ID

1172

Beskrivning

Serious Adverse Event Form (Form 24-SAE-A) 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=B111F21A-A960-319C-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B111F21A-A960-319C-E034-0003BA12F5E7

Nyckelord

Versioner (2)
  1. 2012-08-27 2012-08-27 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
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27 augusti 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Toxicity - Serious Adverse Event Form (Form 24-SAE-A) - 2072974v3.0

Engelsk

SERIOUS ADVERSE EVENT FORM (Form 24-SAE-A) Instructions: Fax Section A within 24 hours in the case of a serious adverse event. Fax Section B within 15 days of initial report and/or for definitive SAE outcome. 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 Formulär  
Section A - Serious Adverse Event Onset
Beskrivning

Section A - Serious Adverse Event Onset

Date of onset (day month year)
Beskrivning

LateAdverseEventOnsetDate

Datatyp

date

Date Section A filled in (date) (within 24 hours of SAE)
Beskrivning

DateSectionAfilledin(date)

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Main Event
Beskrivning

CTCAdverseEventTerm

Datatyp

text

Brief Description
Beskrivning

BriefDescription

Datatyp

text

Daily Dosage
Beskrivning

AgentTotalDose(perday)

Datatyp

double

Trial Phase (select all that apply)
Beskrivning

TrialPhase

Datatyp

text

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

AgentAdminRoute

Datatyp

text

Trial Phase, Other specify
Beskrivning

TrialPhase,Otherspecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Start date of first cycle (chemotheraphy) (day month year)
Beskrivning

FirstDoseStartDate,FirstCycle

Datatyp

date

Date Started (day month year)
Beskrivning

TreatmentBeginDate

Datatyp

date

Date Started (day month year)
Beskrivning

TreatmentBeginDate

Datatyp

date

Date Started (day month year)
Beskrivning

TreatmentBeginDate

Datatyp

date

Date Started (day month year)
Beskrivning

TreatmentBeginDate

Datatyp

date

Date Started (day month year)
Beskrivning

TreatmentBeginDate

Datatyp

date

Trial Therapy
Beskrivning

TrialTherapy

Datatyp

text

Date of Last Administration prior to SAE (day month year)
Beskrivning

DateofLastAdministrationpriortoSAE

Datatyp

text

Concomitant Therapy:
Beskrivning

Concomitant Therapy:

Type of Therapy
Beskrivning

TypeofTherapy

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Metathesaurus Property
C0332307
Name of Medication
Beskrivning

AgentName

Datatyp

text

Daily Dosage
Beskrivning

AgentTotalDose(perday)

Datatyp

double

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

AgentAdminRoute

Datatyp

text

Date Started
Beskrivning

AgentBeginDate

Datatyp

date

Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
Beskrivning

SignificantMedicalHistory,ConcomitantDiseasesand/orRelevantMedicalConditions

Datatyp

text

Reason for seriousness (select one only)
Beskrivning

Reasonforseriousness

Datatyp

text

Other specify (seriousness)
Beskrivning

Otherspecify(seriousness)

Datatyp

text

Causality assessment regarding protocol treatment:
Beskrivning

CTCAdverseEventAttributionCode

Datatyp

text

Toxicity Grade for Events thought to be at least possibly related
Beskrivning

ToxicityGradeforEventsthoughttobeatleastpossiblyrelated

Datatyp

text

In the Investigator?s opinion, the Event was most likely due to:
Beskrivning

IntheInvestigator'sopinion,theEventwasmostlikelydueto:

Datatyp

text

Investigator/Designee Signature
Beskrivning

InvestigatorSignature

Datatyp

text

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

InvestigatorSignature

Datatyp

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
MD Name (please print:)
Beskrivning

TreatingPhysician

Datatyp

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass
C25705
UMLS 2011AA ObjectClass
C1522326
Phone number
Beskrivning

PhoneNumber

Datatyp

double

Fax number
Beskrivning

FaxNumber

Datatyp

double

Date (day month year)
Beskrivning

InvestigatorSignatureDate

Datatyp

date

Ccrr Module For Serious Adverse Event Form (form 24-sae-a)
Beskrivning

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

Patient ID Number (Study No.)
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Patient Initials (f m fl sl)
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient's Date of Birth (day)
Beskrivning

PatientBirthDate

Datatyp

date

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

MainMemberInstitution/Affiliate

Datatyp

text

Center Code (Ver.#1)
Beskrivning

ParticipatingGroupCode

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Date of initial report (within 24 hours of SAE:)
Beskrivning

Dateofinitialreport

Datatyp

text

Date of follow-up report (within 15 days of initial report:)
Beskrivning

PatientFollow-upAssessmentReportDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
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Similar models

