ID

41479

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 - See https://clinicaltrials.gov/ct2/show/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. The Supplemental HIT Assay Data Page is used to record any HIT Assays performed during the course of the Study.

Link

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

Keywords

  1. 10/24/20 10/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 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

Supplemental HIT Assay Data Page

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 17 records. 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

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C2348184
Supplemental HIT Assay Data Page
Description

Supplemental HIT Assay Data Page

Alias
UMLS CUI-1
C0522876
UMLS CUI-2
C1706499
Assay
Description

Type of HIT assay

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0522876
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0522876
Assay Results
Description

HIT assay result

Data type

text

Alias
UMLS CUI [1,1]
C0522876
UMLS CUI [1,2]
C1274040

Similar models

Supplemental HIT Assay Data Page

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
integer
C1516308 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item Group
Supplemental HIT Assay Data Page
C0522876 (UMLS CUI-1)
C1706499 (UMLS CUI-2)
Item
Assay
integer
C0332307 (UMLS CUI [1,1])
C0522876 (UMLS CUI [1,2])
Code List
Assay
CL Item
HPF4  (1)
CL Item
SRA  (2)
CL Item
HIPA (3)
CL Item
Other (Indicate and specify in Comments) (4)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Date of HIT assay
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0522876 (UMLS CUI [1,2])
Item
Assay Results
text
C0522876 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Assay Results
CL Item
Positive (Positive)
CL Item
Negative (Negative)

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