CDE Detailed Report

Disease: Spinal Muscular Atrophy
Sub-Domain: History of Disease/Injury Event
CRF: Medical History of SMA - SMA

Displaying 1 - 9 of 9
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

2179659
C10500 Symptom onset age value SymptomOnsetAgeVal Age when symptoms first experienced Age when symptoms first experienced If yes, indicate age when first noticed Numeric Values

Answer should be recorded in years. History can be obtained from participant/ subject, family member, friend, or chart/ medical record. Answered for all joint conditions and signs, except for Club Foot. If age is unknown, record as Age Unknown for Weakness, Breathing problems, Failure to thrive, Feeding/ swallowing problems, Constipation, Spine abnormality, Eye abnormality, Cognitive abnormality, and Speech delay

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

C12618 Age first suspected something different range Age1stSuspectDifferentRng Age range of participant/subject when it was first suspected that something might be "different" Range of participant/subject's age at which it was first suspected that something might be different with her or him At what age was it first suspected that something might be different? Fetal;At birth;1-2 months;3-6 months;7-12 months;13-24 months;25-36 months;37 months - 10 years;11 - 20 years;21-30 years Fetal;At birth;1-2 months;3-6 months;7-12 months;13-24 months;25-36 months;37 months - 10 years;11 - 20 years;21-30 years Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12632 Spinal muscular atrophy symptom type SMASymptmTyp Type of all spinal muscular atrophy (SMA) symptoms or signs exhibited by the participant/subject Type of all spinal muscular atrophy (SMA) symptoms or signs exhibited by the participant/subject Signs and Symptoms Abnormal position of hands/feet;Joint contractures;Joint hyperlaxity;Joint dislocation;Club foot;Weakness;Breathing problems;Failure to Thrive;Feeding/swallowing problems;Constipation;Spine abnormality;Eye abnormality;Cognitive abnormality;Speech delay Abnormal position of hands/feet;Joint contractures;Joint hyperlaxity;Joint dislocation;Club foot;Weakness;Breathing problems;Failure to Thrive;Feeding/swallowing problems;Constipation;Spine abnormality;Eye abnormality;Cognitive abnormality;Speech delay Alphanumeric

Record whether the participant/subject exhibited each sign

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12633 Spinal muscular atrophy symptom indicator SMASymptmInd Indicator whether the participant/subject exhibits the selected spinal muscular atrophy (SMA) symptom or sign Indicator whether the participant/subject exhibits the selected spinal muscular atrophy (SMA) symptom or sign NULL Yes;No;Unknown Yes;No;Unknown Alphanumeric

Answer for each first sign of SMA

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12634 Spinal muscular atrophy symptom joint type SMASymptmJntTyp Type of joint-related spinal muscular atrophy (SMA) symptom or sign exhibited by the participant/subject Type of joint-related spinal muscular atrophy (SMA) symptom or sign exhibited by the participant/subject NULL Joint contractures;Joint hyperlaxity;Joint dislocation Joint contractures;Joint hyperlaxity;Joint dislocation Alphanumeric

For each joint condition that affects the participant/subject record the anatomic site and laterality

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12635 Spinal muscular atrophy symptom joint type anatomic site SMASymptmJntTypAntmicSite Anatomic site of the selected type of joint-related spinal muscular atrophy (SMA) symptom or sign exhibited by the participant/subject Anatomic site of the selected type of joint-related spinal muscular atrophy (SMA) symptom or sign exhibited by the participant/subject If Yes, indicate location Elbows;Wrists;Fingers;Hips;Knees;Ankles;Toes Elbows;Wrists;Fingers;Hips;Knees;Ankles;Toes Alphanumeric

Answer for' Joint contractures', 'Joint Hyperlaxity', and 'Joint dislocation'

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12636 Spinal muscular atrophy symptom hip dislocate side indicator SMASymptmHipDislocSideInd Indicator of the side of the body on which the participant/subject has a dislocated hip Indicator of the side of the body on which the participant/subject has a dislocated hip If Hip dislocation Right;Left;Bilateral Right;Left;Bilateral (both sides) Alphanumeric

Only answered if "Hips" was answered for "Joint dislocation"

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12637 Spinal muscular atrophy symptom club foot side indicator SMASymptmClubFootSideInd Indicator of the side of the body on which the participant/subject has a club foot Indicator of the side of the body on which the participant/subject has a club foot If yes, indicate location Right;Left;Bilateral Right;Left;Bilateral (both feet) Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of SMA - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

CSV