ID
41476
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 Clinical Endpoints Form has to be filled in on study conclusion. It is used to record if any of the mentioned Events happened during the Study.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (1)
- 10/21/20 10/21/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 21, 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
Clinical Endpoints
- StudyEvent: ODM
Description
Please mark all events that occurred during dosing:
Alias
- UMLS CUI-1
- C2347784
Description
Occurrence/Re-occurrence of thrombosis:
Alias
- UMLS CUI-1
- C2745955
- UMLS CUI-2
- C0040053
Description
Venous thrombosis
Data type
text
Alias
- UMLS CUI [1]
- C0042487
Description
Venous thrombosis - location
Data type
text
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0450429
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0011008
Description
Pulmonary embolus
Data type
text
Alias
- UMLS CUI [1]
- C0034065
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0011008
Description
Arterial thrombosis
Data type
text
Alias
- UMLS CUI [1]
- C0151942
Description
Arterial thrombosis - location
Data type
text
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0450429
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0011008
Description
Clotting in external circuit that requires immediate intervention
Data type
text
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
Description
Clotting in external circuit that requires immediate intervention - specify circuit location
Data type
text
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
- UMLS CUI [3,1]
- C2348235
- UMLS CUI [3,2]
- C0015354
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
- UMLS CUI [3]
- C0011008
Description
Thromboembolic complications:
Alias
- UMLS CUI-1
- C0040038
- UMLS CUI-2
- C0009566
Description
Death due to thromboembolic complication
Data type
text
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
- UMLS CUI [1,4]
- C1148348
Description
Amputation due to thromboembolic complication
Data type
text
Alias
- UMLS CUI [1,1]
- C0002688
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0002688
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
- UMLS CUI [1,4]
- C0011008
Similar models
Clinical Endpoints
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,2])
C0040053 (UMLS CUI-2)
C0450429 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3,1])
C0015354 (UMLS CUI [3,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0009566 (UMLS CUI-2)
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C1148348 (UMLS CUI [1,4])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])