ID
41480
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 Comments Form has to be filled during the entire course of Study whenever asked to by the Protocol. It is used to record additional Information which does not fit elsewhere.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (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
Comments
- StudyEvent: ODM
Description
Comments
Alias
- UMLS CUI-1
- C0947611
Description
CRF section
Data type
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1828479
Description
Originally "CRF Page". Not relevant in this version - identified byy CRF . Replaced with Instance Number to record the exact instance of a form in forms which can have more instances.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C2348184
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Investigator signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
Comments
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1828479 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])