CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Participant Characteristics
CRF: Medical History Core

23 results.
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 Source Form Set Form Field Domain CDASH Variable CDASH Definition CDASH Label Controlled Terminology Prompt Essentiality Question Text CDASH imp guidance SDTM IG target csDSR PhenX Data Type CRF Completion Inst SDTMIG Target Var SDTMIG Target Map Codelist Name PVs Pre Pop Value Query Display List Style
C60210 Medical history for sickle cell condition ongoing indicator MedHxForSCCondOngoingInd Indicator of whether the subject/participant's condition selected in "Medical history for sickle cell condition type" is ongoing. Indicator of whether the subject/participant's condition selected in "Medical history for sickle cell condition type" is ongoing. Ongoing? No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 15:45:51.0 Medical History Core Participant Characteristics General Health History

Single Pre-Defined Value Selected

C60200 Medical history for sickle cell condition lung other text MedHxForSCCndLungOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for lung conditions. The free-text field related to "Medical history for sickle cell condition type" specifying other text for lung conditions. Other Lung Disease, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60211 Influenza vaccine most recent date InfluenzaVaccMstRcntDate Date of the subject/participant's most recent influenza vaccination (if any). Date of the subject/participant's most recent influenza vaccination (if any). Most recent date Date or Date & Time Adult;Pediatric Core 1.00 2021-02-24 15:50:52.0 Medical History Core Participant Characteristics General Health History

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C60201 Medical history for sickle cell condition neurological other text MedHxForSCCndNeuroOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for neurological conditions. The free-text field related to "Medical history for sickle cell condition type" specifying other text for neurological conditions. Other Neurological Problems, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60212 Medical history psychological mental health condition type MedHxPsychMentalHealthCondTyp Type of psychological or mental health condition of which the subject/participant has a history. Type of psychological or mental health condition of which the subject/participant has a history. Psychological/Mental Health Anxiety;Depression;Anorexia or bulimia;Drug Abuse;Alcohol abuse/dependency;Obsessive-compulsive disorder;Attention deficit disorder (ADD or ADHD);Manic depressive or bipolar disorder;PTSD;Other type of psychosis Anxiety;Depression;Anorexia or bulimia;Drug Abuse;Alcohol abuse/dependency;Obsessive-compulsive disorder;Attention deficit disorder (ADD or ADHD);Manic depressive or bipolar disorder;PTSD;Other type of psychosis Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 15:52:12.0 Medical History Core Participant Characteristics General Health History

Single Pre-Defined Value Selected

C60202 Medical history for sickle cell condition blood other text MedHxForSCCndBloodOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for blood conditions other than Sickle Cell. The free-text field related to "Medical history for sickle cell condition type" specifying other text for blood conditions other than Sickle Cell. Other Blood Problems Besides Sickle Cell, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60213 Medical history psychological mental health condition onset year date MdHxPsychMntlHlthCndOnstYrDate Year part of the date of onset of the subject/participant's condition selected in "Medical history psychological mental health condition type". Year part of the date of onset of the subject/participant's condition selected in "Medical history psychological mental health condition type". Year of onset Date or Date & Time Adult;Pediatric Core 1.00 2021-02-24 15:57:31.0 Medical History Core Participant Characteristics General Health History

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C08096 Influenza vaccine history indicator InfluenzaVaccineHistInd Indicator of whether the participant/subject has ever received an influenza vaccination Indicator of whether the participant/subject has ever received an influenza vaccination Influenza vaccine? Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Core 3.00 2013-07-22 09:34:41.527 Medical History Core Participant Characteristics General Health History

Single Pre-Defined Value Selected

C60203 Medical history for sickle cell condition infection other text MedHxForSCCndInfectnOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for infection. The free-text field related to "Medical history for sickle cell condition type" specifying other text for infection. Other Infections, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60214 Medical history psychological mental health condition ongoing indicator MedHxPsychMntlHlthCondOngoInd Indicator of whether the subject/participant's condition selected in "Medical history psychological mental health condition type" is ongoing. Indicator of whether the subject/participant's condition selected in "Medical history psychological mental health condition type" is ongoing. Still present? No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 15:59:45.0 Medical History Core Participant Characteristics General Health History

Single Pre-Defined Value Selected

C18027 Comment text CmmntTxt Provide any additional information that pertains to the question. Provide any additional information that pertains to the question. Comments Alphanumeric Adult;Pediatric Core 3.00 2013-07-16 14:01:43.01 Medical History Core Participant Characteristics General Health History 4000

