ID

1088

Description

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

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

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

English

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 forms  
Sexual/reproductive Function
Description

Sexual/reproductive Function

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

CTCAdverseEventVaginaldrynessGrade

Data type

double

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

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

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

CTCAdverseEventDyspareuniaGrade

Data type

double

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?
Description

Wasthepatienttreatedforvaginaldrynessordyspareunia?

Data type

text

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

Othertopicalestrogen,

Data type

text

Other, (specify)
Description

TreatmentType,Specify

Data type

text

Other, (specify)
Description

TreatmentType,Specify

Data type

text

Decreased Libido (CTC Grade) (sexual interest)
Description

CTCAdverseEventLibidoGrade

Data type

double

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

CTCAdverseEventIncontinenceGrade

Data type

double

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

Vasomotor Menopausal

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

CTCAdverseEventHotflashes/flushesGrade

Data type

double

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

CTCAdverseEventAttributionCode

Data type

text

Was patient treated for hot flashes/night sweats?
Description

Waspatienttreatedforhotflashes/nightsweats?

Data type

text

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

Musculoskeletal

Bone Mineral Densitometry Performed
Description

BoneMineralDensityTestPerformedPerformed

Data type

text

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?
Description

Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?

Data type

text

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

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Bone Fractures
Description

BoneFractures

Data type

text

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

BoneFractureDate

Data type

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)
Description

Maincauseofbonefracture

Data type

text

Other, (specify)
Description

Other,sourceofsurvivalinformation

Data type

text

Site of bone fracture (select all that apply)
Description

Siteofbonefracture

Data type

text

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

CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade

Data type

double

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

Psychological

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

CTCAdverseEventMoodalteration-depressionGrade

Data type

double

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

CTCAdverseEventAttributionCode

Data type

text

Cardiovascular/cerebrovascular
Description

Cardiovascular/cerebrovascular

Hypertension (treated?) (Treated?)
Description

Hypertension(treated?)

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

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

CTCAdverseEventCardiac-ischemia/infarctionGrade

Data type

double

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

CTCAdverseEventThrombosis/embolismGrade

Data type

double

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

CTCAdverseEventCNScerebrovascularischemiaGrade

Data type

double

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

Constitutional Symptoms

Insomnia (CTC Grade) (CTC Grade)
Description

CTCAdverseEventInsomniaGrade

Data type

double

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

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Fatigue (CTC Grade) (CTC Grade)
Description

CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade

Data type

double

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

CTCAdverseEventNauseaGrade

Data type

double

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

Allergic Reaction / Hypersensitivity / Injection Site Reaction

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

CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade

Data type

double

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

CTCAdverseEventAttributionCode

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

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

Ifpossibly,probablyordefinitelyrelatedtostudytreatment,intheInvestigator?sopinion,theeventwasmostlikelydueto:

Data type

text

Other, (specify)
Description

Other,

Data type

text

Injection Site Reaction (CTC Grade) (CTC Grade)
Description

CTCAdverseEventInjectionsitereactionGrade

Data type

double

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

Other Adverse Events

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

CTCAdverseEventTerm,Other

Data type

text

Relation to study treatment(s)
Description

CTCAdverseEventAttributionCode

Data type

text

Investigator/Designee Signature
Description

InvestigatorSignature

Data type

text

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

InvestigatorSignatureDate

Data type

date

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

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

Month Number
Description

MonthNumber

Data type

text

Patient ID Number (Study No.)
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (f m fl sl)
Description

PatientInitialsName

Data type

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)
Description

PatientBirthDate

Data type

date

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

MainMemberInstitution/Affiliate

Data type

text

Center Code (Ver.#1)
Description

ParticipatingGroupCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
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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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Sexual/reproductive Function
Item
Vaginal Dryness (CTC Grade) (CTC Grade select one)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.1
Code List
Vaginal Dryness (CTC Grade) (CTC Grade select one)
CL Item
0 (0)
CL Item
Mild (1)
C70666 (NCI Thesaurus)
C2945599 (UMLS 2011AA)
CL Item
Requiring Treatment And/or Interfering With Sexual Function, Dyspareunia (2)
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)
Item
Dyspareunia (CTC Grade) (pain or discomfort with intercourse)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.3
Code List
Dyspareunia (CTC Grade) (pain or discomfort with intercourse)
CL Item
Not applicable (Not applicable)
CL Item
0 (0)
CL Item
Mild Pain Not Interfering With Function (1)
CL Item
Moderate Pain Interfering With Sexual Activity (2)
CL Item
Severe Pain Preventing Sexual Activity (3)
Item
Was the patient treated for vaginal dryness or dyspareunia?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Was the patient treated for vaginal dryness or dyspareunia?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Othertopicalestrogen,
Item
Other topical estrogen, (specify)
text
TreatmentType,Specify
Item
Other, (specify)
text
TreatmentType,Specify
Item
Other, (specify)
text
Item
Decreased Libido (CTC Grade) (sexual interest)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.7
Code List
Decreased Libido (CTC Grade) (sexual interest)
CL Item
Not applicable (Not applicable)
CL Item
0 (0)
CL Item
Decrease In Interest (1)
CL Item
Severe Loss Of Interest (2)
Item
Urinary Incontinence (CTC Grade) (CTC Grade )
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.9
Code List
Urinary Incontinence (CTC Grade) (CTC Grade )
CL Item
0 (0)
CL Item
With Coughing, Sneezing, Etc. (1)
CL Item
Spontaneous, Some Control (2)
CL Item
No Control (in The Absence Of Fistula) (3)
Item Group
Vasomotor Menopausal
Item
Hot Flashes/Night Sweats (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.11
Code List
Hot Flashes/Night Sweats (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Mild Or No More Than 1 Per Day (1)
CL Item
Moderate And Greater Than 1 Per Day (2)
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
Was patient treated for hot flashes/night sweats?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.13
Code List
Was patient treated for hot flashes/night sweats?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Musculoskeletal
Item
Bone Mineral Densitometry Performed
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
CL.14
Code List
Bone Mineral Densitometry Performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.15
Code List
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?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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
Bone Fractures
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.16
Code List
Bone Fractures
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
Item
Musculoskeletal symptoms (CTC Grade) (i.e., myalgia, arthralgia joint pain, stiffness - not including bone fractures)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.20
Code List
Musculoskeletal symptoms (CTC Grade) (i.e., myalgia, arthralgia joint pain, stiffness - not including bone fractures)
CL Item
0 (0)
CL Item
Mild (1)
C70666 (NCI Thesaurus)
C2945599 (UMLS 2011AA)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life-threatening Or Disabling (4)
Item Group
Psychological
Item
Mood Alteration - Depression (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.22
Code List
Mood Alteration - Depression (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Mild Mood Alteration Not Interfering With Function (1)
CL Item
Moderate Mood Alteration Interfering With Function, But Not Interfering With Activities Of Daily Living (2)
CL Item
Severe Mood Alteration Interfering With Activities Of Daily Living (3)
CL Item
Suicidal Ideation Or Danger To Self (4)
CL Item
Death Related To Toxicity (5)
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)
Item
Cardiac Ischemia/Infarction (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.26
Code List
Cardiac Ischemia/Infarction (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Non-specific T-wave Flattening Or Changes (1)
CL Item
Asymptomatic, St- And T- Wave Changes Suggesting Ischemia (2)
CL Item
Angina Without Evidence Of Infarction (3)
CL Item
Acute Myocardial Infarction (4)
C35204 (NCI Thesaurus)
C0155626 (UMLS 2011AA)
CL Item
Death Related To Toxicity (5)
Item
Thrombosis/Embolism (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.28
Code List
Thrombosis/Embolism (CTC Grade) (CTC Grade)
CL Item
Grade 0 (Grade 0)
CL Item
Deep Vein Thrombosis, Not Requiring Anticoagulant (Grade 2)
CL Item
Deep Vein Thrombosis, Requiring Anticoagulant Therapy (Grade 3)
CL Item
Embolic Event Including Pulmonary Embolism (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
CNS Cerebrovascular Ischemia (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.30
Code List
CNS Cerebrovascular Ischemia (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Transient Ischemic Event Or Attack (tia) (3)
CL Item
Permanent Event (e.g., Cerebral Vascular Accident) (4)
CL Item
Death Related To Toxicity (5)
Item Group
Constitutional Symptoms
Item
Insomnia (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.32
Code List
Insomnia (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Occasional Difficulty Sleeping Not Interfering With Function (1)
CL Item
Difficulty Sleeping Interfering With Function, But Not Interfering With Activities Of Daily Living (2)
CL Item
Frequent Difficulty Sleeping, Interfering With Activities Of Daily Living (3)
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
Fatigue (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.34
Code List
Fatigue (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Increased Fatigue Over Baseline, But Not Altering Normal Activities (1)
CL Item
Moderate (e.g., Decrease In Performance Status By 1 Ecog Level Or 20% Karnofsky Or Lansky) Or Causing Difficulty Performing Some Activities (2)
CL Item
Severe (e.g., Decrease In Performance Status By >= 2 Ecog Levels Or 40% Karnofsky Or Lansky) Or Loss Of Ability To Perform Some Activities (3)
CL Item
Bedridden Or Disabling (4)
Item
Nausea (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.36
Code List
Nausea (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Able To Eat (1)
CL Item
Oral Intake Significantly Decreased (2)
CL Item
No Significant Intake, Requiring Iv Fluids (3)
Item Group
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Item
Allergic Reaction/Hypersensitivity (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.38
Code List
Allergic Reaction/Hypersensitivity (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Transient Rash, Drug Fever <38 Degrees C (<100.4 Degrees F) (1)
CL Item
Urticaria, Drug Fever >= 38 Degrees C (>= 100.4 Degrees F), And/or Asymptomatic Bronchospasm (2)
CL Item
Symptomatic Bronchospasm, Requiring Parenteral Medication(s), With Or Without Urticaria; Allergy-related Edema/angioedema (3)
CL Item
Anaphylaxis (4)
CL Item
Death Related To Toxicity (5)
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
Item
Injection Site Reaction (CTC Grade) (CTC Grade)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.41
Code List
Injection Site Reaction (CTC Grade) (CTC Grade)
CL Item
0 (0)
CL Item
Pain Or Itching Or Erythema (1)
CL Item
Pain Or Swelling, With Inflammation Or Phlebitis (2)
CL Item
Ulceration Or Necrosis That Is Severe Or Prolonged, Or Requiring Surgery (3)
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
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)
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