Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology)
Item
Has the subject fasted? (Haematology)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematologic test
integer
C0018941 (UMLS CUI [1])
Code List
Haematologic test
Numeric result (Haemoatology)
Item
Numeric result (Haemoatology)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Character result (Haematology)
Item
Character result (Haematology)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Item
No result (Haematology)
integer
C0474523 (UMLS CUI [1])
Code List
No result (Haematology)
Item Group
Local Laboratory - Clinical Chemistry (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry)
Item
Has the subject fasted? (Clinical Chemistry)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Code List
Clinical Chemistry Test
CL Item
Total Bilrubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Glucose Fasting (5)
CL Item
Total Protein (7)
CL Item
Alkaline Phosphatase (15)
Numeric result (Clinical Chemistry)
Item
Numeric result (Clinical Chemistry)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry)
Item
Character result (Clinical Chemistry)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Code List
No result (Clinical Chemistry)
Item Group
Investigational Product (Dose) (Period 1 - 3)
C0304229 (UMLS CUI-1)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Number of Inhalations
Item
Number of Inhalations
integer
C0354922 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If subject did not recieve the correct treatment, record reason
Item
If subject did not recieve the correct treatment, record reason
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Item Group
ECG (Period 1 - 3)
C0013798 (UMLS CUI-1)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
CL Item
24 hours Post-Dose (10)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval
Item
QTc (b) Interval
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs (Period 1 - 3)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Vital Signs Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Code List
Vital Signs Timepoint
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
CL Item
24 hours Post-Dose (10)
CL Item
36 hours Post-Dose (11)
CL Item
48 hours Post-Dose (12)
Vital Signs - Actual time
Item
Vital Signs - Actual time
time
C2826762 (UMLS CUI [1])
Vital Signs - Diastolic Blood Pressure
Item
Vital Signs - Diastolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Vital Signs - Systolic Blood Pressure
Item
Vital Signs - Systolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests (Period 1 - 3)
C0024119 (UMLS CUI-1)
Dosing date/time (Pulmonary Function Tests)
Item
Dosing date/time (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1])
C0024119 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item
Pulmonary Function Tests Timepoint
integer
C0024119 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Code List
Pulmonary Function Tests Timepoint
CL Item
2 hours Post-Dose (2)
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 (3 readings) - 1
Item
FEV1 (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2
Item
FEV1 (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3
Item
FEV1 (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (24Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology, 24 Hr Lab)
Item
Date and time sample taken (Haematology, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology, 24 Hr Lab)
Item
Has the subject fasted? (Haematology, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (24 Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematologic test (24 Hr Lab)
integer
C0018941 (UMLS CUI [1])
Code List
Haematologic test (24 Hr Lab)
Numeric result (Haemoatology, 24 Hr Lab)
Item
Numeric result (Haemoatology, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Character result (Haematology, 24 Hr Lab)
Item
Character result (Haematology, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Item
No result (Haematology, 24 Hr Lab)
integer
C0474523 (UMLS CUI [1])
Code List
No result (Haematology, 24 Hr Lab)
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
Item
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
Item
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test (24 Hr Lab)
integer
C0525044 (UMLS CUI [1])
Code List
Clinical Chemistry Test (24 Hr Lab)
CL Item
Total Bilrubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Glucose Fasting (5)
CL Item
Total Protein (7)
CL Item
Alkaline Phosphatase (15)
Numeric result (Clinical Chemistry, 24 Hr Lab)
Item
Numeric result (Clinical Chemistry, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry, 24 Hr Lab)
Item
Character result (Clinical Chemistry, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry, 24 Hr Lab)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Code List
No result (Clinical Chemistry, 24 Hr Lab)
Item Group
Pharmacokinetics Blood (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Dosing date/time (Pharmacokinetics Blood)
Item
Dosing date/time (Pharmacokinetics Blood)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0005767 (UMLS CUI [2,2])
Item Group
Pharmacokinetics Blood (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Pharmacokinetics Blood Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
Code List
Pharmacokinetics Blood Timepoint
CL Item
5 mins Post-Dose (2)
CL Item
15 minsPost-Dose (3)
CL Item
30 mins Post-Dose (4)
CL Item
1 hour Post-Dose (5)
CL Item
2 hours Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
CL Item
16 hours Post-dose (10)
CL Item
20 hours Post-Dose (11)
CL Item
24 hours Post-Dose (Day 2) (12)
CL Item
48 hours Post-Dose (Day 3) (13)
Actual date/time (Pharmacokinetics Blood)
Item
Actual date/time (Pharmacokinetics Blood)
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item Group
Pharmacokinetics Urine (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
Dosing date/time (Pharmacokinetics Urine)
Item
Dosing date/time (Pharmacokinetics Urine)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Item Group
Pharmacokinetics Urine (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
Item
Pharmacokinetics Urine Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
Code List
Pharmacokinetics Urine Timepoint
CL Item
0 - 4 hours Post-Dose (1)
CL Item
4 - 8 hours Post-Dose (2)
CL Item
8 - 12 hours Post-Dose (3)
CL Item
12 - 24 hours Post-Dose (4)
CL Item
24 - 48 hours Post-Dose (5)
Was all of the sample collected for this interval? (Pharmacokinetics Urine)
Item
Was all of the sample collected for this interval? (Pharmacokinetics Urine)
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Start date and Actual start time (Pharmacokinetics Urine)
Item
Start date and Actual start time (Pharmacokinetics Urine)
datetime
C3897500 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Stop date and Actual stop time (Pharmacokinetics Urine)
Item
Stop date and Actual stop time (Pharmacokinetics Urine)
datetime
C3899266 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Total sample volume (Pharmacokinetics Urine)
Item
Total sample volume (Pharmacokinetics Urine)
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])