ID

41344

Description

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Urinalysis Form has to be filled in twice: first, at the screening visit (within 96 hours before treatment initiation) and second, within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

Keywords

Versions (2)
  1. 8/31/20 8/31/20 -
  2. 9/2/20 9/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 2, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

English

Urinalysis (pre-/post-treatment)

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
Visit Type
Description

Visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date:
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042014
Time:
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0042014
Not Done
Description

Laboratory procedures not performed - Urinalysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0445106
UMLS CUI [1,3]
C0042014
Laboratory Name:
Description

(Lab name must match name on lab normals.)

Data type

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0042014
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
Protein - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0428541
Protein - Clinically Significant
Description

Protein in urine measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0428541
UMLS CUI [1,2]
C2826293
Protein - If clinically significant, please comment
Description

Protein in urine measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0428541
UMLS CUI [1,2]
C0947611
Glucose - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0004076
Glucose - Clinically Significant
Description

Urine glucose measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0004076
UMLS CUI [1,2]
C2826293
Glucose - If clinically significant, please comment
Description

Urine glucose measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0004076
UMLS CUI [1,2]
C0947611
Occult Blood - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C2188744
Occult Blood - Clinically Significant
Description

Urine Occult Blood Measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C2188744
UMLS CUI [1,2]
C2826293
Occult Blood - If clinically significant, please comment
Description

Urine Occult Blood Measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C2188744
UMLS CUI [1,2]
C0947611
pH - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0042044
pH - Clinically Significant
Description

Urine pH measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C2826293
pH - If clinically significant, please comment
Description

Urine pH measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0947611
Specific Gravity - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0202517
Specific Gravity - Clinically Significant
Description

Urine specific gravity measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0202517
UMLS CUI [1,2]
C2826293
Specific Gravity - If clinically significant, please comment
Description

Urine specific gravity measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0202517
UMLS CUI [1,2]
C0947611
Ketones - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C1991100
Ketones - Clinically Significant
Description

Urine ketones measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C2826293
Ketones - If clinically significant, please comment
Description

Urine ketones measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0947611
Micro. Analysis - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0430397
Micro. Analysis - Specify:
Description

Urine microscopic analysis - specify

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1521902
Micro. Analysis - Clinically Significant
Description

Urine microscopic analysis - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2826293
Micro. Analysis - If clinically significant, please comment
Description

Urine microscopic analysis - comment

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0947611
Other - Specify:
Description

(specify test name)

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205394
Other - Clinically Significant
Description

Other urinalysis test - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2826293
Other - If clinically significant, please comment
Description

Other urinalysis test - comment

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
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Similar models

Urinalysis (pre-/post-treatment)

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
Visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Pre-Treatment (Pre-Treatment)
CL Item
Post-Treatment (Post-Treatment)
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of urinalysis
Item
Date:
date
C0011008 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Time of urinalysis
Item
Time:
time
C0040223 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Laboratory procedures not performed - Urinalysis
Item
Not Done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Laboratory name - Urinalysis
Item
Laboratory Name:
text
C3258037 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
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])
Protein in urine measurement
Item
Protein - Result
float
C0428541 (UMLS CUI [1])
Item
Protein - Clinically Significant
text
C0428541 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Protein in urine measurement - clinical significance
Code List
Protein - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Protein in urine measurement - comment
Item
Protein - If clinically significant, please comment
text
C0428541 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urine glucose measurement
Item
Glucose - Result
float
C0004076 (UMLS CUI [1])
Item
Glucose - Clinically Significant
text
C0004076 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Protein in urine measurement - clinical significance
Code List
Glucose - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Urine glucose measurement - comment
Item
Glucose - If clinically significant, please comment
text
C0004076 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urine Occult Blood Measurement
Item
Occult Blood - Result
float
C2188744 (UMLS CUI [1])
Item
Occult Blood - Clinically Significant
text
C2188744 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Protein in urine measurement - clinical significance
Code List
Occult Blood - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Urine Occult Blood Measurement - comment
Item
Occult Blood - If clinically significant, please comment
text
C2188744 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urine pH measurement
Item
pH - Result
float
C0042044 (UMLS CUI [1])
Item
pH - Clinically Significant
text
C0042044 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Protein in urine measurement - clinical significance
Code List
pH - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Urine pH measurement - comment
Item
pH - If clinically significant, please comment
text
C0042044 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urine specific gravity measurement
Item
Specific Gravity - Result
float
C0202517 (UMLS CUI [1])
Item
Specific Gravity - Clinically Significant
text
C0202517 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Protein in urine measurement - clinical significance
Code List
Specific Gravity - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Urine specific gravity measurement - comment
Item
Specific Gravity - If clinically significant, please comment
text
C0202517 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urine ketones measurement
Item
Ketones - Result
float
C1991100 (UMLS CUI [1])
Item
Ketones - Clinically Significant
text
C1991100 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Protein in urine measurement - clinical significance
Code List
Ketones - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Urine ketones measurement - comment
Item
Ketones - If clinically significant, please comment
text
C1991100 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urine microscopic analysis
Item
Micro. Analysis - Result
float
C0430397 (UMLS CUI [1])
Urine microscopic analysis - specify
Item
Micro. Analysis - Specify:
text
C0430397 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Micro. Analysis - Clinically Significant
text
C0430397 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Protein in urine measurement - clinical significance
Code List
Micro. Analysis - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Urine microscopic analysis - comment
Item
Micro. Analysis - If clinically significant, please comment
text
C0430397 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Other urinalysis test - specify
Item
Other - Specify:
text
C0042014 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other urinalysis test
Item
Other - Result
float
C0042014 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Other - Clinically Significant
text
C0042014 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Protein in urine measurement - clinical significance
Code List
Other - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Other urinalysis test - comment
Item
Other - If clinically significant, please comment
text
C0042014 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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