CDE Detailed Report

Disease: Spinal Muscular Atrophy
Sub-Domain: History of Disease/Injury Event
CRF: Motor Milestones and Current Level of Function - SMA

Displaying 1 - 7 of 7
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
C12665 Certainty of response type CertainResponsTyp Certainty of recollection of the response or information Certainty of recollection of the response or information Certain/Definite;Best recollection;Unknown/Uncertain Certain/Definite;Best recollection;Unknown/Uncertain Alphanumeric

This element is meant to be recorded with 'certainty of response topic type' to differentiate the four instances 'certainty of response' is asked. For 'milestone currently able,' only the 'certain/definite' and 'unknown/uncertain' permissible values should be used.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Motor Milestones and Current Level of Function - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C10615 Clinical event or milestone type ClinEvntMilestoneTyp Type of clinical event or milestone pertinent to the disease or disorder Type of clinical event or milestone pertinent to the disease or disorder Milestone Noninvasive ventilation (NIV) utilized;Loss of speech;Loss of ambulation;Percutaneous endoscopic gastrostomy (PEG)/feeding tube placement;Tracheostomy performed;Death;Walk by 17 months old;Speak his/her first words by 12 months;Speak in two word combinations by 2 years;Speak in complete sentences by 3 years;Have a cognitive/learning disability;Attend a day care group (with > 5 other children);Head control;Raise both arms above head simultaneously;Roll completely;Maintain seated position supported;Maintain seated position unsupported;Crawl- combat style;Crawl- four point;Stand with support;Cruise along furniture;Stand without support;Walk with support (hand, braces);Walk independently (without braces);Climb stairs Noninvasive ventilation (NIV) utilized;Loss of speech;Loss of ambulation;Percutaneous endoscopic gastrostomy (PEG)/feeding tube placement;Tracheostomy performed;Death;Walk by 17 months old;Speak his/her first words by 12 months;Speak in two word combinations by 2 years;Speak in complete sentences by 3 years;Have a cognitive/learning disability;Attend a day care group (with > 5 other children);Head control;Raise both arms above head simultaneously;Roll completely;Maintain seated position supported;Maintain seated position unsupported;Crawl- combat style;Crawl- four point;Stand with support;Cruise along furniture;Stand without support;Walk with support (hand, braces);Walk independently (without braces);Climb stairs Alphanumeric

For each milestone record whether the participant/subject achieved it, age achieved in months (if applicable), whether the participant/subject is currently able to do it, and age skill lost in months (if applicable). "Maintained seated position unsupported" and "Walked independently (without braces)" are Core while all other milestones are Supplemental.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Motor Milestones and Current Level of Function - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C10616 Clinical event or milestone achieved indicator ClinEvntMilestoneAchvInd Indicator whether the participant/subject achieved or experienced the specific clinical event or milestone pertinent to the disease or disorder Indicator whether the participant/subject achieved or experienced the specific clinical event or milestone pertinent to the disease or disorder Achieved? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for each milestone. "Maintained seated position unsupported" and "Walked independently (without braces)" are Core while all other milestones are Supplemental.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Motor Milestones and Current Level of Function - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12658 Clinical event or milestone achieved age value ClinEvntMilstnAchvAgeVal Age when the participant/subject achieved the clinical event or milestone Age when the participant/subject achieved the clinical event or milestone Numeric Values

For each milestone achieved, record the age in months when it was achieved. "Maintained seated position unsupported" and "Walked independently (without braces)" are Core while all other milestones are Supplemental.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Motor Milestones and Current Level of Function - SMA History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

C12659 Milestone lost age value MilstnLostAgeVal Age when the participant/subject lost the ability to achieve or perform the milestone Age when the participant/subject lost the ability to achieve or perform the milestone Numeric Values

For each milestone the participant/subject is no longer able to perform, record the age in months when it was lost. "Maintained seated position unsupported" and "Walked independently (without braces)" are Core while all other milestones are Supplemental.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Motor Milestones and Current Level of Function - SMA History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

C12660 Milestone currently able indicator MilstnCurrntlyAbleInd Whether the participant/subject is currently able to complete or perform the milestone Whether the participant/subject is currently able to complete or perform the milestone Yes;No;Unknown Yes;No;Unknown Alphanumeric

Record for each milestone that the participant/subject had achieved. Choose one response for each. "Maintained seated position unsupported" and "Walked independently (without braces)" are Core while all other milestones are Supplemental.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Motor Milestones and Current Level of Function - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C12661 Certainty of response topic type MilestnCertainResponsTpicTyp Topic for the certainty of response (i.e., element the 'certainty of response type' describes) Topic for the certainty of response (i.e., element the 'certainty of response type' describes) Milestone achieved;Milestone achieved age;Milestone currently able;Milestone lost age Milestone achieved;Milestone achieved age;Milestone currently able;Milestone lost age Alphanumeric

This element is meant to be recorded with 'certainty of response type' to differentiate the four instances it is asked

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Motor Milestones and Current Level of Function - SMA History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

CSV