ID
41473
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 (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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00039858
Nyckelord
Versioner (1)
- 2020-10-21 2020-10-21 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
21 oktober 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Concomitant Medications (Non-Continuous Infusion)
- StudyEvent: ODM
Beskrivning
Check if No Concomitant Medications were given:
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1705847
- UMLS CUI-3
- C1511497
- UMLS CUI-4
- C0549184
Beskrivning
(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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C1511497
- UMLS CUI [1,4]
- C0549184
Beskrivning
Concomintant Medications (Non-Continuous Infusion)
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1705847
- UMLS CUI-3
- C1511497
Beskrivning
Use a new instance if more than 6 lines are required. Also do not record more than ONE medication on the same instance.
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
(Prefer Trade Name)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Beskrivning
Concomitant agent dose and dose unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [2]
- C2826646
Beskrivning
Concomitant agent route of admission
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beskrivning
Concomitant agent route of admission - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C1521902
Beskrivning
Concomitant agent dosing frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C2826654
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0808070
Beskrivning
(0000-2359)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1301880
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0806020
Beskrivning
(0000-2359)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Beskrivning
Concomitant agent ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Concomitant agent indication
Datatyp
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])