether the participant 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 | 3.10 | 2024-02-29 15:42:39.0 | 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 experienc | 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 |
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| 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 medical history | Date (and time, if applicable and known) for the end of an event in the participant'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 | 3.10 | 2024-02-29 15:42:44.0 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
3145557 | |||||||||
| C18666 | Body system category other text | BodySysCatOTH | 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 | 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 | 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 | 1.10 | 2023-11-07 08:40:35.0 | 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 medical history | Date (and time, if applicable and known) for the start of an event in the participant'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 | 3.10 | 2024-02-29 15:42:43.0 | 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 |
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| C00319 | Medical history condition ongoing indicator | MedclHistCondOngoingInd | Indicator of whether a medical condition/disease experienced by the participant is ongoing | Indicator of whether a medical condition/disease experienced by the participant 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 | 4.00 | 2024-02-29 15:42:44.0 | 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 steril | 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 |
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| 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 syste | 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 |
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| 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 is of childbearing potential | Indicator of whether the participant 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 |
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| C10981 | Birth control method type | BirthCntrlMethdTyp | The participant's method of birth control | The participant'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 | 4.00 | 2024-03-18 15:21:17.0 | Medical History | General Health History | Participant History and Family History |
Multiple Pre-Defined Values Selected |
