ID

43347

Description

Exposure in Utero Form Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA3F35-AE5A-6303-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA3F35-AE5A-6303-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Toxicity - Exposure in Utero Form - 2073340v3.0

English

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.

1 forms  
Mother Information
Description

Mother Information

First day of last menstrual period (D M Y)
Description

Firstdayoflastmenstrualperiod

Data type

text

Estimated date of conception (if available)
Description

Estimateddateofconception

Data type

text

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)
Description

Relevanthistory

Data type

text

Patient's Date of Birth (day)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Estimated pregnancy age at beginning of exposure to Tamoxifen/Exemestane (weeks)
Description

EstimatedpregnancyageatbeginningofexposuretoTamoxifen/Exemestane

Data type

text

Date of outcome of pregnancy (D M Y)
Description

PersonPregnancyOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25742
UMLS 2011AA Property-2
C0032961
Estimated number of weeks of exposure (weeks)
Description

Estimatednumberofweeksofexposure

Data type

text

Outcome of pregnancy (select only one)
Description

Outcomeofpregnancy

Data type

text

Perinatal problems
Description

Perinatalproblems

Data type

text

Yes, (specify)
Description

Yes,describeperinatalproblems

Data type

text

Newborn Information
Description

NewbornInformation

Data type

text

Gender (sex)
Description

PatientGender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Weight at birth (OR, if weight in grams is unknown)
Description

Weightatbirth

Data type

text

Length at birth (select one unit of measure)
Description

Lengthatbirth

Data type

text

Gestational age at birth (weeks)
Description

Gestationalageatbirth

Data type

text

Date (day month year)
Description

InvestigatorSignatureDate

Data type

date

Date (day month year)
Description

InvestigatorSignatureDate

Data type

date

Ccrr Module For Exposure In Utero Form
Description

Ccrr Module For Exposure In Utero Form

Patient ID Number (Study No.)
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (f m fl sl)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient's Date of Birth (day)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Participating Center/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

Center Code (Ver.#1)
Description

ParticipatingGroupCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Type of report
Description

Typeofreport

Data type

text

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Similar models

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.

1 forms
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
CL.1
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
CL.2
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
CL.3
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
CL.4
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)
CL.5
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
CL.6
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
CL.7
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
CL.8
Code List
Type of report
CL Item
Prospective (Prospective)
CL Item
Retrospective (Retrospective)
C28010 (NCI Thesaurus)
C1514923 (UMLS 2011AA)
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