ID

9043

Beschreibung

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

Stichworte

Versionen (2)
  1. 27.08.12 27.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Breast Cancer NCT00659373 Toxicity - Serious Adverse Event Form (Form 24-SAE_B) - 2074086v3.0

Englisch

No Instruction available.

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

Section B - Follow-up Report

Date of onset: (day month year)
Beschreibung

LateAdverseEventOnsetDate

Datentyp

date

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

CTCAdverseEvent,Follow-upReportDate

Datentyp

date

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

Actiontakenregardingprotocoltreatment:

Datentyp

text

Other, (specify)
Beschreibung

Other,

Datentyp

text

Treatments/procedures for SAE: (please describe)
Beschreibung

Treatments/proceduresforSAE:

Datentyp

text

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

AdditionalTherapyInd

Datentyp

boolean

Name of Medication
Beschreibung

AgentName

Datentyp

text

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

AgentAdminRoute

Datentyp

text

Daily Dosage
Beschreibung

AgentTotalDose(perday)

Datentyp

float

Date Started (day month year)
Beschreibung

AgentBeginDate

Datentyp

date

Date Stopped (day month year)
Beschreibung

AgentEndDate

Datentyp

date

Outcome (select one)
Beschreibung

AdverseEventInfectionOutcome

Datentyp

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)
Beschreibung

ResolvedwithSequelae

Datentyp

text

Cause of death:
Beschreibung

DeathReason

Datentyp

text

Autopsy Report available?
Beschreibung

AutopsyInd

Datentyp

text

Investigator/Designee Signature
Beschreibung

InvestigatorSignature

Datentyp

text

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

InvestigatorSignature

Datentyp

text

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

PhoneNumber

Datentyp

float

MD Name (please print:)
Beschreibung

TreatingPhysician

Datentyp

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:
Beschreibung

FaxNumber

Datentyp

float

Date (day month year)
Beschreibung

InvestigatorSignatureDate

Datentyp

date

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

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

Patient ID Number (Study No.)
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Patient Initials (f m fl sl)
Beschreibung

Patient Initials

Datentyp

text

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

PatientBirthDate

Datentyp

date

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

MainMemberInstitution/Affiliate

Datentyp

text

Center Code (Ver.#1)
Beschreibung

ParticipatingGroupCode

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: Serious Adverse Event Form (Form 24-SAE_B)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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