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  1. StudyEvent: NCIC MA.32 Serious Adverse Event Folder
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date Of Event/reporting Period
PrimaryAdverseEventBeginDate
Item
Start Date of Primary AE
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
SeriousAdverseEventReportedtoInvestigatorDate
Item
SAE Reported to Investigator Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL124429 (NCI Metathesaurus Property)
Item
Temporal relation to SAE to protocol treatment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C41335 (NCI Thesaurus Property-2)
C1519255 (UMLS 2011AA Property-2)
CL.1
Code List
Temporal relation to SAE to protocol treatment
CL Item
During Protocol Treatment (during protocol treatment)
CL Item
Within 30 Days After Completion Of Protocol Treatment (within 30 days after completion of protocol treatment)
CL Item
More Than 30 Days After Completion Of Protocol Treatment (more than 30 days after completion of protocol treatment)
ReportSeriousAdverseEventPeriodText
Item
Reporting period at which SAE occurred
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C41335 (NCI Thesaurus Property-2)
C1519255 (UMLS 2011AA Property-2)
Item Group
Event Description
AdverseEventTreatingDescriptionText
Item
Event Description
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus Property)
C1522326 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Item Group
Serious Adverse Events
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
AdverseEventOnsetTime
Item
Event Onset Time
time
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
AdverseEventEndTime
Item
Event End Time
time
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.2
Code List
Grade
CL Item
Absent Adverse Event (0)
C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
Attribution (to Metformin/Placebo)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.3
Code List
Attribution (to Metformin/Placebo)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
CL.4
Code List
Action Taken at Time of Adverse Event
CL Item
There Was No Action Taken Based On The Adverse Event (none)
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
Item
AE Outcome
text
C25626 (NCI Thesaurus Property)
C1705586 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
CL.5
Code List
AE Outcome
CL Item
Recovered Or Resolved Without Sequelae (Recovered/Resolved without Sequelae)
C85257 (NCI Thesaurus)
C2827606 (UMLS 2011AA)
CL Item
Not Recovered Or Not Resolved (Not recovered/Not resolved)
C49494 (NCI Thesaurus)
C1709277 (UMLS 2011AA)
CL Item
Recovered Or Resolved With Sequelae (Recovered/Resolved with Sequelae)
C49495 (NCI Thesaurus)
C1709862 (UMLS 2011AA)
CL Item
Fatal Or Died (Fatal/Died)
Item
Seriousness Attributed to Adverse Event
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.6
Code List
Seriousness Attributed to Adverse Event
CL Item
Not Serious (Not serious)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life threatening)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Intervention Required (Required intervention to prevent permanent impairment/damage)
Item Group
Laboratory Tests - Question
AbnormalPhysicalExaminationLaboratoryProcedureOutcomeInd-2
Item
Are there any relevant laboratory or physical exam tests to report
boolean
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25401 (NCI Thesaurus ObjectClass-2)
C0205161 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus ObjectClass-3)
C0022885 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Laboratory Test
Item
Diagnostic Test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.14
Code List
Diagnostic Test
CL Item
Activated Partial Thromboplastin Time (Activated partial thromboplastin time (APTT))
CL Item
Albumin (Albumin - blood)
C214 (NCI Thesaurus)
C0001924 (UMLS 2011AA)
CL Item
Alkaline Phosphatase (Alkaline phosphatase NOS)
CL Item
Alkaline Phosphatase (Alkaline phosphates NOS)
CL Item
Amylase (Amylase - blood)
CL Item
Absolute Neutrophil Count (ANC)
CL Item
Bacterial Infection (Bacterial infection NOS)
CL Item
Direct Bilirubin (Bilirubin direct - blood)
CL Item
Total Bilirubin (Bilirubin total - blood)
C38037 (NCI Thesaurus)
C0201913 (UMLS 2011AA)
CL Item
Blood Bicarbonate (Blood bicarbonate)
CL Item
Blood Carbon Dioxide (Blood carbon dioxide)
CL Item
Anc (Blood neutrophils (ANC))
CL Item
Bun (Blood urea nitrogen (BUN))
CL Item
Bone Marrow Blasts (Bone Marrow Blasts)
CL Item
Bone Marrow Cellularity (Bone Marrow Cellularity)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
C37923 (NCI Thesaurus-3)
C1516377 (UMLS 2011AA-4)
CL Item
Calcium (Calcium - blood (Ca))
CL Item
Blood Carbon Dioxide (Carbon dioxide - blood (CO2))
CL Item
Chloride (Chloride - blood)
CL Item
Cholesterol (Cholesterol - blood)
CL Item
Creatine Phosphokinase (Creatine phosphokinase - blood (CK))
CL Item
Creatinine (Creatinine - serum (Cr))
CL Item
Creatinine Clearance (Creatinine clearance (CrCl))
CL Item
Fibrin D-dimer (Fibrin D-dimer)
CL Item
Fibrin Degradation Products (Fibrin degradation products (FDP))
CL Item
Fibrinogen (Fibrinogen - blood)
C25736 (NCI Thesaurus)
C0016006 (UMLS 2011AA)
CL Item
Fungal Infection (Fungal infection NOS)
CL Item
Glucose (Glucose - blood)
CL Item
Glutamic-oxaloacetic Transferase (ast, Sgot) (Glutamic-oxaloacetic transferase (AST, SGOT))
CL Item
Glutamic-pyruvate Transferase (alt, Sgpt) (Glutamic-pyruvate transferase (ALT, SGPT))
CL Item
Hematocrit (Hematocrit (Hct))
CL Item
Hemoglobin (hgb) (Hemoglobin (Hb))
CL Item
International Normalized Ratio (International normalised ratio (INR))
CL Item
Ldh (Lactate dehydrogenase - blood (LDH))
CL Item
Lipase (Lipase)
C37988 (NCI Thesaurus)
C0023764 (UMLS 2011AA)
CL Item
Magnesium (Magnesium - blood (Mg))
CL Item
Oxygen Saturation (Oxygen saturation)
C0483415 (NCI Metathesaurus)
CL Item
Peripheral Blasts (Peripheral Blasts)
CL Item
Ph Nos (pH NOS)
CL Item
Phosphorus (Phosphorus)
CL Item
Platelet Count (Platelet count (PLT))
C0032181 (NCI Metathesaurus)
CL Item
Po2 (pO2)
C0483414 (NCI Metathesaurus)
CL Item
Potassium (Potassium - blood (K))
CL Item
Total Protein (Protein NOS (Total))
CL Item
Prothrombin Time (Prothrombin time (PT))
C0033707 (NCI Metathesaurus)
CL Item
Sodium (Sodium - blood)
C830 (NCI Thesaurus)
C0037473 (UMLS 2011AA)
CL Item
Triglycerides (Triglycerides)
C906 (NCI Thesaurus)
C0041004 (UMLS 2011AA)
CL Item
Urinalysis (Urine analysis)
C17241 (NCI Thesaurus)
C0042014 (UMLS 2011AA)
CL Item
Viral Infection (Viral infection NOS)
CL Item
Wbc (White blood cell count (WBC))
LaboratoryProcedurePerformedSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
AdverseEventWorstSymptomValue
Item
Nadir/Worst Value
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
AdverseEventWorstSymptomDate
Item
Nadir/Worst Date (at Time of SAE)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
Item
Nadir/Worst Unit of Measure
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
CL.9
Code List
Nadir/Worst Unit of Measure
CL Item
Percent (%)
C48570 (NCI Thesaurus)
C0439165 (UMLS 2011AA)
CL Item
1000 Per Cubic Millimiter (1000/mm3)
CL Item
1000 Per Microliter (1000/uL)
CL Item
Cubic Centimeters Per Minute (cc/min)
CL Item
Cells Per Liter (cells/L)
CL Item
Grams Per Deciliter (g/dL)
CL Item
Grams Per Liter (g/L)
CL Item
Gram (gm)
C0439208 (NCI Metathesaurus)
CL Item
Grams Per Deciliter (gm/dl)
CL Item
International Units Per Liter (iU/L)
CL Item
Kilopascals (kPa)
CL Item
Milliequivalents Per Liter (mEq/L)
CL Item
Milligrams Per Deciliter (mg/dL)
CL Item
Milligrams Per Liter (mg/L)
CL Item
Minutes (min)
CL Item
Ml/min/1.73m^2 (mL/min/1.73m2)
CL Item
Cubic Millimeters (mm3)
CL Item
Millimeters Of Mercury (mmHg)
CL Item
Millimole Per Liter (mmol/L)
CL Item
Not Applicable (n/a)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Number (number)
C25337 (NCI Thesaurus)
C0237753 (UMLS 2011AA)
CL Item
