Supplemental page

EXCEPTION
Descripción

EXCEPTION

Alias
UMLS CUI-1
C1705847
Was an exception granted?
Descripción

Was an exception granted?

Tipo de datos

text

Alias
UMLS CUI [1]
C1705847
Date exception granted:
Descripción

Date exception granted

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Inclusion number:
Descripción

Inclusion number

Tipo de datos

integer

Exclusion number:
Descripción

Exclusion number

Tipo de datos

integer

Exception granted by (Personnel):
Descripción

Exception granted by (Personnel)

Tipo de datos

text

Comments:
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Please see https://medical-data-models.org/forms/11515 (Previous and current medications)
Descripción

Please see https://medical-data-models.org/forms/11515 (Previous and current medications)

Alias
UMLS CUI-1
C0013227
Please see https://medical-data-models.org/forms/11515 (Pre- treatment events)
Descripción

Please see https://medical-data-models.org/forms/11515 (Pre- treatment events)

Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
Descripción

Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)

Alias
UMLS CUI-1
C0005954
Please see https://medical-data-models.org/forms/11515 (Medical tests and examinations)
Descripción

Please see https://medical-data-models.org/forms/11515 (Medical tests and examinations)

Alias
UMLS CUI-1
C1623258
Please see https://medical-data-models.org/forms/11515 (General Medical History)
Descripción

Please see https://medical-data-models.org/forms/11515 (General Medical History)

Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
Descripción

Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)

Alias
UMLS CUI-1
C1879316
FLUORESCENT IN SITU HYBRIDIZATION (FISH)
Descripción

FLUORESCENT IN SITU HYBRIDIZATION (FISH)

Alias
UMLS CUI-1
C0162789
Was a FISH analysis performed?
Descripción

Was a FISH analysis performed?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162789
Date:
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Sample type:
Descripción

Sample type

Tipo de datos

text

Alias
UMLS CUI [1]
C2347029
For extramedullary site, please mention the site from the followings, 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other:
Descripción

For extramedullary site, please mention the site from the followings, 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other

Tipo de datos

text

Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)
Descripción

Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)

Alias
UMLS CUI-1
C1516800
LABORATORY TEST RESULTS
Descripción

LABORATORY TEST RESULTS

Alias
UMLS CUI-1
C0677077
Were laboratory tests performed?
Descripción

Were laboratory tests performed?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022885
Name of laboratory:
Descripción

Name of laboratory

Tipo de datos

text

Alias
UMLS CUI [1]
C0022877
Date of hematology specimen collection:
Descripción

Date of hematology specimen collection

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Differential:
Descripción

Differential

Tipo de datos

text

Alias
UMLS CUI [1]
C0162401
Hemoglobin:
Descripción

Hemoglobin

Tipo de datos

float

Alias
UMLS CUI [1]
C0019046
Hematocrit:
Descripción

Hematocrit

Tipo de datos

float

Alias
UMLS CUI [1]
C0518014
Red blood cells:
Descripción

Red blood cells

Tipo de datos

float

Alias
UMLS CUI [1]
C0362910
White blood cells:
Descripción

White blood cells

Tipo de datos

float

Alias
UMLS CUI [1]
C0023508
Platelet count:
Descripción

Platelet count

Tipo de datos

float

Alias
UMLS CUI [1]
C0005821
Neutrophils:
Descripción

Neutrophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0027950
Bands:
Descripción

Bands

Tipo de datos

float

Alias
UMLS CUI [1]
C1882076
Lymphocytes:
Descripción

Lymphocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0024264
Monocytes:
Descripción

Monocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0026473
Eosinophils:
Descripción

Eosinophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0362902
Basophils:
Descripción

Basophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0200641
Blasts:
Descripción

Blasts

Tipo de datos

float

Alias
UMLS CUI [1]
C1982687
Promyelocytes:
Descripción

Promyelocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0455279
Myelocytes:
Descripción

Myelocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0455284
Metamyelocytes:
Descripción

Metamyelocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0229635
Other, please specify:
Descripción

Other, please specify

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
Date of coagulation specimen collection:
Descripción

Date of coagulation specimen collection

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
International normalized ratio:
Descripción

International normalized ratio

Tipo de datos

float

Alias
UMLS CUI [1]
C0525032
Other, please specify:
Descripción

Other, please specify

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
Was the subject fasting?
Descripción

Was the subject fasting?

Tipo de datos

text

Alias
UMLS CUI [1]
C0015663
Date of chemistry specimen collection:
Descripción

Date of chemistry specimen collection

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
AST (SGOT):
Descripción

AST (SGOT)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201899
ALT (SGPT):
Descripción

ALT (SGPT)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201836
Total bilirubin:
Descripción

Total bilirubin

Tipo de datos

float

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase:
Descripción

Alkaline phosphatase

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201850
Lactate dehydrogenase (LDH):
Descripción

Lactate dehydrogenase (LDH)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0202113
Creatinine:
Descripción

Creatinine

Tipo de datos

integer

Alias
UMLS CUI [1]
C1561535
Blood urea nitrogen (BUN):
Descripción

Blood urea nitrogen (BUN)

Tipo de datos

float

Alias
UMLS CUI [1]
C0600137
Urea:
Descripción

Urea

Tipo de datos

float

Alias
UMLS CUI [1]
C0523961
Potassium:
Descripción

Potassium

Tipo de datos

float

Alias
UMLS CUI [1]
C0202194
Uric acid
Descripción

Uric acid

Tipo de datos

float

Alias
UMLS CUI [1]
C0365228
Ionized calcium:
Descripción

Ionized calcium

Tipo de datos

float

Alias
UMLS CUI [1]
C0373561
Calcium:
Descripción

Calcium

Tipo de datos

float

Alias
UMLS CUI [1]
C0201925
Phosphorus:
Descripción

Phosphorus

Tipo de datos

float

Alias
UMLS CUI [1]
C0031705
Magnesium:
Descripción

Magnesium

Tipo de datos

float

Alias
UMLS CUI [1]
C0024467
Sodium:
Descripción

Sodium

Tipo de datos

float

Alias
UMLS CUI [1]
C0337443
Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)
Descripción

Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)

Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
Descripción

Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)

Alias
UMLS CUI-1
C1455147
UMLS CUI-2
C0178602
Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)
Descripción

Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)

Alias
UMLS CUI-1
C2347852
Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)
Descripción

Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)

DEATH DATA
Descripción

DEATH DATA

Did the subject die?
Descripción

Did the subject die?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011065
Date of death:
Descripción

Date of death

Tipo de datos

date

Alias
UMLS CUI [1]
C1148348
Cause of death:
Descripción

Cause of death

Tipo de datos

text

Alias
UMLS CUI [1]
C0007465
For the causes asking for specification, please mention details:
Descripción

For the causes asking for specification, please mention details

Tipo de datos

text

Alias
UMLS CUI [1]
C2348235
ENROLLMENT IN PREVIOUS BMS CA180 PROTOCOL
Descripción

ENROLLMENT IN PREVIOUS BMS CA180 PROTOCOL

Previous protocol number:
Descripción

Previous protocol number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C1518419
Previous site number:
Descripción

Previous site number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0205145
UMLS CUI [1,2]
C0237753
Previous subject number:
Descripción

Previous subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1709561
Date subject or legally authorized representative signed informed consent for previous protocol?
Descripción

Date subject or legally authorized representative signed informed consent for previous protocol?

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
DOSE ADMINISTRATION FOR UNSCHEDULED CSF
Descripción

DOSE ADMINISTRATION FOR UNSCHEDULED CSF

Date and time of dose administration (Day prior to CSF ):
Descripción

Date and time of dose administration

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0011008
Last dose received (in mg):
Descripción

Last dose received (in mg)

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Date and time of dose administration (Day of CSF):
Descripción

Date and time of dose administration (Day of CSF)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0011008
Morning dose received (in mg):
Descripción

Morning dose received (in mg)

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
CSF PHARMACOKINETICS
Descripción

CSF PHARMACOKINETICS

Alias
UMLS CUI-1
C0007806
UMLS CUI-2
C0031328
Were any samples collected?
Descripción

Were any samples collected?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0031328
Actual date and time (3- 4 hours post dose):
Descripción

Actual date and time (3- 4 hours post dose)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0011008
Pharmacokinetic sample label:
Descripción

Pharmacokinetic sample label

Tipo de datos

text

Comments:
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
BLOOD PHARMACOKINETICS
Descripción

BLOOD PHARMACOKINETICS

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Were any samples collected?
Descripción

Were any samples collected?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
Pharmacokinetic sample label:
Descripción

Pharmacokinetic sample label

Tipo de datos

text

Actual date and time (3-4 hr post dose):
Descripción

Actual date and time (3-4 hr post dose)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0011008
Comments:
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
DOSE ADMINISTRATION
Descripción

DOSE ADMINISTRATION

Date and time of dose administration:
Descripción

Date and time of dose administration

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0011008
Last dose received (in mg):
Descripción

Last dose received (in mg)

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS
Descripción

PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS

Were any samples collected?
Descripción

Were any samples collected?

Tipo de datos

boolean

Actual date and time of sample collection:
Descripción

Actual date and time of sample collection

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0011008
Pharmacokinetic sample label:
Descripción

Pharmacokinetic sample label

Tipo de datos

text

Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
DIAGNOSTIC PROCEDURES
Descripción

DIAGNOSTIC PROCEDURES

Alias
UMLS CUI-1
C0430022
Did the subject have any non protocol specified diagnostic procedures performed?
Descripción

Did the subject have any non protocol specified diagnostic procedures performed?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430022
Procedure:
Descripción

Procedure

Tipo de datos

text

Alias
UMLS CUI [1]
C0184661
Date of procedure:
Descripción

Date of procedure

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Reason:
Descripción

Reason

Tipo de datos

text

Alias
UMLS CUI [1]
C0392360
Findings:
Descripción

Findings

Tipo de datos

text

Alias
UMLS CUI [1]
C0243095

Similar models

Supplemental page

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
EXCEPTION
C1705847 (UMLS CUI-1)
Item
Was an exception granted?
text
C1705847 (UMLS CUI [1])
Code List
Was an exception granted?
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not applicable (3)
date
Item
Date exception granted:
date
C0011008 (UMLS CUI [1])
Inclusion number
Item
Inclusion number:
integer
Exclusion number
Item
Exclusion number:
integer
Personnel
Item
Exception granted by (Personnel):
text
comment
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Please see https://medical-data-models.org/forms/11515 (Previous and current medications)
C0013227 (UMLS CUI-1)
Item Group
Please see https://medical-data-models.org/forms/11515 (Pre- treatment events)
Item Group
Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
C0005954 (UMLS CUI-1)
Item Group
Please see https://medical-data-models.org/forms/11515 (Medical tests and examinations)
C1623258 (UMLS CUI-1)
Item Group
Please see https://medical-data-models.org/forms/11515 (General Medical History)
Item Group
Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
C1879316 (UMLS CUI-1)
Item Group
FLUORESCENT IN SITU HYBRIDIZATION (FISH)
C0162789 (UMLS CUI-1)
FLUORESCENT IN SITU HYBRIDIZATION
Item
Was a FISH analysis performed?
boolean
C0162789 (UMLS CUI [1])
date
Item
Date:
date
C0011008 (UMLS CUI [1])
Item
Sample type:
text
C2347029 (UMLS CUI [1])
Code List
Sample type:
CL Item
Peripheral blood (1)
CL Item
Bone marrow (2)
CL Item
Extramedullary (3)
Extramedullary site
Item
For extramedullary site, please mention the site from the followings, 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other:
text
Item Group
Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)
C1516800 (UMLS CUI-1)
Item Group
LABORATORY TEST RESULTS
C0677077 (UMLS CUI-1)
LABORATORY TEST
Item
Were laboratory tests performed?
boolean
C0022885 (UMLS CUI [1])
Laboratory name
Item
Name of laboratory:
text
C0022877 (UMLS CUI [1])
date
Item
Date of hematology specimen collection:
date
C0011008 (UMLS CUI [1])
Item
Differential:
text
C0162401 (UMLS CUI [1])
Code List
Differential:
CL Item
% (1)
CL Item
Absolute (2)
Hemoglobin
Item
Hemoglobin:
float
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit:
float
C0518014 (UMLS CUI [1])
Red blood cells
Item
Red blood cells:
float
C0362910 (UMLS CUI [1])
White blood cells
Item
White blood cells:
float
C0023508 (UMLS CUI [1])
Platelet count
Item
Platelet count:
float
C0005821 (UMLS CUI [1])
Neutrophils
Item
Neutrophils:
float
C0027950 (UMLS CUI [1])
Bands
Item
Bands:
float
C1882076 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes:
float
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes:
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils:
float
C0362902 (UMLS CUI [1])
Basophils
Item
Basophils:
float
C0200641 (UMLS CUI [1])
Blasts
Item
Blasts:
float
C1982687 (UMLS CUI [1])
Promyelocytes
Item
Promyelocytes:
float
C0455279 (UMLS CUI [1])
Myelocytes
Item
Myelocytes:
float
C0455284 (UMLS CUI [1])
Metamyelocytes
Item
Metamyelocytes:
float
C0229635 (UMLS CUI [1])
Other
Item
Other, please specify:
text
C0205394 (UMLS CUI [1])
date
Item
Date of coagulation specimen collection:
date
C0011008 (UMLS CUI [1])
International normalized ratio
Item
International normalized ratio:
float
C0525032 (UMLS CUI [1])
other
Item
Other, please specify:
text
C0205394 (UMLS CUI [1])
Item
Was the subject fasting?
text
C0015663 (UMLS CUI [1])
Code List
Was the subject fasting?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
date
Item
Date of chemistry specimen collection:
date
C0011008 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT):
