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Informações:
Falhas:
ID
22986
Descrição
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
Palavras-chave
Versões (2)
- 19/06/2017 19/06/2017 -
- 20/09/2021 20/09/2021 -
Transferido a
19 de junho de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527
Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527
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Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Investigational Product (Treatment period 1, Day 1)
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Start time of inhalation
Item
Start time of inhalation
time
C1301880 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
End time of inhalation
Item
End time of inhalation
time
C1522314 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
investigational product change of administration
Item
Were there any significant changes to investigational product (investigational product not administered as per the requirements of the protocol)?
boolean
C0304229 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Specification investigational product change of administration
Item
If 'Yes', specify investigational product changes, dates, and reasons:
text
C2348235 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
Item Group
Investigational Product (Treatment period 1, Day 2)
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Start time of inhalation
Item
Start time of inhalation
time
C1301880 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
End time of inhalation
Item
End time of inhalation
time
C1522314 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
investigational product change of administration
Item
Were there any significant changes to investigational product (investigational product not administered as per the requirements of the protocol)?
boolean
C0304229 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Specification investigational product change of administration
Item
If 'Yes', specify investigational product changes, dates, and reasons:
text
C2348235 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
Item Group
Hematology Data (Treatment Period 1, Day 1, Pre-dose)
C0474523 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
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])
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])
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])
C2985739 (UMLS CUI [1,2])
CL Item
Hemoglobin (1)
CL Item
Hematocrit (PCV) (2)
CL Item
RBC (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
Platelets (7)
CL Item
Total WBC (8)
CL Item
Neutrophils (9)
CL Item
Lymphocytes (10)
CL Item
Monocytes (11)
CL Item
Eosinophils (12)
CL Item
Basophils (13)
Hematology test result
Item
Hematology test result
float
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
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 (Treatment Period 1, Day 1, Pre-dose)
C2347783 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
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])
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])
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])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Clinical chemistry test
integer
C0525044 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Calcium (4)
CL Item
Glucose (5)
CL Item
CPK (6)
CL Item
Creatinine (7)
CL Item
Urea (8)
CL Item
Total bilirubin (9)
CL Item
Alkaline Phosphatase (10)
CL Item
AST (SGOT) (11)
CL Item
ALT (SGPT) (12)
CL Item
GGT (13)
CL Item
LOH (14)
CL Item
CK-MB (15)
CL Item
Troponin T (16)
Clinical chemistry test result
Item
Clinical chemistry test result
float
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
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 (Treatment Period 1, Day 1, Pre-dose)
C0042014 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
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])
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])
C2985739 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
CL Item
Leucocytes (6)
Item
Dipstick test result
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
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:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
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
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
Code List
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Sedimentary microscopy test result
Item
Sedimentary microscopy test result
float
C2700128 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (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])
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)
Sequence number
Item
Row number (Three pre-dose measurements are to be taken at least 5 mins apart.)
integer
C2348184 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
Date of vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
Mean Pre-Dose (Baseline) (4)
CL Item
15 min (5)
CL Item
30 min (6)
CL Item
1 h (7)
CL Item
2 h (8)
CL Item
3 h (9)
CL Item
4 h (10)
CL Item
5 h (11)
CL Item
6 h (12)
CL Item
8 h (13)
CL Item
10 h (14)
CL Item
12 h (15)
CL Item
14 h (16)
CL Item
16 h (17)
CL Item
22,5 h (18)
CL Item
24 h (19)
CL Item
Unscheduled (20)
Time of measurement
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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])
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])
C0518766 (UMLS CUI [1,2])
Date of vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
45 min (1)
CL Item
Unscheduled (2)
Time of measurement
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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 (Treatment period 1, Day 1)
C0430456 (UMLS CUI-1)
Sequence number
Item
Row number (All measurements to be taken 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])
C0430456 (UMLS CUI [1,2])
Date of ECG
Item
Date
date
C2826640 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
Mean Pre-Dose (Baseline) (4)
CL Item
15 min (5)
CL Item
30 min (6)
CL Item
1 h (7)
CL Item
2 h (8)
CL Item
3 h (9)
CL Item
4 h (10)
CL Item
5 h (11)
CL Item
6 h (12)
CL Item
8 h (13)
CL Item
12 h (14)
CL Item
24 h (15)
CL Item
Unscheduled (16)
Time of ECG
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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])
CL Item
Normal (1)
CL Item
Abnormalities present (2)
ECG abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Item Group
12-Lead Electrocardiogram (Treatment period 1, Day 2)
C0430456 (UMLS CUI-1)
Sequence number
Item
Row number (All measurements to be taken 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])
C0430456 (UMLS CUI [1,2])
Date of ECG
Item
Date
date
C2826640 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
45 min (1)
CL Item
Unscheduled (2)
Time of ECG
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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])
CL Item
Normal (1)
CL Item
Abnormalities present (2)
ECG abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
Date of FEV1
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
Pre-Dose (1)
CL Item
5 min (2)
CL Item
15 min (3)
CL Item
30 min (4)
CL Item
1 h (5)
CL Item
2 h (6)
CL Item
3 h (7)
CL Item
4 h (8)
CL Item
5 h (9)
CL Item
6 h (10)
CL Item
8 h (11)
CL Item
10 h (12)
CL Item
12 h (13)
CL Item
14 h (14)
CL Item
16 h (15)
CL Item
22,5 h (16)
CL Item
24 h (17)
CL Item
Unscheduled (18)
Time of FEV1 measurement
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
Reading 2
Item
Reading 2
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
Reading 3
Item
Reading 3
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
Item Group
Pharmacokinetic sampling (Treatment Period 1, Day 1)
C0201734 (UMLS CUI-1)
Sequence number pharmacokinetic study
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
Date of pharmacokinetic study
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
Pre-Dose (1)
CL Item
15 min (2)
CL Item
30 min (3)
CL Item
45 min (4)
CL Item
1 h (5)
CL Item
2 h (6)
CL Item
3 h (7)
CL Item
4 h (8)
Time of pharmacokinetic study
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
Blood sample taken
Item
4mL blood sample taken
boolean
C1277698 (UMLS CUI [1])
Item Group
Potassium and Glucose (Treatment Period 1, Day 1)
C0202194 (UMLS CUI-1)
C0337438 (UMLS CUI-2)
C0337438 (UMLS CUI-2)
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
C0202194 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
Date of measurement
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
C0202194 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
Pre-Dose (1)
CL Item
30 min (2)
CL Item
1 h (3)
CL Item
2 h (4)
CL Item
3 h (5)
CL Item
4 h (6)
CL Item
8 h (7)
CL Item
12 h (8)
CL Item
24 h (9)
Time of measurement
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
C0202194 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
CL Item
Potassium (1)
CL Item
Glucose (2)
Test result
Item
Result
float
C0587081 (UMLS CUI [1])
Item Group
Pharmacokinetic Urine lnterval Collection Data (Treatment Period 1, Day 1)
C0201734 (UMLS CUI-1)
C1610733 (UMLS CUI-2)
C1610733 (UMLS CUI-2)
Sequence number Pharmacokinetic Urine lnterval Collection
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C1610733 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])
C1610733 (UMLS CUI [1,3])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
CL Item
0-2 h (1)
CL Item
2-8 h (2)
CL Item
8-24 h (3)
Start date urine interval collection
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
Start time urine interval collection
Item
Actual start time
time
C1301880 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
Stop date urine interval collection
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
End time urine interval collection
Item
Actual stop time
time
C1522314 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
Sample number urine interval collection
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
Total sample volume urine interval collection
Item
Total sample volume
integer
C1278293 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
aliquot taken
Item
10 mL aliquot taken
boolean
C1510844 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
all urine collected for this interval
Item
Was all urine collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
Item Group
Hematology Data (Treatment Period 1, Day 1, 24 h Post-Dose)
C0474523 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
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])
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])
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])
C2985739 (UMLS CUI [1,2])
CL Item
Hemoglobin (1)
CL Item
Hematocrit (PCV) (2)
CL Item
RBC (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
Platelets (7)
CL Item
Total WBC (8)
CL Item
Neutrophils (9)
CL Item
Lymphocytes (10)
CL Item
Monocytes (11)
CL Item
Eosinophils (12)
CL Item
Basophils (13)
Hematology test result
Item
Hematology test result
float
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
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 (Treatment Period 1, Day 1, Post-dose)
C2347783 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
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])
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])
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])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Clinical chemistry test
integer
C0525044 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Calcium (4)
CL Item
Glucose (5)
CL Item
CPK (6)
CL Item
Creatinine (7)
CL Item
Urea (8)
CL Item
Total bilirubin (9)
CL Item
Alkaline Phosphatase (10)
CL Item
AST (SGOT) (11)
CL Item
ALT (SGPT) (12)
CL Item
GGT (13)
CL Item
LOH (14)
CL Item
CK-MB (15)
CL Item
Troponin T (16)
Clinical chemistry test result
Item
Clinical chemistry test result
float
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
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 (Treatment Period 1, Day 1, Post-dose)
C0042014 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
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])
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])
C2985739 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
CL Item
Leucocytes (6)
Item
Dipstick test result
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
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:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
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
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
Code List
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Sedimentary microscopy test result
Item
Sedimentary microscopy test result
float
C2700128 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (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])
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)