ID

32041

Descrição

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Palavras-chave

Versões (1)
  1. 15/10/2018 15/10/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

15 de outubro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

Inglês

Hypoglycaemic Events

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

Hypoglycaemic Events

Alias
UMLS CUI-1
C0342312
Start Date of Event
Descrição

Hypoglycaemic Event in Diabetes; Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0808070
Start Time of Event
Descrição

Hypoglycaemic Event in Diabetes; Start Time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1301880
End Date of Event
Descrição

Hypoglycaemic Event in Diabetes; End Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0806020
End Time of Event
Descrição

Hypoglycaemic Event in Diabetes; End Time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1522314
Prior to Hypoglycaemic Event: Date / Time of Last Food Intake
Descrição

Hypoglycaemic Event in Diabetes; Time of last food intake; Date in Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0578574
UMLS CUI [1,3]
C0011008
Prior to Hypoglycaemic Event: Date / Time of Last Blood Glucose
Descrição

Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Date in time; Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Prior to Hypoglycaemic Event: Result of Last Blood Glucose
Descrição

Hypoglycaemic Event in Diabetes; Before; Plasma Glucose Measurement; Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0202042
UMLS CUI [1,4]
C1274040
Blood Glucose Test Result at Time of Event
Descrição

Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Result

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C1274040
Blood Glucose Test Units
Descrição

Hypoglycaemic event in diabetes; Plasma Glucose Measurement; Unit of Measure

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C1519795
Frequency
Descrição

Hypoglycaemic event in diabetes; Frequencies

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0439603
Outcome
Descrição

Hypoglycaemic event in diabetes; Patient Outcome

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1547647
Intervention
Descrição

Hypoglycaemic event in diabetes; Interventional Procedure

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0184661
Maximum Intensity
Descrição

Hypoglycaemic event in diabetes; Symptom Intensity

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0518690
Action Taken With Respect to Investigational Product
Descrição

Hypoglycaemic event in diabetes; Action Taken with Study Treatment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1704758
Did this event meet the definition of an SAE?
Descrição

Hypoglycaemic event in diabetes; Serious Adverse Event

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1519255
Did the subject experience symptoms usually associated with hypoglycaemia?
Descrição

Hypoglycaemic event in diabetes; Symptoms

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1457887
Did the subject require external assistance (defined as unable to help themselves)?
Descrição

Hypoglycaemic event in diabetes; Supportive Assistance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1521721
Relationship to Investigational Product: Is there a reasonable possibility that the hypoglycaemic event may have been caused by the investigational product?
Descrição

Hypoglycaemic event in diabetes; Causations; Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0013230
Withdrawal: Did the subject withdraw from the study as a result of this hypoglycaemic event?
Descrição

Hypoglycaemic event in diabetes; Causations; Withdraw

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C2349954
Voltar ao início da página

Similar models

Hypoglycaemic Events

1 Formulários
  1. StudyEvent: ODM
    1. Hypoglycaemic Events
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Hypoglycaemic Events
C0342312 (UMLS CUI-1)
Hypoglycaemic Event in Diabetes; Start Date
Item
Start Date of Event
date
C0342312 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; Start Time
Item
Start Time of Event
time
C0342312 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; End Date
Item
End Date of Event
date
C0342312 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; End Time
Item
End Time of Event
time
C0342312 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; Time of last food intake; Date in Time
Item
Prior to Hypoglycaemic Event: Date / Time of Last Food Intake
datetime
C0342312 (UMLS CUI [1,1])
C0578574 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Date in time; Time
Item
Prior to Hypoglycaemic Event: Date / Time of Last Blood Glucose
datetime
C0342312 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hypoglycaemic Event in Diabetes; Before; Plasma Glucose Measurement; Result
Item
Prior to Hypoglycaemic Event: Result of Last Blood Glucose
text
C0342312 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0202042 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Result
Item
Blood Glucose Test Result at Time of Event
integer
C0342312 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Blood Glucose Test Units
integer
C0342312 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Hypoglycaemic event in diabetes; Plasma Glucose Measurement; Unit of Measure
Code List
Blood Glucose Test Units
CL Item
mg/dL (1)
CL Item
mmol/L (2)
Item
Frequency
text
C0342312 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Plasma Glucose Measurement; Unit of Measure
Code List
Frequency
Hypoglycaemic event in diabetes; Patient Outcome
Item
Outcome
text
C0342312 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Interventional Procedure
Item
Intervention
text
C0342312 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Symptom Intensity
Item
Maximum Intensity
text
C0342312 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Action Taken with Study Treatment
Item
Action Taken With Respect to Investigational Product
text
C0342312 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Serious Adverse Event
Item
Did this event meet the definition of an SAE?
boolean
C0342312 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Symptoms
Item
Did the subject experience symptoms usually associated with hypoglycaemia?
boolean
C0342312 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Supportive Assistance
Item
Did the subject require external assistance (defined as unable to help themselves)?
boolean
C0342312 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Causations; Investigational New Drugs
Item
Relationship to Investigational Product: Is there a reasonable possibility that the hypoglycaemic event may have been caused by the investigational product?
boolean
C0342312 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Hypoglycaemic event in diabetes; Causations; Withdraw
Item
Withdrawal: Did the subject withdraw from the study as a result of this hypoglycaemic event?
boolean
C0342312 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial