CDE Detailed Report

Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: Physical/Neurological Examination
CRF: Physical Examination

Displaying 1 - 8 of 8
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
C00023 Hand preference type HandPrefTyp Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusivel Hand Preference Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

Choose one. The predominant hand does not have to be the hand that he/she writes with. Unknown should be used in the scenario for infants or other (rare) instances when handedness can not be known or is not yet developed.

Shefner J, Cudkowicz ME, Maragakis N, Cedarbaum JM, Lee J, Jones D, Watson ML, Shaver K, Chen M, Saikali K, Mao J, Russell AK, Hansen L, Malik F, Wolff AA, for the NEALS/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in Amyotrophic Lateral Sclerosis. Amyotroph Lateral Scler. 2012; 13(5): 430–438. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Physical Examination Physical/Neurological Examination Assessments and Examinations

Single Pre-Defined Value Selected

2180147
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);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal (separate from ALS exam);Neurological (separate from ALS exam);Psychiatric;Respiratory Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal (separate from ALS exam);Neurological (separate from ALS exam);Psychiatric;Respiratory 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 Physical Examination Physical/Neurological Examination Assessments and Examinations

Single Pre-Defined Value Selected

2002895
C01010 Physical exam date and time PhysExamDateTime Date (and time if applicable and known) physical exam was performed Date (and time if applicable and known) physical exam was performed Date and Time of Exam 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 2013-08-28 16:08:00.453 Physical Examination Physical/Neurological Examination Assessments and Examinations

Free-Form Entry

2004170
C01012 Physical exam body system result type PhysExamBodySysResltTyp Assessment result of each body system examined Assessment result of each body system examined Result Abnormal;Normal;Not examined Abnormal;Normal;Not examined Alphanumeric

Choose one. Indicate whether each body system examined had any abnormal findings.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Physical Examination Physical/Neurological Examination Assessments and Examinations

Single Pre-Defined Value Selected

2821383
C01013 Physical exam description text PhysExamDescripTxt Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Describe Abnormality or Comment if Body System is Not Examined Alphanumeric

Provide a description of each abnormal result found during the physical exam, or provide an explanation of why the body system was not examined. See the data dictionary for additional information on coding the abnormality using the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT).

SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Physical Examination Physical/Neurological Examination Assessments and Examinations 255

Free-Form Entry

2201880
C01015 Physical exam performed indicator PhysExamPerfrmdInd Indicator of whether a physical exam was performed on the participant/subject Indicator of whether a physical exam was performed on the participant/subject Was a physical exam performed on the participant/subject? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Specify whether or not a physical exam was performed on the participant/subject.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Physical Examination Physical/Neurological Examination Assessments and Examinations

Single Pre-Defined Value Selected

2201750
C01028 Physical exam condition SNOMED CT code PhysExamCondSNOMEDCTcode Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) Alphanumeric

See the data dictionary for additional information on coding the abnormality using the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT).

SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Physical Examination Physical/Neurological Examination Assessments and Examinations 255

Free-Form Entry

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 Core 1.10 2023-11-07 08:40:35.0 Physical Examination Physical/Neurological Examination Assessments and Examinations 4000

Free-Form Entry

2002895
CSV