English

Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Description

Study centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient #
Description

patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Pre-Treatment Anticoagulation
Description

Pre-Treatment Anticoagulation

Alias
UMLS CUI-1
C0003281
UMLS CUI-2
C0332152
UMLS CUI-3
C2347804
Was heparin being administered prior to study Argatroban administration?
Description

*If Yes, ACT or aPTT results must be from BEFORE heparin was administered. **If No, ACT or aPTT results must be completed up to 96 hours prior to treatment initiation. In either case, PT/INR results must be completed within 96 hours before treatment initiation.

Data type

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C4684789
Laboratory Name:
Description

(Lab name must match name on lab normals.)

Data type

text

Alias
UMLS CUI [1]
C3258037
Check to indicate copy of associated lab report is attached to CRF.
Description

Is a copy of the lab report attached?

Data type

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0587081
aPPT
Description

(check if test performed)

Data type

boolean

Alias
UMLS CUI [1]
C0030605
aPPT - Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C2985720
aPPT - Time
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
aPTT - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C0587081
aPTT - Clinically Significant
Description

aPTT - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C2826293
aPTT - If clinically significant, please comment
Description

aPPT - comment on clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C1846819
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C2826293
PT or INR
Description

(check which test was performed)

Data type

text

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
PT or INR - Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C2985720
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C2985720
PT or INR - Time
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0040223
PT or INR - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C0587081
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C0587081
PT or INR - Clinically Significant
Description

PT - clinical significance | INR - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C2826293
PT or INR - If clinically significant, please comment
Description

PT - comment on clinical significance | INR - comment on clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C0947611
UMLS CUI [2,3]
C2826293
ACT
Description

(check if test performed)

Data type

boolean

Alias
UMLS CUI [1]
C0427611
ACT - Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C2985720
ACT - Time
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
ACT - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C0587081
ACT - Clinically Significant
Description

ACT - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C2826293
ACT - If clinically significant, please comment
Description

ACT - comment on clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C2826293
Samples for Pre-Treatment PK and Confirmatory HIT Testing
Description

Samples for Pre-Treatment PK and Confirmatory HIT Testing

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0031328
UMLS CUI-3
C0919799
Pre-treatment PK sample collected?
Description

Pharmacokinetic sample collection pre-treatment

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C2709094
*Date Collected:
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0031328
*Time Collected:
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0031328
*Check to indicate PK sample sent to GSK
Description

Pharmacokinetic sample sent to sponsor

Data type

boolean

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0370003
UMLS CUI [1,4]
C1515023
Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
Description

Confirmatory HIT testing sample collection

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0919799
UMLS CUI [1,3]
C0750484
*Date Collected:
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0919799
*Time Collected:
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0919799
*Check to indicate confirmatory HIT sample sent to central lab
Description

HIT testing sample sent to central lab

Data type

boolean

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0919799
UMLS CUI [1,3]
C0370003
UMLS CUI [1,4]
C1515023
Indication for Argatroban Use
Description

Indication for Argatroban Use

Alias
UMLS CUI-1
C3146298
UMLS CUI-2
C0048470
Cardiac catherization
Description

Cardiac catherization

Data type

boolean

Alias
UMLS CUI [1]
C0018795
Cardiac surgery
Description

Cardiac surgery

Data type

boolean

Alias
UMLS CUI [1]
C0018821
VAD
Description

Artificial ventricle

Data type

boolean

Alias
UMLS CUI [1]
C0085842
ECMO
Description

ECMO

Data type

boolean

Alias
UMLS CUI [1]
C0015357
Hemodialysis
Description

Hemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C0019004
CVVH
Description

CVVH

Data type

boolean

Alias
UMLS CUI [1]
C0472684
Clinical condition requiring continuous infusion therapy
Description

Clinical condition requiring continuous infusion therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1511497
Other
Description

Other clinical condition

Data type

boolean

Alias
UMLS CUI [1]
C3843040
Other, specify:
Description

Other clinical condition - specify

Data type

text

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1521902
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Similar models

Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Item Group
Pre-Treatment Anticoagulation
C0003281 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
Item
Was heparin being administered prior to study Argatroban administration?
text
C0019134 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C4684789 (UMLS CUI [1,3])
Heparin administered prior to study
Code List
Was heparin being administered prior to study Argatroban administration?
CL Item
Yes* (Yes*)
CL Item
No** (No**)
Laboratory Name
Item
Laboratory Name:
text
C3258037 (UMLS CUI [1])
Is a copy of the lab report attached?
Item
Check to indicate copy of associated lab report is attached to CRF.
boolean
C0684224 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
aPPT
Item
aPPT
boolean
C0030605 (UMLS CUI [1])
aPPT - Assessment Date
Item
aPPT - Date
date
C0030605 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
aPPT - Assessment Time
Item
aPPT - Time
time
C0030605 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
aPTT - test result
Item
aPTT - Result
float
C0030605 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
aPTT - Clinically Significant
text
C0030605 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
aPTT - clinical significance
Code List
aPTT - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
aPPT - comment on clinical significance
Item
aPTT - If clinically significant, please comment
text
C1846819 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Item
PT or INR
text
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
PT | INR
Code List
PT or INR
CL Item
PT (PT)
CL Item
INR (INR)
PT - Assessment Date | INR - Assessment Date
Item
PT or INR - Date
date
C0033707 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
PT - Assessment Time | INR - Assessment Time
Item
PT or INR - Time
time
C0033707 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0525032 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
PT - test result | INR - test result
Item
PT or INR - Result
float
C0033707 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
Item
PT or INR - Clinically Significant
text
C0033707 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
aPTT - clinical significance
Code List
PT or INR - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
PT - comment on clinical significance | INR - comment on clinical significance
Item
PT or INR - If clinically significant, please comment
text
C0033707 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0525032 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
ACT
Item
ACT
boolean
C0427611 (UMLS CUI [1])
ACT - Assessment Date
Item
ACT - Date
date
C0427611 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
ACT - Assessment Time
Item
ACT - Time
time
C0427611 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
ACT - test result
Item
ACT - Result
float
C0427611 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
ACT - Clinically Significant
text
C0427611 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
aPTT - clinical significance
Code List
ACT - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
ACT - comment on clinical significance
Item
ACT - If clinically significant, please comment
text
C0427611 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Item Group
Samples for Pre-Treatment PK and Confirmatory HIT Testing
C0200345 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0919799 (UMLS CUI-3)
Item
Pre-treatment PK sample collected?
text
C0200345 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
Pharmacokinetic sample collection
Code List
Pre-treatment PK sample collected?
CL Item
Yes* (Yes*)
CL Item
No (No)
Pharmacokinetic sample collection date
Item
*Date Collected:
date
C1302413 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Pharmacokinetic sample collection time
Item
*Time Collected:
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Pharmacokinetic sample sent to sponsor
Item
*Check to indicate PK sample sent to GSK
boolean
C2347796 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,4])
Item
Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
text
C0200345 (UMLS CUI [1,1])
C0919799 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
Pharmacokinetic sample collection
Code List
Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
CL Item
Yes* (Yes*)
CL Item
No (No)
CL Item
N/A (N/A)
HIT testing sample collection date
Item
*Date Collected:
date
C1302413 (UMLS CUI [1,1])
C0919799 (UMLS CUI [1,2])
HIT testing sample collection time
Item
*Time Collected:
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0919799 (UMLS CUI [1,3])
HIT testing sample sent to central lab
Item
*Check to indicate confirmatory HIT sample sent to central lab
boolean
C1880016 (UMLS CUI [1,1])
C0919799 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,4])
Item Group
Indication for Argatroban Use
C3146298 (UMLS CUI-1)
C0048470 (UMLS CUI-2)
Cardiac catherization
Item
Cardiac catherization
boolean
C0018795 (UMLS CUI [1])
Cardiac surgery
Item
Cardiac surgery
boolean
C0018821 (UMLS CUI [1])
Artificial ventricle
Item
VAD
boolean
C0085842 (UMLS CUI [1])
ECMO
Item
ECMO
boolean
C0015357 (UMLS CUI [1])
Hemodialysis
Item
Hemodialysis
boolean
C0019004 (UMLS CUI [1])
CVVH
Item
CVVH
boolean
C0472684 (UMLS CUI [1])
Clinical condition requiring continuous infusion therapy
Item
Clinical condition requiring continuous infusion therapy
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1511497 (UMLS CUI [1,3])
Other clinical condition
Item
Other
boolean
C3843040 (UMLS CUI [1])
Other clinical condition - specify
Item
Other, specify:
text
C3843040 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
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