INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
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)
Item Group
Patient demographics
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 Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (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)
Item Group
Arm A And Arm B
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)
Code List
On Treatment Report Period
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 9 (Cycle 9)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 11 (Cycle 11)
CL Item
Cycle 12 (Cycle 12)
CL Item
Cycle 13 (Cycle 13)
CL Item
Cycle 14 (Cycle 14)
CL Item
Cycle 15 (Cycle 15)
CL Item
Cycle 16 (Cycle 16)
CL Item
Cycle 17 (Cycle 17)
CL Item
> Cycle 17 (> Cycle 17)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item Group
On Treatment
Item
Patient Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
Code List
Patient Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (M D Y)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Patient status assessment
Item
ECOG Performance Status (Day 1 of this cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status (Day 1 of this cycle)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
CL Item
Dead (5)
Patient Weight
Item
Weight (kg Day 1)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BSA (Patient Body Surface Area Measurement - m^2 Day 1 of this cycle)
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Item Group
Therapy Administered - Cisplatin
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered (If yes M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Agent Total Dose
Item
Agent Total Dose (this cycle)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification
CL Item
Dose Held (Dose held)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Code List
Dose Modification Reason
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Alternative Therapy For Other Reason (Alternative therapy for other reason)
CL Item
Dosing Error (Dosing error)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling)
CL Item
Second Primary Cancer (Second primary)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
AgentNotAdministeredText
Item
Mark 'X' if agent not given
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
Item Group
Therapy Administered - Carboplatin
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered (If yes M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Agent Total Dose
Item
Agent Total Dose (this cycle)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification
CL Item
Dose Held (Dose held)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Code List
Dose Modification Reason
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Alternative Therapy For Other Reason (Alternative therapy for other reason)
CL Item
Dosing Error (Dosing error)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling)
CL Item
Second Primary Cancer (Second primary)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
AgentNotAdministeredText
Item
Mark 'X' if agent not given
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
Item Group
Therapy Administered - Docetaxel
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered (If yes M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Agent Total Dose
Item
Agent Total Dose (this cycle)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification
CL Item
Dose Held (Dose held)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Code List
Dose Modification Reason
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Alternative Therapy For Other Reason (Alternative therapy for other reason)
CL Item
Dosing Error (Dosing error)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling)
CL Item
Second Primary Cancer (Second primary)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
AgentNotAdministeredText
Item
Mark 'X' if agent not given
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
Item Group
Therapy Administered - 5FU
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Treatment Start Date
Item
Date of First dose for this reporting period
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25256 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Date Last Dose
Item
Date of Last dose for this reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C1762893 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
Agent Total Dose
Item
Agent Total Dose (this cycle)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification
CL Item
Dose Held (Dose held)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Code List
Dose Modification Reason
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Alternative Therapy For Other Reason (Alternative therapy for other reason)
CL Item
Dosing Error (Dosing error)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling)
CL Item
Second Primary Cancer (Second primary)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
AgentNotAdministeredText
Item
Mark 'X' if agent not given
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
Item Group
Chemotherapy Dose Modifications
LaboratoryProcedureCreatinineResultSpecifiedValue
Item
Serum creatinine
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
LaboratoryProcedureCreatinineClearanceOutcomeValue
Item
Creatinine Clearance (calculated)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property-2)
C0373595 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Carboplatin was administered
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1282 (NCI Thesaurus ObjectClass)
C0079083 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Carboplatin was administered
CL Item
As Part Of Original Chemotherapy Selected Prior To Registration (As part of original chemotherapy selected prior to registration)
CL Item
In Place Of Cisplatin, Due To Development Of Specific Intolerable Cisplatin-associated Toxicities (In place of Cisplatin, due to development of specific intolerable Cisplatin-associated toxicities)
CarboplatinAgentSubstitutionCisplatinFirstAdministeredInd-2
Item
Is this first administration of carboplatin in place of cisplatin for this patient (Carboplatin Substitution Section only to be completed if patient was on Cisplatin regimen and Carboplatin was administered as a substitution for Cisplatin)
boolean
C1282 (NCI Thesaurus ObjectClass)
C0079083 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C376 (NCI Thesaurus Property)
C0008838 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C54071 (NCI Thesaurus Property-4)
C1706204 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Toxicities that led to the substitution (If yes, - mark all that apply - )
text
C1282 (NCI Thesaurus ObjectClass)
C0079083 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C376 (NCI Thesaurus Property)
C0008838 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C54071 (NCI Thesaurus Property-4)
C1706204 (UMLS 2011AA Property-4)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Toxicities that led to the substitution (If yes, - mark all that apply - )
CL Item
Grade >=2 Sensory Or Motor Neuropathy For >1 Week (Grade >=2 sensory or motor neuropathy for >1 week)
CL Item
Nephrotoxicity (Nephrotoxicity - see sections 5.5.1.5. and 5.5.3.4. of the protocol for details)
CL Item
Grade 2 Persistent Ototoxicity (Grade 2 persistent ototoxicity)
CL Item
Grade 4 Nausea And Vomiting Attributed To Cisplatin Despite Antiemetics (Grade 4 nausea and vomiting attributed to cisplatin despite antiemetics)
Item
Adverse Event (Instructions: If any agent dose was modified for adverse event, mark an 'X' for all that apply:)
text
C25638 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus Property)
C1707811 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-3)
C25572 (NCI Thesaurus Property-2)
Code List
Adverse Event (Instructions: If any agent dose was modified for adverse event, mark an 'X' for all that apply:)
CL Item
Gi Toxicity (GI toxicity)
CL Item
Neurotoxicity (Neurotoxicity)
CL Item
Hepatic Toxicity (Hepatic Toxicity)
CL Item
Arterial Thrombotic Event (Arterial Thrombotic Event)
CL Item
Wound Dehiscence (Wound Dehiscence)
C50863 (NCI Thesaurus)
C0259768 (UMLS 2011AA)
CL Item
Venous Thrombosis/embolism (Venous Thrombosis/Embolism)
CL Item
Hemorrhage (Hemorrhage)
C26791 (NCI Thesaurus)
C0019080 (UMLS 2011AA)
CL Item
Proteinuria (Proteinuria)
C38012 (NCI Thesaurus)
C0033687 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Adverse Event causing Dose Modification, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus Property)
C1707811 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-3)
C25572 (NCI Thesaurus Property-2)
Item Group
Non-protocol Therapy
Non-protocol therapy
Item
Was any non-protocol therapy given during protocol treatment?
boolean
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-1)
C16212 (NCI Thesaurus ObjectClass-2)
C0087111 (UMLS CUI-2)
C25320 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25456 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C38148 (NCI Thesaurus ValueDomain)
Item Group
Comments
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)

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