ID

41346

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 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

Hematology (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
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 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
RBC - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0014772
RBC - Clincally Significant
Description

RBC count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C2826293
RBC - If clinically significant, please comment
Description

RBC count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0014772
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
Neutrophils - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0200633
Neutrophils - Clincally Significant
Description

Neutrophil Cell Count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0200633
UMLS CUI [1,2]
C2826293
Neutrophils - If clinically significant, please comment
Description

Neutrophil Cell Count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0200633
UMLS CUI [1,2]
C0947611
Lymphocytes - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0200635
Lymphocytes - Clincally Significant
Description

Lymphocyte Cell Count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C2826293
Lymphocytes - If clinically significant, please comment
Description

Lymphocyte Cell Count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C0947611
Monocytes - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0750880
Monocytes - Clincally Significant
Description

Monocyte Cell Count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0750880
UMLS CUI [1,2]
C2826293
Monocytes - If clinically significant, please comment
Description

Monocyte Cell Count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0750880
UMLS CUI [1,2]
C0947611
Eosinophils - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0750879
Eosinophils - Clincally Significant
Description

Eosinophil Cell Count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0750879
UMLS CUI [1,2]
C2826293
Eosinophils - If clinically significant, please comment
Description

Eosinophil Cell Count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0750879
UMLS CUI [1,2]
C0947611
Basophils - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0200641
Basophils - Clincally Significant
Description

Basophil Cell Count - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C2826293
Basophils - If clinically significant, please comment
Description

Basophil Cell Count - comment

Data type

text

Alias
UMLS CUI [1,1]
C0200641
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 (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
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 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])
Hemoglobin measurement - clinical significance
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])
Hemoglobin measurement - clinical significance
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])
Hemoglobin measurement - clinical significance
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])
RBC count
Item
RBC - Result
float
C0014772 (UMLS CUI [1])
Item
RBC - Clincally Significant
text
C0014772 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemoglobin measurement - clinical significance
Code List
RBC - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
RBC count - comment
Item
RBC - If clinically significant, please comment
text
C0014772 (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])
Hemoglobin measurement - clinical significance
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])
Neutrophil Cell Count
Item
Neutrophils - Result
float
C0200633 (UMLS CUI [1])
Item
Neutrophils - Clincally Significant
text
C0200633 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemoglobin measurement - clinical significance
Code List
Neutrophils - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
Neutrophil Cell Count - comment
Item
Neutrophils - If clinically significant, please comment
text
C0200633 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Lymphocyte Cell Count
Item
Lymphocytes - Result
float
C0200635 (UMLS CUI [1])
Item
Lymphocytes - Clincally Significant
text
C0200635 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemoglobin measurement - clinical significance
Code List
Lymphocytes - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
Lymphocyte Cell Count - comment
Item
Lymphocytes - If clinically significant, please comment
text
C0200635 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Monocyte Cell Count
Item
Monocytes - Result
float
C0750880 (UMLS CUI [1])
Item
Monocytes - Clincally Significant
text
C0750880 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemoglobin measurement - clinical significance
Code List
Monocytes - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
Monocyte Cell Count - comment
Item
Monocytes - If clinically significant, please comment
text
C0750880 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Eosinophil Cell Count
Item
Eosinophils - Result
float
C0750879 (UMLS CUI [1])
Item
Eosinophils - Clincally Significant
text
C0750879 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemoglobin measurement - clinical significance
Code List
Eosinophils - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
Eosinophil Cell Count - comment
Item
Eosinophils - If clinically significant, please comment
text
C0750879 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Basophil Cell Count
Item
Basophils - Result
float
C0200641 (UMLS CUI [1])
Item
Basophils - Clincally Significant
text
C0200641 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemoglobin measurement - clinical significance
Code List
Basophils - Clincally Significant
CL Item
Yes (Yes)
CL Item
No (No)
Basophil Cell Count - comment
Item
Basophils - If clinically significant, please comment
text
C0200641 (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])
Hemoglobin measurement - clinical significance
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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