Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sampling not done
integer
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sampling not done
CL Item
Haematology sampling not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sampling not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Clinical Chemistry sampling not done
CL Item
Clinical Chemistry sampling not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Urinalysis sampling not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis sampling not done
CL Item
Urinalysis sampling not done (1)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sampling not done
integer
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sampling not done
CL Item
Haematology sampling not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sampling not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Clinical Chemistry sampling not done
CL Item
Clinical Chemistry sampling not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Urinalysis sampling not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis sampling not done
CL Item
Urinalysis sampling not done (1)
AST/ ALT Date and time sample taken
Item
AST/ ALT Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Item
AST/ ALT sampling not done
integer
C0201899 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0201899 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
C1272696 (UMLS CUI [2,4])
Code List
AST/ ALT sampling not done
CL Item
AST/ ALT sampling not done (1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (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 (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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)
Actual date/ time
Item
Actual date/ time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Date of subject completion or date and time of subject withdrawal
Item
Date of subject completion or date and time of subject withdrawal
datetime
C2983670 (UMLS CUI [1])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If subject was withdrawn from study, specify primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If subject was withdrawn from study, specify primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (6)
CL Item
Other, specify (7)
If other reason for withdrawal, please specify
Item
If other reason for withdrawal, please specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Code List
Case book ready for signature
Office Use 1
Item
Office Use 1
boolean
C0442603 (UMLS CUI [1])
Office Use 2
Item
Office Use 2
text
C0442603 (UMLS CUI [1])
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not Applicable (X)