CDE Detailed Report
Subdomain Name: History of Disease/Injury Event
CRF: welcome
Displaying 1 - 31 of 31
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Was participant's 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 |
Choose one. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10509 | Genetic diagnosis established by lab name | GenDiagnosEstLabNam | Name of the clinical laboratory who performed the genetic testing | Name of the clinical laboratory who performed the genetic testing | Where: Name of clinical laboratory that performed genetic testing | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 255 |
Free-Form Entry |
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| 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 | Was participant's 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 |
Choose one. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C06452 | Neuromuscular scoliosis surgery treat indicator | NeuromusclrSclsisSurgTrtInd | Indicator of whether the scoliosis has been surgical treated | Indicator of whether the scoliosis has been surgical treate | Indicate if the participant has had surgery | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. Answer only if question #8 "Was patient diagnosed with scoliosis?" was answered Yes. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-17 09:26:36.973 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10510 | Genetic diagnosis established in city name | GenDiagnosEstCityNam | City where the clinical laboratory that performed the genetic testing is located | The name of city where the clinical laboratory that performed the genetic testing is located | Where: City of clinical laboratory that performed genetic testing | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 255 |
Free-Form Entry |
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| 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 | Was participant's 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 |
Choose one. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10500 | Symptom onset age value | SymptomOnsetAgeVal | Age when symptoms first experienced | Age when symptoms first experienced | Age at Symptom Onset | Numeric Values |
Answer should be recorded in years. History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
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| C10511 | Genetic diagnosis established in country name | GenDiagnosEstCntryNam | Country where the clinical laboratory that performed the genetic testing is located | The name of country where the clinical laboratory that performed the genetic testing is located | Where: Country of clinical laboratory that performed genetic testing | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 255 |
Free-Form Entry |
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| C10523 | Foot surgery indicator | FtSurgInd | The indicator of whether the participant/subject has had foot surgery | The indicator of whether the participant/subject has had foot surgery | 12) Did participant have foot surgery? | 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 |
Choose one. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10501 | Diagnosis initial age value | DiagnosAgeVal | Age of the participant/subject when initially diagnosed with disease/disorder | Age of the participant/subject when initially diagnosed with disease/disorder | Age of Diagnosis | Numeric Values |
Answer should be recorded in years. History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 16:29:10.887 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
year | |||||||||
| C10512 | Friedreich's ataxia length of GAA repeat allele 1 measurement | FALngthGAARptAll1Mes | The length of the GAA trinucleotide repeat on allele 1 found through genetic testing | The length of the GAA trinucleotide repeat on allele 1 found through genetic testing | Result | Numeric Values |
Length of each GAA repeat on each allele; if the patient has a point mutation, provide the exact mutation |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
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| C10524 | Ambulation affected by disease indicator | AmbulAffectDisInd | The indicator of whether the disease/disorder has affected the participant's/subject's ambulatory ability | The indicator of whether the disease/disorder has affected the participant's/subject's ambulatory ability | Was participant's ambulation status 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 |
Choose one. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10502 | Symptom first experienced text | SymptmFirstExpTxt | First symptom of the disease/disorder experienced by the participant/subject | First symptom of the disease/disorder experienced by the participant/subject | First symptom experienced by the patient | Scoliosis;Cardiomyopathy;Diabetes;Instability;Falls;Other, specify | Scoliosis;Cardiomyopathy;Diabetes;Instability;Falls;Other, specify | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10513 | Friedreich's ataxia length of GAA repeat allele 2 measurement | FALngthGAARptAll2Mes | Length of the GAA repeat on allele 2 found through genetic testing | Length of the GAA repeat on allele 2 found through genetic testing | Result | Numeric Values |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
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| C10526 | Assistive walking device started use age value | AsstWlkngDevStrtUse | Age when the participant/subject began using the assistive walking device | Age when the participant/subject began using the assistive walking device | If Yes, indicate age when participant required assistance with walking | Numeric Values |
Record age in years. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
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| C10503 | Neonatal problems indicator | NeonatProblemInd | Whether the participant/subject has a history of problems as an infant during the first month after birth | Whether the participant/subject has a history of problems as an infant during the first month after birth | Problems during neonatal period? | Yes, specify;No | Yes;No | Alphanumeric |
When asking participant/ subject use the following: Has a doctor or other medical professional ever told you that you have/ have had a(n)________? History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10514 | Genetic diagnosis point mutation result | GenDiagnosPtMutReslt | The result of the genetic testing revealed a point mutation describe the position and amino acid change | The result of the genetic testing revealed a point mutation describe the position and amino acid change | Result | Alphanumeric |
Record the position and amino acid change, if applicable. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 255 |
Free-Form Entry |
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| C10709 | Walking assistive device indicator | WalkAssistiveDeviceInd | Indicator of whether the participant/subject uses an assistive device for walking | Indicator of whether the participant/subject uses an assistive device for walking | Does participant use an assistive walking device? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record.;Choose one. If answer is "No" or "Unknown" stop here and do not complete the rest of the form. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10504 | Impaired physical ability during infancy indicator | ImpPhysAbilDurngInfInd | Whether the participant/subject has a history of impaired physical abilities during infancy | Whether the participant/subject has a history of impaired physical abilities during infancy | Impaired physical abilities during infancy? | Yes;No | Yes;No | Alphanumeric |
