CDE Detailed Report

Disease: Cerebral Palsy
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 50 of 117
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 / 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
C22653 Medical history respiratory support indicator MedHistRespSuppInd Indicator of whether the participant/subject utilizes respiratory support/ventilation assist Indicator of whether the participant/subject utilizes respiratory support/ventilation assist Respiratory support/ventilation assist Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:26:36.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10520 Vision affected by disease indicator VisAffectDisInd The indicator of whether the disease/disorder has affected the participant's/subject's vision The indicator of whether the disease/disorder has affected the participant's/subject's vision Is vision affected Yes;No;Unknown History reported and/or confirmed in medical record;History NOT reported and NOT confirmed in medical record;History reported as unknown or could not be collected Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17476 Cardiovascular history condition indicator CardioHistCondInd Indicator as to whether the participant/subject has or had a cardiac condition or complication Indicator as to whether the participant/subject has or had a cardiac condition or complication Cardiac condition Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17489 Psychotic disorder indicator PsychoDisorderInd Indicator as to whether the participant/subject has had a psychotic disorder diagnosis. Indicator as to whether the participant/subject has had a psychotic disorder diagnosis. Psychotic disorder diagnosis Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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

Code each of the medical history conditions 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

C22664 Medical history delayed gastric empty indicator MedHistDlyGasEmpInd Indicator of whether the participant/subject has/had delayed gastric emptying Indicator of whether the participant/subject has/had delayed gastric emptying Delayed gastric emptying Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:33:37.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14127 Seizure generalized classification type SeizGenClassTyp The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks and may include such bilateral networks as ortical and subcortical structures, but do not necessarily include the entire cortex, experienced by the participant/subject. The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks, experienced by the participant/subject. Seizure generalized classification type Tonic clonic;Absence;Typical;Atypical;Myoclonic absence;Eyelid myoclonia;Myoclonic;Myoclonic atonic;Myoclonic tonic;Clonic;Tonic;Atonic;Epileptic spasms, focal or generalized Tonic clonic (in any combination);Absence;Absence-Typical;Absence-Atypical;Absence-Myoclonic absence;Absence-Eyelid myoclonia;Myoclonic (not otherwise specified);Myoclonic-Myoclonic atonic;Myoclonic-Myoclonic tonic;Clonic;Tonic;Atonic;Epileptic spasms, focal or generalized Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19836 Pain anatomic site text PainAntmicSiteTxt Anatomic Site of body pain Anatomic Site of body pain If yes, where Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-05 00:00:00.0 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C06020 Urinary incontinence past three months indicator UrinIncntPstThreeMoInd Indicator of involuntary urine leakage (incontinence) within the last three months. Urinary incontinence is defined by International Continence Society (Abrams et al. 2002) as the complaint of any involuntary leakage of urine. Indicator of involuntary urine leakage (incontinence) within the last three months. Urinary incontinence is defined by International Continence Society (Abrams et al. 2002) as the complaint of any involuntary leakage of urine. Urinary incontinence past three months frequency No;Yes;Not applicable;Unknown No;Yes;Not applicable;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22675 Medical history oppositional defiance indicator MedHIstOppDefInd Indicator of whether participant/subject displays oppositional defiance Indicator of whether participant/subject displays oppositional defiance Oppositional defiance Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:41:22.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17466 Cardiovascular history arrhythmia atrial fibrillation indicator CardioHistArrhythAtrialFibInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial fibrillation Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial fibrillation Atrial Fibrillation Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22654 Medical history respiratory support type MedHistRespSuppTyp Type of respiratory support utilized by a participant/subject Type of respiratory support utilized by a participant/subject If yes, indicate type Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:27:42.0 Medical History General Health History Participant History and Family History 500

Free-Form Entry

C10521 Hearing affected by disease indicator HearAffectDisInd The indicator of whether the disease/disorder has affected the participant's/subject's hearing The indicator of whether the disease/disorder has affected the participant's/subject's hearing Is hearing affected Yes;No;Unknown History reported and/or confirmed in medical record;History NOT reported and NOT confirmed in medical record;History reported as unknown or could not be collected Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17477 Cardiovascular history congenital heart disease indicator CardioHistCongHeartDiseaseInd Indicator as to whether the participant/subject has or had a congenital heart disease Indicator as to whether the participant/subject has or had a congenital heart disease Congenital heart disease Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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 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 History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
C00314 Medical history taken date and time MedclHistTakenDateTime Date (and time, if applicable and known) the participant/subject's medical history was taken Date (and time, if applicable and known) the participant/subject'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.).

