0 Bedömningar
ID

38018

Beskrivning

Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Nyckelord

Versioner (1)
  1. 2019-09-09 2019-09-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 september 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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    Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

    Engelsk

    Adverse Events

    1 Formulär  
    1. StudyEvent: ODM
      1. Adverse Events
    Adverse Events
    Beskrivning

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Sequence Number
    Beskrivning

    Adverse Event, Numbers

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0237753
    Event - Diagnosis Only (if known), Otherwise Signs/Symptoms
    Beskrivning

    Adverse Event

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Modified term
    Beskrivning

    Adverse Event

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Start Date and Time
    Beskrivning

    Adverse Event, Start Date, Start time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C1301880
    Outcome
    Beskrivning

    Adverse Event Outcome

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1705586
    End Date and Time
    Beskrivning

    Adverse Event, End Date, End time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [1,3]
    C1522314
    Date and Time of Death
    Beskrivning

    Adverse Event, Date of Death, Time of Death

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1148348
    UMLS CUI [1,3]
    C1301931
    Frequency
    Beskrivning

    Adverse Event, Frequencies

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439603
    Maximum Intensity
    Beskrivning

    Severity of Adverse Event

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1710066
    Action Taken with Investigational Product(s) as a Result of the AE
    Beskrivning

    Adverse Event, Action Taken with Study Treatment

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1704758
    Did the subject withdraw from study as a result of this AE?
    Beskrivning

    Adverse Event, Withdraw

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2349954
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Beskrivning

    Adverse Event, Relationship, Experimental drug

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
    Does this Adverse Event meet the definition of serious?
    Beskrivning

    Serious Adverse Event

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    If Yes, check all that apply
    Beskrivning

    Serious Adverse Event, Reason and justification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0566251
    Other, specify
    Beskrivning

    Serious Adverse Event, Reason and justification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0566251
    Was this SAE caused by an activity related to study participation (e.g. procedures)?
    Beskrivning

    Serious Adverse Event, Etiology aspects

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0015127
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    Similar models

    Adverse Events

    1 Formulär
    1. StudyEvent: ODM
      1. Adverse Events
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Adverse Event, Numbers
    Item
    Sequence Number
    text
    C0877248 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Adverse Event
    Item
    Event - Diagnosis Only (if known), Otherwise Signs/Symptoms
    text
    C0877248 (UMLS CUI [1])
    Adverse Event
    Item
    Modified term
    text
    C0877248 (UMLS CUI [1])
    Adverse Event, Start Date, Start time
    Item
    Start Date and Time
    datetime
    C0877248 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [1,3])
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    Adverse Event Outcome
    Code List
    Outcome
    CL Item
    Recovered/Resolved, provide End Date and Time (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered/Resolved with sequelae, provide End Date and Time (4)
    CL Item
    Fatal, record Date and Time of Death (5)
    Adverse Event, End Date, End time
    Item
    End Date and Time
    datetime
    C0877248 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Adverse Event, Date of Death, Time of Death
    Item
    Date and Time of Death
    datetime
    C0877248 (UMLS CUI [1,1])
    C1148348 (UMLS CUI [1,2])
    C1301931 (UMLS CUI [1,3])
    Item
    Frequency
    text
    C0877248 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Adverse Event, Frequencies
    Code List
    Frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    Maximum Intensity
    text
    C1710066 (UMLS CUI [1])
    Adverse Event, Frequencies
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (4)
    Item
    Action Taken with Investigational Product(s) as a Result of the AE
    text
    C0877248 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    Adverse Event, Action Taken with Study Treatment
    Code List
    Action 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
    Dose increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (6)
    Adverse Event, Withdraw
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C0877248 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Adverse Event, Relationship, Experimental drug
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0877248 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Serious Adverse Event
    Item
    Does this Adverse Event meet the definition of serious?
    boolean
    C1519255 (UMLS CUI [1])
    Item
    If Yes, check all that apply
    text
    C1519255 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Serious Adverse Event, Reason and justification
    Code List
    If Yes, check all that apply
    CL Item
    Results in death (1)
    CL Item
    Is life-threatening  (2)
    CL Item
    Requires hospitalization or prolongation of existing hospitalization  (3)
    CL Item
    Results in disability/incapacity (4)
    CL Item
    Congenital anomaly/birth defect  (5)
    CL Item
    Other, specify (6)
    Serious Adverse Event, Reason and justification
    Item
    Other, specify
    text
    C1519255 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Serious Adverse Event, Etiology aspects
    Item
    Was this SAE caused by an activity related to study participation (e.g. procedures)?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
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