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DeBaun Forms
C60204 Medical history for sickle cell condition venous thromboembolism other text MedHxForSCCndVTEOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for venous thromboembolisms (VTE). The free-text field related to "Medical history for sickle cell condition type" specifying other text for venous thromboembolisms (VTE). Specify VTE (Venous Thromboembolism) Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60194 Medical history for sickle cell condition type MedHxForScklCellConditionTyp Type of condition of which the sickle-cell subject/participant has a past or ongoing medical history. Type of condition of which the sickle-cell subject/participant has a past or ongoing medical history. Organ System Hip complications;Avascular necrosis in the hip;Shoulder complication;Avascular necrosis in the shoulder;Dactylitis;Leg ulcers;Osteomyelitis (acute or chronic);Osteopenia;Other muscle/bone/joint condition, specify;Heart failure;Heart attack;Arrhythmia or prolonged irregular heart beats;Enlarged heart;Heart valve problems;Cardiomyopathy;High blood pressure/hypertension;Other heart condition, specify:;Chronic renal failure;Pyelonephritis;Acute renal failure;Chronic Renal Insufficiency;Erectile Dysfunction;Hematuria;Priapism;Proteinuria or Nephrotic Syndrome;Microalbuminuria;Other Kidney/Urinary/Genital condition, specify:;Cirrhosis of the liver/hepatic cirrhosis;Liver failure/hepatic failure;Liver fibrosis/hepatic fibrosis;Hepatitis, type A;Hepatitis, type B;Hepatitis, type C;Hepatitis, unspecified;Hepatic sequestration;Intrahepatic cholestasis;Cholecystitis;Gallstones/cholelithiasis/sludge;Pancreatitis;Transfusional hemosiderosis;Other Liver condition, specify:;Splenic infarction;Splenomegaly;Chronic hypersplenism;Splenic sequestration;Other Spleen condition, specify:;Obstructive sleep apnea;Nocturnal hypoxemia;Chronic lung disease;Asthma/wheezing/reactive airway;Pneumonia/acute chest syndrome;Chronic obstructive lung disease (COPD)/emphysema;Chronic restrictive lung disease/pulmonary fibrosis;Pulmonary embolism;DVT;Pulmonary hypertension;Other Lung Disease, specify:;Seizure;Stroke – hemorrhagic;Stroke – infarct;Stroke – a ''silent stroke'' seen only on MRI;Elevated transcranial doppler (TCD) velocities;Transient Ischemic Attack (TIA);Aneurysm;Peripheral neuropathy;Headache – chronic;Headache – migraine;Memory problems;Depression;Other Neurological Problems, specify:;Aplastic episode;Immune and non-immune hemolysis/hyperhemolysis;Other anemia (not related to sickle cell);Low platelets, not due to medication;Low white count, not due to medication;Other Blood Problems Besides Sickle Cell, specify:;Hypercoagulable disorder;Sepsis, pneumococcal;Sepsis, other than pneumococcal;Bacteremia, bacteria in bloodstream (often associated with indwelling catheters);Meningitis;Pneumonia;Hepatitis;Other Infections, specify:;History of Thrombosis;Catheter associated thrombosis;Other VTE (Venous Thromboembolism);Diabetes;Lupus;Rheumatoid arthritis;Retinopathy;Acute multi-organ failure;Iron overload;Vitamin D deficiency;Cancer, describe;Other Diseases/Ailments not listed, specify:;Indwelling catheter;High blood cholesterol/Hypercholesterolemia;Allergic rhinitis Hip complications;Avascular necrosis in the hip;Shoulder complication;Avascular necrosis in the shoulder;Dactylitis (Hand Foot Syndrome);Leg ulcers;Osteomyelitis (acute or chronic);Osteopenia;Other muscle/bone/joint condition, specify;Heart failure;Heart attack;Arrhythmia or prolonged irregular heart beats;Enlarged heart;Heart valve problems;Cardiomyopathy;High blood pressure/hypertension;Other heart condition, specify:;Chronic renal failure;Pyelonephritis;Acute renal failure;Chronic Renal Insufficiency;Erectile Dysfunction;Hematuria;Priapism;Proteinuria or Nephrotic Syndrome;Microalbuminuria;Other Kidney/Urinary/Genital condition, specify:;Cirrhosis of the liver/hepatic cirrhosis;Liver failure/hepatic failure;Liver fibrosis/hepatic fibrosis;Hepatitis, type A;Hepatitis, type B;Hepatitis, type C;Hepatitis, unspecified;Hepatic sequestration;Intrahepatic cholestasis;Cholecystitis;Gallstones/cholelithiasis/sludge;Pancreatitis;Transfusional hemosiderosis;Other Liver condition, specify:;Splenic infarction;Splenomegaly;Chronic hypersplenism;Splenic sequestration;Other Spleen condition, specify:;Obstructive sleep apnea;Nocturnal hypoxemia;Chronic lung disease;Asthma/wheezing/reactive airway;Pneumonia/acute chest syndrome;Chronic obstructive lung disease (COPD)/emphysema;Chronic restrictive lung disease/pulmonary fibrosis;Pulmonary embolism;DVT (Deep Vein Thrombosis);Pulmonary hypertension;Other Lung Disease, specify:;Seizure;Stroke – hemorrhagic;Stroke – infarct;Stroke – a ''silent stroke'' seen only on MRI;Elevated transcranial doppler (TCD) velocities;Transient Ischemic Attack (TIA);Aneurysm;Peripheral neuropathy (numbness or tingling, not due to previous stroke);Headache – chronic;Headache – migraine;Memory problems;Depression;Other Neurological Problems, specify:;Aplastic episode;Immune and non-immune hemolysis/hyperhemolysis;Other anemia (not related to sickle cell);Low platelets, not due to medication;Low white count, not due to medication;Other Blood Problems Besides Sickle Cell, specify:;Hypercoagulable disorder;Sepsis, pneumococcal;Sepsis, other than pneumococcal;Bacteremia, bacteria in bloodstream (often associated with indwelling catheters);Meningitis;Pneumonia;Hepatitis;Other Infections, specify:;History of Thrombosis;Catheter associated thrombosis;Other VTE (Venous Thromboembolism);Diabetes;Lupus;Rheumatoid arthritis;Retinopathy;Acute multi-organ failure;Iron overload;Vitamin D deficiency;Cancer, describe;Other Diseases/Ailments not listed, specify:;Indwelling catheter;High blood cholesterol/Hypercholesterolemia;Allergic rhinitis Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 12:58:20.0 Medical History Core Participant Characteristics General Health History