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

Free-Form Entry

2179659
C22665 Medical history chronic constipation indicator MedHIstChrnConsInd Indicator of whether the participant/subject has/had chronic constipation Indicator of whether the participant/subject has/had chronic constipation Chronic constipation Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:34:16.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14130 Seizure focal classification type SeizFocClassTyp The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. Seizure focal classification type Without impairment of consciousness or responsiveness;With observable motor or autonomic components;Involving subjective sensory or psychic phenomena only;With impairment of consciousness or responsiveness;Evolving to a bilateral, convulsive seizure Without impairment of consciousness or responsiveness;Without impairment of consciousness or responsiveness-With observable motor or autonomic components (roughly corresponds to the concept of "simple partial seizure");Without impairment of consciousness or responsiveness-Involving subjective sensory or psychic phenomena only (corresponds to the concept of "aura");With impairment of consciousness or responsiveness (roughly corresponds to the concept of "complex partial seizure");Evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components replaces the term "secondarily generalized seizure") Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19856 Medical history gastrostomy tube since last visit indicator MedHistGtubeSLVInd Indicator of Gtube placed since last study visit Indicator of Gtube placed since last study visit Gastrostomy tube No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C06192 Fecal incontinence past three month average frequency FclInctPstThrMoAvgFreq Average frequency of incontinence to solid or liquid stools within the last three months. Fecal incontinence is defined as involuntary passage of stools. Average frequency of incontinence to solid or liquid stools within the last three months. Fecal incontinence is defined as involuntary passage of stools. Fecal incontinence past three month average frequency Never;Not applicable;Less than once per month;Not every day but at least once per week;Not every week but at least once per month;Once every month;One episode per day;Two or more episodes per day;Unknown Never;Not applicable;Less than once per month;Not every day but at least once per week;Not every week but at least once per month;Once every month;One episode per day;Two or more episodes per day;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22676 Medical history disruptive behavior disorder indicator MedHistDisrpBehDisInd Indicator of whether participant/subject has disruptive behavior disorder Indicator of whether participant/subject has disruptive behavior disorder Disruptive behavior disorder Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:41:51.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17467 Cardiovascular history arrhythmia atrial flutter indicator CardioHistArrhythAtrialFlutInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial flutter Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial flutter Atrial Flutter Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22655 Medical history respiratory distress syndrome indicator MedHistRespDstSyndInd Indicator of whether the participant/subject has been diagnosed with respiratory distress syndrome Indicator of whether the participant/subject has been diagnosed with respiratory distress syndrome Respiratory distress syndrome Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:28:37.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10522 Speech affected by disease indicator SpchAffectDisInd The indicator of whether the disease/disorder has affected the participant's/subject's speech The indicator of whether the disease/disorder has affected the participant's/subject's speech Is speech affected? Yes;No;Unknown History reported and/or confirmed in medical record;History NOT reported and NOT confirmed in medical record;History reported as unknown or could not be collected Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17478 Cardiovascular history heart failure indicator CardioHistHeartFailureInd Indicator as to whether the participant/subject has ever experienced heart failure Indicator as to whether the participant/subject has ever experienced heart failure Heart failure Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C18862 Death location other text DeathLoctnOTH The free-text field related to 'Death location type' specifying other text. Type of location where the participant/subject died The free-text field related to 'Death location type' specifying other text. Type of location where the participant/subject died Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C00315 Medical history global assessment indicator MedclHistGlobalAssmtInd Indicator of whether the participant/subject has a history of any medical problems/conditions Indicator of whether the participant/subject 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.

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

3145578
C22666 Medical history oropharyngeal dysphagia indicator MedHistOrphDysInd Indicator of whether the participant/subject has/had oropharyngeal dysphagia Indicator of whether the participant/subject has/had oropharyngeal dysphagia Oropharyngeal dysphagia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:34:45.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14536 Seizure diagnosis method type SeizDiagnosMethdTyp Describes how the diagnosis of seizure was established. Describes how the diagnosis of seizure was established. Seizure diagnosis method type Clinical manifestations;EEG;Unknown Clinical manifestations;EEG;Not documented or Cannot be determined Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C22469 Medical history tuberculosis condition indicator MedHisTBCondInd The indicator related to medical history of the condition tuberculosis (TB). The indicator related to medical history of the condition tuberculosis (TB). Cerebral visual impairment Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-10 15:58:46.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C06316 Menstruation scale MenstruationScale Scale for how the female participant's menstruation is affected by the spinal cord injury Psychogenic erection is penile tumescence with resulting increase in size and firmness of the penis that occurs without physical stimulation, which in usual circumstances should be adequate to allow penetration. Sexual dysfunction indicator Normal;Reduced/altered;Unknown;Not applicable (For female);Not applicable (Patient male) Refers to no change in duration, frequency or quantity of menstrual flow and no change in subjective experience or symptoms of menstruation after the spinal cord lesion;i.e. Menstruation has been initiated, though partially impaired or changed. This refers to a change in the duration, frequency or amount of menstrual blood flow after spinal cord lesion. It can also refer to a change in the quality of sensations or other autonomic phenomena associated with menses;Means the impact of the spinal cord lesion on menstruation is unknown;Means the woman was not menstruating at the time of spinal cord lesion, thus there is not an impact on menstruation; Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22677 Medical history self injurious behavior disorder MedHistSlfInjBehDisInd Indicator of whether participant/subject has self-injurious behavior disorder Indicator of whether participant/subject has self-injurious behavior disorder Self-injurious behavior disorder Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:42:28.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17468 Cardiovascular history arrhythmia bradycardia indicator CardioHistArrhythBradycardInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of bradycardia Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of bradycardia Bradycardia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22656 Medical history bronchopulmonary dysplasia indicator MedHistBrncplmDyspInd Indicator of whether the participant/subject has been diagnosed with bronchopulmonary dysplasia Indicator of whether the participant/subject has been diagnosed with bronchopulmonary dysplasia Bronchopulmonary dysplasia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:29:03.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10539 Diabetes first diagnosis age value DiabetFrstDiagnosisAgeVal Value representing the age, in years, at which the participant/subject was first diagnosed with diabetes mellitus Value representing the age, in years, at which the participant/subject was first diagnosed with diabetes mellitus Indicate age when diabetes was first diagnosed (years) Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Free-Form Entry

