ID

38018

Beschrijving

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

Trefwoorden

Versies (1)
  1. 09-09-19 09-09-19 -
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GlaxoSmithKline

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9 september 2019

DOI

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Licentie

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

Engels

Adverse Events

1 Formulieren  
  1. StudyEvent: ODM
    1. Adverse Events
Adverse Events
Beschrijving

Adverse Events

Alias
UMLS CUI-1
C0877248
Sequence Number
Beschrijving

Adverse Event, Numbers

Datatype

text

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

Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Modified term
Beschrijving

Adverse Event

Datatype

text

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

Adverse Event, Start Date, Start time

Datatype

datetime

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

Adverse Event Outcome

Datatype

text

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

Adverse Event, End Date, End time

Datatype

datetime

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

Adverse Event, Date of Death, Time of Death

Datatype

datetime

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

Adverse Event, Frequencies

Datatype

text

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

Severity of Adverse Event

Datatype

text

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

Adverse Event, Action Taken with Study Treatment

Datatype

text

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

Adverse Event, Withdraw

Datatype

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?
Beschrijving

Adverse Event, Relationship, Experimental drug

Datatype

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?
Beschrijving

Serious Adverse Event

Datatype

boolean

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

Serious Adverse Event, Reason and justification

Datatype

text

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

Serious Adverse Event, Reason and justification

Datatype

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)?
Beschrijving

Serious Adverse Event, Etiology aspects

Datatype

boolean

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

Adverse Events

1 Formulieren
  1. StudyEvent: ODM
    1. Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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