ID

10749

Description

CALGB: 10603 Laboratory Normals and Units Form NCT00651261 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=621DF241-3FFA-FE24-E040-BB89AD432D16

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=621DF241-3FFA-FE24-E040-BB89AD432D16

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 6/8/15 6/8/15 -
Uploaded on

June 8, 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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CALGB: 10603 Laboratory Normals and Units Form DRKS00003845 NCT00651261

English

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 forms  
Header
Description

Header

CALGB Form
Description

Form ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Description

Protocol ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Reporting Period Start Date (MM DD YYYY)
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (MM DD YYYY)
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Description

Patient demographics

Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Lab
Description

Lab

Name of Laboratory
Description

PathologyCoreFacilityLaboratoryIdentifierName

Data type

text

Alias
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus ObjectClass-2
C18189
UMLS 2011AA ObjectClass-2
C0030664
NCI Thesaurus ObjectClass-3
C15896
UMLS 2011AA ObjectClass-3
C1511521
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Lab
Description

LaboratoryProcedurePerformedName

Data type

text

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Other, specify
Description

UnitsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ObjectClass
C25709
UMLS 2011AA ObjectClass
C1519795
ULN
Description

LaboratoryProcedurePerformedUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
LLN
Description

LaboratoryProcedurePerformedLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Overall Response
Description

