CDE Detailed Report

Disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Subdomain Name: General Health History
CRF: Medical History - Immune Module

Displaying 1 - 50 of 113
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
C57958 Antibiotic long term repeated history indicator AntibLongTermRepeatHistInd Indicator related to whether the participant/subject has a history of repeated or long-term antibiotic use Indicator related to whether the participant/subject has a history of repeated or long-term antibiotic use Does the participant/subject have a history of repeated or long-term antibiotic use? No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-05 09:42:20.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57366 ROME III criteria indicator ROMEIIICritInd The indicator relating to whether the ROME III Diagnostic Criteria for Irritable Bowel Syndrome has been met The indicator relating to whether the ROME III Diagnostic Criteria for Irritable Bowel Syndrome has been me Meets Rome III diagnostic criteria for irritable bowel syndrome No;Yes No;Yes Alphanumeric Adult Supplemental-Highly Recommended 1.00 2018-01-05 12:57:52.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57606 Gut condition medication name GutCondMedName The name of the medication(s) the subject is taking for gut condition(s) The name of the medication(s) the subject is taking for gut condition(s) Medication name(s) Alphanumeric Adult Exploratory 1.00 2018-01-09 11:31:17.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57269 Lunc condition diagnosis year value LungCondDiagnosYrVal The year that the subject was diagnosed with a lung condition(s) The year that the subject was diagnosed with a lung condition(s) Year(s) of diagnosis Numeric Values Adult Exploratory 1.00 2018-01-05 10:06:10.0 Medical History - Immune Module General Health History Participant History and Family History

Free-Form Entry

C57285 Skin condition diagnosis year value SkinCondDiagYrVal The year skin condition(s) was diagnosed The year skin condition(s) was diagnosed Year(s) of diagnosis Numeric Values Adult Exploratory 1.00 2018-01-05 10:24:44.0 Medical History - Immune Module General Health History Participant History and Family History

Free-Form Entry

C57417 Ear nose throat condition diagnosed type EarNoseThroatCondDiagnosTyp Any ear, nose, and/or throat condition that the subject has ever been diagnosed with Any ear, nose, and/or throat condition that the subject has ever been diagnosed wit Condition Diagnosed Chronic rhinitis (runny nose);Chronic sinusitis;Chronic/repeated otitis media (ear infections);Hay fever;Impaired hearing;Easy nasal bleeding;Nasal allergies;Tonsillectomy;Other, specify;Chronically infected tonsils Chronic rhinitis (runny nose);Chronic sinusitis;Chronic/repeated otitis media (ear infections);Hay fever;Impaired hearing;Easy nasal bleeding;Nasal allergies;Tonsillectomy;Other, specify;Chronically infected tonsils Alphanumeric Adult Exploratory 1.00 2018-01-08 09:20:35.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57768 Blood immune system condition diagnosis type BldImmCondDiagnosTyp Any type of blood and/or immune system condition(s) that the subject has ever been diagnosed with Any type of blood and/or immune system condition(s) that the subject has ever been diagnosed wit Condition diagnosed Anemia;Sickle cell disease;Thalassemia;Hemochromatosis;Myeloproliferative disorders (myelodysplasia);Other, specify Anemia;Sickle cell disease;Thalassemia;Hemochromatosis;Myeloproliferative disorders (myelodysplasia);Other, specify Alphanumeric Adult Exploratory 1.00 2018-01-10 12:54:37.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57344 Vaccine unusual history indicator VaccUnusualHistInd The indicator relating to whether the participant/subject has a history of unusual vaccines The indicator relating to whether the participant/subject has a history of unusual vaccine History of unusual vaccines No;Yes No;Yes Alphanumeric

(e.g., related to international travel)

