EXPOSURE IN UTERO FORM (Form 24-EIU) Instructions: Submit this form if patient becomes pregnant during protocol therapy (tamoxifen, exemestane, ovarian function suppression). If outcome is unknown, submit this form again, completing Q6-15. Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Mother Information
Firstdayoflastmenstrualperiod
Item
First day of last menstrual period (D M Y)
text
Estimateddateofconception
Item
Estimated date of conception (if available)
text
Relevanthistory
Item
Relevant history (any maternal health problems and medications, smoking, alcohol use during the pregnancy, previous pregnancies and outcomes, family history of congenital anomaly and genetic diseases)
text
PatientBirthDate
Item
Patient's Date of Birth (day)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Estimated pregnancy age at beginning of exposure to Tamoxifen/Exemestane (weeks)
text
Code List
Estimated pregnancy age at beginning of exposure to Tamoxifen/Exemestane (weeks)
CL Item
First Trimester (First trimester)
CL Item
Second Trimester (Second trimester)
CL Item
Third Trimester (Third trimester)
PersonPregnancyOutcomeDate
Item
Date of outcome of pregnancy (D M Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25742 (NCI Thesaurus Property-2)
C0032961 (UMLS 2011AA Property-2)
Estimatednumberofweeksofexposure
Item
Estimated number of weeks of exposure (weeks)
text
Item
Outcome of pregnancy (select only one)
text
Code List
Outcome of pregnancy (select only one)
CL Item
Full Term Live Birth (Full term live birth)
CL Item
Preterm Live Birth (Preterm live birth)
CL Item
Stillbirth (Stillbirth)
CL Item
Neonatal Death (Neonatal death)
CL Item
Miscarriage/spontaneous Abortion (Miscarriage/spontaneous abortion)
CL Item
Induced/elective Abortion (Induced/elective abortion)
Item
Perinatal problems
text
Code List
Perinatal problems
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes, specify)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Yes,describeperinatalproblems
Item
Yes, (specify)
text
Item
Newborn Information
text
Code List
Newborn Information
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Congenital Anomaly, Specify And Submit Forms 24-sae-a And 24-sae-b (Congenital anomaly, specify and submit Forms 24-SAE-A and 24-SAE-B)
Item
Gender (sex)
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
Code List
Gender (sex)
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
Item
Weight at birth (OR, if weight in grams is unknown)
text
Code List
Weight at birth (OR, if weight in grams is unknown)
CL Item
Grams (grams)
CL Item
Lbs. (lbs.)
CL Item
Oz. (oz.)
Item
Length at birth (select one unit of measure)
text
Code List
Length at birth (select one unit of measure)
CL Item
Cm (cm)
CL Item
In. (in.)
Gestationalageatbirth
Item
Gestational age at birth (weeks)
text
InvestigatorSignatureDate
Item
Date (day month year)
date
InvestigatorSignatureDate
Item
Date (day month year)
date
Item Group
Ccrr Module For Exposure In Utero Form
PatientStudyID,CoordinatingGroup
Item
Patient ID Number (Study No.)
text
Patient Initials
Item
Patient Initials (f m fl sl)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientBirthDate
Item
Patient's Date of Birth (day)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
MainMemberInstitution/Affiliate
Item
Participating Center/Affiliate
text
ParticipatingGroupCode
Item
Center Code (Ver.#1)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Item
Type of report
text
Code List
Type of report
CL Item
Prospective (Prospective)
CL Item
Retrospective (Retrospective)
C28010 (NCI Thesaurus)
C1514923 (UMLS 2011AA)

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