ID
41473
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 Concomitant Medications (Non-Continuous Infusion) Form has to be filled in each time any change in medication (except for those administered as a continuous infusion) occurs during the Study. Please use one Instance of this Form per medication administered.
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
Concomitant Medications (Non-Continuous Infusion)
- StudyEvent: ODM
Description
Check if No Concomitant Medications were given:
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1705847
- UMLS CUI-3
- C1511497
- UMLS CUI-4
- C0549184
Description
(except for continuous IV infusions) Otherwise, please complete below and do not record more than ONE medication on same instance. Include all medications taken within 14 days, and all investigational drugs taken within 30 days (if investigational drug is administered within 30 days, please contact Medical Monitor [protocol violation]), prior to initiation of Argatroban infusion, and throughout study and 30-day follow-up period.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C1511497
- UMLS CUI [1,4]
- C0549184
Description
Concomintant Medications (Non-Continuous Infusion)
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1705847
- UMLS CUI-3
- C1511497
Description
Use a new instance if more than 6 lines are required. Also do not record more than ONE medication on the same instance.
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
(Prefer Trade Name)
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Description
Concomitant agent dose and dose unit
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [2]
- C2826646
Description
Concomitant agent route of admission
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Description
Concomitant agent route of admission - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C1521902
Description
Concomitant agent dosing frequency
Data type
text
Alias
- UMLS CUI [1]
- C2826654
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0808070
Description
(0000-2359)
Data type
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1301880
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0806020
Description
(0000-2359)
Data type
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Description
Concomitant agent ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Concomitant agent indication
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Similar models
Concomitant Medications (Non-Continuous Infusion)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1705847 (UMLS CUI-2)
C1511497 (UMLS CUI-3)
C0549184 (UMLS CUI-4)
C1705847 (UMLS CUI [1,2])
C1511497 (UMLS CUI [1,3])
C0549184 (UMLS CUI [1,4])
C1705847 (UMLS CUI-2)
C1511497 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C2826646 (UMLS CUI [2])
C0013153 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])