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  1. StudyEvent: E3201 Cover Page for Adverse Event Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
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)
Item
Patient Group
text
C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
Code List
Patient Group
CL Item
Group I (Group I)
CL Item
Group II (Group II)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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)
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)
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)
Item Group
On Treatment
Item
On Treatment Time Period (Group I)
text
Code List
On Treatment Time Period (Group I)
CL Item
Completion Of Concurrent Chemo/rt (Completion of Concurrent Chemo/RT)
CL Item
One Month Post Surgery, Or 8 Weeks Post Chemo/rt If Surgery Not Performed (One month post surgery, or 8 weeks post Chemo/RT if surgery not performed)
CL Item
Off Treatment Step 2 (Off Treatment Step 2)
Item
On Treatment Time Period (Group II)
text
Code List
On Treatment Time Period (Group II)
CL Item
Completion Of First Portion Of Chemo (arms D And E After 4 Cycles, Arm F After 1 Cycle) (Completion of First Portion of Chemo (Arms D and E after 4 cycles, Arm F after 1 cycle))
CL Item
Completion Of Concurrent Chemo/rt (Completion of Concurrent Chemo/RT)
CL Item
Off Treatment Step 2 (Off Treatment Step 2)
Item
Off Treatment Time Period
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)
Code List
Off Treatment Time Period
CL Item
3 Months (3 months)
CL Item
6 Months (6 months)
CL Item
9 Months (9 months)
CL Item
12 Months (12 months)
CL Item
15 Months (15 months)
CL Item
18 Months (18 months)
CL Item
24 Months (24 months)
CL Item
30 Months (30 months)
CL Item
36 Months (36 months)
CL Item
42 Months (42 months)
CL Item
48 Months (48 months)
CL Item
54 Months (54 months)
CL Item
60 Months (60 months)
CL Item
72 months (6 years) (72 months (6 years))
CL Item
84 months (7 years) (84 months (7 years))
CL Item
96 months (8 years) (96 months (8 years))
CL Item
108 months (9 years) (108 months (9 years))
CL Item
120 months (10 years) (120 months (10 years))
Item Group
Ccrr Module For E3201 Cover Page For Adverse Event Form

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