ID

9043

Beschrijving

Serious Adverse Event Form (Form 24-SAE_B) 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=B0EA7BE0-EB0F-636A-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA7BE0-EB0F-636A-E034-0003BA12F5E7

Trefwoorden

Versies (2)
  1. 27-08-12 27-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Toxicity - Serious Adverse Event Form (Form 24-SAE_B) - 2074086v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: Serious Adverse Event Form (Form 24-SAE_B)
    1. No Instruction available.
Section B - Follow-up Report
Beschrijving

Section B - Follow-up Report

Date of onset: (day month year)
Beschrijving

LateAdverseEventOnsetDate

Datatype

date

Date of this follow-up report: (day month year)
Beschrijving

CTCAdverseEvent,Follow-upReportDate

Datatype

date

Action taken regarding protocol treatment: (select all that apply)
Beschrijving

Actiontakenregardingprotocoltreatment:

Datatype

text

Other, (specify)
Beschrijving

Other,

Datatype

text

Treatments/procedures for SAE: (please describe)
Beschrijving

Treatments/proceduresforSAE:

Datatype

text

Were there changes in previous Concomitant Therapy? (Complete ONLY if different from initial report in Section A.)
Beschrijving

AdditionalTherapyInd

Datatype

boolean

Name of Medication
Beschrijving

AgentName

Datatype

text

Admin. (e.g., i.v., p.o.)
Beschrijving

AgentAdminRoute

Datatype

text

Daily Dosage
Beschrijving

AgentTotalDose(perday)

Datatype

float

Date Started (day month year)
Beschrijving

AgentBeginDate

Datatype

date

Date Stopped (day month year)
Beschrijving

AgentEndDate

Datatype

date

Outcome (select one)
Beschrijving

AdverseEventInfectionOutcome

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Resolved with Sequelae: (please specify)
Beschrijving

ResolvedwithSequelae

Datatype

text

Cause of death:
Beschrijving

DeathReason

Datatype

text

Autopsy Report available?
Beschrijving

AutopsyInd

Datatype

text

Investigator/Designee Signature
Beschrijving

InvestigatorSignature

Datatype

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator/Designee Signature
Beschrijving

InvestigatorSignature

Datatype

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Phone number:
Beschrijving

PhoneNumber

Datatype

float

MD Name (please print:)
Beschrijving

TreatingPhysician

Datatype

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Fax number:
Beschrijving

FaxNumber

Datatype

float

Date (day month year)
Beschrijving

InvestigatorSignatureDate

Datatype

date

Ccrr Module For Serious Adverse Event Form (form 24-sae_b)
Beschrijving

Ccrr Module For Serious Adverse Event Form (form 24-sae_b)

Patient ID Number (Study No.)
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Patient Initials (f m fl sl)
Beschrijving

Patient Initials

Datatype

text

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

PatientBirthDate

Datatype

date

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

MainMemberInstitution/Affiliate

Datatype

text

Center Code (Ver.#1)
Beschrijving

ParticipatingGroupCode

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: Serious Adverse Event Form (Form 24-SAE_B)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Section B - Follow-up Report
LateAdverseEventOnsetDate
Item
Date of onset: (day month year)
date
CTCAdverseEvent,Follow-upReportDate
Item
Date of this follow-up report: (day month year)
date
Item
Action taken regarding protocol treatment: (select all that apply)
text
CL.1
Code List
Action taken regarding protocol treatment: (select all that apply)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Treatment Delayed (Treatment delayed)
CL Item
Treatment Temporarily Discontinued (Treatment temporarily discontinued)
CL Item
Treatment Permanently Discontinued (Treatment permanently discontinued)
CL Item
Other, Specify (Other, specify)
Other,
Item
Other, (specify)
text
Treatments/proceduresforSAE:
Item
Treatments/procedures for SAE: (please describe)
text
AdditionalTherapyInd
Item
Were there changes in previous Concomitant Therapy? (Complete ONLY if different from initial report in Section A.)
boolean
AgentName
Item
Name of Medication
text
AgentAdminRoute
Item
Admin. (e.g., i.v., p.o.)
text
AgentTotalDose(perday)
Item
Daily Dosage
float
AgentBeginDate
Item
Date Started (day month year)
date
AgentEndDate
Item
Date Stopped (day month year)
date
Item
Outcome (select one)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
CL.3
Code List
Outcome (select one)
CL Item
Resolved: (Resolved:)
CL Item
Resolved with Sequelae: (Resolved with Sequelae:)
CL Item
Not resolved/ongoing (Not resolved/ongoing)
CL Item
Death, date of death: (Death, date of death:)
ResolvedwithSequelae
Item
Resolved with Sequelae: (please specify)
text
DeathReason
Item
Cause of death:
text
Item
Autopsy Report available?
text
CL.4
Code List
Autopsy Report available?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes.)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
InvestigatorSignature
Item
Investigator/Designee Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignature
Item
Investigator/Designee Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PhoneNumber
Item
Phone number:
float
TreatingPhysician
Item
MD Name (please print:)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
FaxNumber
Item
Fax number:
float
InvestigatorSignatureDate
Item
Date (day month year)
date
Item Group
Ccrr Module For Serious Adverse Event Form (form 24-sae_b)
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)
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