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44766

Beschreibung

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

Stichworte

  1. 27.06.16 27.06.16 -
  2. 27.06.16 27.06.16 -
  3. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  4. 17.11.21 17.11.21 -
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GlaxoSmithKline

Hochgeladen am

17. November 2021

DOI

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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)
    Beschreibung

    Adverse Events (AE)

    Event (diagnosis only, otherwise sign/symptom)
    Beschreibung

    Event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Modified term
    Beschreibung

    Modified term

    Datentyp

    text

    Start date
    Beschreibung

    Start date

    Datentyp

    date

    Maßeinheiten
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    DDMONYYYY
    Outcome
    Beschreibung

    Outcome

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [2]
    C1522314 (End Time)
    SNOMED
    397898000
    If "Fatal", record Date and Time of Death
    Beschreibung

    If

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1148348 (Date of death)
    SNOMED
    399753006
    LOINC
    MTHU014693
    UMLS CUI [2]
    C1301931 (Time of death)
    SNOMED
    398299004
    LOINC
    LP94386-7
    Maximum Intensity
    Beschreibung

    Maximum Intensity

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0518690 (Symptom intensity)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Actions taken with Investigational Product(s) as a Result of the AE
    Beschreibung

    Actions taken with Investigational Product

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1704758 (Action Taken with Study Treatment)
    Did the subject withdraw from study as a result of this AE?
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3641099 (Study Treatment Causality)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Does the Adverse Event meet the definition of serious?
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1710056 (Seriousness of Adverse Event)
    If "Yes", check all that apply
    Beschreibung

    If "Yes", check all that apply

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1710056 (Seriousness of Adverse Event)
    If "Other", please specify
    Beschreibung

    If "Other", please specify

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2348235 (Specification)
    UMLS CUI [1,2]
    C1710056 (Seriousness of Adverse Event)
    Was SAE caused by an activity related to study participation (e.g., procedures)?
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C3641099 (Study Treatment Causality)
    Clinical Outcome Determination (OUT)
    Beschreibung

    Clinical Outcome Determination (OUT)

    Clinical success
    Beschreibung

    Clinical success

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0085565 (Outcome Assessment, Health Care)
    Clinical recurrence
    Beschreibung

    Clinical recurrence

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0679254 (Disease recurrence)
    If "Yes", please specify if this was due to Primary or Secondary lesion:
    Beschreibung

    If

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3640841 (Clinical Failure)
    UMLS CUI [1,2]
    C1402294 (Primary Lesion)
    UMLS CUI [2,1]
    C3640841 (Clinical Failure)
    UMLS CUI [2,2]
    C1519215 (Secondary Lesion)
    Date of recurrence
    Beschreibung

    Date of recurrence

    Datentyp

    date

    Maßeinheiten
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0807712 (Date of Recurrence)
    DDMONYYYY
    Unable to determine clinical outcome, please specify:
    Beschreibung

    Unable to determine clinical outcome, please specify:

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0085565 (Outcome Assessment, Health Care)
    UMLS CUI [1,2]
    C3845108 (Unclear or unknown)
    LOINC
    LA10109-9

    Ähnliche Modelle

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

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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