CDE Detailed Report

Disease: Mitochondrial Disease
Subdomain Name: General Health History
CRF: Reproductive and Hormonal History

Displaying 1 - 33 of 33
CDE ID CDE Name Variable Name Definition Short Description 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 / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C59708 Hormone therapy replace indicator HormoneTherapyReplaceInd Indicator of whether the participant has taken hormonal replacement therapy Indicator of whether the participant has taken hormonal replacement therapy Has the participant taken hormonal replacement therapy? No;Yes;Unknown No;Yes;Unknown Alphanumeric

Choose one for participants that have ever had a menstrual period.

No references available Adult;Pediatric Supplemental 1.00 2024-02-02 12:30:04.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C59712 Post-menopausal cause type other text PostMnpslCauseOTH The free-text field related to "Post-menopausal cause type", specifying other text. Type of cause or reason for the post-menopausal period in the participant The free-text field related to "Post-menopausal cause type", specifying other text. Type of cause or reason for the post-menopausal period in the participant Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2024-02-02 13:13:27.0 Reproductive and Hormonal History General Health History Participant History and Family History 4000

Free-Form Entry

C59714 Sex steroid deficiency diagnosis indicator SexStrdDefDiagnosInd Indicator of whether the participant has been diagnosed with sex steroid deficiency Indicator of whether the participant has been diagnosed with sex steroid deficiency Has the participant ever been diagnosed with sex steroid (estrogen/progesterone or testosterone) deficiency? No;Yes;Unknown No;Yes;Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2024-02-02 13:36:27.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C59715 Sex steroid receive indicator SexStrdRecInd Indicator of whether the participant received sex steroids Indicator of whether the participant received sex steroids If YES, did the participant receive sex steroids (either estrogen/progesterone or testosterone/HCG)? No;Yes;Unknown No;Yes;Unknown Alphanumeric

Only answered if "YES" is answered for "Has the participant ever been diagnosed with sex steroid (estrogen/progesterone or testosterone) deficiency?"

No references available Adult;Pediatric Supplemental 1.00 2024-02-02 13:42:41.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C59700 Pregnancy self or contribute sperm status PregSelfOrContributeSpermStat Status related to whether the participant has ever been pregnant or contributed sperm to a pregnancy Status related to whether the participant has ever been pregnant or contributed sperm to a pregnancy Has the participant ever been pregnant or contributed sperm to a pregnancy? Unknown;No;Yes, contributed sperm to a pregnancy;Yes, been pregnant Unknown;No;Yes, contributed sperm to a pregnancy;Yes, been pregnant Alphanumeric

Choose one. Include current pregnancy and any past pregnancies that resulted in early pregnancy loss. If YES, answer questions on pregnancy data.

No references available Adult;Pediatric Supplemental 1.00 2024-02-01 12:06:29.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C59701 Pregnancy other outcome comment text PregOthrOutcomeCommentTxt The free-text field describing the other comments and outcomes of a pregnancy The free-text field describing the other comments and outcomes of a pregnancy Other comments and outcomes (such as twins, use of fertility drugs or in vitro fertilization, etc.) Alphanumeric

Record other comments and outcomes for each pregnancy

No references available Adult;Pediatric Supplemental 1.00 2024-02-01 16:51:27.0 Reproductive and Hormonal History General Health History Participant History and Family History 255

Free-Form Entry

C59702 Polycystic ovarian syndrome diagnosis indicator PolycOvrnSyndDiagnosInd Indicator of whether the participant has ever been diagnosed with polycystic ovarian syndrome Indicator of whether the participant has ever been diagnosed with polycystic ovarian syndrome Has the participant ever been diagnosed with polycystic ovarian syndrome? No;Yes;Unknown No;Yes;Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2024-02-02 08:28:20.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C59703 Sex steroid deficiency cause type SexStrdDefCsTyp Type of cause of the participant's sex steroid deficiency Type of cause of the participant's sex steroid deficiency If YES, indicate cause Primary (premature ovarian or testicular insufficiency);Secondary/tertiary (central) Primary (premature ovarian or testicular insufficiency);Secondary/tertiary (central) Alphanumeric

Only answered if "YES" is answered for "Has the participant ever been diagnosed with sex steroid (estrogen/progesterone or testosterone) deficiency?"

