ID

25925

Beschreibung

Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

Stichworte

Versionen (1)
  1. 27.09.17 27.09.17 -
Rechteinhaber

Glaxo Smith Kline

Hochgeladen am

27. September 2017

DOI

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GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease.-Repeat Screening Visit/Unscheduled

Englisch

Repeat Screening Visit/Unscheduled

1 Formulare  
Electrocardiogram
Beschreibung

Electrocardiogram

Alias
UMLS CUI-1
C1623258
- Check that the ECG date on the Case Report Form page matches the ECG date on the source document - Check that the time of the ECG is entered in the Case Report Form page. - Check that ECG intervals (PR interval, QT interval, QRS duration, QTc interval) are entered in the Case Report Form page. - Check that ventricular rate/heart rate in beats/min has been entered on the Case Report Form page. - Check that either NORMAL or ABNORMALITIES PRESENT is checked. - If NORMAL is checked, check that no abnormality details are present. - If ABNORMALITIES PRESENT is checked, check that YES or NO is checked to indicate whether they are clinically significant. - If NO is checked, check that none of the listed abnormalities is checked. - If YES is checked, check that at least one of the listed abnormalities is checked. - If VENTRICULAR RHYTHM or MYOCARDIAL INFARCTION is checked, check that details are noted in the comment section. - If OTHER is checked, check that details are specified in the comment section. - Check that either YES or NO is checked to indicate whether there was a clinically significant change [from baseline or the previous ECG]. If YES is checked ensure details are specified.
Beschreibung

Monitor Data Validation Checks Electrocardiogram

Datentyp

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C1623258
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of ECG
Beschreibung

Day Month Year

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Ventricular rate/heart rate
Beschreibung

Ventricular rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2189285
bpm
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT Interval
Beschreibung

QT Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG
Beschreibung

ECG result

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
Were any of the abnormalities clinically significant?
Beschreibung

ECG Result

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
ECG Abnormalities:If YES, check all that apply
Beschreibung

ECG Abnormalities

Datentyp

text

Alias
UMLS CUI [1]
C0522055
Sinus bradycardia
Beschreibung

Sinus bradycardia

Datentyp

boolean

Alias
UMLS CUI [1]
C0085610
Sinus tachycardia
Beschreibung

Sinus tachycardia

Datentyp

boolean

Alias
UMLS CUI [1]
C0039239
Sinus pause
Beschreibung

Sinus pause

Datentyp

boolean

Alias
UMLS CUI [1]
C1955864
Ectopic supraventricular beats
Beschreibung

Ectopic supraventricular beats

Datentyp

boolean

Alias
UMLS CUI [1]
C0033036
Junctional rhythm (<= 100/min)
Beschreibung

Junctional rhythm

Datentyp

boolean

Alias
UMLS CUI [1]
C0232208
Supraventricular tachycardia (>100/min)
Beschreibung

Supraventricular tachycardia

Datentyp

boolean

Alias
UMLS CUI [1]
C0039240
Atrial flutter
Beschreibung

Atrial flutter

Datentyp

boolean

Alias
UMLS CUI [1]
C0004239
Atrial Fibrillation
Beschreibung

Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
Ectopic ventricular beats
Beschreibung

Ectopic ventricular beats

Datentyp

boolean

Alias
UMLS CUI [1]
C0151636
Ventricular rhythm, comment below
Beschreibung

Ventricular rhythm

Datentyp

boolean

Alias
UMLS CUI [1]
C0232216
Pacemaker
Beschreibung

Pacemaker

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C2981711
Left atrial abnormality (P mitrale)
Beschreibung

Left atrial abnormality (P mitrale)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344711
UMLS CUI [1,2]
C0232310
Right atrial abnormality (P pulmonale)
Beschreibung

Right atrial abnormality (P pulmonale)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344696
UMLS CUI [1,2]
C0232308
First degree AV block (PR interval> 0.20 sec)
Beschreibung

First degree AV block

Datentyp

boolean

Alias
UMLS CUI [1]
C0085614
Second degree AV block (Mobitz type 1)
Beschreibung

Second degree AV block (Mobitz type 1)

Datentyp

boolean

Alias
UMLS CUI [1]
C0264907
Second degree AV block (Mobitz type 2)
Beschreibung

Second degree AV block (Mobitz type 2)

Datentyp

boolean

Alias
UMLS CUI [1]
C0155700
Third degree AV block
Beschreibung

Third degree AV block

Datentyp

boolean

Alias
UMLS CUI [1]
C0151517
Left axis deviation (QRS axis more negative than - 30 degrees)
Beschreibung

Left axis deviation (QRS axis more negative than - 30 degrees)

Datentyp

boolean

Alias
UMLS CUI [1]
C0232297
Right axis deviation (ORS axis more positive than + 110 degrees)
Beschreibung

Right axis deviation

Datentyp

boolean

Alias
UMLS CUI [1]
C0232296
Incomplete right bundle branch block
Beschreibung

Incomplete right bundle branch block

Datentyp

boolean

Alias
UMLS CUI [1]
C0262525
Right bundle branch block
Beschreibung

Right bundle branch block

Datentyp

boolean

Alias
UMLS CUI [1]
C0085615
Left bundle branch block
Beschreibung

Left bundle branch block

Datentyp

boolean

Alias
UMLS CUI [1]
C0023211
Nonspecific intraventricular conduction delay (QRS greater than 0,12sec)
Beschreibung

Nonspecific intraventricular conduction delay

Datentyp

boolean

Alias
UMLS CUI [1]
C1882112
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Beschreibung

Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0264897
UMLS CUI [1,2]
C0043202
QT/QTc prolongation
Beschreibung

QT/QTc prolongation

Datentyp

boolean

Alias
UMLS CUI [1]
C0855333
Myocardial infarction, old
Beschreibung

Myocardial infarction, old

Datentyp

boolean

Alias
UMLS CUI [1]
C0155668
Myocardial infarction, other
Beschreibung

comment below

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
Non-specific ST-T changes
Beschreibung

Non-specific ST-T changes

Datentyp

boolean

Alias
UMLS CUI [1]
C1112720
Low QRS voltage
Beschreibung

Low QRS voltage

Datentyp

boolean

Alias
UMLS CUI [1]
C2349945
Other, specify in comments
Beschreibung

Other

Datentyp

boolean

Alias
UMLS CUI [1]
C0205394
Comment
Beschreibung

ECG Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C3845569
Hematology
Beschreibung

Hematology

Alias
UMLS CUI-1
C0018941
Lab code
Beschreibung

For GSK use only

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
Beschreibung

Investigator Instructions

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442085
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
Beschreibung

Monitor Data Validation Checks Hematology

Datentyp

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0200627
Date hematology sample taken
Beschreibung

Date hematology sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0018941
Time of sample
Beschreibung

Time of blood sample

Datentyp

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0018941
Were there any clinically significant hematology abnormalities?
Beschreibung

If YES, record primary reason for the clinically significant abnormality in the column below, by using the following key: D - Due to disease under study, C - Due to other concurrent disease, T - Reasonable possibility due to investigational product, M- Reasonable possibility due to other concomitant medication, X - Other, specify text in the box

Datentyp

boolean

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

Hemoglobin

Datentyp

float

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0587081
Hemoglobin if abnormal: Primary reason for clinically significant abnormality
Beschreibung

Hemoglobin

Datentyp

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Hematocrit (PCV)
Beschreibung

Hematocrit

Datentyp

float

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C0587081
Hematocrit (PCV) Primary reason for clinically significant abnormality
Beschreibung

Hematocrit

Datentyp

text

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
RBC
Beschreibung

RBC

Datentyp

float

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0587081
RBC Primary reason for clinically significant abnormality
Beschreibung

RBC

Datentyp

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Mean Corpuscular Volume
Beschreibung

