Vital Signs - Semi-Supine - Actual date/time
Item
Vital Signs - Semi-Supine - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Systolic Blood pressure - Semi-Supine
Item
Systolic Blood pressure - Semi-Supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood pressure - Semi-Supine
Item
Diastolic Blood pressure - Semi-Supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Temperature - Semi-supine
Item
Temperature - Semi-supine
text
C0005903 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Vital signs Predose - Semi-supine - Heart rate
Item
Vital signs - Semi-supine - Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,3])
Respiration rate - Semi-Supine
Item
Respiration rate - Semi-Supine
integer
C0231832 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,3])
Vital Signs - Standing - Actual date/time
Item
Vital Signs - Standing - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Systolic Blood pressure - Standing
Item
Systolic Blood pressure - Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Pre-dose - Standing
Item
Diastolic Blood pressure Pre-dose - Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Vital signs - Standing - Heart rate
Item
Vital signs - Standing - Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,3])
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
12-Lead ECG - Hart rate
Item
12-Lead ECG - Hart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
PR Intreval
Item
PR Intreval
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])
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)
Electronically Transferred Lab Data - Dosing Date and Time
Item
Electronically Transferred Lab Data - Dosing Date and Time
datetime
C0745590 (UMLS CUI [1,1])
C1705822 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
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 sample not taken
integer
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sample not taken
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 sample not taken
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Clinical Chemistry sample not taken
Serum Prolactin Date and time sample taken
Item
Serum Prolactin Date and time sample taken
datetime
C0373706 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Serum Prolactin sample not taken
integer
C0373706 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Serum Prolactin sample not taken
TSH Date and time sample taken
Item
TSH Date and time sample taken
datetime
C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
TSH sample not taken
integer
C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
TSH sample not taken
Testosterone Date and time sample taken
Item
Testosterone Date and time sample taken
datetime
C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Testosterone sample not taken
integer
C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Testosterone sample not taken
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis Sample not taken
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis Sample not taken
Item
Urinalysis Dipstick - pH
integer
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - pH
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Dipstick - pH Numeric Result
Item
Urinalysis Dipstick - pHN umeric Result
float
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - pH Character Result
Item
Urinalysis Dipstick - pH Character Result
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Specific Gravity
integer
C0430383 (UMLS CUI [1])
Code List
Urinalysis Dipstick - Specific Gravity
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Dipstick - Specific Gravitiy Numeric Result
Item
Urinalysis Dipstick - Specific Gravitiy Numeric Result
float
C0430383 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Urinalysis Dipstick - Specific Gravitiy Character Result
Item
Urinalysis Dipstick - Specific Gravitiy Character Result
text
C0430383 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Urinalysis Dipstick - Protein
integer
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - Protein
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Dipstick - Protein Numeric Result
Item
Urinalysis Dipstick - Protein Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - Protein Character Result
Item
Urinalysis Dipstick - Protein Character Result
text
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Glucose
integer
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - Glucose
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Dipstick - Glucose Numeric Result
Item
Urinalysis Dipstick - Glucose Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - Glucose Character Result
Item
Urinalysis Dipstick - Glucose Character Result
text
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Ketones
integer
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - Ketones
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Dipstick - Ketones Numeric Result
Item
Urinalysis Dipstick - Ketones Numeric Result
float
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Urinalysis Dipstick - Ketones Character Result
Item
Urinalysis Dipstick - Ketones Character Result
text
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - RBC
integer
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - RBC
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Dipstick - RBC Numeric Result
Item
Urinalysis Dipstick - RBC Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - RBC Character Result
Item
Urinalysis Dipstick - RBC Character Result
text
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - WBC
integer
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - WBC
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Dipstick - WBC Numeric Result
Item
Urinalysis Dipstick - WBC Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - WBC Character Result
Item
Urinalysis Dipstick - WBC Character Result
text
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of dipstick
If positive urine dipstick result, was sedimentary microscopy performed?
Item
If positive urine dipstick result, was sedimentary microscopy performed?
boolean
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0430397 (UMLS CUI [2,1])
C2700128 (UMLS CUI [2,2])
Urinalysis Microscopy - Date and time sample taken
Item
Urinalysis Microscopy - Date and time sample taken
datetime
C0430397 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Item
Urinalysis Microscopy - White blood cells
integer
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - White blood cells
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Microscopy - White blood cells Numeric Result
Item
Urinalysis Microscopy - White blood cells Numeric Result
float
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - White blood cells Character Result
Item
Urinalysis Microscopy - White blood cells Character Result
text
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Red blood cells
integer
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Red blood cells
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Microscopy - Red blood cells Numeric Result
Item
Urinalysis Microscopy - Red blood cells Numeric Result
float
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Red blood cells Character Result
Item
Urinalysis Microscopy - Red blood cells Character Result
text
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Hyaline casts
text
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Hyaline casts
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Microscopy - Hyaline casts Numeric Result
Item
Urinalysis Microscopy - Hyaline casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Hyaline casts Character Result
Item
Urinalysis Microscopy - Hyaline casts Character Result
text
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Granular casts
integer
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Granular casts
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Microscopy - Granular casts Numeric Result
Item
Urinalysis Microscopy - Granular casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Granular casts Character Result
Item
Urinalysis Microscopy - Granular casts Character Result
text
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Cellular casts
integer
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Cellular casts
CL Item
Numeric result (1)
CL Item
Character result (2)
Urinalysis Microscopy - Cellular casts Numeric Result
Item
Urinalysis Microscopy - Cellular casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Cellular casts Character Result
Item
Urinalysis Microscopy - Cellular casts Character Result
text
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Date of decision to withdraw
Item
If the subject withdrawn from the study, record Date of decision to withdraw.
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If the subject withdrawn from the study, record primary Reason for Withdrawal.
integer
Code List
If the subject withdrawn from the study, record primary Reason for Withdrawal.
CL Item
Adverse Event (1)
CL Item
Record detaiis on the Non-Serious Adverse Events or Serious Adverse (1)
CL Item
Events forrns as appropriate. (2)
CL Item
Protocol deviation (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Withdrew consent (6)
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Code List
Case book ready for signature