Adult Exploratory 1.00 2018-01-05 11:19:35.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57497 Lung condition medication currently indicator LungCondMedCurrentInd The indicator relating to whether the subject currently takes medication for lung condiiton(s) The indicator relating to whether the subject currently takes medication for lung condiiton(s) Currently take medication(s) No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-08 13:59:10.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject ID: Alphanumeric Adult Exploratory 1.00 2014-06-05 13:10:49.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57808 Infection diagnosis other text InfecDiagnosOthrTxt Text specifying an infection other than the ones previously mentioned that the subject has ever been diagnosed with Text specifying an infection other than the ones previously mentioned that the subject has ever been diagnosed wit Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-11 08:39:29.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C58430 Atopy allergic disorder condition diagnosis other text AtopyAllDisordrCondDiagOthTxt The free-text field to describe other type of condition(s) that the participant/subject was diagnosed with in relation to his/her history of atopy/allergic disorders The free-text field to describe other type of condition(s) that the participant/subject was diagnosed with in relation to his/her history of atopy/allergic disorder Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-05 10:51:03.0 Medical History - Immune Module General Health History Participant History and Family History 500

Free-Form Entry

C57367 Irritable Bowel Syndrome predominant stool pattern subtype type IBSPredStoolPatSubTyp The subtype of Irritable Bowel Syndrome (IBS) observed by a predominant stool pattern in the subject The subtype of Irritable Bowel Syndrome (IBS) observed by a predominant stool pattern in the subjec Irritable bowel syndrome subtypes by predominant stool pattern IBS with Constipation (IBS-C);IBS with Diarrhea (IBS-D);Mixed IBS (IBS-M);Unsubtyped IBS Hard or lumpy stool (Type 1 or 2) with more than 25% of bowel movements, and loose or watery stools (Type 6 or 7) with less than 25% of bowel movements;Loose or watery stools (Type 6 or 7) with more than 25% of bowel movements, and hard lumpy stools (Type 1 or 2) with less than 25% of bowel movements;Hard or lumpy stool (Type 1 or 2) with more than 25% of bowel movement, plus loose or watery stool (Type 6 or 7) with more than 25% of bowel movements;Insufficient abnormality of stool consistency to meet criteria for IBS-C, IBS-D, or IBS-M Alphanumeric

You must not be taking laxatives or antidiarrheal medicines that will change your bowel habits.

Adult Exploratory 1.00 2018-01-05 13:00:05.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57607 Gut condition medication work well indicator GutCondMedWorkWellInd The indicator relating to whether the medication(s) for gut condition the subject is taking is(are) working well The indicator relating to whether the medication(s) for gut condition the subject is taking is(are) working well Medications work well Yes;No;Not applicable Yes;No;Not applicable Alphanumeric Adult Exploratory 1.00 2018-01-09 11:33:16.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57270 Medical history immune malignancy name text MedHistImmMalignancyNameTxt The name of any malignancy or malignancies affecting the subject's immune system as part of the medical history The name of any malignancy or malignancies affecting the subject's immune system as part of the medical history Name of syndrome: Alphanumeric Adult Exploratory 1.00 2018-01-05 10:07:25.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57308 Food hypersensitivity component other text FoodHyperCompOthrTxt Text describing another food component to which the subject has hypersensitivity Text describing another food component to which the subject has hypersensitivity Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-05 10:38:04.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57418 Lung condition diagnosed other text LungCondDiagOthrTxt Text specifying other lung condition(s) the subject has ever been diagnosed with Text specifying other lung condition(s) the subject has ever been diagnosed with Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-08 09:27:04.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57769 Blood immune condition diagnosis other text BldImmuneCondDiagnosOthrTxt Text specifying a blood and/or immune system condition other than the ones previously mentioned that the subject has ever been diagnosed with Text specifying a blood and/or immune system condition other than the ones previously mentioned that the subject has ever been diagnosed wit Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-10 12:58:27.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57345 Vaccine unusual history name VaccUnusualHistName The name of unusual vaccine(s) that the participant/subject has taken The name of unusual vaccine(s) that the participant/subject has taken Vaccine Name Alphanumeric Adult Exploratory 1.00 2018-01-05 11:20:50.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57498 Lung condition medication name LungCondMedName The name of any medication(s) the subject is taking for lung condition(s) The name of any medication(s) the subject is taking for lung condition(s) Medication name(s) Alphanumeric Adult Exploratory 1.00 2018-01-08 14:05:21.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C19256 Study protocol name StudyProtocolName Name of study protocol Name of study protocol Study name/ID Alphanumeric Adult Exploratory 1.00 2014-06-05 16:38:14.0 Medical History - Immune Module General Health History Participant History and Family History 4000