year
C17479 Cardiovascular history ischemia heart disease indicator CardioHistIschHeartDiseaseInd Indicator as to whether the participant/subject has or had ischemia heart disease Indicator as to whether the participant/subject has or had ischemia heart disease Ischemia heart disease Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C18961 Genetic disorder other text GeneticDisOTH The free-text field related to 'Genetic disorder type' specifying other text. Whether the participant/subject has a known single gene disorder The free-text field related to 'Genetic disorder type' specifying other text. Whether the participant/subject has a known single gene disorder Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

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/subject's medical history Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history End Date Date or Date & Time

"Record the date (and time) the medical condition/disease stopped. For surgeries, start and stop dates will most likely be the same date. 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.)."

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

Free-Form Entry

3145557
C22667 Medical history sialorrhea indicator MedHistSiaInd Indicator of whether the participant/subject has/ had sialorrhea Indicator of whether the participant/subject has/ had sialorrhea Sialorrhea Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:35:18.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14543 Genetic disorder type GeneticDisTyp Whether the participant/subject has a known single gene disorder Whether the participant/subject has a known single gene disorder Genetic disorder type No known single gene disorder;Mendelian;Mitochondrial;Other, specify No known single gene disorder;Mendelian;Mitochondrial;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22478 Attention deficit hyperactivity disorder indicator AttDefHyperDisInd The indicator related to the disorders of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). The indicator related to the disorders of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). Attention Deficit Hyperactivity Disorder (ADHD) No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-10 16:30:55.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C06358 Diabetes mellitus type DiabetesMellitusTyp Type of diabetes mellitus Type of diabetes mellitus If Yes, Indicate type Type 1;Type 2 Type 1;Type 2 Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22678 Medical history aggressive behavior disorder indicator MedHistAggBehDisInd Indicator of whether participant/subject has aggressive behavior disorder Indicator of whether participant/subject has aggressive behavior disorder Aggressive behavior disorder Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:42:52.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17469 Cardiovascular history arrhythmia indicator CardioHistArrhythInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia Indicator as to whether the participant/subject has or had a cardiac arrhythmia Arrhythmia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22657 Medical history recurrent pneumonia indicator MedHistReccPneInd Indicator of whether the participant/subject has been diagnosed with recurrent pneumonia Indicator of whether the participant/subject has been diagnosed with recurrent pneumonia Recurrent pneumonia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:29:37.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10541 Diabetes treatment type DiabetTreatTyp Type of treatment the participant/subject is receiving or has received for diabetes mellitus Type of treatment the participant/subject is receiving or has received for diabetes mellitus Indicate the treatments taken for diabetes (Choose all that apply) Diet;Oral medication;Insulin;None Diet;Oral medication;Insulin;None Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C17480 Diabetes mellitus complications type EndocrineHistDiabMellCompliTyp Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing Indicate the complications of diabetes (choose all that apply) Nephropathy;Neuropathy;Retinopathy;Other, specify;None Nephropathy;Neuropathy;Retinopathy;Other, specify;None Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19057 Diabetes mellitus complications other text EndocrineHistDiabMellCompliOTH The free-text field related to 'Diabetes mellitus complications type' specifying other text. Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing The free-text field related to 'Diabetes mellitus complications type' specifying other text. Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

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/subject's medical history Date (and time, if applicable and known) for the start of an event in the participant's/subject'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.).

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

Free-Form Entry

2543596
C22668 Medical history neurogenic detrusor indicator MedHistNeurDetrusInd Indicator of whether participant/subject has a neurogenic detrusor Indicator of whether participant/subject has a neurogenic detrusor Neurogenic detrusor, detrusor sphincter dyssernigia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:36:08.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV