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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Mitochondrial Disease
Sub-Domain: General Health History
CRF: Reproductive and Hormonal History
Item count: 38 (38 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C16167
Given birth or fathered a child indicator
GivenBirthFartheredChildInd
Indicates whether participant/subject has ever given birth or fathered a child
Have you ever given birth or fathered a child
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. Include current pregnancy and any pregnancies that resulted in early pregnancy loss, whether by choice or not.
If "Yes" is answered, go to next question.
If "No" is answered and participant/subject is a woman, skip to question 3.
If "No" is answered and participant/subject is male, end form.
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Given birth or fathered a child indicator
 
Single Pre-Defined Value Selected
       
C16168
Pregnancy self or spouse number
PregSelfSpouseNum
Number of each pregnancy of participant/subject or participant/subject's partner.
#
  
Numeric Values
Numbers should be assigned in ascending numerical order, #1 being the most recent pregnancy.
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Pregnancy self or spouse number
 
Free-Form Entry
       
C16169
Pregnancy outcome type
PregOutcmeTyp
Type of outcome of the pregnancy experienced by the participant/subject
Pregnancy Outcome
Currently pregnant;Live birth;Miscarriage;Therapeutic abortion or elective termination;Still birth;
Currently pregnant;Live birth;Spontaneous abortion (<20 weeks);Therapeutic abortion or elective termination;Fetal death/stillbirth (>20 weeks);
Alphanumeric
Choose one. Answer for all pregnancies experienced by the participant/subject or the participant/subject's partner
No references available
Adult;Pediatric
Supplemental
3.0
7/16/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Pregnancy outcome type
 
Single Pre-Defined Value Selected
       
C16193
Pregnancy outcome date
PregOutcomeDate
The date and time (if applicable and known) of the outcome (i.e., delivery of live birth, miscarriage, etc.) of the pregnancy experienced by the participant/subject or the participant/subject's partner
Date
  
Date or Date & Time
At a minimum record the month and year for each pregnancy.
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
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Pregnancy outcome date
 
Free-Form Entry
       
C10980
Childbearing potential indicator
ChldbrngPtntlInd
Indicator of whether the participant/subject is of childbearing potential.
Are you of child-bearing potential
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. No should be chosen if the participant/subject is a male.
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Childbearing potential indicator
 
Single Pre-Defined Value Selected
       
C16170
Menstrual period occurrence indicator
MenstrualPrdOcurInd
Indicates whether participant/subject has ever had a menstrual period.
Have you ever had a menstrual period
Yes;No;
Yes;No;
Alphanumeric
Choose one. If participant/subject is male, select "N/A - male".
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Menstrual period occurrence indicator
 
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.
What age was your first 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
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Menstrual period first occurrence age value
 
Free-Form Entry
0
100
year
    
C16008
Birth control indicator
BirthControlInd
Indicates if participant/subject uses birth control
Do you use any forms of contraception (periods may be regular or irregular)
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/16/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Birth control indicator
 
Single Pre-Defined Value Selected
       
C10981
Birth control method type
BirthCntrlMethdTyp
The female participant's/subject's method of birth control
Indicate all forms of contraception used
Oral contraceptives – combined pill;Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Implantable devices with hormone;Abstinence;None of these;
Oral contraceptives – combined pill;Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Implantable devices with hormone;Abstinence;None of these;
Alphanumeric
Only answered if "Is the subject of childbearing potential?" is answered Yes. Choose all that apply.
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Birth control method type
 
Multiple Pre-Defined Values Selected
       
C16172
Pregnant current indicator
PregCurntInd
Whether the female participant/subject is currently pregnant
Are you currently pregnant
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one for females
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Pregnant current indicator
 
Single Pre-Defined Value Selected
       
C16173
Pregnancy estimated delivery date and time
PregEstDeliveryDateTime
The date and time (if applicable) the participant/subject is estimated to deliver the pregnancy
Indicate your due date
  
Date or Date & Time
Only answered if "Yes" is answered for "Are you currently pregnant?"
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
3.0
7/16/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Pregnancy estimated delivery date
 
Free-Form Entry
       
C16174
Menopause indicator
MenopauseInd
Indicates whether participant/subject is currently menopausal.
Do you believe you are currently experiencing menopause
Yes;No;
Yes;No;
Alphanumeric
Choose one for females
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Menopause indicator
 
