ID
41345
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 This Form has to be filled in at the screening visit after the Investigator decides whether Patient should be enrolled into the Study. Please fax GSK immediately after a patient is enrolled or failed the screen. Use the fax form provided. (fax form not included in CRF)
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (2)
- 8/31/20 8/31/20 -
- 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
Patient Enrollment / Screen Failure
- StudyEvent: ODM
Description
Patient Enrollment / Screen Failure
Alias
- UMLS CUI-1
- C4041024
- UMLS CUI-2
- C1710476
Description
*If No, check reason for patient not being enrolled into study:
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1516879
- UMLS CUI [1,3]
- C0048470
Description
Eligibility Criteria not met
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1516637
- UMLS CUI [1,2]
- C0231175
Description
Age stratification group full
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0441833
- UMLS CUI [1,2]
- C1514983
- UMLS CUI [1,3]
- C0001779
- UMLS CUI [1,4]
- C0443225
Description
Consent withdrawal
Data type
boolean
Alias
- UMLS CUI [1]
- C1707492
Description
Other reason of screen failure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
Description
Other reason of screen failure - specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Similar models
Patient Enrollment / Screen Failure
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C1710476 (UMLS CUI-2)
C1516879 (UMLS CUI [1,2])
C0048470 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C1514983 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0443225 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])