CDE Detailed Report

Disease: Headache
Sub-Domain: General Health History
CRF: Medical and Family History

Displaying 1 - 39 of 39
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
C08087 Sibling death age value SiblingDeathAgeVal Age of sibling when he/she died Age of sibling when he/she died Age at death Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C56024 Relative second degree decease death age value RelSecondDegDecDeathAgeVal Value representing the age of the subject's second-degree relative at their time of death. Value representing the age of the subject's second-degree relative at their time of death. Age at death Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-05 12:57:31.0 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C16019 Family history relative first-degree affect count FamHistReltv1stDegAffctCt The number of first-degree relatives affected with the medical condition. The number of first-degree relatives affected with the medical condition. Number of first degree relatives Numeric Values

If there is a history of this condition in the family, indicate the total number of relatives with a history of the condition, the number of relatives affected (patient reported diagnosis), and if the number of relatives that were diagnosed by a physician.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C17992 Additional comment text AddtnalCommntTxt Text describing any additional information about the participant or the participant's family history Text describing any additional information about the participant or the participant's family history Additional Comments Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History 255

Free-Form Entry

C08147 Data source DataSource Source of the data provided on the case report form Source of the data provided on the case report form Source from which medical and family history obtained? Participant/subject;Family, specify relation;Unknown Participant/subject;Family, specify relation;Unknown Alphanumeric

Choose all that apply

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:46:24.96 Medical and Family History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C56025 Relative second degree decease primary cause text RelSecondDegDecPrimCauseTxt Text describing the primary cause of the subject's second-degree relative's death. Text describing the primary cause of the subject's second-degree relative's death. Primary cause of death Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-05 12:58:52.0 Medical and Family History General Health History Participant History and Family History 255

Free-Form Entry

C16021 Family history second-degree relative affected count FamHistScndDegReltvAffctCt The number of second-degree relatives affected with the medical condition. The number of second-degree relatives affected with the medical condition. Number of second-degree relatives Numeric Values

Affected' is defined as patient reported diagnosis. Answer this question for each medical condition.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

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

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 and Family History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
C10813 Adopted indicator AdoptedInd Whether the subject/participant was adopted Whether the subject/participant was adopted Are you adopted? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

C56028 Sibling count SiblingCt The total number of siblings the subject has The total number of siblings the subject has How many siblings do you have? Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-05 13:18:48.0 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C16025 Family history second-degree physician diagnosis count FamHistScndDegPhyscnDiagnsCt The number of second-degree relatives with the medical condition confirmed by a physician The number of second-degree relatives with the medical condition confirmed by a physician Number of second-degree relatives Numeric Values

Answer this question for each medical condition. Choose one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C18678 Family history medical condition other text FamHistMedclCondOTH The free-text field related to 'Family history medical condition type' specifying other text. Type of medical condition or health related event for which the family history is taken The free-text field related to 'Family history medical condition type' specifying other text. Type of medical condition or health related event for which the family history is taken Other, specify Alphanumeric

Comorbid conditions Musculo-Skeletal, Arthritis – if type of arthritis known, specify type in comments section Psychiatric, Depression – if type of depression known, specify type in comments section If a family member has a diagnosis or condition not listed, specify the diagnosis and/or condition under the "Other, specify" fields.

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Medical and Family History General Health History Participant History and Family History 4000

Free-Form Entry

3165585
C15997 Relative first degree total count Reltv1stDegTotlCt Count of the total number of first-degree relatives the participant/subject has Count of the total number of first-degree relatives the participant/subject has How many total number of first-degree relatives do you have? Numeric Values