Seconds (seconds)
CL Item
Units Per Liter (U/L)
CL Item
Micrograms Per Milliliter (ug/mL)
CL Item
Microliter (ul)
C48153 (NCI Thesaurus)
C0439243 (UMLS 2011AA)
CL Item
Micromole Per Liter (umol/L)
CL Item
Volume Fraction (Vol Frac)
C67469 (NCI Thesaurus)
C0560268 (UMLS 2011AA)
LaboratoryProcedurePerformedLowerLimitofNormalValue
Item
LLN
float
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedurePerformedUpperLimitofNormalValue
Item
ULN
float
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryFindingRecoveryInd-2
Item
Has the patient recovered
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38470 (NCI Thesaurus ObjectClass)
C70827 (NCI Thesaurus Property)
C0237820 (UMLS 2011AA Property)
AdverseEventMostRecentRecoveryValue
Item
Recovery or Latest Value
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
AdverseEventMostRecentRecoveryDate
Item
Date of Recovery or Death
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
PathologyCoreFacilityLaboratoryIdentifierName
Item
Name of Laboratory (where tests were completed)
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item Group
Blood Pressure - Question
AbnormalBloodPressureLaboratoryProcedureOutcomeInd-2
Item
Are there any relevant blood pressure results to report
boolean
C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C54706 (NCI Thesaurus ObjectClass-3)
C0005823 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Blood Pressure
AdverseEventWorstSymptomDate
Item
Nadir/Worst Date (at Time of SAE)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
Systolic blood pressure
Item
Blood Pressure, Systolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Systolic blood pressure
Item
Blood Pressure, Systolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood pressure, Diastolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood pressure, Diastolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
LaboratoryFindingRecoveryInd-2
Item
Has the patient recovered
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38470 (NCI Thesaurus ObjectClass)
C70827 (NCI Thesaurus Property)
C0237820 (UMLS 2011AA Property)
AdverseEventMostRecentRecoveryDate
Item
Date of Recovery or Death
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
Item Group
Other Investigations - Question
AbnormalOtherLaboratoryProcedureOutcomeInd-2
Item
Are there any other relevant investigations to report
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25401 (NCI Thesaurus ObjectClass-2)
C0205161 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus ObjectClass-3)
C0022885 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Other Investigations - Question
Item
Diagnostic Test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.14
Code List
Diagnostic Test
CL Item
Activated Partial Thromboplastin Time (Activated partial thromboplastin time (APTT))
CL Item
Albumin (Albumin - blood)
C214 (NCI Thesaurus)
C0001924 (UMLS 2011AA)
CL Item
Alkaline Phosphatase (Alkaline phosphatase NOS)
CL Item
Alkaline Phosphatase (Alkaline phosphates NOS)
CL Item
Amylase (Amylase - blood)
CL Item
Absolute Neutrophil Count (ANC)
CL Item
Bacterial Infection (Bacterial infection NOS)
CL Item
Direct Bilirubin (Bilirubin direct - blood)
CL Item
Total Bilirubin (Bilirubin total - blood)
C38037 (NCI Thesaurus)
C0201913 (UMLS 2011AA)
CL Item
Blood Bicarbonate (Blood bicarbonate)
CL Item
Blood Carbon Dioxide (Blood carbon dioxide)
CL Item
Anc (Blood neutrophils (ANC))
CL Item
Bun (Blood urea nitrogen (BUN))
CL Item
Bone Marrow Blasts (Bone Marrow Blasts)
CL Item
Bone Marrow Cellularity (Bone Marrow Cellularity)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
C37923 (NCI Thesaurus-3)
C1516377 (UMLS 2011AA-4)
CL Item
Calcium (Calcium - blood (Ca))
CL Item
Blood Carbon Dioxide (Carbon dioxide - blood (CO2))
CL Item
Chloride (Chloride - blood)
CL Item
Cholesterol (Cholesterol - blood)
CL Item
Creatine Phosphokinase (Creatine phosphokinase - blood (CK))
