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  1. StudyEvent: Melanoma-Treatment Summary Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Crf Header
CoordinatingGroupProtocolNumber
Item
Coordinating Group Protocol Number
text
CoordinatingGroupCode
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
ProtocolTitle
Item
Protocol Title
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA Property)
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientStudyID,ParticipatingGroup
Item
Patient Study ID, Participating Group
text
ParticipatingGroupCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
InstitutionName
Item
Institution Name
text
AffiliateName
Item
Affiliate Name
text
PatientName,Last
Item
Patient Name, Last
text
PatientName,First
Item
Patient Name, First
text
PatientName,Middle
Item
Patient Name, Middle
text
Item Group
Melanoma: Treatment Schedule-surgery
Item
Protocol Surgery Ind
text
CL.1
Code List
Protocol Surgery Ind
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProtocolSurgeryDate
Item
Protocol Surgery Date
date
ProtocolSurgeryType
Item
Protocol Surgery Type
text
Item
Surgical Treatment Completed
text
CL.2
Code List
Surgical Treatment Completed
CL Item
Yes, Surgical Treatment Was Completed As Per Protocol (Yes)
CL Item
No, Surgical Treatment Was Not Done (specify) (no, surgical treatment was not done (specify))
CL Item
No, Surgical Treatment Was Modified From Protocol Specification (specify) (no, surgical treatment was modified from protocol specification (specify))
SurgicalTreatmentCompleted,Specify
Item
Surgical Treatment Completed, Specify
text
RadialMarginDistance
Item
Radial Margin Distance
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item Group
Melanoma: Treatment Schedule-systemic Therapy
TreatmentBeginDate
Item
Treatment Begin Date
date
AgentCountCoursesAdministered
Item
Agent Count Courses Administered
double
TreatmentEndDate
Item
Treatment End Date
date
AgentTotalDose
Item
Agent Total Dose
double
Item
Agent Dose Units
text
CL.5
Code List
Agent Dose Units
CL Item
Curie (Ci)
C0700085 (NCI Metathesaurus)
CL Item
Unit (unit)
C44278 (NCI Thesaurus)
C0439148 (UMLS 2011AA)
CL Item
Hertz (Hz)
CL Item
International Unit (IU)
C28255 (NCI Thesaurus)
CL Item
Joules Per Centimeter Square (JCM2)
CL Item
Liter (L)
CL Item
Megahertz (MHz)
CL Item
Milligrams Per Milliliter Per Minute (MMM)
CL Item
Million Electron Volts (MeV)
CL Item
Megarad (Mrad)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Osmole (Osmol)
CL Item
Pascal (Pa)
C42547 (NCI Thesaurus)
C0439473 (UMLS 2011AA)
CL Item
Viral Particles (VP)
CL Item
Centimeter (cm)
C49668 (NCI Thesaurus)
C0475210 (UMLS 2011AA)
CL Item
Deciliter (dL)
CL Item
Decimeter (dm)
CL Item
Gram (g)
C0439208 (NCI Metathesaurus)
CL Item
Gravity (in Centrifugation) (gravity)
CL Item
Kilohertz (kHz)
CL Item
Kilopascal (kPa)
CL Item
Kilo-electron Volt (keV)
CL Item
Kilogram (kg)
C28252 (NCI Thesaurus)
C0439209 (UMLS 2011AA)
CL Item
Meter (m)
C0475209 (NCI Metathesaurus)
CL Item
Millicurie (mCi)
CL Item
Milliequivalent (mEq)
CL Item
Milliliter (mL)
C28254 (NCI Thesaurus)
C0439242 (UMLS 2011AA)
CL Item
Milliosmole (mOsmol)
CL Item
Million Unit (mU)
CL Item
Millivolt (mV)
C0456691 (NCI Metathesaurus)
CL Item
Microcurie (mcCi)
CL Item
Microliter (mcL)
CL Item
Microgram (mcg)
CL Item
Micrometer (mcm)
CL Item
Milligram (mg)
C28253 (NCI Thesaurus)
C0439210 (UMLS 2011AA)
CL Item
Milliunit (milliunit)
CL Item
Millimeter (mm)
C28251 (NCI Thesaurus)
C0439200 (UMLS 2011AA)
CL Item
Millimole (mmol)
CL Item
Gram-molecular Weight (mole) (mol)
CL Item
Nanocurie (nCi)
C0560007 (NCI Metathesaurus)
CL Item
Nanogram (ng)
CL Item
Nanometer (nm)
C0439202 (NCI Metathesaurus)
CL Item
Nanometers Of Light (nm light)
CL Item
Plaque Forming Unit (pfu)
CL Item
Picogram (pg)
C0439213 (NCI Metathesaurus)
CL Item
Pounds Per Square Inch (psi)
C0439472 (NCI Metathesaurus)
CL Item
Gram-equivalent Weight (Eq)
AgentName
Item
Agent Name
text
Item Group
Melanoma: Treatment Schedule-vaccine Therapy
VaccineDate,First
Item
Vaccine Date, First
date
VaccineDate,Last
Item
Vaccine Date, Last
date
Item
Vaccine Site
text
CL.4
Code List
Vaccine Site
CL Item
Left Lower Extremity (left lower extremity)
CL Item
Left Upper Extremity (left upper extremity)
CL Item
Trunk (trunk)
C33816 (NCI Thesaurus)
C0460005 (UMLS 2011AA)
CL Item
Right Lower Extremity (right lower extremity)
CL Item
Right Upper Extremity (right upper extremity)
