CDE Detailed Report
Disease: Mitochondrial Disease
Sub-Domain: General Health History
CRF: Reproductive and Hormonal History
Displaying 1 - 38 of 38
Sub-Domain: General Health History
CRF: Reproductive and Hormonal History
Displaying 1 - 38 of 38
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C16173 | Pregnancy estimated delivery date and time | PregEstDeliveryDateTime | The date and time (if applicable) the participant/subject is estimated to deliver the pregnancy | 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 | 3.00 | 2013-07-16 14:01:43.01 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C20004 | Hypoglycemia diagnosis type | HypoglycemDxTyp | The type related to having concern or diagnosis of hypoglycemia or low blood sugar. | 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 | Adult;Pediatric | Supplemental | 1.00 | 2015-02-11 23:35:02.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16008 | Birth control indicator | BirthControlInd | Indicates if participant/subject uses birth control | 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 references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C20015 | Growth hormone treatment indicator | GrowthHorTreatInd | The indicator related to receiving growth hormone. | The indicator related to receiving growth hormone. | Did you receive growth hormone? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-12 00:17:10.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16174 | Menopause indicator | MenopauseInd | Indicates whether participant/subject is currently menopausal. | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| 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. | The free-text field to specify the symptom related to having concern or diagnosis of hypoglycemia or low blood sugar. | Specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-11 23:35:02.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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| C16163 | Hormone therapy name | HormoneTherapyNme | The name of the hormone therapy taken by the participant/subject | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History | 255 |
Free-Form Entry |
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| C20016 | Hormone-related syndrome type | HormoneRltdSyndmTyp | The type related to known hormone-related/endocrine syndromes or disorders | The type related to known hormone-related/endocrine syndromes or disorders | If Yes, indicate all that apply | Hyperthyroidism;Hypothyroidism;Diabetes;Polycystic ovary syndrome;Constitutional delay of growth and puberty;Hypogonadotropic hypogonadism;Cushing's syndrome;Hypoparathyroidism;Adrenal insufficiency;Dyslipidemia;Exocrine pancreatic insufficiency;Other, specify | Hyperthyroidism;Hypothyroidism;Diabetes;Polycystic ovary syndrome;Constitutional delay of growth and puberty;Hypogonadotropic hypogonadism;Cushing's syndrome;Hypoparathyroidism;Adrenal insufficiency;Dyslipidemia;Exocrine pancreatic insufficiency;Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-18 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16175 | Menstrual period last date | MenstrualPeriodLastDate | Date of the participant's/subject's last menstrual period | 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 | 3.00 | 2013-07-16 14:01:43.01 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C20006 | Bone fracture indicator | BoneFractInd | The indicator related to having a bone fracture. | The indicator related to having a bone fracture. | Have there even been bone fractures? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-11 23:48:46.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16164 | Hormonal therapy start date | HormonalTherapyStartDate | The date and time (if applicable and known) the participant/subject started hormonal therapy | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C20017 | Hormone-related syndrome other text | HormoneRltdSyndmOTH | The free-text field related to other specify of known hormone-related/endocrine syndromes or disorders | The free-text field related to other specify of known hormone-related/endocrine syndromes or disorders | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-18 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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| C16176 | Hormone therapy indicator | HormoneTherapyInd | Indicates whether participant/subject has taken hormonal therapy | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C20007 | Bone fracture text | BoneFractTxt | The free-text field related to having a bone fracture. | The free-text field related to having a bone fracture. | Specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-11 23:48:46.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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| C16165 | Hormonal therapy stop date | HormonalTherapyStopDate | The date and time (if applicable and known) the participant/subject stopped hormonal therapy | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C20018 | Hormone-related syndrome diagnosis age value | HormoneRltdSyndmDiagAgVal | The age value of participant/subject related to known hormone-related/endocrine syndromes or disorders | The age value of participant/subject related to known hormone-related/endocrine syndromes or disorders | Age at diagnosis | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2015-02-18 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 120 | year | |||||||||
| C16177 | Post-menopausal indicator | PostMnpslInd | Indicates whether participant/subject is post-menopausal | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C20008 | Bone spine abnormal diagnosis indicator | BoneSpineAbDiagInd | The indicator related to having condition or abnormality of the spine or skeleton. | 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? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-11 23:35:02.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16167 | Given birth or fathered a child indicator | GivenBirthFartheredChildInd | Indicates whether participant/subject has ever given birth or fathered a child | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16178 | Post-menopausal cause type | PostMnpslCauseTyp | Cause or reason for the post-menopausal period in the female participant/subject | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Multiple Pre-Defined Values Selected |
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| C20009 | Bone spine abnormal diagnosis text | BoneSpineAbDiagTxt | The free-text field related to having condition or abnormality of the spine or skeleton. | The free-text field related to having condition or abnormality of the spine or skeleton. | Specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-11 23:35:02.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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| C16168 | Pregnancy self or spouse number | PregSelfSpouseNum | Number of each pregnancy of participant/subject or participant/subject's partner. | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C16179 | Post-menopausal surgery date | PostMnpslSurgDate | The date and time (if applicable and known) of the surgery that induced the post-menopausal period | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C20010 | Dual X-ray absorptiometry scanner performed text | DEXAScanPerfTxt | The free-text field related to DEXA scan performed | The free-text field related to DEXA scan performed | Specify indication and results | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-05 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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| C16169 | Pregnancy outcome type | PregOutcmeTyp | Type of outcome of the pregnancy experienced by the participant/subject | 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 | 3.00 | 2013-07-16 14:01:43.01 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16180 | Hormone-related syndrome indicator | HormoneRltdSyndmInd | Whether the participant/subject has known hormone-related/endocrine syndromes or disorders | Whether the participant/subject has known hormone-related/endocrine syndromes or disorders | Any other known hormone-related/endocrine syndromes or disorders | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C20011 | Rickets diagnosis indicator | RicketsDiagInd | The indicator for diagnosis of rickets which is caused by vitamin D or calcium deficiency. | The indicator for diagnosis of rickets which is caused by vitamin D or calcium deficiency. | Have you ever been told that you have rickets or ever taken high dose vitamin D (>= 20,000 IU daily, or >= 50,000 IU weekly)? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-12 00:04:37.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| 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. | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| 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 (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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C20012 | World Health Organization (WHO) Fracture Risk Assessment tool (FRAX) - fracture probability percentage value | WHOFRAXFractProbPerVal | The score as the 10 year probability of fracture related to the World Health Organization (WHO) Fracture Risk Assessment tool (FRAX) - score for adults between the ages of 40-90. | The score or 10 year probability of fracture related to the World Health Organization (WHO) Fracture Risk Assessment tool (FRAX) - score for adults between the ages of 40-90. | For adults between the ages of 40-90, World Health Organization (WHO) Fracture Risk Assessment tool (FRAX) score | Numeric Values | Adult | Supplemental | 1.00 | 2015-02-18 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 100 | percentage | |||||||||
| 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. | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 100 | year | |||||||
| C19803 | Dual X-ray absorptiometry scanner performed indicator | DEXAScanPerfInd | Indicator of DEXA scan performed | Indicator of DEXA scan performed | Has a DXA scan ever been performed? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-05 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C10980 | Childbearing potential indicator | ChldbrngPtntlInd | Indicator of whether the participant/subject is of childbearing potential. | 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 | 3.00 | 2013-07-22 16:57:17.79 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C20013 | Short stature diagnosis indicator | ShorStatureDiagInd | The indicator related to being diagnosed for short stature or height. | The indicator related to being diagnosed for short stature or height. | Have you ever been diagnosed with short stature? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-12 00:17:10.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16172 | Pregnant current indicator | PregCurntInd | Whether the female participant/subject is currently pregnant | 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 | 3.00 | 2013-06-11 00:00:00.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C20003 | Hypoglycemia diagnosis indicator | HypoglycemDiagInd | The indicator related to having hypoglycemia or low blood sugar. | The indicator related to having hypoglycemia or low blood sugar. | Has there ever been clinical concern for hypoglycemia? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-11 23:35:02.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C10981 | Birth control method type | BirthCntrlMethdTyp | The female participant's/subject's method of birth control | 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 | 3.00 | 2013-07-22 16:57:17.79 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Multiple Pre-Defined Values Selected |
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| C20014 | Growth hormone deficiency diagnosis indicator | GrowthHorDefDiagInd | The indicator related to being diagnosed for deficiency in growth hormone. | The indicator related to being diagnosed for deficiency in growth hormone. | Have you ever been diagnosed with growth hormone deficiency? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-12 00:17:10.0 | Reproductive and Hormonal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