Single Pre-Defined Value Selected

C60205 Medical history for sickle cell condition cancer other text MedHxForSCCndCancerOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for cancer. The free-text field related to "Medical history for sickle cell condition type" specifying other text for cancer. Cancer, describe Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60195 Medical history for sickle cell condition muscle bone joint other text MedHxForSCCndMscBnJtOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for muscle/bone/joint conditions. The free-text field related to "Medical history for sickle cell condition type" specifying other text for muscle/bone/joint conditions. Other muscle/bone/joint condition, specify Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60206 Medical history for sickle cell condition other disease ailment other text MedHxForSCCndOthDzAilOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for other diseases or ailments.. The free-text field related to "Medical history for sickle cell condition type" specifying other text for other diseases or ailments. Other Diseases/Ailments not listed, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60196 Medical history for sickle cell condition heart other text MedHxForSCCndHeartOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for heart conditions. The free-text field related to "Medical history for sickle cell condition type" specifying other text for heart conditions. Other heart condition, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60207 Iron overload ever assess liver biopsy indicator IronOvrfldEvrAsesLivrBiopsyInd Indicator of whether iron overload in the subject/participant has ever been assessed by liver biopsy. Indicator of whether iron overload in the subject/participant has ever been assessed by liver biopsy. Has iron overload ever been assessed by liver biopsy? No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 15:37:48.0 Medical History Core Participant Characteristics General Health History

Single Pre-Defined Value Selected

C60197 Medical history for sickle cell condition kidney urinary genital other text MedHxForSCCndKdnyUrnyGenOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for kidney/urinary/genital conditions. The free-text field related to "Medical history for sickle cell condition type" specifying other text for kidney/urinary/genital conditions. Other Kidney/Urinary/Genital condition, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60208 Medical history for sickle cell condition past history indicator MexHxFrSCCondPstHxInd Indicator of whether the subject/participant has a past history of the condition selected in "Medical history for sickle cell condition type". Indicator of whether the subject/participant has a past history of the condition selected in "Medical history for sickle cell condition type". Past History No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 15:41:27.0 Medical History Core Participant Characteristics General Health History

Single Pre-Defined Value Selected

C60198 Medical history for sickle cell condition liver other text MedHxForSCCndLiverOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for liver conditions. The free-text field related to "Medical history for sickle cell condition type" specifying other text for liver conditions. Other Liver condition, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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C60209 Medical history for sickle cell condition diagnosis year date MedHxForSCCondDxYrDate Year part of the date of diagnosis of the subject/participant's condition selected in "Medical history for sickle cell condition type". Year part of the date of diagnosis of the subject/participant's condition selected in "Medical history for sickle cell condition type". Year(s) of Diagnosis Date or Date & Time Adult;Pediatric Core 1.00 2021-02-24 15:43:24.0 Medical History Core Participant Characteristics General Health History

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C60199 Medical history for sickle cell condition spleen other text MedHxForSCCndSpleenOTH The free-text field related to "Medical history for sickle cell condition type" specifying other text for spleen conditions. The free-text field related to "Medical history for sickle cell condition type" specifying other text for spleen conditions. Other Spleen condition, specify: Alphanumeric Adult;Pediatric Core 1.00 2021-02-24 14:25:43.0 Medical History Core Participant Characteristics General Health History 255

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23 results.
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