ID

5540

Descrizione

NCIC MA.32 Serious Adverse Event Folder A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E4E526-5F38-E26A-E040-BB89AD43175C

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E4E526-5F38-E26A-E040-BB89AD43175C

Keywords

Adverse event

D001943

Caricato su

8 agosto 2014

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Breast Cancer NCT01101438 Toxicity - NCIC MA.32 Serious Adverse Event Folder - 3027655v1.0

model
Dettagli

No Instruction available.

1 moduli

StudyEvent: NCIC MA.32 Serious Adverse Event Folder
1. No Instruction available.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Date of Event/Reporting Period

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)
C0877248 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

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)

ReportSeriousAdverseEventPeriodType

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)
C1519255 (UMLS 2011AA Property)

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)
C1519255 (UMLS 2011AA Property)

Event Description

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)
C0678257 (UMLS 2011AA Property)

Serious Adverse Events

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)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)

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)

AdverseEventSeverityGrade

Item

Grade

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)

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)

CTCAdverseEventAttributionScale

Item

Attribution (to Metformin/Placebo)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA 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)

AdverseEventActionType

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)

AdverseEventPresentStatus

Item

AE Outcome

text

C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA 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)

AdverseEventSeriousnessAttributionScale

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)

Tests (Numeric) - Question

Item Group

Laboratory Tests - Question

AbnormalPhysicalExaminationLaboratoryProcedureOutcomeInd-2

Item

Are there any relevant laboratory or physical exam tests to report

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.7

Code List

Are there any relevant laboratory or physical exam tests to report

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Tests (Numeric)

Item Group

Laboratory Test

LaboratoryProcedurePhysicalExaminationAssessmentType

Item

Diagnostic Test

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property)
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)
C1516377 (UMLS 2011AA)

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

double

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)
C1522166 (UMLS 2011AA Property)

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)
C1522166 (UMLS 2011AA Property)

AdverseEventWorstSymptomUOM

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)
C1522166 (UMLS 2011AA Property)

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)
C1264666 (UMLS 2011AA)

LaboratoryProcedurePerformedLowerLimitofNormalValue

Item

LLN

double

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)
C1518030 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePerformedUpperLimitofNormalValue

Item

ULN

double

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)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryFindingRecoveryInd-2

Item

Has the patient recovered

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38470 (NCI Thesaurus ObjectClass)
C70827 (NCI Thesaurus Property)
C0237820 (UMLS 2011AA Property)

CL.12

Code List

Has the patient recovered

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

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)
C1513491 (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)
C1513491 (UMLS 2011AA Property)

PathologyCoreFacilityLaboratoryIdentifierName

Item

Name of Laboratory (where tests were completed)

text

C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C15896 (NCI Thesaurus ObjectClass)
C1511521 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

Tests (Blood Pressure) - Question

Item Group

Blood Pressure - Question

AbnormalBloodPressureLaboratoryProcedureOutcomeInd-2

Item

Are there any relevant blood pressure results to report

text

C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C54706 (NCI Thesaurus ObjectClass)
C0005823 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.11

Code List

Are there any relevant blood pressure results to report

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Tests (Blood Pressure)

Item Group

Blood Pressure

AdverseEventWorstSymptomDate

Item

Nadir/Worst Date (at Time of SAE)

date

Systolic blood pressure

Item

Blood Pressure, Systolic (mmHg, Recovery Value)

double

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)

double

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)

double

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)

double

C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)

LaboratoryFindingRecoveryInd-2

Item

Has the patient recovered

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38470 (NCI Thesaurus ObjectClass)
C70827 (NCI Thesaurus Property)
C0237820 (UMLS 2011AA Property)

CL.12

Code List

Has the patient recovered

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AdverseEventMostRecentRecoveryDate

Item

Date of Recovery or Death

date

Tests (Non-numeric) - Question

Item Group

ID

Descrizione

collegamento

Keywords

versioni (4)

Caricato su

DOI

Licenza

Commenti del modello :

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Breast Cancer NCT01101438 Toxicity - NCIC MA.32 Serious Adverse Event Folder - 3027655v1.0

No Instruction available.

Descrizione

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Descrizione

Tipo di dati

Alias

Descrizione

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Descrizione

Tipo di dati

Alias

Descrizione

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati

Alias

Descrizione

Tipo di dati