ID
41371
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 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
Stichworte
Versionen (1)
- 14.09.20 14.09.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
14. 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
Study Completion
- StudyEvent: ODM
Beschreibung
Study Completion
Alias
- UMLS CUI-1
- C2348577
Beschreibung
If b. = YES, complete below (indicate all that apply):
Alias
- UMLS CUI-1
- C2348577
Beschreibung
Resolution of underlying condition requiring anticoagulation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1514893
- UMLS CUI [1,2]
- C0277554
- UMLS CUI [1,3]
- C0449867
- UMLS CUI [1,4]
- C1514873
Beschreibung
Oral or subcutaneous anticoagulation therapy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0003281
- UMLS CUI [1,2]
- C1527415
- UMLS CUI [2,1]
- C0003281
- UMLS CUI [2,2]
- C0443315
Beschreibung
Study drug trial period complete
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C2347804
Beschreibung
If b. = NO, indicate reason(s) below: (indicate all that apply)
Alias
- UMLS CUI-1
- C2348577
- UMLS CUI-2
- C1272696
Beschreibung
Major bleed
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3160769
Beschreibung
Bleeding unresponsive to treatment
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0205269
Beschreibung
Interruption of infusion procedures
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1512900
- UMLS CUI [1,2]
- C0574032
Beschreibung
Adverse event
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Adverse event - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Beschreibung
Intercurrent Illness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Intercurrent Illness - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Beschreibung
Protocol violation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1709750
Beschreibung
Protocol violation - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beschreibung
Surgery
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0543467
Beschreibung
Surgery - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C1521902
Beschreibung
Lack of drug efficacy | drug efficacy insuficient
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0235828
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2,1]
- C0598333
- UMLS CUI [2,2]
- C0231180
Beschreibung
Withdrawal by subject
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1710677
Beschreibung
Other reason why study not completed by subject
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C3840932
Beschreibung
Other reason why study not completed by subject - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C3840932
- UMLS CUI [1,4]
- C1521902
Beschreibung
I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE
Alias
- UMLS CUI-1
- C2346576
Ähnliche Modelle
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])