Free-Form Entry

C57809 Infection condition active indicator InfectCondActInd The indicator relating to whether the subject currently has an infection The indicator relating to whether the subject currently has an infection Condition active No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-11 08:43:34.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C58435 Eye condition inactive resolved other text EyeCondInactResolvOthTxt Free-text field to describe other eye conditions that are considered no longer active or resolved Free-text field to describe other eye conditions that are considered no longer active or resolved Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-08 09:14:39.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57372 Medical history eye condition type MedHistEyeCondTyp The type of any eye conditions that the subject has ever had The type of any eye conditions that the subject has ever ha Condition diagnosed: Optic neuritis;Uveitis or scleritis;Dry eye;Eye infections;Sjogren's syndrome;Other, specify Optic neuritis;Uveitis or scleritis;Dry eye;Eye infections;Sjogren's syndrome;Other, specify Alphanumeric

Check any eye condtiions if you were ever diagnosed

Adult Exploratory 1.00 2018-01-05 14:17:55.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57709 Gut condition inactive resolved type GutCondInactResolvTyp Any type of gut condition that is no longer active in the subject or is considered resolved or cured Any type of gut condition that is no longer active in the subject or is considered resolved or cure Condition(s) no longer active/resolved Peptic ulcer;Hiatus hernia;Hepatitis A;Hepatitis B;Hepatitis C;Hepatitis, type unspecified;Gall bladder disease;Liver disease;Cirrhosis;Chronic pancreatitis;Pancreatitis;Celiac disease;Irritable bowel syndrome;Crohn's disease;Colorectal cancer;Ulcerative colitis;Other, specify Peptic ulcer;Hiatus hernia;Hepatitis A;Hepatitis B;Hepatitis C;Hepatitis, type unspecified;Gall bladder disease;Liver disease;Cirrhosis;Chronic pancreatitis;Pancreatitis;Celiac disease;Irritable bowel syndrome;Crohn's disease;Colorectal cancer;Ulcerative colitis;Other, specify Alphanumeric Adult Exploratory 1.00 2018-01-10 10:03:15.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57271 Medical history immune diagnosis year text MedHistImmDiagYrTxt Year of diagnosis for immune condition(s) the participant/subject has as part of medical history Year of diagnosis for immune condition(s) the participant/subject has as part of medical history Year of diagnosis Alphanumeric Adult Exploratory 1.00 2018-01-05 10:08:32.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57312 Adverse drug reaction indicator AdvDrugRxnInd The indicator relating to whether the subject experiences reactions to adverse drugs The indicator relating to whether the subject experiences reactions to adverse drug Adverse drug reactions No;Yes No;Yes Alphanumeric

If yes, specify

Adult Exploratory 1.00 2018-01-05 10:41:26.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57419 Ear nose throat condition active indicator EarNoseThroatCondActInd The indicator relating to whether the subject currently has an active ear, nose, throat condition The indicator relating to whether the subject currently has an active ear, nose, throat condition Condition active No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-08 09:28:44.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57770 Blood immune condition medication past year indicator BldImmuneMedPastYrInd The indicator relating to whether the subject has taken medication for blood or immune conditions in the past year The indicator relating to whether the subject has taken medication for blood or immune conditions in the past year Take medication No;Yes No;Yes Alphanumeric