When asking participant/subject use the following: Has a doctor or other medical professional ever told you that you have/ have had a(n)________? History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10515 | Scoliosis diagnosis indicator | ScolDiagnosInd | The indicator of whether the participant/subject has been diagnosed with scoliosis | The indicator of whether the participant/subject has been diagnosed with scoliosis | Was patient diagnosed with scoliosis? | 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 |
When asking participant/ subject use the following: Has a doctor or other medical professional ever told you that you have/ have had a(n)________? History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information is not documented in the medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C18618 | Neonatal problem other text | NeonatalProblemOtherText | Specify in text the problems other than those listed that occurred during the neonatal period | Specify in text the problems other than those listed that occurred during the neonatal period | Yes, specify | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 1.00 | 2013-10-11 00:00:00.0 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 255 |
Free-Form Entry |
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| C10505 | Delayed motor milestones indicator | DelayMotorMIlstnInd | Whether the participant/subject has a history of delayed motor milestones. If participant had delayed motor milestones, indicate type of delayed motor milestones | Whether the participant/subject has a history of delayed motor milestones. If participant had delayed motor milestones, indicate type of delayed motor milestones | Delayed motor milestones? | Yes, specify;No | Yes;No | Alphanumeric |
When asking participant/ subject use the following: Has a doctor or other medical professional ever told you that you have/ have had a(n)________? History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10516 | Scoliosis maximum spine curvature measurement | ScolMaxSpnCrvtrMsrmnt | The maximum curvature of the spine in degrees for a participant/subject who has been diagnosed with scoliosis | The maximum curvature of the spine in degrees for a participant/subject who has been diagnosed with scoliosi | If Yes, Indicate degree of maximum curvature | Numeric Values |
Record in degrees. Answer only if question #8 "Was patient diagnosed with scoliosis?" was answered Yes. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
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| C18619 | Delayed motor milestone specify text | MotorMilestonesDelayedST | Specify in text the motor milestones that are were delayed | Specify in text the motor milestones that are were delayed | Yes, specify | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 1.00 | 2013-10-11 00:00:00.0 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 255 |
Free-Form Entry |
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| C10506 | Genetic diagnosis established indicator | GeneticDiagnosEstablishedInd | Whether a genetic diagnosis for the disease/disorder was established | Whether a genetic diagnosis for the disease/disorder was established | Was genetic diagnosis established? | Yes;No | Yes;No | Alphanumeric |
When asking participant/ subject use the following: Has a doctor or other medical professional ever told you that you have/ have had a(n)________? History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-14 03:55:23.71 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C10517 | Scoliosis maximum spine curvature anatomic site | ScolMaxSpnCrvtrAntmicSite | The location of the maximum spine curvature for a participant/subject who has been diagnosed with scoliosis | The location of the maximum spine curvature for a participant/subject who has been diagnosed with scoliosis | Indicate location of maximum curvature | Cervical (C);Thoracic (T);Lumbar (L);Unknown/Not documented | vertebrae are the seven spinal bones that support the neck;vertebrae are the 12 spinal bones that connect to the rib cage;vertebrae are the five lowest and largest bones of the spinal column. Most of the body's weight and stress falls on the lumbar vertebrae; | Alphanumeric |
Choose one. Answer only if question #8 "Was patient diagnosed with scoliosis?" was answered Yes. History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Single Pre-Defined Value Selected |
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| C18802 | Symptom first experienced other text | SymptmFirstExpOTH | The free-text field related to 'Symptom first experienced text' specifying other text. First symptom of the disease/disorder experienced by the participant/subject | The free-text field related to 'Symptom first experienced text' specifying other text. First symptom of the disease/disorder experienced by the participant/subject | Other, specify | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 21:00:23.88 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 4000 |
Free-Form Entry |
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| C10507 | Genetic diagnosis confirmation type | GenDiagnosConfrmTyp | Manner in which genetic diagnosis was confirmed | Manner in which genetic diagnosis was confirmed | If Yes, Genetic diagnosis confirmed by | Participant/subject report;Medical record;Commercial testing;Research testing | Participant/subject report;Medical record;Commercial testing;Research testing | Alphanumeric |
Choose all that apply. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Multiple Pre-Defined Values Selected |
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| C10518 | Scoliosis last assessment date and time | ScolLstAssmntDate | Date (and time if applicable and known) the participant/subject was last assessed for scoliosis | Date (and time if applicable and known) the participant/subject was last assessed for scoliosis | Indicate date of last assessment | 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.). |
ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html) | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
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| C18804 | Delayed motor milestones specify text | DelayMotorMIlstnST | The free-text field related to 'Delayed motor milestones indicator'. Whether the participant/subject has a history of delayed motor milestones. If participant had delayed motor milestones, indicate type of delayed motor milestones | The free-text field related to 'Delayed motor milestones indicator'. Whether the participant/subject has a history of delayed motor milestones. If participant had delayed motor milestones, indicate type of delayed motor milestones | Yes, specify | Alphanumeric |
When asking participant/ subject use the following: Has a doctor or other medical professional ever told you that you have/ have had a(n)________? History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events | 4000 |
Free-Form Entry |
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| C10508 | Genetic diagnosis established date and time | GenDiagnosEstDateTime | Date (and time if applicable and known) the genetic diagnosis was established | Date (and time if applicable and known) the genetic diagnosis was established | When | 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.). |
ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html) | Adult;Pediatric | Core | 3.00 | 2013-07-11 15:03:49.2 | Medical History of Friedreich's Ataxia | History of Disease/Injury Event | Disease/Injury Related Events |
Free-Form Entry |
