ID

38018

Descrição

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

Palavras-chave

Versões (1)
  1. 09/09/2019 09/09/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

9 de setembro de 2019

DOI

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Licença

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

Inglês

Adverse Events

1 Formulários  
  1. StudyEvent: ODM
    1. Adverse Events
Adverse Events
Descrição

Adverse Events

Alias
UMLS CUI-1
C0877248
Sequence Number
Descrição

Adverse Event, Numbers

Tipo de dados

text

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

Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
Modified term
Descrição

Adverse Event

Tipo de dados

text

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

Adverse Event, Start Date, Start time

Tipo de dados

datetime

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

Adverse Event Outcome

Tipo de dados

text

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

Adverse Event, End Date, End time

Tipo de dados

datetime

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

Adverse Event, Date of Death, Time of Death

Tipo de dados

datetime

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

Adverse Event, Frequencies

Tipo de dados

text

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

Severity of Adverse Event

Tipo de dados

text

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

Adverse Event, Action Taken with Study Treatment

Tipo de dados

text

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

Adverse Event, Withdraw

Tipo de dados

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?
Descrição

Adverse Event, Relationship, Experimental drug

Tipo de dados

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?
Descrição

Serious Adverse Event

Tipo de dados

boolean

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

Serious Adverse Event, Reason and justification

Tipo de dados

text

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

Serious Adverse Event, Reason and justification

Tipo de dados

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)?
Descrição

Serious Adverse Event, Etiology aspects

Tipo de dados

boolean

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

Adverse Events

1 Formulários
  1. StudyEvent: ODM
    1. Adverse Events
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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