ID
41475
Beschrijving
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 Adverse Events Form has to be filled in each time such Event occurs during the Study. Please use one Instance of this Form for every 12 Records.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Trefwoorden
Versies (1)
- 21-10-20 21-10-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 oktober 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Adverse Events
- StudyEvent: ODM
Beschrijving
Did the patient experience any AEs?
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Use a new instance if more than 12 lines are required.
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
(List all events during the study - including 30-day follow-up period)
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0808070
Beschrijving
(0000-2359)
Datatype
time
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1301880
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0806020
Beschrijving
(0000-2359)
Datatype
time
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1522314
Beschrijving
(List all Applicable)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [1,3]
- C0549184
Beschrijving
(List all Applicable)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2]
- C0558681
Beschrijving
(List all Applicable)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2]
- C2826232
Beschrijving
(List all Applicable)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1512900
Beschrijving
(List all Applicable) (record on Concomitant Medications form)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2,1]
- C0686904
- UMLS CUI [2,2]
- C0087111
Beschrijving
Adverse event outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Adverse event relationship to study drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschrijving
Adverse event severity
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
*Serious event requires SAE page, AND must be reported via fax to GSK within 24 hours at
Datatype
text
Alias
- UMLS CUI [1]
- C1710056
Similar models
Adverse Events
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
C1704758 (UMLS CUI [1,2])
C0558681 (UMLS CUI [2])
C1704758 (UMLS CUI [1,2])
C2826232 (UMLS CUI [2])
C1704758 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
C1704758 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])