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)
  1. 9/14/20 9/14/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 14, 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

English

Study Completion

1 forms  
  1. StudyEvent: ODM
    1. Study Completion
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Description

Study centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient #
Description

patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Study Completion
Description

Study Completion

Alias
UMLS CUI-1
C2348577
a. Discharge Summary attached?
Description

Discharge summary

Data type

boolean

Alias
UMLS CUI [1]
C0743221
b. Did patient complete study?
Description

Completion of study by subject

Data type

boolean

Alias
UMLS CUI [1]
C2348577
If b. = YES, complete below (indicate all that apply):
Description

If b. = YES, complete below (indicate all that apply):

Alias
UMLS CUI-1
C2348577
Resolution of underlying condition requiring anticoagulation
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
Patient transferred to oral or subcutaneous anticoagulation therapy
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
Patient completed 14 days of study drug
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
If b. = NO, indicate reason(s) below: (indicate all that apply)
Description

If b. = NO, indicate reason(s) below: (indicate all that apply)

Alias
UMLS CUI-1
C2348577
UMLS CUI-2
C1272696
Major bleed (as defined per protocol)
Description

Major bleed

Data type

boolean

Alias
UMLS CUI [1]
C3160769
Bleeding unresponsive to usual clinical interventions
Description

Bleeding unresponsive to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205269
Infusion interrupted for more than 24 consecutive hours
Description

Interruption of infusion procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C0574032
Adverse event (specify)
Description

Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Adverse event - specify:
Description

Adverse event - specify

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Intercurrent Illness (specify)
Description

Intercurrent Illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Intercurrent Illness - specify:
Description

Intercurrent Illness - specify

Data type

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1521902
Protocol violation (specify)
Description

Protocol violation

Data type

boolean

Alias
UMLS CUI [1]
C1709750
Protocol violation - specify:
Description

Protocol violation - specify

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Surgery (specify)
Description

Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0543467
Surgery - specify:
Description

Surgery - specify

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1521902
Clinical efficacy of drug insufficient or lacking
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
Patient request to withdraw
Description

Withdrawal by subject

Data type

boolean

Alias
UMLS CUI [1]
C1710677
Other (specify)
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
Other - specify:
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
I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE
Description

I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE

Alias
UMLS CUI-1
C2346576
Signed:
Description

Principal Investigator

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date of Investigator Signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Completion

1 forms
  1. StudyEvent: ODM
    1. Study Completion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Study Completion
C2348577 (UMLS CUI-1)
Discharge summary
Item
a. Discharge Summary attached?
boolean
C0743221 (UMLS CUI [1])
Completion of study by subject
Item
b. Did patient complete study?
boolean
C2348577 (UMLS CUI [1])
Item Group
If b. = YES, complete below (indicate all that apply):
C2348577 (UMLS CUI-1)
Resolution of underlying condition requiring anticoagulation
Item
Resolution of underlying condition requiring anticoagulation
boolean
C1514893 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])
C0449867 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
Oral or subcutaneous anticoagulation therapy
Item
Patient transferred to oral or subcutaneous anticoagulation therapy
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2,1])
C0443315 (UMLS CUI [2,2])
Study drug trial period complete
Item
Patient completed 14 days of study drug
boolean
C0304229 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Item Group
If b. = NO, indicate reason(s) below: (indicate all that apply)
C2348577 (UMLS CUI-1)
C1272696 (UMLS CUI-2)
Major bleed
Item
Major bleed (as defined per protocol)
boolean
C3160769 (UMLS CUI [1])
Bleeding unresponsive to treatment
Item
Bleeding unresponsive to usual clinical interventions
boolean
C0019080 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Interruption of infusion procedures
Item
Infusion interrupted for more than 24 consecutive hours
boolean
C1512900 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Adverse event
Item
Adverse event (specify)
boolean
C0877248 (UMLS CUI [1])
Adverse event - specify
Item
Adverse event - specify:
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Intercurrent Illness
Item
Intercurrent Illness (specify)
boolean
C0009488 (UMLS CUI [1])
Intercurrent Illness - specify
Item
Intercurrent Illness - specify:
text
C0009488 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Protocol violation
Item
Protocol violation (specify)
boolean
C1709750 (UMLS CUI [1])
Protocol violation - specify
Item
Protocol violation - specify:
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Surgery
Item
Surgery (specify)
boolean
C0543467 (UMLS CUI [1])
Surgery - specify
Item
Surgery - specify:
text
C0543467 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Lack of drug efficacy | drug efficacy insuficient
Item
Clinical efficacy of drug insufficient or lacking
boolean
C0235828 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0598333 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
Withdrawal by subject
Item
Patient request to withdraw
boolean
C1710677 (UMLS CUI [1])
Other reason why study not completed by subject
Item
Other (specify)
boolean
C2348577 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Other reason why study not completed by subject - specify
Item
Other - specify:
text
C2348577 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Signed:
text
C2346576 (UMLS CUI [1])
Date of Investigator Signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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