ID
41344
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 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 The Urinalysis Form has to be filled in twice: first, at the screening visit (within 96 hours before treatment initiation) and second, within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.
Länk
https://clinicaltrials.gov/ct2/show/NCT00039858
Nyckelord
Versioner (2)
- 2020-08-31 2020-08-31 -
- 2020-09-02 2020-09-02 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 september 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
Urinalysis (pre-/post-treatment)
- StudyEvent: ODM
Beskrivning
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042014
Beskrivning
(0000-2359)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0042014
Beskrivning
Laboratory procedures not performed - Urinalysis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0445106
- UMLS CUI [1,3]
- C0042014
Beskrivning
(Lab name must match name on lab normals.)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3258037
- UMLS CUI [1,2]
- C0042014
Beskrivning
Is a copy of the lab report attached?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0587081
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1]
- C0428541
Beskrivning
Protein in urine measurement - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C2826293
Beskrivning
Protein in urine measurement - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C0947611
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1]
- C0004076
Beskrivning
Urine glucose measurement - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C2826293
Beskrivning
Urine glucose measurement - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0947611
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1]
- C2188744
Beskrivning
Urine Occult Blood Measurement - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C2826293
Beskrivning
Urine Occult Blood Measurement - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C0947611
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1]
- C0042044
Beskrivning
Urine pH measurement - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C2826293
Beskrivning
Urine pH measurement - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0947611
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1]
- C0202517
Beskrivning
Urine specific gravity measurement - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C2826293
Beskrivning
Urine specific gravity measurement - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C0947611
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1]
- C1991100
Beskrivning
Urine ketones measurement - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C2826293
Beskrivning
Urine ketones measurement - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C0947611
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1]
- C0430397
Beskrivning
Urine microscopic analysis - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1521902
Beskrivning
Urine microscopic analysis - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2826293
Beskrivning
Urine microscopic analysis - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0947611
Beskrivning
(specify test name)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beskrivning
(numeric value only)
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other urinalysis test - clinical significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826293
Beskrivning
Other urinalysis test - comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Similar models
Urinalysis (pre-/post-treatment)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0445106 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0042014 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])