Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Code List
Subject position
Heart rate
Item
Heart rate
text
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Code List
Location of temperature
CL Item
Intra-arterial (5)
Haematology Date sample taken
Item
Haematology Date sample taken
date
C0018941 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Haematology sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sample taken - Not Done
Biochemistry Date sample take
Item
Biochemistry Date sample taken
date
C0005477 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Biochemistry sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Biochemistry sample taken - Not Done
Urinalysis Date sample taken
Item
Urinalysis Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item
Urinalysis sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis sample taken - Not Done
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Sample taken before infusion?
Item
Sample taken before infusion?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
Sample taken before infusion - Actual date and time
Item
Sample taken before infusion - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
Sample taken before infusion - Sample Identifier/ Sample Number
Item
Sample taken before infusion - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
Sample taken at end of infusion?
Item
Sample taken at end of infusion?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
Sample taken at end of infusion - Actual date and time
Item
Sample taken at end of infusion - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
Sample taken at end of infusion - Sample Identifier/ Sample Number
Item
Sample taken at end of infusion - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
PK Type Code
Item
PK Type Code
text
C0031328 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Investigational Product - Sequence Number
Item
Investigational Product - Sequence Number
integer
C0304229 (UMLS CUI [1])
C2348184 (UMLS CUI [2])
Investigational product code
Item
Investigational product code
text
C0304229 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product - Start date and time
Item
Investigational product - Start date and time
datetime
C3897500 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product - Stop date and time
Item
Investigational product - Stop date and time
datetime
C3899266 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Was dose interrupted?
Item
Was dose interrupted?
boolean
C3174092 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Item
Primary reason for interruption
text
C3174092 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Code List
Primary reason for interruption
CL Item
Adverse event (13)
CL Item
Subject non-compliance (7)
CL Item
Mechanical problem (8)
CL Item
Other, specify reason (OT)
Rate of Infusion
Item
Rate of Infusion
integer
C2964135 (UMLS CUI [1])
Rate of infusion unit
Item
Rate of infusion unit
text
C2964135 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Total volume of infusion administered
Item
Total volume of infusion administered
integer
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Was the total volume of infusion administered?
Item
Was the total volume of infusion administered?
boolean
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Primary reason for stoppage?
text
C0574032 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C1947925 (UMLS CUI [2,2])
Code List
Primary reason for stoppage?
CL Item
Adverse event (13)
CL Item
Subject non-compliance (7)
CL Item
Mechanical problem (8)
CL Item
Other, Specify (OT)
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])