This number can be calculated with informant after enumerating relatives of each type provided in the 'Name of Family Member with Condition" code list.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C16207 Family history medical condition first-degree relative type FamHistMedclCondFrstDegReltTyp Relationship of the first-degree family member or ancestor with the medical condition or health related event to the participant/subject Relationship of the first-degree family member or ancestor with the medical condition or health related event to the participant/subject Relationship of first-degree realtive(s) to participant/subject 1;2;3;4;5;6;7;8;9;10 Biological Mother;Biological Father;Sibling Male;Sibling Female;Non-identical or dizygotic twin Male;Non-identical or dizygotic twin Female;Identical twin Male;Identical twin Female;Full biologic child Male;Full biologic child Female Numeric Values

Select the relationship from the options of the family members provided in the "Name of Family Member with Condition" code list. Record more than 1 family member, if applicable. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C56017 Relative first degree decease death age value RelFirstDegDecDeathAgeVal Value representing the age of the subject's first-degree relative at their time of death. Value representing the age of the subject's first-degree relative at their time of death. Age at death Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-05 12:57:31.0 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C15998 Relative first degree live count Reltv1stDegLivCt The total number of the participant/subject first-degree living relatives The total number of the participant/subject first-degree living relatives Number alive Numeric Values

Provide the number of first/second degree relatives. The participant/subject should refer to the Name of Family Member with Condition" code list to provide any information on each of family member that he/she has knowledge of.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C16208 Family history medical condition second-degree relative type FamHistMedclCondScndDegReltTyp Relationship of the second-degree family member or ancestor with the medical condition or health related event to the participant/subject Relationship of the second-degree family member or ancestor with the medical condition or health related event to the participant/subject Relationship of second-degree relative(s) to participant/subject 11;12;13;14;15;16;17;18;19;20;21;22;23;24 Half-Sibling Male;Half-Sibling Female;Maternal Grandmother;Maternal Grandfather;Paternal Grandmother;Paternal Grandfather;Maternal Aunt;Maternal Uncle;Paternal Aunt;Paternal Uncle;Grandchild Male;Grandchild Female;Nephew;Niece Numeric Values

Select the relationship from the options of the family members provided in the "Name of Family Member with Condition" code list. Record more than 1 family member, if applicable. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C56018 Relative first degree decease primary cause text RelFirstDegDecPrimCauseTxt Text describing the primary cause of the subject's first-degree relative's death. Text describing the primary cause of the subject's first-degree relative's death. Primary cause of death Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-05 12:58:52.0 Medical and Family History General Health History Participant History and Family History 255

Free-Form Entry

C15999 Relative first degree decease count Reltv1stDegDeceasCt The total number of the participant/subject first-degree deceased relatives The total number of the participant/subject first-degree deceased relatives Number deceased Numeric Values

Provide the number of first/second degree relatives. The participant/subject should refer to the Name of Family Member with Condition" code list to provide any information on each of family member that he/she has knowledge of.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C17986 Relative first degree total count unknown indicator Reltv1stDegTotCntUnknownInd Indicator of the unknown total number of first-degree relatives Indicator of the unknown total number of first-degree relatives the participant/subject has How many total number of first-degree relatives do you have? Unknown Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C56019 Sibling live count SiblingLiveCt The total number of alive siblings that the subject has. The total number of alive siblings that the subject has. Number alive Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-05 13:01:45.0 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C16001 Relative second degree total count ReltvScndDegTotlCt The total number of the participant/subject second-degree relatives The total number of the participant/subject second-degree relatives How many total number of second-degree relatives do you have? Numeric Values

This number can be calculated with informant after enumerating relatives of each type provided in the 'Name of Family Member with Condition" code list.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C17987 Relative first degree live count unknown indicator Reltv1stDegLivCtUnknownInd Indicator of the unknown number of living first-degree relatives Indicator of the unknown number of living first-degree relatives Number alive Unknown Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C56020 Sibling live count unknown indicator SiblingLiveCtUnkInd The indicator relating to whether or not the subject knows how many living siblings he/she has. The indicator relating to whether or not the subject knows how many living siblings he/she has. Number alive Unknown Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-05 13:02:42.0 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value 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. Condition 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

