ID
41371
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 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 This Form is to be completed on Study Conclusion and is used to verify that no important steps were omitted. Also includes Investigator's Signature.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (1)
- 9/14/20 9/14/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 14, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Study Completion
- StudyEvent: ODM
Description
Study Completion
Alias
- UMLS CUI-1
- C2348577
Description
If b. = YES, complete below (indicate all that apply):
Alias
- UMLS CUI-1
- C2348577
Description
Resolution of underlying condition requiring anticoagulation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514893
- UMLS CUI [1,2]
- C0277554
- UMLS CUI [1,3]
- C0449867
- UMLS CUI [1,4]
- C1514873
Description
Oral or subcutaneous anticoagulation therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0003281
- UMLS CUI [1,2]
- C1527415
- UMLS CUI [2,1]
- C0003281
- UMLS CUI [2,2]
- C0443315
Description
Study drug trial period complete
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C2347804
Description
If b. = NO, indicate reason(s) below: (indicate all that apply)
Alias
- UMLS CUI-1
- C2348577
- UMLS CUI-2
- C1272696
Description
Major bleed
Data type
boolean
Alias
- UMLS CUI [1]
- C3160769
Description
Bleeding unresponsive to treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0205269
Description
Interruption of infusion procedures
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1512900
- UMLS CUI [1,2]
- C0574032
Description
Adverse event
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse event - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Description
Intercurrent Illness
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Intercurrent Illness - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Description
Protocol violation
Data type
boolean
Alias
- UMLS CUI [1]
- C1709750
Description
Protocol violation - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Description
Surgery
Data type
boolean
Alias
- UMLS CUI [1]
- C0543467
Description
Surgery - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C1521902
Description
Lack of drug efficacy | drug efficacy insuficient
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0235828
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2,1]
- C0598333
- UMLS CUI [2,2]
- C0231180
Description
Withdrawal by subject
Data type
boolean
Alias
- UMLS CUI [1]
- C1710677
Description
Other reason why study not completed by subject
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C3840932
Description
Other reason why study not completed by subject - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C3840932
- UMLS CUI [1,4]
- C1521902
Description
I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE
Alias
- UMLS CUI-1
- C2346576
Similar models
Study Completion
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0277554 (UMLS CUI [1,2])
C0449867 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C1527415 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2,1])
C0443315 (UMLS CUI [2,2])
C0205197 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1272696 (UMLS CUI-2)
C0205269 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0598333 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
C1272696 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
No comments