CL Item
Other, Specify (other, specify)
VaccineSite,Other
Item
Vaccine Site, Other
text
AgentTotalDose
Item
Agent Total Dose
double
Item
Agent Dose Units
text
CL.5
Code List
Agent Dose Units
CL Item
Curie (Ci)
C0700085 (NCI Metathesaurus)
CL Item
Unit (unit)
C44278 (NCI Thesaurus)
C0439148 (UMLS 2011AA)
CL Item
Hertz (Hz)
CL Item
International Unit (IU)
C28255 (NCI Thesaurus)
CL Item
Joules Per Centimeter Square (JCM2)
CL Item
Liter (L)
CL Item
Megahertz (MHz)
CL Item
Milligrams Per Milliliter Per Minute (MMM)
CL Item
Million Electron Volts (MeV)
CL Item
Megarad (Mrad)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Osmole (Osmol)
CL Item
Pascal (Pa)
C42547 (NCI Thesaurus)
C0439473 (UMLS 2011AA)
CL Item
Viral Particles (VP)
CL Item
Centimeter (cm)
C49668 (NCI Thesaurus)
C0475210 (UMLS 2011AA)
CL Item
Deciliter (dL)
CL Item
Decimeter (dm)
CL Item
Gram (g)
C0439208 (NCI Metathesaurus)
CL Item
Gravity (in Centrifugation) (gravity)
CL Item
Kilohertz (kHz)
CL Item
Kilopascal (kPa)
CL Item
Kilo-electron Volt (keV)
CL Item
Kilogram (kg)
C28252 (NCI Thesaurus)
C0439209 (UMLS 2011AA)
CL Item
Meter (m)
C0475209 (NCI Metathesaurus)
CL Item
Millicurie (mCi)
CL Item
Milliequivalent (mEq)
CL Item
Milliliter (mL)
C28254 (NCI Thesaurus)
C0439242 (UMLS 2011AA)
CL Item
Milliosmole (mOsmol)
CL Item
Million Unit (mU)
CL Item
Millivolt (mV)
C0456691 (NCI Metathesaurus)
CL Item
Microcurie (mcCi)
CL Item
Microliter (mcL)
CL Item
Microgram (mcg)
CL Item
Micrometer (mcm)
CL Item
Milligram (mg)
C28253 (NCI Thesaurus)
C0439210 (UMLS 2011AA)
CL Item
Milliunit (milliunit)
CL Item
Millimeter (mm)
C28251 (NCI Thesaurus)
C0439200 (UMLS 2011AA)
CL Item
Millimole (mmol)
CL Item
Gram-molecular Weight (mole) (mol)
CL Item
Nanocurie (nCi)
C0560007 (NCI Metathesaurus)
CL Item
Nanogram (ng)
CL Item
Nanometer (nm)
C0439202 (NCI Metathesaurus)
CL Item
Nanometers Of Light (nm light)
CL Item
Plaque Forming Unit (pfu)
CL Item
Picogram (pg)
C0439213 (NCI Metathesaurus)
CL Item
Pounds Per Square Inch (psi)
C0439472 (NCI Metathesaurus)
CL Item
Gram-equivalent Weight (Eq)
AgentName
Item
Agent Name
text
Item Group
Melanoma: Treatment Schedule Summary-radiation Therapy
RTBeginDate
Item
RT Begin Date
date
RTEndDate
Item
RT End Date
date
Item
RT Site
text
CL.6
Code List
RT Site
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
CL Item
Lymph Nodes (soft Tissue) (Lymph nodes (soft tissue))
CL Item
Head And Neck (Head and Neck)
C12418 (NCI Thesaurus)
C0460004 (UMLS 2011AA)
RTSite,Other
Item
RT Site, Other
text
RTTotalDose
Item
RT Total Dose
double
Item
RT Interruptions Ind
text
CL.7
Code List
RT Interruptions Ind
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, For Other Reasons, Specify (Yes, for other reasons, specify)
CL Item
Yes, Due To Toxicity (Yes, due to toxicity)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
RTInterruptionsReason
Item
RT Interruptions Reason
text
Item Group
Melanoma: Treatment Modifications
Item
Dose Modification (Change)
text
CL.8
Code List
Dose Modification (Change)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DoseModificationReason
Item
Dose Modification Reason
text
Item Group
Melanoma: Off-treatment
Item
Off Treatment Reason
text
CL.9
Code List
Off Treatment Reason
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death After Beginning Protocol Therapy (Death after beginning protocol therapy)
CL Item
Death On Study (Death on study)
CL Item
Death Prior To Beginning Protocol Therapy (Death prior to beginning protocol therapy)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Disease Progression, Relapse Prior To Beginning Protocol Therapy (Disease progression, relapse prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Toxicity/side Effects/complications (Toxicity/Side effects/Complications)
CL Item
New Primary (New primary)
OffTreatmentReason,Toxicity
Item
Off Treatment Reason, Toxicity
text
OffTreatmentReason,Other
Item
Off Treatment Reason, Other
text
Item Group
Melanoma: Treatment Schedule-non-protocol Therapy
Item
Non-Protocol Therapy Ind
text
CL.10
Code List
Non-Protocol Therapy Ind
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
OtherTherapyType
Item
Other Therapy Type
text
Non-ProtocolTherapyDate,First
Item
Non-Protocol Therapy Date, First
date
Item Group
Allows Documentation Of Any Additional Cooments
Comments
Item
Comments
text
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