MCV

Datentyp

float

Maßeinheiten
  • fl
Alias
UMLS CUI [1]
C0524587
fl
Mean Corpuscular Volume Primary reason for clinically significant abnormality
Beschreibung

MCV

Datentyp

text

Alias
UMLS CUI [1,1]
C0524587
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
MCH
Beschreibung

MCH

Datentyp

float

Maßeinheiten
  • pg
Alias
UMLS CUI [1,1]
C0369183
UMLS CUI [1,2]
C0587081
pg
MCH Primary reason for clinically significant abnormality
Beschreibung

MCH

Datentyp

text

Alias
UMLS CUI [1,1]
C0369183
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
MCHC
Beschreibung

MCHC

Datentyp

float

Alias
UMLS CUI [1,1]
C0474535
UMLS CUI [1,2]
C0587081
MCHC Primary reason for clinically significant abnormality
Beschreibung

MCHC

Datentyp

text

Alias
UMLS CUI [1,1]
C0474535
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Platelets
Beschreibung

Platelets

Datentyp

float

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C0587081
Platelets Primary reason for clinically significant abnormality
Beschreibung

Platelets

Datentyp

text

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Total WBC
Beschreibung

Total WBC

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0587081
Total WBC Primary reason for clinically significant abnormality
Beschreibung

Total WBC

Datentyp

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Neutrophils
Beschreibung

Neutrophils

Datentyp

float

Alias
UMLS CUI [1,1]
C0200633
UMLS CUI [1,2]
C0587081
Neutrophils Primary reason for clinically significant abnormality
Beschreibung

Neutrophils

Datentyp

text

Alias
UMLS CUI [1,1]
C0200633
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

float

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C0587081
Lymphocytes Primary reason for clinically significant abnormality
Beschreibung

Lymphocytes

Datentyp

text

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Monocytes
Beschreibung

Monocytes count

Datentyp

float

Alias
UMLS CUI [1,1]
C0200637
UMLS CUI [1,2]
C0587081
Monocytes Primary reason for clinically significant abnormality
Beschreibung

Monocytes count

Datentyp

text

Alias
UMLS CUI [1,1]
C0200637
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Eosinophils
Beschreibung

Eosinophils count

Datentyp

float

Alias
UMLS CUI [1]
C0750879
Eosinophils Primary reason for clinically significant abnormality
Beschreibung

Eosinophils count

Datentyp

text

Alias
UMLS CUI [1,1]
C0750879
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Basophils
Beschreibung

Basophils

Datentyp

float

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C0587081
Basophils Primary reason for clinically significant abnormality
Beschreibung

Basophils

Datentyp

text

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Clinical Chemistry
Beschreibung

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Lab code
Beschreibung

For GSK use only

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
Beschreibung

Investigator Instructions

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442085
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
Beschreibung

Monitor Data Validation Checks Hematology

Datentyp

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0200627
Date clinical chemistry sample taken
Beschreibung

Date clinical chemistry sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
Time of sample
Beschreibung

Time of sample

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
Were there any clinically significant clinical chemistry abnormalities?
Beschreibung

If YES, record primary reason for the clinically significant abnormality in the column below, by using the following key: D - Due to disease under study C - Due to other concurrent disease T - Reasonable possibility due to investigational product M - Reasonable possibility due to other concomitant medication X - Other, specify text in the box

Datentyp

text

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

Sodium

Datentyp

float

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C0587081
Sodium result Primary reason for clinically significant abnormality
Beschreibung

Sodium

Datentyp

text

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Potassium
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C0587081
Potassium Primary reason for clinically significant abnormality
Beschreibung

Potassium

Datentyp

text

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Chloride
Beschreibung

Chloride

Datentyp

float

Alias
UMLS CUI [1,1]
C0201952
UMLS CUI [1,2]
C0587081
Chloride Primary reason for clinically significant abnormality
Beschreibung

Chloride

Datentyp

text

Alias
UMLS CUI [1,1]
C0201952
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Bicarbonate
Beschreibung

