0 Ratings
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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