ID

43725

Descripción

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Palabras clave

  1. 18/6/17 18/6/17 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0

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Screening - GSK Milveterol COPD 100527

Screening - GSK Milveterol COPD 100527

Inclusion/Exclusion criteria
Descripción

Inclusion/Exclusion criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
Descripción

Inclusion/exclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Demography
Descripción

Demography

Alias
UMLS CUI-1
C0011298
Date of assessment
Descripción

Date of assessment

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2985720
dd.mm.yyyy
Date of birth
Descripción

Date of birth

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0421451
dd.mm.yyyy
Sex
Descripción

Gender

Tipo de datos

integer

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

integer

Alias
UMLS CUI [1]
C0034510
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Duration of Asthma
Descripción

Duration of Asthma

Alias
UMLS CUI-1
C0004096
UMLS CUI-2
C0449238
Duration of Asthma
Descripción

Duration of Asthma

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0449238
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Row number (Three measurements to be taken at least 5 minutes apart.)
Descripción

Sequence number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0518766
Date
Descripción

Date of vital signs

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826644
dd.mm.yyyy
Actual time
Descripción

Time of measurement

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
hh:mm
Systolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
Descripción

SBP

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
Descripción

DBP

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (Heart rate measurement must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead Electrocardiogram
Descripción

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Row number (All measurements must be taken at least 5 mins apart with the subject in a SUPINE position, having rested in this postion for at least 10 min.)
Descripción

Sequence number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0430456
Date
Descripción

Date of ECG

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826640
dd.mm.yyyy
Actual time
Descripción

Time of ECG

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
hh:mm
Ventricular rate
Descripción

Ventricular rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Descripción

PR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Descripción

QRS Duration

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT Interval
Descripción

QT Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Descripción

QTc Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG finding
Descripción

ECG finding

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
Is the abnormality clinically significant?
Descripción

ECG abnormality clinically significant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
FEV1 / Reversibility Testing
Descripción

FEV1 / Reversibility Testing

Alias
UMLS CUI-1
C0024119
Row number
Descripción

Sequence number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0024119
Date
Descripción

Date of lung function test

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
dd.mm.yyyy
Test
Descripción

Lung function test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0332307
Actual time of first reading
Descripción

Time of pulmonary function test

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0024119
hh:mm
Reading 1
Descripción

Reading 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Reading 2
Descripción

Reading 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Reading 3
Descripción

Reading 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Highest reading FEV1 Pre-Salbutamol (A)
Descripción

Highest reading

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0802965
UMLS CUI [1,4]
C0024119
Predicted normal FEV1 (B)
Descripción

Predicted normal

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0802965
UMLS CUI [1,4]
C0024119
% Predicted value (A/B x 100)
Descripción

Percent of Predicted value

Tipo de datos

integer

Unidades de medida
  • %
Alias
UMLS CUI [1]
C2239179
%
Highest reading FEV1 Post-Salbutamol (C)
Descripción

Highest reading

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0802965
UMLS CUI [1,4]
C0024119
% Reversibility (C-A/A x 100)
Descripción

Percent of Reversibility

Tipo de datos

integer

Unidades de medida
  • %
Alias
UMLS CUI [1]
C3830088
%
Highest reading FEV1/FVC
Descripción

Highest reading FEV1/FVC

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0429745
UMLS CUI [1,4]
C0024119
Is the pre-sambutamol FEV1 >60% of predicted?
Descripción

FEV1 percent of predicted value

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239179
Is there an increase in FEV 1 of ≥ 12% over baseline and an absolute change of ≥300ml within 30 minutes following 400µg salbutamol administration?
Descripción

FEV1, volume, reversibility post salbutamol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0802965
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C1271924
Is the post-salbutamol FEV1/FVC ratio ≥ 0.7?
Descripción

post-salbutamol FEV1/FVC ratio

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1271924
UMLS CUI [1,2]
C0429745
Hematology Data
Descripción

Hematology Data

Alias
UMLS CUI-1
C0474523
Lab code
Descripción

Laboratory code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date hematology sample taken
Descripción

Date hematology sample taken

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0474523
dd.mm.yyyy
Time of sample
Descripción

Time of blood sample

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0040223
hh:mm
Were there any clinically significant hematology abnormalities?
Descripción

Hematology abnormality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0850715
UMLS CUI [1,2]
C2985739
Hemoglobin
Descripción

Hemoglobin

Tipo de datos

float

Alias
UMLS CUI [1]
C0019046
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Hematocrit (PCV)
Descripción

Hematocrit

Tipo de datos

float

Alias
UMLS CUI [1]
C0518014
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
RBC
Descripción

RBC

Tipo de datos

float

Alias
UMLS CUI [1]
C0014772
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
MCV
Descripción

MCV

Tipo de datos

float

Alias
UMLS CUI [1]
C1948043
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
MCH
Descripción

MCH

Tipo de datos

float

Alias
UMLS CUI [1]
C0369183
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
MCHC
Descripción

MCHC

Tipo de datos

float

Alias
UMLS CUI [1]
C0474535
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Platelets
Descripción

Platelet count

Tipo de datos

float

Alias
UMLS CUI [1]
C0032181
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Total WBC
Descripción

WBC

Tipo de datos

float

Alias
UMLS CUI [1]
C0023508
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Neutrophils
Descripción

Neutrophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0948762
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Lymphocytes
Descripción

Lymphocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0200635
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Monocytes
Descripción

Monocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0200637
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Eosinophils
Descripción

Eosinophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0200638
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Basophils
Descripción

Basophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0200641
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Clinical Chemistry Data
Descripción

Clinical Chemistry Data

Alias
UMLS CUI-1
C2347783
Lab code
Descripción

Laboratory code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date clinical chemistry sample taken
Descripción

Date clinical chemistry sample taken

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
dd.mm.yyyy
Time of sample
Descripción

Time of sample

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
hh:mm
Were there any clinically significant clinical chemistry abnormalities?
Descripción

clinically significant clinical chemistry abnormalities

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1704258
Sodium
Descripción

Sodium

Tipo de datos

float

Alias
UMLS CUI [1]
C0337443
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Potassium
Descripción

Potassium

Tipo de datos

float

Alias
UMLS CUI [1]
C0202194
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Chloride
Descripción

Chloride

Tipo de datos

float

Alias
UMLS CUI [1]
C0201952
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Calcium
Descripción

Calcium

Tipo de datos

float

Alias
UMLS CUI [1]
C0201925
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Glucose
Descripción

Glucose

Tipo de datos

float

Alias
UMLS CUI [1]
C0202042
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
CPK
Descripción

Creatinine kinase

Tipo de datos

float

Alias
UMLS CUI [1]
C0201973
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Creatinine
Descripción

Creatinine, Serum

Tipo de datos

float

Alias
UMLS CUI [1]
C0201976
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Urea
Descripción

Urea

Tipo de datos

float

Alias
UMLS CUI [1]
C0523961
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Total Bilirubin
Descripción

Total Bilirubin

Tipo de datos

float

Alias
UMLS CUI [1]
C0201913
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Alkaline Phosphatase
Descripción

Alkaline Phosphatase

Tipo de datos

float

Alias
UMLS CUI [1]
C0201850
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
AST (SGOT)
Descripción

AST

Tipo de datos

float

Alias
UMLS CUI [1]
C0201899
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
ALT (SGPT)
Descripción

ALT

Tipo de datos

float

Alias
UMLS CUI [1]
C0201836
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
GGT
Descripción

GGT

Tipo de datos

float

Alias
UMLS CUI [1]
C0202035
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
LDH
Descripción

LDH

Tipo de datos

float

Alias
UMLS CUI [1]
C0202113
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
CK-MB
Descripción

CK MB

Tipo de datos

float

Alias
UMLS CUI [1]
C0523584
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Troponin T
Descripción

Troponin T

Tipo de datos

float

Alias
UMLS CUI [1]
C1141947
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Urinalysis
Descripción

Urinalysis

Alias
UMLS CUI-1
C0042014
Lab code
Descripción

Lab code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042036
dd.mm.yyyy
Time of sample
Descripción

Time sample taken

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042036
hh:mm
Were there any clinically significant urinalysis abnormalities?
Descripción

clinically significant urinalysis abnormalities

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C1704258
Dip sticks: Protein
Descripción

Urine Protein

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430371
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Dip sticks: Blood
Descripción

Urine blood

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430372
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Dip sticks: Ketones
Descripción

Urine Ketones

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430377
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Dip sticks: Glucose
Descripción

Urine Glucose

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430376
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Dip sticks: Bilirubin
Descripción

Urine Bilirubin

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430374
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Dip sticks: Leucocytes
Descripción

Urine Leucocytes

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430381
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Sedimentary microscopy: WBC (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
Descripción

Sedimentary microscopy: WBC

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C0023508
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Sedimentary microscopy: RBC (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
Descripción

Sedimentary microscopy: RBC

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C0014772
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Sedimentary microscopy: Hyaline casts (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
Descripción

Sedimentary microscopy: Hyaline casts

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C2697631
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Sedimentary microscopy: Granular casts (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
Descripción

Sedimentary microscopy: Granular casts

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C2697521
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Sedimentary microscopy: Cellular casts (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
Descripción

Sedimentary microscopy: Cellular casts

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C2699157
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Descripción

clinically significant abnormality reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251

Similar models

Screening - GSK Milveterol COPD 100527

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion/Exclusion criteria
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Inclusion/exclusion criteria
Item
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
White (Origins in the original peoples of Europe, the Middle East, Western Russia, Afghanistan, or the white racial groups of Africa.) (1)
CL Item
Black (Origins in any of the black racial groups of Africa.) (2)
CL Item
Asian (Origins in the original peoples of the Indian subcontinent, the Far East, Southeast Asia, or the Pacific islands.) (3)
CL Item
Other (People whose racial group is not represented above, or whose predominant origin cannot be determined.) (4)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Duration of Asthma
C0004096 (UMLS CUI-1)
C0449238 (UMLS CUI-2)
Item
Duration of Asthma
integer
C0004096 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Code List
Duration of Asthma
CL Item
< 6 months (1)
CL Item
≥ 6 months to < 1 year (2)
CL Item
≥ 1 year to < 3 years  (3)
CL Item
≥ 3 years (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Sequence number
Item
Row number (Three measurements to be taken at least 5 minutes apart.)
integer
C2348184 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Date of vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Time of measurement
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
SBP
Item
Systolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0871470 (UMLS CUI [1])
DBP
Item
Diastolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (Heart rate measurement must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Sequence number
Item
Row number (All measurements must be taken at least 5 mins apart with the subject in a SUPINE position, having rested in this postion for at least 10 min.)
integer
C2348184 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Date of ECG
Item
Date
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
integer
C0577807 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0855331 (UMLS CUI [1])
Item
ECG finding
integer
C0438154 (UMLS CUI [1])
Code List
ECG finding
CL Item
Normal (1)
CL Item
Abnormalities present (2)
ECG abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
FEV1 / Reversibility Testing
C0024119 (UMLS CUI-1)
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Date of lung function test
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Item
Test
integer
C0024119 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Test
CL Item
FEV1 (L) Pre-Salbutamol (1)
CL Item
FEV1 (L) Post-Salbutamol (2)
CL Item
FVC (L) Post-Salbutamol (3)
CL Item
FEV1/FVC Post-Salbutamol (4)
Time of pulmonary function test
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
integer
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Reading 2
Item
Reading 2
integer
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Reading 3
Item
Reading 3
integer
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Highest reading
Item
Highest reading FEV1 Pre-Salbutamol (A)
integer
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
Predicted normal
Item
Predicted normal FEV1 (B)
integer
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
Percent of Predicted value
Item
% Predicted value (A/B x 100)
integer
C2239179 (UMLS CUI [1])
Highest reading
Item
Highest reading FEV1 Post-Salbutamol (C)
integer
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
Percent of Reversibility
Item
% Reversibility (C-A/A x 100)
integer
C3830088 (UMLS CUI [1])
Highest reading FEV1/FVC
Item
Highest reading FEV1/FVC
integer
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0429745 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
FEV1 percent of predicted value
Item
Is the pre-sambutamol FEV1 >60% of predicted?
boolean
C2239179 (UMLS CUI [1])
FEV1, volume, reversibility post salbutamol
Item
Is there an increase in FEV 1 of ≥ 12% over baseline and an absolute change of ≥300ml within 30 minutes following 400µg salbutamol administration?
boolean
C0802965 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C1271924 (UMLS CUI [1,3])
post-salbutamol FEV1/FVC ratio
Item
Is the post-salbutamol FEV1/FVC ratio ≥ 0.7?
boolean
C1271924 (UMLS CUI [1,1])
C0429745 (UMLS CUI [1,2])
Item Group
Hematology Data
C0474523 (UMLS CUI-1)
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date hematology sample taken
Item
Date hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Time of blood sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Hematology abnormality
Item
Were there any clinically significant hematology abnormalities?
boolean
C0850715 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Hematocrit
Item
Hematocrit (PCV)
float
C0518014 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
RBC
Item
RBC
float
C0014772 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
MCV
Item
MCV
float
C1948043 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
MCH
Item
MCH
float
C0369183 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Platelet count
Item
Platelets
float
C0032181 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
WBC
Item
Total WBC
float
C0023508 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Monocytes
Item
Monocytes
float
C0200637 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item Group
Clinical Chemistry Data
C2347783 (UMLS CUI-1)
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date clinical chemistry sample taken
Item
Date clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
clinically significant clinical chemistry abnormalities
Item
Were there any clinically significant clinical chemistry abnormalities?
boolean
C2985739 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Creatinine kinase
Item
CPK
float
C0201973 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Creatinine, Serum
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
GGT
Item
GGT
float
C0202035 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
CK MB
Item
CK-MB
float
C0523584 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Troponin T
Item
Troponin T
float
C1141947 (UMLS CUI [1])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
Time sample taken
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
clinically significant urinalysis abnormalities
Item
Were there any clinically significant urinalysis abnormalities?
boolean
C0042014 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Dip sticks: Protein
integer
C0430371 (UMLS CUI [1])
Code List
Dip sticks: Protein
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item
Dip sticks: Blood
integer
C0430372 (UMLS CUI [1])
Code List
Dip sticks: Blood
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item
Dip sticks: Ketones
integer
C0430377 (UMLS CUI [1])
Code List
Dip sticks: Ketones
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item
Dip sticks: Glucose
integer
C0430376 (UMLS CUI [1])
Code List
Dip sticks: Glucose
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item
Dip sticks: Bilirubin
integer
C0430374 (UMLS CUI [1])
Code List
Dip sticks: Bilirubin
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item
Dip sticks: Leucocytes
integer
C0430381 (UMLS CUI [1])
Code List
Dip sticks: Leucocytes
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Sedimentary microscopy: WBC
Item
Sedimentary microscopy: WBC (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Sedimentary microscopy: RBC
Item
Sedimentary microscopy: RBC (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Sedimentary microscopy: Hyaline casts
Item
Sedimentary microscopy: Hyaline casts (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C2697631 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Sedimentary microscopy: Granular casts
Item
Sedimentary microscopy: Granular casts (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Sedimentary microscopy: Cellular casts
Item
Sedimentary microscopy: Cellular casts (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)

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