ID
41344
Beschreibung
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
Stichworte
Versionen (2)
- 31.08.20 31.08.20 -
- 02.09.20 02.09.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
2. September 2020
DOI
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Lizenz
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
Beschreibung
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042014
Beschreibung
(0000-2359)
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0042014
Beschreibung
Laboratory procedures not performed - Urinalysis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0445106
- UMLS CUI [1,3]
- C0042014
Beschreibung
(Lab name must match name on lab normals.)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3258037
- UMLS CUI [1,2]
- C0042014
Beschreibung
Is a copy of the lab report attached?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0587081
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1]
- C0428541
Beschreibung
Protein in urine measurement - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C2826293
Beschreibung
Protein in urine measurement - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C0947611
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1]
- C0004076
Beschreibung
Urine glucose measurement - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C2826293
Beschreibung
Urine glucose measurement - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0947611
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1]
- C2188744
Beschreibung
Urine Occult Blood Measurement - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C2826293
Beschreibung
Urine Occult Blood Measurement - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C0947611
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1]
- C0042044
Beschreibung
Urine pH measurement - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C2826293
Beschreibung
Urine pH measurement - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0947611
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1]
- C0202517
Beschreibung
Urine specific gravity measurement - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C2826293
Beschreibung
Urine specific gravity measurement - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C0947611
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1]
- C1991100
Beschreibung
Urine ketones measurement - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C2826293
Beschreibung
Urine ketones measurement - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C0947611
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1]
- C0430397
Beschreibung
Urine microscopic analysis - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1521902
Beschreibung
Urine microscopic analysis - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2826293
Beschreibung
Urine microscopic analysis - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0947611
Beschreibung
(specify test name)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschreibung
(numeric value only)
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other urinalysis test - clinical significance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826293
Beschreibung
Other urinalysis test - comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Ähnliche Modelle
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])