Bicarbonate

Datentyp

float

Alias
UMLS CUI [1,1]
C0202059
UMLS CUI [1,2]
C0587081
Bicarbonate Primary reason for clinically significant abnormality
Beschreibung

Bicarbonate

Datentyp

text

Alias
UMLS CUI [1,1]
C0202059
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Glucose
Beschreibung

Glucose

Datentyp

float

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0587081
Glucose Primary reason for clinically significant abnormality
Beschreibung

Glucose

Datentyp

text

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Total Protein
Beschreibung

Total Protein

Datentyp

float

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C0587081
Total Protein Primary reason for clinically significant abnormality
Beschreibung

Total Protein

Datentyp

text

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Albumin
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C0587081
Albumin Primary reason for clinically significant abnormality
Beschreibung

Albumin

Datentyp

text

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Creatinine
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0587081
Creatinine Primary reason for clinically significant abnormality
Beschreibung

Creatinine

Datentyp

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Urea/BUN
Beschreibung

Urea/BUN

Datentyp

float

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C0587081
Urea/BUN Primary reason for clinically significant abnormality
Beschreibung

Urea/BUN

Datentyp

text

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

float

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0587081
Total Bilirubin Primary reason for clinically significant abnormality
Beschreibung

Total Bilirubin

Datentyp

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

float

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0587081
Alkaline Phosphatase Primary reason for clinically significant abnormality
Beschreibung

Alkaline Phosphatase

Datentyp

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
AST (SGOT)
Beschreibung

AST

Datentyp

float

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0587081
AST (SGOT) Primary reason for clinically significant abnormality
Beschreibung

AST

Datentyp

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
ALT (SGPT)
Beschreibung

ALT

Datentyp

float

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0587081
ALT (SGPT) Primary reason for clinically significant abnormality
Beschreibung

ALT

Datentyp

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
GGT
Beschreibung

GGT

Datentyp

float

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C0587081
GGT Primary reason for clinically significant abnormality
Beschreibung

GGT

Datentyp

text

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Urinalysis
Beschreibung

Urinalysis

Alias
UMLS CUI-1
C0042014
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
Beschreibung

Monitor Data Validation Checks Urinalysis

Datentyp

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0042014
Lab code
Beschreibung

(For GSK use only)

Datentyp

integer

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

Date urinalysis sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042014
Time of sample
Beschreibung

Time of sample

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042014
Were there any clinically significant clinical chemistry abnormalities?
Beschreibung

If YES, record primary reason for the clinically significant abnormality in the column below, by using the following key: D - Due to disease under study C - Due to other concurrent disease T - Reasonable possibility due to investigational product M - Reasonable possibility due to other concomitant medication X - Other, specify text in the box

Datentyp

text

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1704258
Dipstick test
Beschreibung

Urinalysis dipstick

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0332307
Dipstick test result
Beschreibung

Dipstick test result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0587081
Dipstick testing Primary reason for clinically significant abnormality
Beschreibung

clinically significant abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0749990
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0749990
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2985739
Sedimentary microscopy
Beschreibung

Sedimentary microscopy

Datentyp

integer

Alias
UMLS CUI [1]
C0430397
Sedimentary microscopy Primary reason for clinically significant abnormality
Beschreibung

clinically significant abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0427860
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0427860
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2985739
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Ähnliche Modelle

