CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: General Health History
CRF: Reproductive and Hormonal 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
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

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

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

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

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

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

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

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

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
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

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

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

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

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

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

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

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 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

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

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

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

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

CSV