Single Pre-Defined Value Selected
       
C16175
Menstrual period last date
MenstrualPeriodLastDate
Date of the participant's/subject's last menstrual period
If Yes, indicate the approximate date of your last menstrual period
  
Date or Date & Time
Only answered if "Yes" is answered for "Do you believe you are currently experiencing menopause?"
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
3.0
7/16/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Menstruation last occurrence date
 
Free-Form Entry
       
C16176
Hormone therapy indicator
HormoneTherapyInd
Indicates whether participant/subject has taken hormonal therapy
Have you taken hormonal therapy
Yes;No;
Yes;No;
Alphanumeric
Choose one for females
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Hormone therapy indicator
 
Single Pre-Defined Value Selected
       
C16163
Hormone therapy name
HormoneTherapyNme
The name of the hormone therapy taken by the participant/subject
Specify name of hormonal therapy taken
  
Alphanumeric
Only answered if "Yes" is answered for "Have you taken hormonal therapy?"
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Hormone therapy name
255
Free-Form Entry
       
C16164
Hormonal therapy start date
HormonalTherapyStartDate
The date and time (if applicable and known) the participant/subject started hormonal therapy
Date Started
  
Date or Date & Time
Only answered if "Yes" is answered for "Have you taken hormonal therapy?"
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
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Hormonal therapy start date
 
Free-Form Entry
       
C16165
Hormonal therapy stop date
HormonalTherapyStopDate
The date and time (if applicable and known) the participant/subject stopped hormonal therapy
Date Stopped
  
Date or Date & Time
Only answered if "Yes" is answered for "Have you taken hormonal therapy?"
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
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Hormonal therapy stop date
 
Free-Form Entry
       
C16177
Post-menopausal indicator
PostMnpslInd
Indicates whether participant/subject is post-menopausal
Are you post-menopausal
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one if female
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Post-menopausal indicator
 
Single Pre-Defined Value Selected
       
C16178
Post-menopausal cause type
PostMnpslCauseTyp
Cause or reason for the post-menopausal period in the female participant/subject
Indicate cause
Natural;Surgical (complete hysterectomy- ovaries and uterus removed);Surgical (partial hysterectomy-only uterus removed);Medications or chemotherapy;
Natural;Surgical (complete hysterectomy- ovaries and uterus removed);Surgical (partial hysterectomy-only uterus removed);Medications or chemotherapy;
Alphanumeric
Only answered if "Yes" is answered for "Are you post-menopausal?". Choose all that apply.
No references available
Adult;Pediatric
Supplemental
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Post-menopausal cause type
 
Multiple Pre-Defined Values Selected
       
C16179
Post-menopausal surgery date
PostMnpslSurgDate
The date and time (if applicable and known) of the surgery that induced the post-menopausal period
Date
  
Date or Date & Time
Only answered if "Surgical (complete hysterectomy - ovaries and uterus removed)" or "Surgical (partial hysterectomy - only uterus removed) are answered for "If yes, indicate cause"
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
3.0
6/11/2013
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
Post-menopausal surgery date
 
Free-Form Entry
       
C20003
Hypoglycemia diagnosis indicator
HypoglycemDiagInd
The indicator related to having hypoglycemia or low blood sugar.
Has there ever been clinical concern for hypoglycemia?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/11/2015
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C20004
Hypoglycemia diagnosis type
HypoglycemDxTyp
The type related to having concern or diagnosis of hypoglycemia or low blood sugar.
Specify all that apply
Symptomatic;Laboratory blood glucose < 50 mg/dL;Post-prandial;Fasting;Symptoms improved with feeding;
Symptomatic;Laboratory blood glucose < 50 mg/dL;Post-prandial;Fasting;Symptoms improved with feeding;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/11/2015
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C20005
Hypoglycemia symptom diagnosis text
HypoglycemSymDxTxt
The free-text field to specify the symptom related to having concern or diagnosis of hypoglycemia or low blood sugar.
Specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/11/2015
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C20006
Bone fracture indicator
BoneFractInd
The indicator related to having a bone fracture.
Have there even been bone fractures?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/11/2015
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C20007
Bone fracture text
BoneFractTxt
The free-text field related to having a bone fracture.
Specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/11/2015
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C20008
Bone spine abnormal diagnosis indicator
BoneSpineAbDiagInd
The indicator related to having condition or abnormality of the spine or skeleton.
Have you ever been diagnosed with any condition or abnormality of the spine or skeleton?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/11/2015
Aliases for variable name not defined
Reproductive and Hormonal History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
07-20-2019
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