CL Item
Creatinine (Creatinine - serum (Cr))
CL Item
Creatinine Clearance (Creatinine clearance (CrCl))
CL Item
Fibrin D-dimer (Fibrin D-dimer)
CL Item
Fibrin Degradation Products (Fibrin degradation products (FDP))
CL Item
Fibrinogen (Fibrinogen - blood)
C25736 (NCI Thesaurus)
C0016006 (UMLS 2011AA)
CL Item
Fungal Infection (Fungal infection NOS)
CL Item
Glucose (Glucose - blood)
CL Item
Glutamic-oxaloacetic Transferase (ast, Sgot) (Glutamic-oxaloacetic transferase (AST, SGOT))
CL Item
Glutamic-pyruvate Transferase (alt, Sgpt) (Glutamic-pyruvate transferase (ALT, SGPT))
CL Item
Hematocrit (Hematocrit (Hct))
CL Item
Hemoglobin (hgb) (Hemoglobin (Hb))
CL Item
International Normalized Ratio (International normalised ratio (INR))
CL Item
Ldh (Lactate dehydrogenase - blood (LDH))
CL Item
Lipase (Lipase)
C37988 (NCI Thesaurus)
C0023764 (UMLS 2011AA)
CL Item
Magnesium (Magnesium - blood (Mg))
CL Item
Oxygen Saturation (Oxygen saturation)
C0483415 (NCI Metathesaurus)
CL Item
Peripheral Blasts (Peripheral Blasts)
CL Item
Ph Nos (pH NOS)
CL Item
Phosphorus (Phosphorus)
CL Item
Platelet Count (Platelet count (PLT))
C0032181 (NCI Metathesaurus)
CL Item
Po2 (pO2)
C0483414 (NCI Metathesaurus)
CL Item
Potassium (Potassium - blood (K))
CL Item
Total Protein (Protein NOS (Total))
CL Item
Prothrombin Time (Prothrombin time (PT))
C0033707 (NCI Metathesaurus)
CL Item
Sodium (Sodium - blood)
C830 (NCI Thesaurus)
C0037473 (UMLS 2011AA)
CL Item
Triglycerides (Triglycerides)
C906 (NCI Thesaurus)
C0041004 (UMLS 2011AA)
CL Item
Urinalysis (Urine analysis)
C17241 (NCI Thesaurus)
C0042014 (UMLS 2011AA)
CL Item
Viral Infection (Viral infection NOS)
CL Item
Wbc (White blood cell count (WBC))
LaboratoryProcedurePerformedSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
AdverseEventAssessmentText
Item
Results
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Protocol Treatment
TreatmentAssignmentCode
Item
Treatment Assignment Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
Medication Dose
Item
Actual dose
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
UnitsText
Item
Units
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ObjectClass)
C1519795 (UMLS 2011AA ObjectClass)
Item
Route of Administration
text
C25284 (NCI Thesaurus ValueDomain)
C0449311 (UMLS CUI-1)
CL111054 (NCI Metathesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
CL.15
Code List
Route of Administration
CL Item
Oral Administration Of Drug (PO)
Item
Schedule
text
C1708 (NCI Thesaurus ObjectClass)
C3476109 (UMLS CUI-1)
C25515 (NCI Thesaurus ValueDomain)
C25382 (NCI Thesaurus Property)
CL.16
Code List
Schedule
CL Item
Daily (Daily)
C25473 (NCI Thesaurus)
C0332173 (UMLS 2011AA)
PatientRandomizationDate
Item
Randomization Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
TreatmentLastAdministeredDate
Item
Last Administered Date (Prior to SAE)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
AgentSourceText
Item
Agent Source
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus Property)
C0449416 (UMLS 2011AA Property)
Item
Patient rechallenged with agent
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C54055 (NCI Thesaurus Property)
C0376495 (UMLS 2011AA Property)
CL.17
Code List
Patient rechallenged with agent
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Decision Pending (Decision Pending)
SeriousAdverseEventRepeatOccurrenceInd-2
Item
Did event reoccur
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C54035 (NCI Thesaurus ObjectClass-2)
C0205404 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C47886 (NCI Thesaurus Property-2)
C0205341 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Prior Systemic Therapy - Question
SystemicTherapyAdministeredInd-3
Item
Has the patient received systemic therapy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Prior Radiation Therapy - Question
AdjuvantRadiationTherapyAdministeredInd-3
Item
Has the patient received adjuvant RT
