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ID

44766

Description

Documentation part: Adverse Events & Clinical Outcome Evaluation A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo. ClinicalTrials.gov Identifier: NCT00133874 Other Study ID Numbers: TOC100224 Responsible Party: GlaxoSmithKline

Keywords

  1. 6/27/16 6/27/16 -
  2. 6/27/16 6/27/16 -
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 11/17/21 11/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 17, 2021

DOI

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License

Creative Commons BY-NC 4.0

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    Adverse Events & Clinical Outcome Evaluation Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

    Adverse Events & Clinical Outcome Evaluation Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

    Adverse Events (AE)
    Description

    Adverse Events (AE)

    Event (diagnosis only, otherwise sign/symptom)
    Description

    Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Modified term
    Description

    Modified term

    Data type

    text

    Start date
    Description

    Start date

    Data type

    date

    Measurement units
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0808070
    DDMONYYYY
    Outcome
    Description

    Outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
    Description

    If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time

    Data type

    text

    Alias
    UMLS CUI [1]
    C0806020
    UMLS CUI [2]
    C1522314
    If "Fatal", record Date and Time of Death
    Description

    If

    Data type

    text

    Alias
    UMLS CUI [1]
    C1148348
    UMLS CUI [2]
    C1301931
    Maximum Intensity
    Description

    Maximum Intensity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0877248
    Actions taken with Investigational Product(s) as a Result of the AE
    Description

    Actions taken with Investigational Product

    Data type

    text

    Alias
    UMLS CUI [1]
    C1704758
    Did the subject withdraw from study as a result of this AE?
    Description

    Did the subject withdraw from study as a result of this AE?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Is there a reasonable possibility that the AE may have been caused by the investigational product?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3641099
    UMLS CUI [1,2]
    C0877248
    Does the Adverse Event meet the definition of serious?
    Description

    If Yes, complete paper SAE form and fax to GSK Safety within 24 hr

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710056
    If "Yes", check all that apply
    Description

    If "Yes", check all that apply

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710056
    If "Other", please specify
    Description

    If "Other", please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C1710056
    Was SAE caused by an activity related to study participation (e.g., procedures)?
    Description

    Was SAE caused by an activity related to study participation (e.g., procedures)?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C3641099
    Clinical Outcome Determination (OUT)
    Description

    Clinical Outcome Determination (OUT)

    Clinical success
    Description

    Clinical success

    Data type

    text

    Alias
    UMLS CUI [1]
    C0085565
    Clinical recurrence
    Description

    Clinical recurrence

    Data type

    text

    Alias
    UMLS CUI [1]
    C0679254
    If "Yes", please specify if this was due to Primary or Secondary lesion:
    Description

    If

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3640841
    UMLS CUI [1,2]
    C1402294
    UMLS CUI [2,1]
    C3640841
    UMLS CUI [2,2]
    C1519215
    Date of recurrence
    Description

    Date of recurrence

    Data type

    date

    Measurement units
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0807712
    DDMONYYYY
    Unable to determine clinical outcome, please specify:
    Description

    Unable to determine clinical outcome, please specify:

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0085565
    UMLS CUI [1,2]
    C3845108

    Similar models

    Adverse Events & Clinical Outcome Evaluation Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adverse Events (AE)
    Event
    Item
    Event (diagnosis only, otherwise sign/symptom)
    text
    C0877248 (UMLS CUI [1])
    Modified term
    Item
    Modified term
    text
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    Code List
    Outcome
    CL Item
    Recovered/Resolved (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered with sequelae (4)
    CL Item
    Fatal (5)
    If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
    Item
    If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
    text
    C0806020 (UMLS CUI [1])
    C1522314 (UMLS CUI [2])
    If
    Item
    If "Fatal", record Date and Time of Death
    text
    C1148348 (UMLS CUI [1])
    C1301931 (UMLS CUI [2])
    Item
    Maximum Intensity
    integer
    C0518690 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    Actions taken with Investigational Product(s) as a Result of the AE
    text
    C1704758 (UMLS CUI [1])
    Code List
    Actions taken with Investigational Product(s) as a Result of the AE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Doce increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (X)
    Did the subject withdraw from study as a result of this AE?
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C0422727 (UMLS CUI [1])
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C3641099 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Does the Adverse Event meet the definition of serious?
    text
    C1710056 (UMLS CUI [1])
    Code List
    Does the Adverse Event meet the definition of serious?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    If "Yes", check all that apply
    text
    C1710056 (UMLS CUI [1])
    Code List
    If "Yes", check all that apply
    CL Item
    Results in death (A)
    CL Item
    Is life-threatening (B)
    CL Item
    Requires hospitalisation or prolongation of existing hospitalisation  (C)
    CL Item
    Results in disability/incapacity (D)
    CL Item
    Congenital anomaly/birth defect (E)
    CL Item
    Other (F)
    If "Other", please specify
    Item
    If "Other", please specify
    text
    C2348235 (UMLS CUI [1,1])
    C1710056 (UMLS CUI [1,2])
    Item
    Was SAE caused by an activity related to study participation (e.g., procedures)?
    text
    C1519255 (UMLS CUI [1,1])
    C3641099 (UMLS CUI [1,2])
    Code List
    Was SAE caused by an activity related to study participation (e.g., procedures)?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item Group
    Clinical Outcome Determination (OUT)
    Item
    Clinical success
    text
    C0085565 (UMLS CUI [1])
    Code List
    Clinical success
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Clinical recurrence
    text
    C0679254 (UMLS CUI [1])
    Code List
    Clinical recurrence
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If "Yes", please specify if this was due to Primary or Secondary lesion:
    text
    C3640841 (UMLS CUI [1,1])
    C1402294 (UMLS CUI [1,2])
    C3640841 (UMLS CUI [2,1])
    C1519215 (UMLS CUI [2,2])
    Code List
    If "Yes", please specify if this was due to Primary or Secondary lesion:
    CL Item
    Primary lesion (P)
    CL Item
    Secondary lesion (S)
    Date of recurrence
    Item
    Date of recurrence
    date
    C0807712 (UMLS CUI [1])
    Unable to determine clinical outcome, please specify:
    Item
    Unable to determine clinical outcome, please specify:
    text
    C0085565 (UMLS CUI [1,1])
    C3845108 (UMLS CUI [1,2])

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