ID

41462

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 Hematology Form (treatment period) is to be completed during the Treatment Period. To be completed daily and as clinically indicated.

Link

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

Keywords

Versions (1)
  1. 10/18/20 10/18/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 18, 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

Hematology (treatment period)

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
Check if (additional) supplemental instance of this form was used.
Description

Use one instance for every three lab result sets. Check this box on all instances except for the last one.

Data type

boolean

Alias
UMLS CUI [1]
C1706499
Instance Number
Description

Fill in the instance number, starting from 1. On all instances except for the last one, the preceding box has to be checked.

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C2348184
N/A
Description

Only for supplemental instances

Data type

boolean

Alias
UMLS CUI [1]
C1272460
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Date:
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0018941
Time:
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0018941
Not Done
Description

Laboratory procedures not performed - hematology

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0445106
UMLS CUI [1,3]
C0474523
Laboratory Name:
Description

(Lab name must match name on lab normals.)

Data type

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0474523
Check to indicate copy of associated lab report for each draw is attached to CRF.
Description

Copy of hematology report attached

Data type

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0474523
Hemoglobin - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0518015
Hemoglobin - Clinically Significant
Description

Hemoglobin measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C2826293
Hemoglobin - If clinically significant, please comment
Description

Hemoglobin measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0947611
Hematocrit - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0518014
Hematocrit - Clinically Significant
Description

Hematocrit measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C2826293
Hematocrit - If clinically significant, please comment
Description

Hematocrit measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C0947611
Platelets - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0032181
Platelets - Clinically Significant
Description

Platelet count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C2826293
Platelets - If clinically significant, please comment
Description

Platelet count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C0947611
WBC - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0023508
WBC - Clincally Significant
Description

WBC count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C2826293
WBC - If clinically significant, please comment
Description

WBC count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0947611
Other - Specify:
Description

(specify test name)

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1521902
Other - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0474523
Other - Clincally Significant
Description

Other hematologic test - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C2826293
Other - If clinically significant, please comment
Description

Other hematologic test - comment

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0947611
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Similar models

Hematology (treatment period)

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])
Additional form
Item
Check if (additional) supplemental instance of this form was used.
boolean
C1706499 (UMLS CUI [1])
CRF Sequential Number
Item
Instance Number
text
C1516308 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
N/A
Item
N/A
boolean
C1272460 (UMLS CUI [1])
Item Group
Hematology
C0474523 (UMLS CUI-1)
Date of hematologic test
Item
Date:
date
C0011008 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Time of hematologic test
Item
Time:
time
C0040223 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Laboratory procedures not performed - hematology
Item
Not Done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Laboratory name - hematology
Item
Laboratory Name:
text
C3258037 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Copy of hematology report attached
Item
Check to indicate copy of associated lab report for each draw is attached to CRF.
boolean
C0684224 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Hemoglobin measurement
Item
Hemoglobin - Result
float
C0518015 (UMLS CUI [1])
Item
Hemoglobin - Clinically Significant
text
C0518015 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Laboratory procedures not performed - hematology
Code List
Hemoglobin - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Hemoglobin measurement - comment
Item
Hemoglobin - If clinically significant, please comment
text
C0518015 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Hematocrit measurement
Item
Hematocrit - Result
float
C0518014 (UMLS CUI [1])
Item
Hematocrit - Clinically Significant
text
C0518014 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Laboratory procedures not performed - hematology
Code List
Hematocrit - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Hematocrit measurement - comment
Item
Hematocrit - If clinically significant, please comment
text
C0518014 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Platelet count
Item
Platelets - Result
float
C0032181 (UMLS CUI [1])
Item
Platelets - Clinically Significant
text
C0032181 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Laboratory procedures not performed - hematology
Code List
Platelets - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Platelet count - comment
Item
Platelets - If clinically significant, please comment
text
C0032181 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
WBC count
Item
WBC - Result
float
C0023508 (UMLS CUI [1])
Item
WBC - Clincally Significant
text
C0023508 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Laboratory procedures not performed - hematology
Code List
WBC - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
WBC count - comment
Item
WBC - If clinically significant, please comment
text
C0023508 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Other hematologic test - specify
Item
Other - Specify:
text
C0205394 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other hematologic test - result
Item
Other - Result
float
C0205394 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Item
Other - Clincally Significant
text
C0205394 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Laboratory procedures not performed - hematology
Code List
Other - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
Other hematologic test - comment
Item
Other - If clinically significant, please comment
text
C0205394 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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