Overall Response

Completed by (print or type name)
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
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 (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
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)
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
Lab
PathologyCoreFacilityLaboratoryIdentifierName
Item
Name of Laboratory
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
Lab
text
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
CL.2
Code List
Lab
CL Item
Albumin Measurement (Albumin)
C64431 (NCI Thesaurus)
C0201838 (UMLS 2011AA)
CL Item
Alkaline Phosphatase Measurement (Alkaline Phosphatase)
C64432 (NCI Thesaurus)
C0201850 (UMLS 2011AA)
CL Item
Alanine Aminotransferase Measurement (ALT (SGPT))
C64433 (NCI Thesaurus)
C0201836 (UMLS 2011AA)
CL Item
Absolute Neutrophil Count (ANC (Absolute Neutrophil Count))
C63321 (NCI Thesaurus)
C0948762 (UMLS 2011AA)
CL Item
Aspartate Aminotransferase Measurement (AST (SGOT))
C64467 (NCI Thesaurus)
C0201899 (UMLS 2011AA)
CL Item
Blood Urea Nitrogen Measurement (BUN (Blood Urea Nitrogen))
C61019 (NCI Thesaurus)
C0005845 (UMLS 2011AA)
CL Item
Calcium Measurement (Calcium)
C64488 (NCI Thesaurus)
C0201925 (UMLS 2011AA)
CL Item
Chloride Measurement (Chloride)
C64495 (NCI Thesaurus)
C0201952 (UMLS 2011AA)
CL Item
Fibrinogen Measurement (Fibrinogen)
C64606 (NCI Thesaurus)
C0337428 (UMLS 2011AA)
CL Item
Plasma Glucose Measurement (Glucose)
C41376 (NCI Thesaurus)
C0202042 (UMLS 2011AA)
CL Item
Hematocrit (Hematocrit)
C64796 (NCI Thesaurus)
C0018935 (UMLS 2011AA)
CL Item
Hemoglobin Measurement (Hemoglobin)
C64848 (NCI Thesaurus)
C0518015 (UMLS 2011AA)
CL Item
International Normalized Ratio (INR (International Normalized Ratio))
C25352 (NCI Thesaurus)
C0525032 (UMLS 2011AA)
CL Item
Echocardiogram Ejection Fraction (Left Ventricular Ejection Fraction by echocardiogram)
C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)
C37946 (NCI Thesaurus-3)
C2700377 (UMLS 2011AA-4)
CL Item
Radionuclide Ventriculogram Scan Ejection Fraction (Left Ventricular Ejection Fraction by MUGA)
C38073 (NCI Thesaurus)
C0521317 (UMLS 2011AA)
C37946 (NCI Thesaurus-3)
C2700377 (UMLS 2011AA-4)
CL Item
Magnesium Measurement (Magnesium)
C64840 (NCI Thesaurus)
C0373675 (UMLS 2011AA)
CL Item
Platelet Count (Platelet Count)
C51951 (NCI Thesaurus)
C0032181 (UMLS 2011AA)
CL Item
Potassium Measurement (Potassium)
C64853 (NCI Thesaurus)
C0202194 (UMLS 2011AA)
CL Item
Prothrombin Time (PT (Prothrombin Time))
C62656 (NCI Thesaurus)
C0033707 (UMLS 2011AA)
CL Item
Partial Thromboplastin Time (PTT (Partial Thromboplastin Time))
C3315 (NCI Thesaurus)
CL Item
Serum Creatinine Measurement (Serum Creatinine)
C13325 (NCI Thesaurus)
C0229671 (UMLS 2011AA)
C64547 (NCI Thesaurus-3)
C0201975 (UMLS 2011AA-4)
CL Item
Serum Hcg Measurement (Serum HCG (Human Chorionic Gonadotropin))
C73495 (NCI Thesaurus)
C2348195 (UMLS 2011AA)
CL Item
Sodium (Sodium)
CL Item
Thyroxine (Thyroxine)
C2302 (NCI Thesaurus)
C0040165 (UMLS 2011AA)
CL Item
Total Bilirubin Measurement (Total Bilirubin)
C38037 (NCI Thesaurus)
C0201913 (UMLS 2011AA)
CL Item
Total Protein Measurement (Total Protein)
C64858 (NCI Thesaurus)
C0555903 (UMLS 2011AA)
CL Item
Thyroid Stimulating Hormone Thyrotropin Measurement (TSH (Thyroid Stimulating Hormone/Thyrotropin))
C2280 (NCI Thesaurus)
C0040160 (UMLS 2011AA)
C64813 (NCI Thesaurus-3)
C0202230 (UMLS 2011AA-4)
CL Item
Uric Acid Crystal Measurement (Uric Acid)
C74684 (NCI Thesaurus)
C2700121 (UMLS 2011AA)
CL Item
Urine Human Chorionic Gonadotropin (Urine HCG (Human Chorionic Gonadotropin))
C13283 (NCI Thesaurus)
C0042036 (UMLS 2011AA)
C2275 (NCI Thesaurus-3)
C1141639 (UMLS 2011AA-4)
CL Item
Leukocyte Count (WBC Count)
C51948 (NCI Thesaurus)
C0023508 (UMLS 2011AA)
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
CL.3
Code List
Units
CL Item
Percent (%)
CL Item
Microliter (/mcL)
C48153 (NCI Thesaurus)
C0439243 (UMLS 2011AA)
CL Item
/ml (/mL)
CL Item
/nl (/nL)
CL Item
/mcl (/uL)
CL Item
1000 Per Microliter (1000/mcL)
CL Item
1000 Per Cubic Millimiter (1000/mm^3)
CL Item
10^9 Per Liter (10^9/L)
CL Item
Cubic Centimeters Per Minute (cc/min)
CL Item
Cells Per Liter (cells/L)
CL Item
Grams/24 Hours (g/24 hrs)
CL Item
Grams Per Deciliter (g/dL)
CL Item
Grams Per Liter (g/L)
CL Item
Grams (gm)
CL Item
Grams Per Deciliter (gm/dL)
CL Item
Ie/l (IE/L)
CL Item
International Units Per Liter (iU/L)
CL Item
International Units Per Liter (IU/L)
CL Item
K/mm^3 (k/mm^3)
CL Item
Kilopascal (kPa)
CL Item
Micrograms/deciliter (mcg/dl)
CL Item
Micrograms Per Liter (mcg/L)
CL Item
Micrograms Per Milliliter (mcg/mL)
CL Item
Mciu/ml (mcIU/mL)
CL Item
Mckat Per Liter (mcKat/L)
CL Item
Microliter (mcL)
CL Item
Micromoles Per Liter (mcmol/L)
CL Item
Mcmol/l (mcmol/L)
CL Item
Milliequivalent Per Liter (mEq/L)
CL Item
Milligrams/24 Hours (mg/24 hrs)
CL Item
Milligrams Per Deciliter (mg/dL)
CL Item
Milligrams Per Liter (mg/L)
CL Item
Minutes (min)
CL Item
Milliliters Per Minute (ml/min)
CL Item
Ml/min/1.73m^2 (mL/Min/1.73m^2)
CL Item
Millimeters Of Mercury (mmHg)
CL Item
Millimole Per Liter (mmol/L)
CL Item
Cubic Millimeters (mm^3)
CL Item
Mu/ml (mU/mL)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
N/milligram (n/mg)
CL Item
Nanograms Per Deciliter (ng/dL)
CL Item
Nanograms Per Milliliter (ng/mL)
CL Item
Nanomoles Per Liter (nmol/l)
CL Item
Not Otherwise Specified (NOS)
CL006269 (NCI Metathesaurus)
CL Item
Number (number)
C25337 (NCI Thesaurus)
C0237753 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Ratio (Ratio)
CL Item
Seconds (seconds)
C0457385 (NCI Metathesaurus)
CL Item
Units Per Liter (U/L)
CL Item
Vol Frac (Vol Frac)
CL Item
X1000 (x1000)
CL Item
10^3 Per Microliter (x10^3/mcL)
CL Item
X10^6 Cells/kg (x10^6 cells/kg)
CL Item
10^9 Per Liter (x10^9/L)
UnitsText
Item
Other, specify
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)
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)
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)
Item Group
Overall Response
Person Completing Form
Item
Completed by (print or type name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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