ID

43347

Descrizione

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

collegamento

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

Keywords

versioni (3)
  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

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Licenza

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

Inglese

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 moduli  
Mother Information
Descrizione

Mother Information

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

Firstdayoflastmenstrualperiod

Tipo di dati

text

Estimated date of conception (if available)
Descrizione

Estimateddateofconception

Tipo di dati

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)
Descrizione

Relevanthistory

Tipo di dati

text

Patient's Date of Birth (day)
Descrizione

PatientBirthDate

Tipo di dati

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)
Descrizione

EstimatedpregnancyageatbeginningofexposuretoTamoxifen/Exemestane

Tipo di dati

text

Date of outcome of pregnancy (D M Y)
Descrizione

PersonPregnancyOutcomeDate

Tipo di dati

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)
Descrizione

Estimatednumberofweeksofexposure

Tipo di dati

text

Outcome of pregnancy (select only one)
Descrizione

Outcomeofpregnancy

Tipo di dati

text

Perinatal problems
Descrizione

Perinatalproblems

Tipo di dati

text

Yes, (specify)
Descrizione

Yes,describeperinatalproblems

Tipo di dati

text

Newborn Information
Descrizione

NewbornInformation

Tipo di dati

text

Gender (sex)
Descrizione

PatientGender

Tipo di dati

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)
Descrizione

Weightatbirth

Tipo di dati

text

Length at birth (select one unit of measure)
Descrizione

Lengthatbirth

Tipo di dati

text

Gestational age at birth (weeks)
Descrizione

Gestationalageatbirth

Tipo di dati

text

Date (day month year)
Descrizione

InvestigatorSignatureDate

Tipo di dati

date

Date (day month year)
Descrizione

InvestigatorSignatureDate

Tipo di dati

date

Ccrr Module For Exposure In Utero Form
Descrizione

Ccrr Module For Exposure In Utero Form

Patient ID Number (Study No.)
Descrizione

PatientStudyID,CoordinatingGroup

Tipo di dati

text

Patient Initials (f m fl sl)
Descrizione

Patient Initials

Tipo di dati

text

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

PatientBirthDate

Tipo di dati

date

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

MainMemberInstitution/Affiliate

Tipo di dati

text

Center Code (Ver.#1)
Descrizione

ParticipatingGroupCode

Tipo di dati

text

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

Typeofreport

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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