SERIOUS ADVERSE EVENT FORM (Form 24-SAE-A) Instructions: Fax Section A within 24 hours in the case of a serious adverse event. Fax Section B within 15 days of initial report and/or for definitive SAE outcome. 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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Section A - Serious Adverse Event Onset
LateAdverseEventOnsetDate
Item
Date of onset (day month year)
date
DateSectionAfilledin(date)
Item
Date Section A filled in (date) (within 24 hours of SAE)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
CTCAdverseEventTerm
Item
Main Event
text
BriefDescription
Item
Brief Description
text
AgentTotalDose(perday)
Item
Daily Dosage
double
Item
Trial Phase (select all that apply)
text
CL.1
Code List
Trial Phase (select all that apply)
CL Item
On Chemotherapy (On chemotherapy)
CL Item
On Endocrine Therapy (On endocrine therapy)
CL Item
On Immunotherapy (On immunotherapy)
CL Item
On Radiation Therapy (On radiation therapy)
CL Item
Other, Specify (Other, specify)
CL Item
On Follow-up Phase (On follow-up phase)
AgentAdminRoute
Item
Admin. (e.g., i.v., p.o.)
text
TrialPhase,Otherspecify
Item
Trial Phase, Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
FirstDoseStartDate,FirstCycle
Item
Start date of first cycle (chemotheraphy) (day month year)
date
TreatmentBeginDate
Item
Date Started (day month year)
date
TreatmentBeginDate
Item
Date Started (day month year)
date
TreatmentBeginDate
Item
Date Started (day month year)
date
TreatmentBeginDate
Item
Date Started (day month year)
date
TreatmentBeginDate
Item
Date Started (day month year)
date
TrialTherapy
Item
Trial Therapy
text
DateofLastAdministrationpriortoSAE
Item
Date of Last Administration prior to SAE (day month year)
text
Item Group
Concomitant Therapy:
Item
Type of Therapy
text
C15368 (NCI Thesaurus ObjectClass)
C0332307 (NCI Metathesaurus Property)
CL.2
Code List
Type of Therapy
CL Item
Antidepressants (Antidepressants)
CL Item
Antihypertensives (Antihypertensives)
CL Item
Oral Hypoglycemic / Insulin (Oral Hypoglycemic / Insulin)
CL Item
Anticoagulants (Anticoagulants)
CL Item
Antibiotics (Antibiotics)
CL Item
Radiotherapy (Radiotherapy)
CL Item
Other(s) (Other(s))
AgentName
Item
Name of Medication
text
AgentTotalDose(perday)
Item
Daily Dosage
double
AgentAdminRoute
Item
Admin. (e.g., i.v., p.o.)
text
AgentBeginDate
Item
Date Started
date
SignificantMedicalHistory,ConcomitantDiseasesand/orRelevantMedicalConditions
Item
Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
text
Item
Reason for seriousness (select one only)
text
CL.3
Code List
Reason for seriousness (select one only)
CL Item
Fatal. (Fatal.)
CL Item
Life-threatening (Life-threatening)
CL Item
Required Or Prolonged Hospitalization (Required or prolonged hospitalization)
CL Item
Resulted In Severe Or Permanent Disability (Resulted in severe or permanent disability)
CL Item
Unexpected Grade 4 Toxicity (Unexpected grade 4 toxicity)
CL Item
Overdose (Overdose)
CL Item
Second Primary Cancer (Second primary cancer)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Other, Specify (Other, specify)
Otherspecify(seriousness)
Item
Other specify (seriousness)
text
Item
Causality assessment regarding protocol treatment:
text
CL.4
Code List
Causality assessment regarding protocol treatment:
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definite)
CL Item
Cannot be classified (Cannot be classified)
ToxicityGradeforEventsthoughttobeatleastpossiblyrelated
Item
Toxicity Grade for Events thought to be at least possibly related
text
IntheInvestigator'sopinion,theEventwasmostlikelydueto:
Item
In the Investigator?s opinion, the Event was most likely due to:
text
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)
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)
C1522326 (UMLS 2011AA ObjectClass)
PhoneNumber
Item
Phone number
double
FaxNumber
Item
Fax number
double
InvestigatorSignatureDate
Item
Date (day month year)
date
Item Group
Ccrr Module For Serious Adverse Event Form (form 24-sae-a)
PatientStudyID,CoordinatingGroup
Item
Patient ID Number (Study No.)
text
PatientInitialsName
Item
Patient Initials (f m fl sl)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA 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)
Dateofinitialreport
Item
Date of initial report (within 24 hours of SAE:)
text
PatientFollow-upAssessmentReportDate
Item
Date of follow-up report (within 15 days of initial report:)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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