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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