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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.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
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)
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)
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)
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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)
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)
C1512698 (UMLS 2011AA ValueDomain)
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)
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)
C1512698 (UMLS 2011AA ValueDomain)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
BoneFractures
Item
Bone Fractures
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA 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)
C0011008 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
CL Item
Metastasis (Metastasis)
C19151 (NCI Thesaurus)
C0027627 (UMLS 2011AA)
C0027627 (UMLS 2011AA)
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
C0029456 (UMLS 2011AA)
CL Item
Trauma (Trauma)
CL Item
Other, Specify (Other, specify)
Other,sourceofsurvivalinformation
Item
Other, (specify)
text
CL Item
Hip (Hip)
C64193 (NCI Thesaurus)
C0019552 (UMLS 2011AA)
C0019552 (UMLS 2011AA)
CL Item
Wrist/forearm (Wrist/forearm)
CL Item
Vertebra (Vertebra)
C12933 (NCI Thesaurus)
C0549207 (UMLS 2011AA)
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
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)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
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)
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)
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventInsomniaGrade
Item
Insomnia (CTC Grade) (CTC Grade)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
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)
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)
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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)
C0445356 (UMLS 2011AA)
CL Item
Cannot be classified (Cannot be classified)
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)
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
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)
C0039286 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
C0060116 (UMLS 2011AA)
CL Item
Triptorelin (Triptorelin)
C1267 (NCI Thesaurus)
C0077275 (UMLS 2011AA)
C0077275 (UMLS 2011AA)
CL Item
Goserelin (Goserelin)
C1374 (NCI Thesaurus)
C0120107 (UMLS 2011AA)
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)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Did the patient have other Grade 3 or higher adverse event(s)? (Use terminology and grading from CTC)
text
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)
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)
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)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date (day month year)
date
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)
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)
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)
C0805701 (UMLS 2011AA ValueDomain)