Protocol ID Coordinating Group
Item
Coordinating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Coordinating Group Code
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
C2986303 (UMLS CUI-1)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
Registering Group Code
Item
Registering Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-2)
Medical Record Number
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Other 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)
Registering Institution Code
Item
Registering Institution Code
text
C25162 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-2)
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Are data amended (If data are amended, please circle in red when using paper form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C0680532 (UMLS CUI-1)
Cycle Number
Item
Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Treatment Start Date
Item
First Date (any modality of) protocol therapy was given (for this cycle)
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C3173309 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Treatment End Date
Item
Last Date (any modality of) protocol therapy was given (for this cycle)
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Agent Delayed
Item
Agent Delayed
boolean
C38147 (NCI Thesaurus ValueDomain)
C25477 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property-2)
C1521826 (UMLS CUI-1)
C0205421 (UMLS CUI-2)
Reasons for treatment delay
Item
Reason Cycle was Delayed
text
C25704 (NCI Thesaurus ValueDomain)
C1298642 (UMLS CUI-1)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Concomitant Medication used
Item
Were concomitant medications used during this cycle? (including alternative medicines)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C2347852 (UMLS CUI-1)
C1521801 (UMLS CUI-2)
Concomitant Medication Use Indication
Item
Reason for Administration
text
C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
Concomitant Agent
Item
Concomitant Agent Name
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C2347852 (UMLS CUI-1)
Growth factor administered
Item
Was growth factor administered?
boolean
C38148 (NCI Thesaurus ValueDomain)
C20424 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C0018284 (UMLS CUI-1)
C1521801 (UMLS CUI-2)
Specify growth factor
Item
Specify growth factor
text
C25704 (NCI Thesaurus ValueDomain)
C0018284 (UMLS CUI-1)
C20424 (NCI Thesaurus ObjectClass)
C2360065 (UMLS CUI-2)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
Patient received radiation therapy
Item
Has the patient received radiation therapy?
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C15313 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C1522449 (UMLS CUI-1)
C1514756 (UMLS CUI-2)
Reason for no radiation therapy
Item
Specify reason
text
C25638 (NCI Thesaurus ValueDomain)
C3846110 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
CL052458 (NCI Metathesaurus Property)
Radiation Therapy Start Date
Item
Radiation Therapy Start Date
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C0808070 (UMLS CUI-2)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Radiation Therapy End Date
Item
Radiation Therapy End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Item
RT Administered Type
text
C25284 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
Code List
RT Administered Type
CL Item
Brachytherapy (Brachytherapy)
CL054378 (NCI Metathesaurus)
CL Item
Adjuvant (Adjuvant RT)
C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)
CL Item
External Beam Radiation (External beam radiation)
CL Item
Neoadjuvant (Neoadjuvant RT)
CL Item
Other (Other specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
Radiation Therapy, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0436308 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
Radiation Therapy Body Site
Item
Radiation Therapy Site
text
C25191 (NCI Thesaurus ValueDomain)
C1997599 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C15313 (NCI Thesaurus ObjectClass)
Radiation Therapy Total Dose
Item
RT Total Dose
float
C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Were there any unscheduled interruptions in radiation therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)
Code List
Were there any unscheduled interruptions in radiation therapy?
CL Item
Yes, Due To Toxicity (Yes, due to toxicity)
CL Item
Yes, For Other Reasons, Specify (Yes, for other reasons, specify)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Radiation Therapy Interruption Reason
Item
Specify RT interruption reason
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C3538832 (UMLS CUI-2)
C25211 (NCI Thesaurus Property-2)
C25542 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
Number of Prior Regimens
Item
No. of Prior Regimens
integer
C25629 (NCI Thesaurus ObjectClass)
C0750480 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C25463 (NCI Thesaurus ValueDomain)
C0040808 (UMLS CUI-2)
C15697 (NCI Thesaurus Property)
C0332152 (UMLS CUI-3)
Item
Type of Systemic Therapy (check all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C1515119 (UMLS CUI-1)
C15698 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Type of Systemic Therapy (check all that apply)
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Immunotherapy (Immunotherapy)
C15262 (NCI Thesaurus)
C0021083 (UMLS 2011AA)
CL Item
Other Specify (Other)
Therapy Name
Item
Other specify
text
C25364 (NCI Thesaurus Property)
C2826274 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C42614 (NCI Thesaurus ValueDomain)
Concomitant Agent
Item
Concomitant Agent Name
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C2347852 (UMLS CUI-1)
Concomitant Medication Start Date
Item
Agent Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C2826734 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Concomitant Medication End Date
Item
Agent End Date
date
C25164 (NCI Thesaurus ValueDomain)
C2826744 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent Total Dose
Item
Agent Total Dose
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Units
Item
Units
text
C25704 (NCI Thesaurus ValueDomain)
C1519795 (UMLS CUI-1)
C44278 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
Overall Response Duration
Item
Overall Response Duration (weeks)
integer
C25755 (NCI Thesaurus ObjectClass)
C0237585 (UMLS CUI-1)
C25605 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25605 (NCI Thesaurus ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (check one)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (check one)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Therapy Modification
Item
Name of Therapy (If yes,)
text
C25191 (NCI Thesaurus ValueDomain)
C1299575 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Reason for Therapy Modification
Item
Reason for Therapy Modification
text
C25638 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C1299575 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)