ID
41344
Descripción
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Palabras clave
Versiones (2)
- 31/8/20 31/8/20 -
- 2/9/20 2/9/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
2 de septiembre de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042014
Descripción
(0000-2359)
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0042014
Descripción
Laboratory procedures not performed - Urinalysis
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0445106
- UMLS CUI [1,3]
- C0042014
Descripción
(Lab name must match name on lab normals.)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3258037
- UMLS CUI [1,2]
- C0042014
Descripción
Is a copy of the lab report attached?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0587081
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0428541
Descripción
Protein in urine measurement - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C2826293
Descripción
Protein in urine measurement - comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C0947611
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0004076
Descripción
Urine glucose measurement - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C2826293
Descripción
Urine glucose measurement - comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0947611
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C2188744
Descripción
Urine Occult Blood Measurement - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C2826293
Descripción
Urine Occult Blood Measurement - comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C0947611
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0042044
Descripción
Urine pH measurement - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C2826293
Descripción
Urine pH measurement - comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0947611
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0202517
Descripción
Urine specific gravity measurement - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C2826293
Descripción
Urine specific gravity measurement - comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C0947611
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C1991100
Descripción
Urine ketones measurement - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C2826293
Descripción
Urine ketones measurement - comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C0947611
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0430397
Descripción
Urine microscopic analysis - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1521902
Descripción
Urine microscopic analysis - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2826293
Descripción
Urine microscopic analysis - comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0947611
Descripción
(specify test name)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Descripción
(numeric value only)
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
Descripción
Other urinalysis test - clinical significance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826293
Descripción
Other urinalysis test - comment
Tipo de datos
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])