CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: General Health History
CRF: Pediatric Developmental History

Displaying 1 - 21 of 21
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
C17442 Clinical event or milestone day care indicator ClincEvntMilestDayCareInd Whether the participant/subject achieved or experienced the specific clinical event or milestone of attending a day care group (with > 5 other children) which is pertinent to the disease or disorder. Whether the participant/subject achieved or experienced the specific clinical event or milestone of attending a day care group (with > 5 other children) which is pertinent to the disease or disorder. Attend a day care group (with > 5 other children) Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16182 Formula fed indicator FormulaFedInd Indicates whether participant/subject was formula fed Indicates whether participant/subject was formula fed Formula fed Yes;No;Unknown Yes;No;Unknown Alphanumeric

No additional instructions

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17443 Clinical event or milestone 1 year speech indicator ClincEvntMilest1YrSpechInd Whether the participant/subject achieved or experienced the specific clinical event or milestone of speaking his/her first words by 12 months which is pertinent to the disease or disorder. Whether the participant/subject achieved or experienced the specific clinical event or milestone of speaking his/her first words by 12 months which is pertinent to the disease or disorder. Speak his/her first words by 12 months (Clinical event or milestone 1 year speach indicator) Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16183 Formula fed duration value FormulaFedDurationVal The duration of time the participant/subject was formula fed The duration of time the participant/subject was formula fed Indicate duration Numeric Values

Only answer if "Yes" is answered for "Formula fed?" Record answer in months

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Free-Form Entry

month
C17444 Clinical event or milestone 2 year word combination indicator ClincEvntMilest2YrWrdCombInd Whether the participant/subject achieved or experienced the specific clinical event or milestone of speaking in two word combinations by 2 years which is pertinent to the disease or disorder. Whether the participant/subject achieved or experienced the specific clinical event or milestone of speaking in two word combinations by 2 years which is pertinent to the disease or disorder. Speak in two word combinations by 2 years (Clinical event or milestone 2 year word combination indicator) Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16184 Formula fed to infant name FormulaFedInfantNme The name of the formula fed to participant/subject The name of the formula fed to participant/subject Formula type Alphanumeric

Only answered if "Yes" is answered for "Formula fed?"

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History 255

Free-Form Entry

C17445 Clinical event or milestone 3 year sentence indicator ClincEvntMilest3YrSentncInd Whether the participant/subject achieved or experienced the specific clinical event or milestone of speaking in complete sentences by 3 years which is pertinent to the disease or disorder. Whether the participant/subject achieved or experienced the specific clinical event or milestone of speaking in complete sentences by 3 years which is pertinent to the disease or disorder. Speak in complete sentences by 3 years (Clinical event or milestone 3 year sentence indicator) Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16186 Education performance status EduPerfStatus Participant/subject's cognitive status with regards to education Participant/subject's cognitive status with regards to education Indicate patient's cognitive status with regards to education: Above average (receives mostly As in school);Normal (functions well in school, receives mostly Bs, Cs);Minimal difficulty (struggling but obtains passing grades);Moderate difficulty (needs assistance with school work such as an Educational Assistant);Special needs class setting, actively participating in learning;Severe (unable to function in regular classroom even in special class setting, not an active participant in learning activities);Limited cognition (unrelated to demyelination or predates demyelination);N/A (patient is too young for school);Unknown Above average (receives mostly As in school);Normal (functions well in school, receives mostly Bs, Cs);Minimal difficulty (struggling but obtains passing grades);Moderate difficulty (needs assistance with school work such as an Educational Assistant);Special needs class setting, actively participating in learning;Severe (unable to function in regular classroom even in special class setting, not an active participant in learning activities);Limited cognition (unrelated to demyelination or predates demyelination);N/A (patient is too young for school);Unknown Alphanumeric

Complete according to last year in education and utilize grades reported on report cards from the past year. Choose one

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17446 Clinical event or milestone walk indicator ClincEvntMilestWalkInd Whether the participant/subject achieved or experienced the specific clinical event or milestone of walking by 17 months old which is pertinent to the disease or disorder. Whether the participant/subject achieved or experienced the specific clinical event or milestone of walking by 17 months old which is pertinent to the disease or disorder. Walk by 17 months old Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16187 Vaccine type VaccTyp Vaccination received by pediatric patient Vaccination received by pediatric patient Vaccine Routine: measles, mumps, rubella;Routine: tetanus, pertussis, diptheria, polio;Hepatitis B;Hemophilus Influenza Type B;Chicken pox vaccine Routine: measles, mumps, rubella;Routine: tetanus, pertussis, diptheria, polio;Hepatitis B;Hemophilus Influenza Type B;Chicken pox vaccine Alphanumeric

For each vaccine type record whether the participant/subject received it and if he/she was hospitalized following the vaccination

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00018 Education service type EduSrvcTyp Type of educational services received Type of educational services received Type of educational services received Special Education;Regular Education;None;Unknown;Early Intervention Special Education;Regular Education;None;Unknown;Early Intervention Alphanumeric

Choose one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16188 Vaccine received indicator VaccRcvdInd Indicates whether participant/subject received the vaccine Indicates whether participant/subject received the vaccine Did patient receive this vaccine Yes;No;Unknown;Not Asked Yes;No;Unknown;Not Asked Alphanumeric

Answer, choosing one, for all vaccination types, except vaccination within one month of 1st demyselinating attack. Record from vaccination record where possible. For vaccines which require more than one immunization, yes refers to completion of all immunizations required for participant/subject's current age.

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C08076 Breastfed indicator BreastfedInd Indicator of whether the participant/subject was breastfed by his/her mother Indicator of whether the participant/subject was breastfed by his/her mother Breast fed Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one response

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16189 Vaccine hospitalization indicator VaccineHosznpInd Indicates whether participant/subject was hospitalized due to serious complications from vaccine Indicates whether participant/subject was hospitalized due to serious complications from vaccine Hospitalized Yes;No Yes;No Alphanumeric

Answer for each vaccination type. Choose one

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14117 School repeat grade indicator SchoolRepeatGradeInd Whether the participant/subject ever repeated a grade in school Whether the participant/subject ever repeated a grade in school Has the participant/subject ever repeated a grade in school Yes;No;Unknown Yes;No;Unknown Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16191 Chicken pox infection age value ChickenPoxInfctAgeVal The age value of participant/subject when they experienced a natural infection of chicken pox. The age value of participant/subject when they experienced a natural infection of chicken pox. If participant/subject experienced a natural infection of chicken pox, specify age at which natural infection occurred Numeric Values

Record age in years

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Free-Form Entry

year
C16170 Menstrual period occurrence indicator MenstrualPrdOcurInd Indicates whether participant/subject has ever had a menstrual period. Indicates whether participant/subject has ever had a menstrual period. Has participant/subject ever had a menstrual period Yes;No;N/A - male Yes;No;N/A - male Alphanumeric

Choose one. If participant/subject is male, select "N/A - male".

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16192 Vaccination within one month of demyelinating attack indicator VaccOneMoDemyltsAttckInd Whether or not the participant/subject received a vaccination within one month of his/her first demyelinating attack Whether or not the participant/subject received a vaccination within one month of his/her first demyelinating attack Vaccination within one month of 1st demyelinating attack Yes;No;Unknown;Not Asked Yes;No;Unknown;Not Asked Alphanumeric

Choose one. If yes, specify type of vaccine.

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16171 Menstrual period first occurrence age value MenstrualPrd1stOcurAgeVal Youngest age the female participant/subject had a menstrual period, otherwise known as the age of menarche. Youngest age the female participant/subject had a menstrual period, otherwise known as the age of menarche. Youngest age the female participant/subject had a menstrual period Numeric Values

If YES is answered for having received a menstrual period, record the age first received in years

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Free-Form Entry

0 100 year
C17441 Clinical event or milestone cognitive learning disability indicator ClinEvntMilstneCogLearDisInd Whether the participant/subject achieved or experienced the specific clinical event or milestone of having a cognitive/learning disability which is pertinent to the disease or disorder. Whether the participant/subject achieved or experienced the specific clinical event or milestone of having a cognitive/learning disability which is pertinent to the disease or disorder. Have a cognitive/learning disability Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16181 Breast fed duration value BreastFedDurationVal The duration of time the participant/subject was breast fed The duration of time the participant/subject was breast fed Indicate duration Numeric Values

Only answer if "Yes" is answered for "Breast fed?" Record answer in months

No references available Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Pediatric Developmental History General Health History Participant History and Family History

Free-Form Entry

month
CSV