ID

9003

Descrição

Adverse Event Form (Form 24-AE) 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=B0FAA5C4-439E-0ACB-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0FAA5C4-439E-0ACB-E034-0003BA12F5E7

Palavras-chave

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

9 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Toxicity - Adverse Event Form (Form 24-AE) - 2072124v3.0

Inglês

Instructions: Indicate whether or not the patient experienced any of the adverse events listed below by marking an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done. This form is to be completed: -> Prior to starting any protocol therapy (Tamoxifen, Exemestane, OFS), and -> On the same schedule as the Follow-Up Form (24-E) (every 3 months in Year 1, every six months in Years 2-5) (during Tamoxifen, Exemestane, OFS), and -> At 6 & 12 months after the last dose of all protocol therapy (Tamoxifen, Exemestane, OFS). -> No AE Forms are required after first relapse/recurrence.

1 Formulários  
Sexual/reproductive Function
Descrição

Sexual/reproductive Function

Vaginal Dryness (CTC Grade) (CTC Grade select one)
Descrição

CTCAdverseEventVaginaldrynessGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Dyspareunia (CTC Grade) (pain or discomfort with intercourse)
Descrição

CTCAdverseEventDyspareuniaGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was the patient treated for vaginal dryness or dyspareunia?
Descrição

Wasthepatienttreatedforvaginaldrynessordyspareunia?

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other topical estrogen, (specify)
Descrição

Othertopicalestrogen,

Tipo de dados

text

Other, (specify)
Descrição

TreatmentType,Specify

Tipo de dados

text

Other, (specify)
Descrição

TreatmentType,Specify

Tipo de dados

text

Decreased Libido (CTC Grade) (sexual interest)
Descrição

CTCAdverseEventLibidoGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Urinary Incontinence (CTC Grade) (CTC Grade )
Descrição

CTCAdverseEventIncontinenceGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Vasomotor Menopausal
Descrição

Vasomotor Menopausal

Hot Flashes/Night Sweats (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventHotflashes/flushesGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Was patient treated for hot flashes/night sweats?
Descrição

Waspatienttreatedforhotflashes/nightsweats?

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Musculoskeletal
Descrição

Musculoskeletal

Bone Mineral Densitometry Performed
Descrição

BoneMineralDensityTestPerformedPerformed

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C61545
UMLS 2011AA ObjectClass
C0177804
If yes, was bone mineral density T-score at least 1.5 standard deviations below the young adult normal mean in at least one site?
Descrição

Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Bone Fractures
Descrição

BoneFractures

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of bone fracture (D M Y)
Descrição

BoneFractureDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C3046
UMLS 2011AA Property
C0016658
Main cause of bone fracture (select all that apply)
Descrição

Maincauseofbonefracture

Tipo de dados

text

Other, (specify)
Descrição

Other,sourceofsurvivalinformation

Tipo de dados

text

Site of bone fracture (select all that apply)
Descrição

Siteofbonefracture

Tipo de dados

text

Musculoskeletal symptoms (CTC Grade) (i.e., myalgia, arthralgia joint pain, stiffness - not including bone fractures)
Descrição

CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Psychological
Descrição

Psychological

Mood Alteration - Depression (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventMoodalteration-depressionGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Cardiovascular/cerebrovascular
Descrição

Cardiovascular/cerebrovascular

Hypertension (treated?) (Treated?)
Descrição

Hypertension(treated?)

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Cardiac Ischemia/Infarction (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventCardiac-ischemia/infarctionGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Thrombosis/Embolism (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventThrombosis/embolismGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CNS Cerebrovascular Ischemia (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventCNScerebrovascularischemiaGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Constitutional Symptoms
Descrição

Constitutional Symptoms

Insomnia (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventInsomniaGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Fatigue (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Nausea (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventNauseaGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Descrição

Allergic Reaction / Hypersensitivity / Injection Site Reaction

Allergic Reaction/Hypersensitivity (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

If possibly, probably or definitely related to study treatment, in the Investigator?s opinion, the event was most likely due to: (select one)
Descrição

Ifpossibly,probablyordefinitelyrelatedtostudytreatment,intheInvestigator?sopinion,theeventwasmostlikelydueto:

Tipo de dados

text

Other, (specify)
Descrição

Other,

Tipo de dados

text

Injection Site Reaction (CTC Grade) (CTC Grade)
Descrição

CTCAdverseEventInjectionsitereactionGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Other Adverse Events
Descrição

Other Adverse Events

Did the patient have other Grade 3 or higher adverse event(s)? (Use terminology and grading from CTC)
Descrição

CTCAdverseEventTerm,Other

Tipo de dados

text

Relation to study treatment(s)
Descrição

CTCAdverseEventAttributionCode

Tipo de dados

text

Investigator/Designee Signature
Descrição

InvestigatorSignature

Tipo de dados

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date (day month year)
Descrição

InvestigatorSignatureDate

Tipo de dados

date

Ccrr Module For Adverse Event Form (form 24-ae)
Descrição

Ccrr Module For Adverse Event Form (form 24-ae)

Month Number
Descrição

MonthNumber

Tipo de dados

text

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
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Similar models

Instructions: Indicate whether or not the patient experienced any of the adverse events listed below by marking an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done. This form is to be completed: -> Prior to starting any protocol therapy (Tamoxifen, Exemestane, OFS), and -> On the same schedule as the Follow-Up Form (24-E) (every 3 months in Year 1, every six months in Years 2-5) (during Tamoxifen, Exemestane, OFS), and -> At 6 & 12 months after the last dose of all protocol therapy (Tamoxifen, Exemestane, OFS). -> No AE Forms are required after first relapse/recurrence.

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Sexual/reproductive Function
CTCAdverseEventVaginaldrynessGrade
Item
Vaginal Dryness (CTC Grade) (CTC Grade select one)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
CTCAdverseEventDyspareuniaGrade
Item
Dyspareunia (CTC Grade) (pain or discomfort with intercourse)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Wasthepatienttreatedforvaginaldrynessordyspareunia?
Item
Was the patient treated for vaginal dryness or dyspareunia?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Othertopicalestrogen,
Item
Other topical estrogen, (specify)
text
TreatmentType,Specify
Item
Other, (specify)
text
TreatmentType,Specify
Item
Other, (specify)
text
CTCAdverseEventLibidoGrade
Item
Decreased Libido (CTC Grade) (sexual interest)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventIncontinenceGrade
Item
Urinary Incontinence (CTC Grade) (CTC Grade )
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Vasomotor Menopausal
CTCAdverseEventHotflashes/flushesGrade
Item
Hot Flashes/Night Sweats (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Waspatienttreatedforhotflashes/nightsweats?
Item
Was patient treated for hot flashes/night sweats?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Musculoskeletal
BoneMineralDensityTestPerformedPerformed
Item
Bone Mineral Densitometry Performed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?
Item
If yes, was bone mineral density T-score at least 1.5 standard deviations below the young adult normal mean in at least one site?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
BoneFractures
Item
Bone Fractures
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BoneFractureDate
Item
Date of bone fracture (D M Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
Item
Main cause of bone fracture (select all that apply)
text
CL.17
Code List
Main cause of bone fracture (select all that apply)
CL Item
Metastasis (Metastasis)
C19151 (NCI Thesaurus)
C0027627 (UMLS 2011AA)
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
CL Item
Trauma (Trauma)
CL Item
Other, Specify (Other, specify)
Other,sourceofsurvivalinformation
Item
Other, (specify)
text
Item
Site of bone fracture (select all that apply)
text
CL.18
Code List
Site of bone fracture (select all that apply)
CL Item
Hip (Hip)
C64193 (NCI Thesaurus)
C0019552 (UMLS 2011AA)
CL Item
Wrist/forearm (Wrist/forearm)
CL Item
Vertebra (Vertebra)
C12933 (NCI Thesaurus)
C0549207 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade
Item
Musculoskeletal symptoms (CTC Grade) (i.e., myalgia, arthralgia joint pain, stiffness - not including bone fractures)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Psychological
CTCAdverseEventMoodalteration-depressionGrade
Item
Mood Alteration - Depression (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item Group
Cardiovascular/cerebrovascular
Item
Hypertension (treated?) (Treated?)
text
CL.24
Code List
Hypertension (treated?) (Treated?)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
New Start Of Antihypertensive Medication (New start of antihypertensive medication)
CL Item
Treated With Same Antihypertensive Medications As Reported On Previous Form (Treated with same antihypertensive medications as reported on previous form)
CL Item
Increase Or Change In This Time Period Because Of Inadequate Efficacy Of Previous Antihypertensive (Increase or change in this time period because of inadequate efficacy of previous antihypertensive)
CL Item
Acute Hypertensive Crisis (Acute hypertensive crisis)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
CTCAdverseEventCardiac-ischemia/infarctionGrade
Item
Cardiac Ischemia/Infarction (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventThrombosis/embolismGrade
Item
Thrombosis/Embolism (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventCNScerebrovascularischemiaGrade
Item
CNS Cerebrovascular Ischemia (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Constitutional Symptoms
CTCAdverseEventInsomniaGrade
Item
Insomnia (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade
Item
Fatigue (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventNauseaGrade
Item
Nausea (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Allergic Reaction / Hypersensitivity / Injection Site Reaction
CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade
Item
Allergic Reaction/Hypersensitivity (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
Item
If possibly, probably or definitely related to study treatment, in the Investigator?s opinion, the event was most likely due to: (select one)
text
CL.40
Code List
If possibly, probably or definitely related to study treatment, in the Investigator?s opinion, the event was most likely due to: (select one)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Triptorelin (Triptorelin)
C1267 (NCI Thesaurus)
C0077275 (UMLS 2011AA)
CL Item
Goserelin (Goserelin)
C1374 (NCI Thesaurus)
C0120107 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
Other,
Item
Other, (specify)
text
CTCAdverseEventInjectionsitereactionGrade
Item
Injection Site Reaction (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Other Adverse Events
Item
Did the patient have other Grade 3 or higher adverse event(s)? (Use terminology and grading from CTC)
text
CL.43
Code List
Did the patient have other Grade 3 or higher adverse event(s)? (Use terminology and grading from CTC)
CL Item
Grade 3 (Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 - Fatal (Grade 5 - Fatal)
Item
Relation to study treatment(s)
text
CL.44
Code List
Relation to study treatment(s)
CL Item
Definite (Definite)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
InvestigatorSignature
Item
Investigator/Designee Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date (day month year)
date
Item Group
Ccrr Module For Adverse Event Form (form 24-ae)
MonthNumber
Item
Month Number
text
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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