ID

18580

Description

A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Adverse Events

Keywords

Versions (2)
  1. 11/2/16 11/2/16 -
  2. 11/11/16 11/11/16 -
Uploaded on

November 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Events Galafold (migalastat) AT1001-012 NCT01218659

English

Adverse Events Galafold (migalastat) AT1001-012 NCT01218659

1 forms  
Additional Observations
Description

Additional Observations

Alias
UMLS CUI-1
C0700325
Reference date
Description

reference date

Data type

date

Alias
UMLS CUI [1]
C1719096
Visit Type
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
electronic case report form
Description

eCRF

Data type

text

Alias
UMLS CUI [1]
C1516308
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Are there any adverse events to report?
Description

adverse events

Data type

integer

Alias
UMLS CUI [1]
C0877248
Description of Event
Description

Please specify if an adverse event occurd

Data type

text

Alias
UMLS CUI [1]
C0678257
Start date
Description

Please specify if an adverse event occurd

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop date
Description

Please specify if an adverse event occurd

Data type

date

Alias
UMLS CUI [1]
C0806020
Seriousness of Adverse Event
Description

Please specify if an adverse event occurd

Data type

integer

Alias
UMLS CUI [1]
C1710056
Severity of adverse event
Description

Please specify if an adverse event occurd

Data type

integer

Alias
UMLS CUI [1]
C1710066
Relationship to study drug
Description

Please specify if an adverse event occurd

Data type

integer

Alias
UMLS CUI [1]
C0013227
Outcome
Description

Please specify if an adverse event occurd

Data type

integer

Alias
UMLS CUI [1]
C1705586
Action taken (other than with study drug)
Description

Please specify if an adverse event occurd

Data type

integer

Alias
UMLS CUI [1]
C0441472
Action taken with study drug
Description

Please specify if an adverse event occurd

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441472
UMLS CUI [1,3]
C0013227
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Similar models

Adverse Events Galafold (migalastat) AT1001-012 NCT01218659

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Additional Observations
C0700325 (UMLS CUI-1)
reference date
Item
Reference date
date
C1719096 (UMLS CUI [1])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
eCRF
Item
electronic case report form
text
C1516308 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Item
Are there any adverse events to report?
integer
C0877248 (UMLS CUI [1])
adverse events
Code List
Are there any adverse events to report?
CL Item
Yes (1)
CL Item
No (2)
Description of Event
Item
Description of Event
text
C0678257 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Item
Seriousness of Adverse Event
integer
C1710056 (UMLS CUI [1])
Seriousness of Adverse Event
Code List
Seriousness of Adverse Event
CL Item
Yes, complete Serious Adverse Event Form (1)
CL Item
No (2)
Item
Severity of adverse event
integer
C1710066 (UMLS CUI [1])
Severity
Code List
Severity of adverse event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study drug
integer
C0013227 (UMLS CUI [1])
Relationship to study drug
Code List
Relationship to study drug
CL Item
Definite (1)
CL Item
Probable (2)
CL Item
Possible (3)
CL Item
Unlikely (4)
CL Item
Unrelated (5)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Resolved with Sequelae (2)
CL Item
Ongoing (3)
CL Item
Fatal (4)
Item
Action taken (other than with study drug)
integer
C0441472 (UMLS CUI [1])
Action taken
Code List
Action taken (other than with study drug)
CL Item
None (1)
CL Item
Conmed, Complete Concomitant Medications Form (2)
CL Item
Non-Drug Therapy (3)
Item
Action taken with study drug
integer
C0877248 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Action taken
Code List
Action taken with study drug
CL Item
None (1)
CL Item
Interrupted and later re-started (2)
CL Item
Dose Reduced (3)
CL Item
Stopped permanently (4)
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