No references available Adult;Pediatric Supplemental 1.00 2024-02-02 09:19:06.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16193 Pregnancy outcome date/time PregOutcomeDateTime 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 or the pregnant individual (if the participant contributed sperm to the pregnancy) 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 or the pregnant individual (if the participant contributed sperm to the pregnancy) 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 (https://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 4.00 2024-02-01 16:22:32.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

C16170 Menstrual period occurrence indicator MenstrualPrdOcurInd Indicates whether participant has ever had a menstrual period Indicates whether participant has ever had a menstrual period Has the participant ever had a menstrual period? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If NO, please go to Short Stature/Growth Hormone Deficiency/Sex Steroid Deficiency section

No references available Adult;Pediatric Supplemental 3.10 2024-02-02 08:23:32.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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 heigh Has the participant ever been diagnosed with short stature? No;Yes;Unknown No;Yes;Unknown Alphanumeric

No instructions available

No references available 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

C16171 Menstrual period first occurrence age value MenstrualPrd1stOcurAgeVal Youngest age the participant had a menstrual period, otherwise known as the age of menarche Youngest age the participant had a menstrual period, otherwise known as the age of menarche If YES, what age was the participant's first period? Numeric Values

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

No references available Adult;Pediatric Supplemental 3.10 2024-02-02 08:26:11.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

0 100 year
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 hormon Has the participant ever been diagnosed with growth hormone deficiency? No;Yes;Unknown No;Yes;Unknown Alphanumeric

No instructions available

No references available 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

C16172 Pregnant current indicator PregCurntInd Indicator of whether the participant is currently pregnant Indicator of whether the participant is currently pregnant Is the participant currently pregnant? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for participants that have ever had a menstrual period.

No references available Adult;Pediatric Supplemental 3.10 2024-02-02 11:45:08.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C20015 Growth hormone treatment indicator GrowthHorTreatInd The indicator related to receiving growth hormone The indicator related to receiving growth hormon If YES, did the participant receive growth hormone? No;Yes;Unknown No;Yes;Unknown Alphanumeric

No instructions available

No references available 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

C10980 Childbearing potential indicator ChldbrngPtntlInd Indicator of whether the participant is of childbearing potential Indicator of whether the participant is of childbearing potential Is the participant able to become pregnant? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one.

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

C16173 Pregnancy estimate delivery date and time PregEstDeliveryDateTime The date and time (if applicable) the participant is estimated to deliver the pregnancy The date and time (if applicable) the participant is estimated to deliver the pregnancy If YES, indicate the participant's due date Date or Date & Time

Only answered if "YES" is answered for "Is the participant currently pregnant?"
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://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 3.10 2024-02-02 11:48:32.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

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;Cushing's syndrome;Hypoparathyroidism;Adrenal insufficiency;Dyslipidemia;Exocrine pancreatic insufficiency;Other, specify Hyperthyroidism;Hypothyroidism;Diabetes;Cushing's syndrome;Hypoparathyroidism;Adrenal insufficiency;Dyslipidemia;Exocrine pancreatic insufficiency;Other, specify Alphanumeric

Only answered if "YES" is answered for "Any other known hormone-related/endocrine syndromes or disorders?"

No references available Adult;Pediatric Supplemental 2.00 2024-02-02 13:59:17.0 Reproductive and Hormonal History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C10981 Birth control method type BirthCntrlMethdTyp The participant's method of birth control The participant's method of birth control If YES, indicate all forms of contraception used Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Abstinence;None of these;Oral contraceptives - estrogen/progestin pill;Implantable hormonal device;Hormonal IUD;Non-hormonal IUD Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Abstinence;None of these;Oral contraceptives - estrogen/progestin pill;Implantable hormonal device;Hormonal IUD;Non-hormonal IUD Alphanumeric

Only answered if "Does the participant use any forms of contraception to prevent becoming pregnant?" is answered Yes. Choose all that apply.

No references available Adult;Pediatric Supplemental 4.00 2024-03-18 15:21:17.0 Reproductive and Hormonal History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C16174 Menopause indicator MenopauseInd Indicates whether participant is currently menopausal Indicates whether participant/subject is currently menopausa Does the participant believe they are currently experiencing menopause? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for participants that have ever had a menstrual period.

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

C20017 Hormone-related syndrome other text HormoneRltdSyndmOTH The free-text field related to "Hormone-related syndrome type", specifying other text. The type related to known hormone-related/endocrine syndromes or disorders The free-text field related to "Hormone-related syndrome type", specifying other text. The type related to known hormone-related/endocrine syndromes or disorders Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.10 2024-02-02 14:03:33.0 Reproductive and Hormonal History General Health History Participant History and Family History 4000

Free-Form Entry

C16008 Birth control indicator BirthControlInd Indicates if participant uses birth control Indicates if participant uses birth control Does the participant use any forms of contraception to prevent becoming pregnant? Yes;No;Unknown Yes;No;Unknown Alphanumeric