In the past year

Adult Exploratory 1.00 2018-01-10 13:00:12.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57346 Vaccine unusual received year text VaccUnusualRecYrTxt The year(s) the participant/subject received unusual vaccine(s) The year(s) the participant/subject received unusual vaccine(s) Year(s) Received Alphanumeric Adult Exploratory 1.00 2018-01-05 11:21:44.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57499 Lung condition medication work well indicator LungCondMedWorkWellInd The indicator relating to whether the medication(s) the subject is taking for lung condition(s) is(are) working The indicator relating to whether the medication(s) the subject is taking for lung condition(s) is(are) working Medications work well Yes;No;Not applicable Yes;No;Not applicable Alphanumeric Adult Exploratory 1.00 2018-01-08 14:06:42.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57261 Immune symptom onset type ImmSymptmOnsetTyp The type of general immune/infectious symptom(s) that the subject experienced at onset (within first month of illness) The type of general immune/infectious symptom(s) that the subject experienced at onset (within first month of illness At onset (within first month of illness), did participant/subject experience of the following? Fever;Chills;Night sweats;Sore throats;Swollen/tender glands;Rashes;N/V/D;Arthalgia/arthritis;Mouth ulcers;History of autoimmune disease;Family history of autoimmune disease (biological relatives only, if applicable) Fever;Chills;Night sweats;Sore throats;Swollen/tender glands;Rashes;N/V/D;Arthalgia/arthritis;Mouth ulcers;History of autoimmune disease;Family history of autoimmune disease (biological relatives only, if applicable) Alphanumeric

Check all that apply

Adult Core 1.00 2018-01-05 09:23:33.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57810 Infection condition medication past year indicator InfectCondMedPastYrInd The indicator relating to whether the subject has taken medication for infections in the past year The indicator relating to whether the subject has taken medication for infections in the past year Take medications No;Yes No;Yes Alphanumeric

In the past year

Adult Exploratory 1.00 2018-01-11 08:46:57.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C58436 Lung condition inactive resolved other text LundCondInactResolvOthTxt Free-text field to specify any other lung conditions the subject has had that are no longer active or are considered resolved or cured Free-text field to specify any other lung conditions the subject has had that are no longer active or are considered resolved or cured Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-09 09:29:41.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57373 Medical history eye condition other text MedHistEyeCondOthrTxt Text describing another eye condition the subject has a medical history of Text describing another eye condition the subject has a medical history o Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-05 14:20:56.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57711 Skin condition diagnosis type SkinCondDiagnosTyp Any type of the skin conditions listed that the subject has ever been diagnosed with Any type of the skin conditions listed that the subject has ever been diagnosed wit Condition diagnosed Psoriasis;Eczema;Dermatomyositis;Contact dermatitis;Vasculitis;Zoster;Other allergic skin reactions;Other, specify;Hives Psoriasis;Eczema;Dermatomyositis;Contact dermatitis;Vasculitis;Zoster;Other allergic skin reactions;Other, specify;Hives Alphanumeric Adult Exploratory 1.00 2018-01-10 10:09:26.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57273 Gut condition diagnosis year value GutCondDiagnosYrVal The year that the subject was diagnosed with gut condition(s) The year that the subject was diagnosed with gut condition(s) Year(s) of diagnosis Numeric Values Adult Exploratory 1.00 2018-01-05 10:09:40.0 Medical History - Immune Module General Health History Participant History and Family History

Free-Form Entry

C57313 Adverse reaction drug name AdverseRxnDrugName The name of the drug to which the participant/subject has an adverse reaction The name of the drug to which the participant/subject has an adverse reaction Drug name Alphanumeric Adult Exploratory 1.00 2018-01-05 10:42:39.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57420 Ear nose throat condition medication past year indicator EarNoseThroatCondMedPastYrInd The indicator relating to whether the subject has taken medication for an ear, nose, throat condition in the past year The indicator relating to whether the subject has taken medication for an ear, nose, throat condition in the past yea Take medications No;Yes No;Yes Alphanumeric