Repeat Screening Visit/Unscheduled

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Electrocardiogram
C1623258 (UMLS CUI-1)
Monitor Data Validation Checks Electrocardiogram
Item
- Check that the ECG date on the Case Report Form page matches the ECG date on the source document - Check that the time of the ECG is entered in the Case Report Form page. - Check that ECG intervals (PR interval, QT interval, QRS duration, QTc interval) are entered in the Case Report Form page. - Check that ventricular rate/heart rate in beats/min has been entered on the Case Report Form page. - Check that either NORMAL or ABNORMALITIES PRESENT is checked. - If NORMAL is checked, check that no abnormality details are present. - If ABNORMALITIES PRESENT is checked, check that YES or NO is checked to indicate whether they are clinically significant. - If NO is checked, check that none of the listed abnormalities is checked. - If YES is checked, check that at least one of the listed abnormalities is checked. - If VENTRICULAR RHYTHM or MYOCARDIAL INFARCTION is checked, check that details are noted in the comment section. - If OTHER is checked, check that details are specified in the comment section. - Check that either YES or NO is checked to indicate whether there was a clinically significant change [from baseline or the previous ECG]. If YES is checked ensure details are specified.
text
C1519941 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular rate/heart 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
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
ECG result
Code List
ECG
CL Item
Normal (N)
CL Item
Abnormalities present (A)
Item
Were any of the abnormalities clinically significant?
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
ECG Result
Code List
Were any of the abnormalities clinically significant?
CL Item
Yes (Y)
CL Item
No (N)
ECG Abnormalities
Item
ECG Abnormalities:If YES, check all that apply
text
C0522055 (UMLS CUI [1])
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Sinus tachycardia
Item
Sinus tachycardia
boolean
C0039239 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm (<= 100/min)
boolean
C0232208 (UMLS CUI [1])
Supraventricular tachycardia
Item
Supraventricular tachycardia (>100/min)
boolean
C0039240 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial Fibrillation
Item
Atrial Fibrillation
boolean
C0004238 (UMLS CUI [1])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular rhythm
Item
Ventricular rhythm, comment below
boolean
C0232216 (UMLS CUI [1])
Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1,1])
C2981711 (UMLS CUI [1,2])
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
First degree AV block
Item
First degree AV block (PR interval> 0.20 sec)
boolean
C0085614 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation (QRS axis more negative than - 30 degrees)
Item
Left axis deviation (QRS axis more negative than - 30 degrees)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation
Item
Right axis deviation (ORS axis more positive than + 110 degrees)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Nonspecific intraventricular conduction delay
Item
Nonspecific intraventricular conduction delay (QRS greater than 0,12sec)
boolean
C1882112 (UMLS CUI [1])
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C0264897 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
QT/QTc prolongation
Item
QT/QTc prolongation
boolean
C0855333 (UMLS CUI [1])
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, other
Item
Myocardial infarction, other
boolean
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
Other
Item
Other, specify in comments
boolean
C0205394 (UMLS CUI [1])
ECG Abnormalities
Item
Comment
text
C0522055 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item Group
Hematology
C0018941 (UMLS CUI-1)
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Investigator Instructions
Item
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
text
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Monitor Data Validation Checks Hematology
Item
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
text
C1519941 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
Date hematology sample taken
Item
Date hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Time of blood sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0018941 (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
C0518015 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Hemoglobin if abnormal: Primary reason for clinically significant abnormality
text
C0518015 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Hemoglobin if abnormal: Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hematocrit
Item
Hematocrit (PCV)
float
C0518014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Hematocrit (PCV) Primary reason for clinically significant abnormality
text
C0518014 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Hematocrit (PCV) Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
RBC Primary reason for clinically significant abnormality
text
C0014772 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
RBC Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
MCV
Item
Mean Corpuscular Volume
float
C0524587 (UMLS CUI [1])
Item
Mean Corpuscular Volume Primary reason for clinically significant abnormality
text
C0524587 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Mean Corpuscular Volume Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
MCH
Item
MCH
float
C0369183 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
MCH Primary reason for clinically significant abnormality
text
C0369183 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
MCH Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
MCHC Primary reason for clinically significant abnormality
text
C0474535 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
MCHC Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Platelets
Item
Platelets
float
C0032181 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Platelets Primary reason for clinically significant abnormality
text
C0032181 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Platelets Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Total WBC
Item
Total WBC
integer
C0023508 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Total WBC Primary reason for clinically significant abnormality
text
C0023508 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Total WBC Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Neutrophils Primary reason for clinically significant abnormality
text