No instructions available

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

C16175 Menstrual period last date MenstrualPeriodLastDate Date of the participant's last menstrual period Date of the participant's last menstrual period If YES, indicate the approximate date of the participant's last menstrual period Date or Date & Time

Only answered if "YES" is answered for "Does the participant believe they are currently experiencing menopause?"
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://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 3.10 2024-02-02 12:18:50.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

C20018 Hormone-related syndrome diagnosis age value HormoneRltdSyndmDiagAgVal The age value of participant related to known hormone-related/endocrine syndromes or disorders The age value of participant related to known hormone-related/endocrine syndromes or disorders Age at diagnosis Numeric Values

No instructions available

No references available Adult;Pediatric Supplemental 1.10 2024-02-02 14:01:10.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

0 120 year
C16163 Hormone therapy name HormoneTherapyNme The name of the hormone therapy taken by the participant The name of the hormone therapy taken by the participant/subjec If YES, specify name of hormonal therapy taken Alphanumeric

Only answered if "YES" is answered for "Has the participant taken hormonal replacement 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

C16177 Post-menopausal indicator PostMnpslInd Indicates whether participant is post-menopausal Indicates whether participant/subject is post-menopausal Is the participant post-menopausal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for participants that have ever had a menstrual period.

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

C16164 Hormonal therapy start date/time HormonalTherapyStartDateTime The date and time (if applicable and known) the participant started hormonal therapy Date (and time, if applicable and known) the participant started hormonal therapy Date Started Date or Date & Time

Only answered if "YES" is answered for "Has the participant taken hormonal replacement therapy?"
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://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 4.00 2024-02-02 12:57:37.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

C16178 Post-menopausal cause type PostMnpslCauseTyp Type of cause or reason for the post-menopausal period in the participant Tpye of cause or reason for the post-menopausal period in the participant If YES, indicate cause Surgical (complete hysterectomy- ovaries and uterus removed);Surgical (partial hysterectomy-only uterus removed);Medications or chemotherapy;Advancing age;Other, specify Surgical (complete hysterectomy- ovaries and uterus removed);Surgical (partial hysterectomy-only uterus removed);Medications or chemotherapy;Advancing age;Other, specify Alphanumeric

Only answered if "YES" is answered for "Is the participant post-menopausal?". Choose all that apply.

No references available Adult;Pediatric Supplemental 4.00 2024-03-18 15:21:17.0 Reproductive and Hormonal History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C16165 Hormonal therapy stop date/time HormonalTherapyStopDateTIme The date and time (if applicable and known) the participant stopped hormonal therapy Date (and time, if applicable and known) the participant stopped hormonal therapy Date Stopped Date or Date & Time

Only answered if "YES" is answered for "Has the participant taken hormonal replacement therapy?"
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://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 4.00 2024-02-02 13:04:55.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

C16179 Post-menopausal surgery date/time PostMnpslSurgDateTime 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 (https://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 4.00 2024-02-02 13:21:13.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

C16168 Pregnancy self or contribute sperm number PregSelfOrContributeSpermNum Number of each pregnancy for the participant or the pregnant individual (if the participant contributed sperm to the pregnancy) Number of each pregnancy for the participant or the pregnant individual (if the participant contributed sperm to the pregnancy) # Numeric Values

Numbers should be assigned in ascending numerical order, #1 being the most recent pregnancy.

No references available Adult;Pediatric Supplemental 4.00 2024-02-01 15:39:08.0 Reproductive and Hormonal History General Health History Participant History and Family History

Free-Form Entry

C16180 Hormone-related syndrome indicator HormoneRltdSyndmInd Indicator of whether the participant has known hormone-related/endocrine syndromes or disorders Indicator of whether the participant 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 3.10 2024-02-02 13:55:35.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16169 Pregnancy outcome type PregOutcmeTyp Type of outcome of the pregnancy experienced by the participant or the pregnant individual (if the participant contributed sperm to the pregnancy) Type of outcome of the pregnancy experienced by the participant or the pregnant individual (if the participant contributed sperm to the pregnancy) Pregnancy Outcome Currently pregnant;Live birth;Miscarriage;Still birth;Other termination Currently pregnant;Live birth;Spontaneous abortion (<20 weeks);Fetal death/stillbirth (>20 weeks);Other termination Alphanumeric

Choose one. Please describe the outcome of each pregnancy for the participant or the pregnant individual (if the participant contributed sperm to the pregnancy), starting with the most recent.

No references available Adult;Pediatric Supplemental 4.00 2024-03-18 15:21:17.0 Reproductive and Hormonal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV