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
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
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)
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)
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)
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
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)
Item
Treatment Evaluation Period Type
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Code List
Treatment Evaluation Period Type
CL Item
Cycle 4 Step 1 (Cycle 4 Step 1)
CL Item
Cycle 8 Step 1 (Cycle 8 Step 1)
CL Item
Cycle 12 Step 1 (Cycle 12 Step 1)
CL Item
Cycle 4 Step 2 (Cycle 4 Step 2)
CL Item
Cycle 8 Step 2 (Cycle 8 Step 2)
CL Item
Cycle 12 Step 2 (Cycle 12 Step 2)
Deep Vein Thrombosis prophylaxis
Item
Did patient recieve DVT prophylaxis
boolean
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
DVT prophylaxis start date
Item
Start date of first (prophylactic) treatment
date
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C0808070 (UMLS CUI-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
DVT prophylaxis most recent date
Item
Date of most recent (prophylactic) treatment
date
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1513491 (UMLS CUI-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-3)
C25577 (NCI Thesaurus ValueDomain-2)
Aspirin 81 mg
Item
Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0783425 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C49341 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
Aspirin 325 mg
Item
Aspirin (325 mg)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0714615 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C287 (NCI Thesaurus Property-2)
C49342 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
Aspirin, other dose
Item
Aspirin (other dose)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0004057 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
Aspirin dose
Item
If other dose of Aspirin given, specify dose
float
C49343 (NCI Thesaurus ObjectClass)
C0004057 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C0178602 (UMLS CUI-2)
C25639 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
Warfarin
Item
Coumadin
boolean
C49343 (NCI Thesaurus ObjectClass)
C0043031 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C945 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
Warfarin dose
Item
If Coumadin given, specify dose
boolean
C49343 (NCI Thesaurus ObjectClass)
C0366686 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C945 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
Heparin, Low-Molecular-Weight
Item
Low molecular weight heparin (enoxaparin; Lovenox)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0019139 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C2578 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
DVT prevention, specify
Item
Other, specify
text
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1521902 (UMLS CUI-2)
C25685 (NCI Thesaurus ValueDomain)
Erythropoietin-type agents
Item
Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0014822 (UMLS CUI-1)
C20429 (NCI Thesaurus ObjectClass)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
ThrombosisAdverseEventObservedInd-3
Item
Did patient experience a thrombotic event (NOTE: Event must be reported through AdEERS and on the E4A03 Adverse Event Form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C0040053 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
ThrombosisAdverseEventObservedDate
Item
Date of thrombotic event (If yes, - List Date of thrombotic events this report period. Mark an ¿X¿ in the box on the right if not applicable.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C0040053 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
DataUnknownText
Item
Mark an 'X' if N/A
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
ThrombosisPreventionTherapyReceivedInd-2
Item
Was the patient on thrombotic prophylaxis (NOTE: If more then one thrombotic event this report period, answer question below with regards to the first thrombotic event this report period.)
boolean
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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
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)