integer
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT):
integer
C0201836 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin:
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase:
integer
C0201850 (UMLS CUI [1])
Lactate dehydrogenase (LDH)
Item
Lactate dehydrogenase (LDH):
integer
C0202113 (UMLS CUI [1])
Creatinine
Item
Creatinine:
integer
C1561535 (UMLS CUI [1])
Blood urea nitrogen (BUN)
Item
Blood urea nitrogen (BUN):
float
C0600137 (UMLS CUI [1])
Urea
Item
Urea:
float
C0523961 (UMLS CUI [1])
Potassium
Item
Potassium:
float
C0202194 (UMLS CUI [1])
Uric acid
Item
Uric acid
float
C0365228 (UMLS CUI [1])
Ionized calcium
Item
Ionized calcium:
float
C0373561 (UMLS CUI [1])
Calcium
Item
Calcium:
float
C0201925 (UMLS CUI [1])
Phosphorus
Item
Phosphorus:
float
C0031705 (UMLS CUI [1])
Magnesium
Item
Magnesium:
float
C0024467 (UMLS CUI [1])
Sodium
Item
Sodium:
float
C0337443 (UMLS CUI [1])
Item Group
Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)
Item Group
Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
C1455147 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item Group
Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)
C2347852 (UMLS CUI-1)
Item Group
Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)
Item Group
DEATH DATA
death
Item
Did the subject die?
boolean
C0011065 (UMLS CUI [1])
death date
Item
Date of death:
date
C1148348 (UMLS CUI [1])
Item
Cause of death:
text
C0007465 (UMLS CUI [1])
Code List
Cause of death:
CL Item
Disease (Specify) (1)
CL Item
Study drug toxicity (Specify) (2)
CL Item
Infection (Specify) (3)
CL Item
Other malignancy/ Neoplasm (Specify) (4)
CL Item
Cardiovascular disease (Specify) (5)
CL Item
Fatal bleeding (Specify) (6)
CL Item
Unknown (7)
CL Item
Other (Specify) (8)
specification
Item
For the causes asking for specification, please mention details:
text
C2348235 (UMLS CUI [1])
Item Group
ENROLLMENT IN PREVIOUS BMS CA180 PROTOCOL
protocol number
Item
Previous protocol number:
text
C3274381 (UMLS CUI [1,1])
C1518419 (UMLS CUI [1,2])
Site number
Item
Previous site number:
integer
C0205145 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Subject number
Item
Previous subject number:
integer
C1709561 (UMLS CUI [1])
Date
Item
Date subject or legally authorized representative signed informed consent for previous protocol?
date
C0011008 (UMLS CUI [1])
Item Group
DOSE ADMINISTRATION FOR UNSCHEDULED CSF
date and time
Item
Date and time of dose administration (Day prior to CSF ):
datetime
C0011008 (UMLS CUI [1])
dose
Item
Last dose received (in mg):
float
C3174092 (UMLS CUI [1])
date and time
Item
Date and time of dose administration (Day of CSF):
datetime
C0011008 (UMLS CUI [1])
dose
Item
Morning dose received (in mg):
float
C3174092 (UMLS CUI [1])
Item Group
CSF PHARMACOKINETICS
C0007806 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
CSF PHARMACOKINETICS
Item
Were any samples collected?
boolean
C0007806 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
date and time
Item
Actual date and time (3- 4 hours post dose):
datetime
C0011008 (UMLS CUI [1])
Pharmacokinetic sample
Item
Pharmacokinetic sample label:
text
comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
BLOOD PHARMACOKINETICS
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
BLOOD PHARMACOKINETICS
Item
Were any samples collected?
boolean
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
Pharmacokinetic sample
Item
Pharmacokinetic sample label:
text
date and time
Item
Actual date and time (3-4 hr post dose):
datetime
C0011008 (UMLS CUI [1])
Comment
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
DOSE ADMINISTRATION
date and time
Item
Date and time of dose administration:
datetime
C0011008 (UMLS CUI [1])
dose
Item
Last dose received (in mg):
float
C3174092 (UMLS CUI [1])
Item Group
PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS
PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS
Item
Were any samples collected?
boolean
date and time
Item
Actual date and time of sample collection:
datetime
C0011008 (UMLS CUI [1])
Pharmacokinetic sample
Item
Pharmacokinetic sample label:
text
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
DIAGNOSTIC PROCEDURES
C0430022 (UMLS CUI-1)
DIAGNOSTIC PROCEDURES
Item
Did the subject have any non protocol specified diagnostic procedures performed?
boolean
C0430022 (UMLS CUI [1])
Procedure
Item
Procedure:
text
C0184661 (UMLS CUI [1])
date
Item
Date of procedure:
date
C0011008 (UMLS CUI [1])
Item
Reason:
text
C0392360 (UMLS CUI [1])
Code List
Reason:
CL Item
Adverse event (1)
CL Item
Other (2)
Findings
Item
Findings:
text
C0243095 (UMLS CUI [1])