ID
41475
Description
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
Keywords
Versions (1)
- 10/21/20 10/21/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 21, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Adverse Events
- StudyEvent: ODM
Description
Did the patient experience any AEs?
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Use a new instance if more than 12 lines are required.
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
(List all events during the study - including 30-day follow-up period)
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0808070
Description
(0000-2359)
Data type
time
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1301880
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0806020
Description
(0000-2359)
Data type
time
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1522314
Description
(List all Applicable)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [1,3]
- C0549184
Description
(List all Applicable)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2]
- C0558681
Description
(List all Applicable)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2]
- C2826232
Description
(List all Applicable)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1512900
Description
(List all Applicable) (record on Concomitant Medications form)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [2,1]
- C0686904
- UMLS CUI [2,2]
- C0087111
Description
Adverse event outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Adverse event relationship to study drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Description
Adverse event severity
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
*Serious event requires SAE page, AND must be reported via fax to GSK within 24 hours at
Data type
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])