Informações:
Falhas:
ID
20062
Descrição
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.
Palavras-chave
Versões (2)
- 31/12/2016 31/12/2016 -
- 04/02/2017 04/02/2017 -
Transferido a
4 de fevereiro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Screen Failure Log: Adverse Events [AE_1] NCT01117584
Screen Failure Log: Adverse Events [AE_1] NCT01117584
- StudyEvent: ODM
Similar models
Screen Failure Log: Adverse Events [AE_1] NCT01117584
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Any Adverse Event
Item
Was any adverse event reported or observed?
boolean
C0877248 (UMLS CUI [1])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C0877248 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with Sequelae (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
CL Item
Single Episode (1)
CL Item
Intermittent (2)
CL Item
Continous (3)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Serious AE
Item
Serious AE?
boolean
C1519255 (UMLS CUI [1])
Serious AE Number
Item
Serious AE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Death
Item
Death
boolean
C1705232 (UMLS CUI [1])
Requires or prolongs hospitalization
Item
Requires or prolongs hospitalization
boolean
C0877248 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Life-threatening
Item
Life-threatening
boolean
C1517874 (UMLS CUI [1])
Disability
Item
Persistent or significant disability/incapacity
boolean
C0877248 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
Medical Importance
Item
Other medical importance
boolean
CL Item
Dose Not Changed (1)
CL Item
Drug Interrupted (2)
CL Item
Drug Withdrawn (3)
CL Item
Not Applicable (4)
CL Item
Unknown (5)
Treatment
Item
Was there any treatment required?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Medication Therapy
Item
Medication Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Non-Medication Therapy
Item
Non-Medication Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Relationship to Study Drug
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
CL Item
Not Related (1)
CL Item
Possible (2)
CL Item
Probable (3)