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Relevant Major Medical Problems - Question
ConcomitantDiseasePersonalMedicalHistoryInd-2
Item
Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Item Group
Relevant Major Medical Problems
PatientMedicalConditionDate
Item
Date Documented
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)
Item
Relevant major medical problems
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C12919 (NCI Thesaurus Property-2)
C0460002 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.22
Code List
Relevant major medical problems
CL Item
Acquired Immunodeficiency Syndrome (AIDS)
C2851 (NCI Thesaurus)
C0001175 (UMLS 2011AA)
CL Item
Immunology Hypersensitivity (Allergy/Immunology)
C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)
C18011 (NCI Thesaurus-3)
C0152036 (UMLS 2011AA-4)
CL Item
Auditory (Auditory/Ear)
C37915 (NCI Thesaurus)
C0439825 (UMLS 2011AA)
CL Item
Bone Marrow Blood (Blood/Bone Marrow)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
C12434 (NCI Thesaurus-3)
C0229664 (UMLS 2011AA-4)
CL Item
Cardiac (Cardiac)
C13306 (NCI Thesaurus)
C1522601 (UMLS 2011AA)
CL Item
Coagulation (Coagulation)
C20812 (NCI Thesaurus)
C0005778 (UMLS 2011AA)
CL Item
Dermatologic (Dermatology/Skin)
C41128 (NCI Thesaurus)
C0205489 (UMLS 2011AA)
CL Item
Endocrine (Endocrine)
C41064 (NCI Thesaurus)
C0521425 (UMLS 2011AA)
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Hepatobiliary System (Hepatobiliary/Pancreas)
C43612 (NCI Thesaurus)
C1711359 (UMLS 2011AA)
CL Item
Infection (Infection)
C26726 (NCI Thesaurus)
C0009450 (UMLS 2011AA)
CL Item
Metabolic (Metabolic/Laboratory)
C28240 (NCI Thesaurus)
C0311400 (UMLS 2011AA)
CL Item
Soft Tissue Musculoskeletal (Musculoskeletal/Soft Tissue)
C25348 (NCI Thesaurus)
C0497254 (UMLS 2011AA)
C12471 (NCI Thesaurus-3)
C0225317 (UMLS 2011AA-4)
CL Item
Neurology (Neurology)
C16908 (NCI Thesaurus)
C0027855 (UMLS 2011AA)
CL Item
Ocular (Ocular)
C87163 (NCI Thesaurus)
C1299003 (UMLS 2011AA)
C87163 (NCI Thesaurus-3)
C1299003 (UMLS 2011AA-4)
CL Item
Ocular (Ocular/Eye)
C87163 (NCI Thesaurus)
C1299003 (UMLS 2011AA)
C87163 (NCI Thesaurus-3)
C1299003 (UMLS 2011AA-4)
CL Item
Other (Other)
CL Item
Other Malignant Neoplasm (Other Malignancy)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C9305 (NCI Thesaurus-3)
C0006826 (UMLS 2011AA-4)
CL Item
Pulmonary (Pulmonary/Upper Respiratory)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
CL Item
Genitourinary Renal (Renal/Genitourinary)
C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)
C25350 (NCI Thesaurus-3)
C0042066 (UMLS 2011AA-4)
CL Item
Surgical Procedure (Surgical Procedure)
C15329 (NCI Thesaurus)
C0543467 (UMLS 2011AA)
ConcomitantDiseaseOrganSystemPersonalMedicalHistorySpecify
Item
Specify other disease/condition
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C12919 (NCI Thesaurus Property-2)
C0460002 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientHistoryText
Item
Other Relevant Details
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Item Group
Concomitant Medications - Question
ConcomitantMedicationUseInd-3
Item
Did the participant report taking any concomitant medication
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Item Group
Concomitant Medications
Concomitant Medication
Item
Concomitant Medication (335 permissible values)
text
C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)
Concomitant Medication Use Indication
Item
Agent Type (116 permissible values not coded)
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)
SeriousAdverseEventTherapyInd-2
Item
Was this medication used to treat the SAE
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
Medication Start Date
Item
Start date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Medication End Date
Item
Stop date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item Group
Sae Notification Form
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