C0200633 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Neutrophils Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Lymphocytes Primary reason for clinically significant abnormality
text
C0200635 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Lymphocytes Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Monocytes count
Item
Monocytes
float
C0200637 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Monocytes Primary reason for clinically significant abnormality
text
C0200637 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Monocytes Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Eosinophils count
Item
Eosinophils
float
C0750879 (UMLS CUI [1])
Item
Eosinophils Primary reason for clinically significant abnormality
text
C0750879 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Eosinophils Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Basophils Primary reason for clinically significant abnormality
text
C0200641 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Basophils Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Investigator Instructions
Item
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
text
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Monitor Data Validation Checks Hematology
Item
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
text
C1519941 (UMLS CUI [1,1])
C0200627 (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])
Item
Were there any clinically significant clinical chemistry abnormalities?
text
C2985739 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
ECG Result
Code List
Were there any clinically significant clinical chemistry abnormalities?
CL Item
Yes (Y)
CL Item
No (N)
Sodium
Item
Sodium result
float
C0337443 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Sodium result Primary reason for clinically significant abnormality
text
C0337443 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Sodium result Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Potassium Primary reason for clinically significant abnormality
text
C0202194 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Potassium Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Chloride Primary reason for clinically significant abnormality
text
C0201952 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Chloride Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Bicarbonate
Item
Bicarbonate
float
C0202059 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Bicarbonate Primary reason for clinically significant abnormality
text
C0202059 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Bicarbonate Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Glucose Primary reason for clinically significant abnormality
text
C0202042 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Glucose Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Total Protein Primary reason for clinically significant abnormality
text
C0555903 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Total Protein Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Albumin Primary reason for clinically significant abnormality
text
C0201838 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Albumin Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Creatinine Primary reason for clinically significant abnormality
text
C0201976 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Creatinine Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Urea/BUN
Item
Urea/BUN
float
C0005845 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Urea/BUN Primary reason for clinically significant abnormality
text
C0005845 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Urea/BUN Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Total Bilirubin Primary reason for clinically significant abnormality
text
C0201913 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Total Bilirubin Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Alkaline Phosphatase Primary reason for clinically significant abnormality
text
C0201850 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Alkaline Phosphatase Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
AST (SGOT) Primary reason for clinically significant abnormality
text
C0201899 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
AST (SGOT) Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
ALT (SGPT) Primary reason for clinically significant abnormality
text
C0201836 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
ALT (SGPT) Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
GGT Primary reason for clinically significant abnormality
text
C0202035 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
GGT Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Monitor Data Validation Checks Urinalysis
Item
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
text
C1519941 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date urinalysis sample taken
Item
Date urinalysis sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Item
Were there any clinically significant clinical chemistry abnormalities?
text
C2985739 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
ECG Result
Code List
Were there any clinically significant clinical chemistry abnormalities?
CL Item
Yes (Y)
CL Item
No (N)
Item
Dipstick test
integer
C0430370 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Urinalysis dipstick
Code List
Dipstick test
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Leucocytes (5)
CL Item
Total Bilirubin (6)
Item
Dipstick test result
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Dipstick test result
Code List
Dipstick test result
CL Item
none or negative (0)
CL Item
trace (0.5)
CL Item
+ (1)
CL Item
++ (2)
CL Item
+++ (3)
CL Item
++++ (4)
Item
Dipstick testing Primary reason for clinically significant abnormality
text
C2985739 (UMLS CUI [1,1])
C0749990 (UMLS CUI [1,2])
Hemoglobin
Code List
Dipstick testing Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0749990 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item
Sedimentary microscopy
integer
C0430397 (UMLS CUI [1])
Sedimentary microscopy
Code List
Sedimentary microscopy
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Item
Sedimentary microscopy Primary reason for clinically significant abnormality
text
C2985739 (UMLS CUI [1,1])
C0427860 (UMLS CUI [1,2])
Hemoglobin
Code List
Sedimentary microscopy Primary reason for clinically significant abnormality
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0427860 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
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