In the past year

Adult Exploratory 1.00 2018-01-08 09:30:14.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57772 Blood immune condition medication currently indicator BldImmuneMedCurrentInd The indicator relating to whether the subject takes medication for blood or immune conditions daily The indicator relating to whether the subject takes medication for blood or immune conditions daily Currently take medication(s) No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-10 13:00:12.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57358 ROME I criteria type ROMEICritTyp The type of ROME I criteria for Irritable Bowel Syndrome that has continuously or recurrently occurred for at least 3 months The type of ROME I criteria for Irritable Bowel Syndrome that has continuously or recurrently occurred for at least 3 month At least three months of continuous or recurrent symptoms: Abdominal pain or dscomfort;Two or more of the following, on at least one-fourth of occasions or days Abdominal pain or dscomfort;Two or more of the following, on at least one-fourth of occasions or days Alphanumeric Adult Supplemental-Highly Recommended 1.00 2018-01-05 12:11:14.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57584 Ear nose throat condition diagnosed other specify text EarNoseThroatCondDiagOthSpTxt Free-text field related to describe other ear, nose, throat conditions with which the participant/subject has been diagnosed Free-text field related to describe other ear, nose, throat conditions with which the participant/subject has been diagnosed Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-09 09:23:51.0 Medical History - Immune Module General Health History Participant History and Family History 500

Free-Form Entry

C57262 Antibiotic long term repeated history indication text AntibLngTermRepHistIndicTxt Free-text field to describe the indication for which the participant/subject has had a history of long-term or repeated use Free-text field to describe the indication for which the participant/subject has had a history of long-term or repeated use Indication: Alphanumeric Adult Exploratory 1.00 2018-01-05 09:42:20.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57812 Infection condition medication currently indicator InfectCondMedCurrentInd The indicator relating to whether the subject takes medication for infections daily The indicator relating to whether the subject takes medication for infections daily Currently take medications No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-11 08:46:57.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C58437 Gut condition inactive resolved other text GutCondInactResolvOthTxt Free-text field to describe other type of gut condition that is no longer active in the subject or is considered resolved or cured Free-text field to describe other type of gut condition that is no longer active in the subject or is considered resolved or cure Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-10 10:03:15.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57378 Eye condition active indicator EyeCondActiveInd The indicator relating to whether the subject currently has an eye condition The indicator relating to whether the subject currently has an eye condition Condition active Optic neuritis;Uveitis or scleritis;Dry eye;Eye infections;Sjogren's syndrome;Other, specify Optic neuritis;Uveitis or scleritis;Dry eye;Eye infections;Sjogren's syndrome;Other, specify Alphanumeric Adult Exploratory 1.00 2018-01-08 08:39:13.0 Medical History - Immune Module General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C57712 Skin condition diagnosis other text SkinCondDiagnosOthrTxt Text specifying another skin condition the subject has ever been diagnosed with Text specifying another skin condition the subject has ever been diagnosed wit Other, specify: Alphanumeric Adult Exploratory 1.00 2018-01-10 10:37:03.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57274 Food hypersensitivity indicator FoodHypersensInd The indicator relating to whether the subject has food hypersensitivity The indicator relating to whether the subject has food hypersensitivity Food hypersensitivity No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-05 10:10:39.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

C57315 Adverse reaction drug route text AdverseRxnDrugRouteTxt Free-text field to describe the route used for a drug which causes an adverse reaction for the participant/subject Free-text field to describe the route used for a drug which causes an adverse reaction for the participant/subject Route Alphanumeric Adult Exploratory 1.00 2018-01-05 10:45:43.0 Medical History - Immune Module General Health History Participant History and Family History 255

Free-Form Entry

C57422 Ear nose throat condition medication current indicator EarNoseThroatCondMedCurrInd The indicator relating to whether the subject currently takes medication for an ear, nose, throat condition The indicator relating to whether the subject currently takes medication for an ear, nose, throat condition Currently take medications No;Yes No;Yes Alphanumeric Adult Exploratory 1.00 2018-01-08 09:30:14.0 Medical History - Immune Module General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV