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StudyEvent: E1609 Adverse Event Form (CTCAE v4) - Arm B
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Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header Module

Item Group

Header

C1320722 (UMLS CUI-1)

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step (Place ID Label Here)

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Patient Initials

Item

Patient Initials (Last, First)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Data amended

Item

Please mark an 'X' if data have been amended.

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (s M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

ON TREATMENT

Item Group

On Treatment

C3538994 (UMLS CUI-1)

Cycle number

Item

On Treatment Report Period

text

C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)

CL.1

Code List

On Treatment Report Period

CL Item

Week 1 (Week 1)

CL Item

Week 4 (Week 4)

CL Item

Week 7 (Week 7)

CL Item

Week 10 (Week 10)

CL Item

Week 12 (Week 12)

CL Item

Week 18 (Week 18)

CL Item

Week 24 (Week 24)

CL Item

Week 30 (Week 30)

CL Item

Week 36 (Week 36)

CL Item

Week 42 (Week 42)

CL Item

Week 48 (Week 48)

CL Item

Week 54 (Week 54)

CL Item

Week 60 (Week 60)

PersonOff-TreatmentTimePeriodType

Item

Off Treatment Report Period (Choose one)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.2

Code List

Off Treatment Report Period (Choose one)

CL Item

3 Months (3 Months Post Registration)

CL Item

6 Months (6 Months Post Registration)

CL Item

9 Months (9 Months Post Registration)

CL Item

12 Months (12 Months Post Registration)

CL Item

15 Months (15 Months Post Registration)

CL Item

18 Months (18 Months Post Registration)

CL Item

21 Months Post Registration (21 Months Post Registration)

CL Item

2 Years (24 Months Post Registration)

CL Item

30 Months (30 Months Post Registration)

CL Item

3 Years (36 Months Post Registration)

CL Item

42 Months (42 Months Post Registration)

CL Item

4 Years (48 Months Post Registration)

CL Item

54 Months (54 Months Post Registration)

CL Item

5 Years (60 Months Post Registration)

CL Item

6 Years (72 Months Post Registration)

CL Item

84 Months Post Registration (84 Months Post Registration)

CL Item

8 Years (96 months post registration)

CL Item

9 Years (108 months post registration)

CL Item

10 Years (120 months post registration)

CL Item

11 Years Post Registration (132 Months Post Registration)

CL Item

12 Years Post Registration (144 Months Post Registration)

CL Item

13 Years Post Registration (156 Months Post Registration)

CL Item

14 Years Post Registration (168 Months Post Registration)

CL Item

15 Years Post Registration (180 Months Post Registration)

CL Item

16 Years Post Registration (192 Months Post Registration)

CL Item

17 Years Post Registration (204 Months Post Registration)

CL Item

18 Years Post Registration (216 Months Post Registration)

CL Item

19 Years Post Registration (228 Months Post Registration)

CL Item

20 Years Post Registration (240 Months Post Registration)

Adverse Event

Item Group

Adverse Event

C0877248 (UMLS CUI-1)

AdverseEventCurrentAssessmentInd

Item

Were adverse events assessed during this report period (cycle)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

CL.3

Code List

Were adverse events assessed during this report period (cycle)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)

CL Item

Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)

Adverse Event Start Date

Item

CTC Adverse Event Report Begin Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)

Adverse Event End Date

Item

CTC Adverse Event Report End Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. M D Y - mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C2697886 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)

Adverse event hematologic or metabolic

Item Group

Adverse event hematologic or metabolic

Meddra Low Level Term

Item

CTC Adverse Event Term

text

C41331 (NCI Thesaurus ObjectClass)
C49704 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
C45255 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C2347090 (UMLS CUI-1)

Adverse Event Severity Grade

Item

CTC Adverse Event Grade (v4.0 - this cycle/report period)

text

C41331 (NCI Thesaurus ObjectClass)
C48309 (NCI Thesaurus Property)
C49705 (NCI Thesaurus Property-2)
C25676 (NCI Thesaurus Property-3)
C41331 (NCI Thesaurus ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C2985921 (UMLS CUI-1)

CL.12

Code List

CTC Adverse Event Grade (v4.0 - this cycle/report period)

CL Item

Mild Adverse Event (1)

C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CTC Adverse Event Attribution Category

Item

CTC AE Attribution Code (v4.0)

text

C25664 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
C1706735 (UMLS CUI-1)

CL.13

Code List

CTC AE Attribution Code (v4.0)

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS CUI-1)

CL Item

Unlikely (unlikely)

C0750558 (UMLS CUI-1)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)
C0332149 (UMLS CUI-1)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)
C1709683 (UMLS CUI-1)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)
C1704787 (UMLS CUI-1)

Adverse event attributed to investigational treatment

Item

Was this attributed to investigational protocol treatment

boolean

C41331 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C15206 (NCI Thesaurus Property-3)
C25358 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C0596130 (UMLS CUI-2)
C1517586 (UMLS CUI-3)

AdverseDrugExperienceReportText

Item

AE Expedited report filed?

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C0085425 (NCI Metathesaurus ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)

Adverse event, immune-related

Item

Mark 'X' if likely to be immune-related

boolean

C25704 (NCI Thesaurus ValueDomain)
C25626 (NCI Thesaurus Property)
C41331 (NCI Thesaurus ObjectClass)
C12735 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS CUI-1)
C0020962 (UMLS CUI-2)

Other Adverse Events

Item Group

III. Other Adverse Events (INCLUDING INFECTIONS)

C0877248 (UMLS CUI-1)

Meddra Low Level Term

Item

Other, specify (specific infection or AE CTC Adverse Event Term not listed)

text

C41331 (NCI Thesaurus ObjectClass)
C49704 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25704 (NCI Thesaurus ValueDomain-2)
C17649 (NCI Thesaurus ValueDomain-3)
C45255 (NCI Thesaurus ValueDomain-4)
C49704 (NCI Thesaurus ValueDomain-5)
C45559 (NCI Thesaurus ValueDomain-6)
C25714 (NCI Thesaurus ValueDomain-7)
C2347090 (UMLS CUI-1)

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