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Randomisation and Investigational Product - IV Dosing

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Cohort
Description

Cohort

Data type

text

Alias
UMLS CUI [1]
C0599755
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

If yes, provide Randomisation Number and Date/time of randomisation

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0332149
Randomisation Number
Description

if applicable

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date/time of randomisation
Description

if applicable

Data type

datetime

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1264639
Investigational Product - IV dosing
Description

Investigational Product - IV dosing

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0678766
UMLS CUI-3
C0348016
Start Date and Time
Description

Time is optional

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Stop Date and Time
Description

Time is optional

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Total dose given
Description

Dose of investigational product

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
mg
Units
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C1519795
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

If no, record reasons. Per Protocol treatment: 0.0004 mg/kg (Cohort 1), 0.002 mg/kg (Cohort 2), 0.01 mg/kg (Cohort 3), 0.05 mg/kg (Cohort 4), 0.25 mg/kg (Cohort 5), 2.0 mg/kg (Cohort 6/7), administered over 1 hour (Cohort 1), 2 hours (Cohort 2) or 3 hours (Cohorts 3 to 7).

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
Record reason(s)
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3827420
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Similar models

Randomisation and Investigational Product - IV Dosing

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Cohort
text
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Part A Cohort 1 (A)
CL Item
Part A Cohort 2 (B)
CL Item
Part A Cohort 3 (C)
CL Item
Part B Cohort 4 (D)
CL Item
Part B Cohort 5 (E)
CL Item
Part B Cohort 6 (F)
CL Item
Part B Cohort 7 (open label) (G)
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomisation Date/Time
Item
Date/time of randomisation
datetime
C0034656 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Investigational Product - IV dosing
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C0348016 (UMLS CUI-3)
Start Date/Time Investigational Product Administration
Item
Start Date and Time
partialDatetime
C3897500 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Stop Date/Time Investigational Product Administration
Item
Stop Date and Time
partialDatetime
C3899266 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Dose of investigational product
Item
Total dose given
float
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
Item
Units
text
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Investigational product dose units
Code List
Units
CL Item
Litre  (L)
CL Item
Millilitre (ML)
CL Item
Microlitre (MCL)
CL Item
Gram (G)
CL Item
Milligram (MG)
CL Item
Microgram (UG) (UG)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Correct treatment received
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No (N)
Reason incorrect treatment
Item
Record reason(s)
text
C0566251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
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