ID

43347

Descrição

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

Palavras-chave

Versões (3)
  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

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

Inglês

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 Formulários  
Mother Information
Descrição

Mother Information

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

Firstdayoflastmenstrualperiod

Tipo de dados

text

Estimated date of conception (if available)
Descrição

Estimateddateofconception

Tipo de dados

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)
Descrição

Relevanthistory

Tipo de dados

text

Patient's Date of Birth (day)
Descrição

PatientBirthDate

Tipo de dados

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)
Descrição

EstimatedpregnancyageatbeginningofexposuretoTamoxifen/Exemestane

Tipo de dados

text

Date of outcome of pregnancy (D M Y)
Descrição

PersonPregnancyOutcomeDate

Tipo de dados

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)
Descrição

Estimatednumberofweeksofexposure

Tipo de dados

text

Outcome of pregnancy (select only one)
Descrição

Outcomeofpregnancy

Tipo de dados

text

Perinatal problems
Descrição

Perinatalproblems

Tipo de dados

text

Yes, (specify)
Descrição

Yes,describeperinatalproblems

Tipo de dados

text

Newborn Information
Descrição

NewbornInformation

Tipo de dados

text

Gender (sex)
Descrição

PatientGender

Tipo de dados

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)
Descrição

Weightatbirth

Tipo de dados

text

Length at birth (select one unit of measure)
Descrição

Lengthatbirth

Tipo de dados

text

Gestational age at birth (weeks)
Descrição

Gestationalageatbirth

Tipo de dados

text

Date (day month year)
Descrição

InvestigatorSignatureDate

Tipo de dados

date

Date (day month year)
Descrição

InvestigatorSignatureDate

Tipo de dados

date

Ccrr Module For Exposure In Utero Form
Descrição

Ccrr Module For Exposure In Utero Form

Patient ID Number (Study No.)
Descrição

PatientStudyID,CoordinatingGroup

Tipo de dados

text

Patient Initials (f m fl sl)
Descrição

Patient Initials

Tipo de dados

text

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

PatientBirthDate

Tipo de dados

date

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

MainMemberInstitution/Affiliate

Tipo de dados

text

Center Code (Ver.#1)
Descrição

ParticipatingGroupCode

Tipo de dados

text

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

Typeofreport

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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