ID
41472
Beskrivning
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 (Continuous Infusion) Form has to be filled in each time any change in medication administered as continous infusion occurs during the Study. Please use one Instance of this Form per medication administered.
Länk
https://clinicaltrials.gov/ct2/show/NCT00039858
Nyckelord
Versioner (1)
- 2020-10-21 2020-10-21 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
21 oktober 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Concomitant Medications (Continuous Infusion)
- StudyEvent: ODM
Beskrivning
Concomintant Medications (Continuous Infusion)
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1511497
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0549184
- UMLS CUI [1,3]
- C1511497
Beskrivning
If ‘Yes’, please include dosing in Continuous Infusion Section.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0048470
- UMLS CUI [1,2]
- C0805733
- UMLS CUI [1,3]
- C0231290
- UMLS CUI [1,4]
- C2347804
Beskrivning
Concomintant Medications (Continuous Infusion)
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1511497
Beskrivning
(one drug per page) (Prefer Trade Name)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C2347852
Beskrivning
Concomitant continuous IV agent indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C3146298
Beskrivning
Concomitant continuous IV agent dose and dose unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [2,1]
- C2826646
- UMLS CUI [2,2]
- C1511497
Beskrivning
Any changes in rate MUST be recorded as a new line entry.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C2964135
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1511497
- UMLS CUI [2,3]
- C2964135
- UMLS CUI [2,4]
- C1519795
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C0808070
Beskrivning
(0000-2359)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C1301880
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C0806020
Beskrivning
(0000-2359)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C1522314
Beskrivning
Concomitant continous IV agent ongoing
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C1511497
- UMLS CUI [1,3]
- C0444496
Similar models
Concomitant Medications (Continuous Infusion)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1511497 (UMLS CUI-2)
C0549184 (UMLS CUI [1,2])
C1511497 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C1511497 (UMLS CUI-2)
C1511497 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1511497 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C1511497 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2826646 (UMLS CUI [2,1])
C1511497 (UMLS CUI [2,2])
C1511497 (UMLS CUI [1,2])
C2964135 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2,1])
C1511497 (UMLS CUI [2,2])
C2964135 (UMLS CUI [2,3])
C1519795 (UMLS CUI [2,4])
C1511497 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1511497 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C1511497 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1511497 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1511497 (UMLS CUI [1,2])
C0444496 (UMLS CUI [1,3])