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

Single Pre-Defined Value Selected

2002895
C16002 Relative second degree live count ReltvScndDegLivCt The total number of the participant/subject second-degree living relatives The total number of the participant/subject second-degree living relatives Number alive Numeric Values

Provide the number of first/second degree relatives. The participant/subject should refer to the Name of Family Member with Condition" code list to provide any information on each of family member that he/she has knowledge of.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C17988 Relative first degree decease count unknown indicator Reltv1stDegDecCntUnknownInd Indicator of the unknown number of deceased first-degree relatives Indicator of the unknown number of deceased first-degree relatives Number deceased Unknown Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C56021 Sibling decease count SiblingDeceaseCt The total number of deceased siblings that the subject has. The total number of deceased siblings that the subject has. Number deceased Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-05 13:01:45.0 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

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 Condition Alphanumeric

Code each of the medical/family history conditions using SNOMED CT

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

Free-Form Entry

C16003 Relative second degree decease count ReltvScndDegDeceasCt The number of the participant/subject second-degree deceased relatives The number of the participant/subject second-degree deceased relatives Number deceased Numeric Values

Provide the number of first/second degree relatives. The participant/subject should refer to the Name of Family Member with Condition" code list to provide any information on each of family member that he/she has knowledge of.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C17989 Relative second degree total count unknown indicator ReltvSecDegTotlCntUnknownInd Indicator of the unknown total number of second-degree relatives Indicator of the unknown total number of second-degree relatives How many total number of second-degree relatives do you have? Unknown Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00720 Family history medical condition type FamHistMedclCondTyp Type of medical condition or health related event for which the family history is taken Type of medical condition or health related event for which the family history is taken Condition Cancer;Heart disease;Acute coronary syndrome;Hypertension;Hypotension;Dyslipidemia;Mitral valve prolapse;Patent-Foramen Ovale (PFO)/Right-left shunt (RLS);Cerebral aneurysm;Intracerebral hemorrhage;Ischemic Stroke;Extracranial aneurysm;Coronary vascular disease;Periphereal vascular disease;Reynaud's Syndrome;Diabetes mellitus;Gastroparesis;Irritable bowel syndrome (IBS);Thyroid condition;Obesity;Painful bladder;Interstitial Cystitis;Endometriosis;Polycystic ovary syndrome;(Pre)eclampsia;Emotional/Verbal abuse;Physical abuse;Sexual abuse;Allerg(ies);Asthma;Eczema;Systemic lupus erythematosus (SLE);Arthritis;Fibromyalgia;Muscle disease;Autism;Alzheimer's disease;Amyotrophic lateral sclerosis (ALS);Ataxia;Chronic ataxia;Dementia;Dystonia;Epilepsy;Memory loss;Developmental delays;Multiple sclerosis;Restless leg syndrome (RLS);Tourette syndrome;Traumatic brain injury;Tremor;Vertigo;Anxiety;Bi-polar disorder;Depression;Obsessive-compulsive disorder (OCD);Post traumatic stress disorder (PTSD);Schizophrenia;Suicide or suicide attempt;Alcohol use disorder;Illicit substance use disorder;Prescription use disorder;Anorexia;Bulimia;Binge eating;Insomnia;Sleep apnea;Narcolepsy;Other Immunological Disorders, specify:;Other neurological disorder, specify;Other Sleep condition, specify;Other, specify Cancer;Heart disease;Acute coronary syndrome;Hypertension;Hypotension;Dyslipidemia;Mitral valve prolapse;Patent-Foramen Ovale (PFO)/Right-left shunt (RLS);Cerebral aneurysm;Intracerebral hemorrhage;Ischemic Stroke;Extracranial aneurysm;Coronary vascular disease;Periphereal vascular disease;Reynaud's Syndrome;Diabetes mellitus;Gastroparesis;Irritable bowel syndrome (IBS);Thyroid condition;Obesity;Painful bladder;Interstitial Cystitis;Endometriosis;Polycystic ovary syndrome;(Pre)eclampsia;Emotional/Verbal abuse;Physical abuse;Sexual abuse;Allerg(ies);Asthma;Eczema;Systemic lupus erythematosus (SLE);Arthritis;Fibromyalgia;Muscle disease;Autism;Alzheimer's disease;Amyotrophic lateral sclerosis (ALS);Ataxia;Chronic ataxia;Dementia;Dystonia;Epilepsy;Memory loss;Developmental delays;Multiple sclerosis;Restless leg syndrome (RLS);Tourette syndrome;Traumatic brain injury;Tremor;Vertigo;Anxiety;Bi-polar disorder;Depression;Obsessive-compulsive disorder (OCD);Post traumatic stress disorder (PTSD);Schizophrenia;Suicide or suicide attempt;Alcohol use disorder;Illicit substance use disorder;Prescription use disorder;Anorexia;Bulimia;Binge eating;Insomnia;Sleep apnea;Narcolepsy;Other Immunological Disorders, specify:;Other neurological disorder, (specify);Other Sleep condition, specify;Other, specify Alphanumeric

Comorbid conditions Musculo-Skeletal, Arthritis – if type of arthritis known, specify type in comments section Psychiatric, Depression – if type of depression known, specify type in comments section If a family member has a diagnosis or condition not listed, specify the diagnosis and/or condition under the "Other, specify" fields.

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

Multiple Pre-Defined Values Selected

3165585
C56022 Sibling decease count unknown indicator SiblingDeceaseCtUnkInd The indicator relating to whether or not the subject knows how many deceased siblings he/she has. The indicator relating to whether or not the subject knows how many deceased siblings he/she has. Number deceased Unknown Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-05 13:02:42.0 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16006 Family history first-degree physician diagnosed count FamHist1stDegPhyscnDiagnsCt The number of first-degree relatives with the medical condition confirmed by a physician The number of first-degree relatives with the medical condition confirmed by a physician Number of first degree relatives Numeric Values

If there is a history of this condition in the family, indicate the total number of relatives with a history of the condition, the number of relatives affected (patient reported diagnosis), and if the number of relatives that were diagnosed by a physician.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Free-Form Entry

C17990 Relative second degree live count unknown indicator ReltvSecDegLivCntUnknownInd Indicator of the unknown number of living second-degree relatives Indicator of the unknown number of living second-degree relatives Number alive Unknown Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00721 Family history medical condition indicator FamHistMedclCondInd Indicator of whether a family member or first and second degree blood relatives of the participant/subject has had a history of the particular medical condition or health related event Indicator of whether a family member or first and second degree blood relatives of the participant/subject has had a history of the particular medical condition or health related event Relative affected Yes;No;Unknown Yes;No;Unknown Alphanumeric

First and second-degree relatives ONLY

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

Single Pre-Defined Value Selected

3165788
C56023 Sibling decease primary cause text SiblingDeceasePrimCauseTxt Text describing the primary cause of the subject's sibling's death. Text describing the primary cause of the subject's sibling's death. Primary cause of death Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-05 13:07:18.0 Medical and Family History General Health History Participant History and Family History 255

Free-Form Entry

C16012 Medical history condition diagnosis indicator MedclHistCondDiagnsInd Indicator of whether the participant/subject has been diagnosed with the medical condition/disease Indicator of whether the participant/subject has been diagnosed with the medical condition/disease Participant/subject diagnosed? Yes;No;Unknown Yes;No;Unknown Alphanumeric

If the participant/subject has a history of this condition, indicate yes.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17991 Relative second degree decease count unknown indicator ReltvSecDegDecCntUnknownInd Indicator of the unknown number of deceased second-degree relatives Indicator of the unknown number of deceased second-degree relatives Number deceased Unknown Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical and Family History General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV