ID

18573

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 Suicidality

Mots-clés

Versions (2)
  1. 02/11/2016 02/11/2016 -
  2. 11/11/2016 11/11/2016 -
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11 novembre 2016

DOI

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Licence

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

Anglais

Suicidality Galafold (migalastat) AT1001-012 NCT01218659

1 Formulaires  
Additional Observations
Description

Additional Observations

Alias
UMLS CUI-1
C0700325
Reference date
Description

reference date

Type de données

date

Alias
UMLS CUI [1]
C1719096
Visit Type
Description

Visit

Type de données

text

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

eCRF

Type de données

text

Alias
UMLS CUI [1]
C1516308
Comment
Description

Comment

Type de données

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

Type de données

integer

Alias
UMLS CUI [1]
C0877248
Description of Event
Description

Please specify if an adverse event occurd

Type de données

text

Alias
UMLS CUI [1]
C0678257
Start date
Description

Please specify if an adverse event occurd

Type de données

date

Alias
UMLS CUI [1]
C0808070
Stop date
Description

Please specify if an adverse event occurd

Type de données

date

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

Please specify if an adverse event occurd

Type de données

integer

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

Please specify if an adverse event occurd

Type de données

integer

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

Please specify if an adverse event occurd

Type de données

integer

Alias
UMLS CUI [1]
C0013227
Outcome
Description

Please specify if an adverse event occurd

Type de données

integer

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

Please specify if an adverse event occurd

Type de données

integer

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

Please specify if an adverse event occurd

Type de données

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441472
UMLS CUI [1,3]
C0013227
Suicidality
Description

Suicidality

Alias
UMLS CUI-1
C0438696
In the investigator's judgement, were there any possible suicidality-related adverse events?
Description

Suicidality

Type de données

integer

Alias
UMLS CUI [1]
C0438696
UMLS CUI [2]
C0877248
Please insert adverse event number
Description

Adverse Event number

Type de données

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Adverse Event date
Description

Adverse Event start date

Type de données

date

Alias
UMLS CUI [1]
C2697888
Provide a brief description of the possible suicidality-related adverse event
Description

Adverse Event Description

Type de données

text

Alias
UMLS CUI [1]
C2699044
Possible causes of possible suicidality-related adverse event: Disease under study
Description

Adverse Event Cause, Disease under study

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0012634
Possible causes of possible suicidality-related adverse event: Concomitant medications
Description

Adverse Event Cause, Concomitant medications

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C2347852
Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
Description

Adverse Event Cause, Comorbid psychiatric condition(s)

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0004936
Possible causes of possible suicidality-related adverse event: Medical condition(s)
Description

Adverse Event Cause, Medical condition(s)

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0009488
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
Description

Psycho-social stressors

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0748073
Possible causes of possible suicidality-related adverse event: Withdrawal of investigationalproduct(s)
Description

Withdrawal of investigational product

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C2349954
Possible causes of possible suicidality-related adverse event: Investigational product dose change
Description

Investigational product dose change

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1707811
Possible causes of possible suicidality-related adverse event: Lack of efficacy
Description

Lack of efficacy

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0235828
Possible causes of possible suicidality-related adverse event: Investigational product(s)
Description

Investigational product(s)

Type de données

integer

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0304229
Possible causes of possible suicidality-related adverse event: Other, please specify
Description

undefined item

Type de données

text

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
Has the subject had any psychiatric conditions in the past (other than the one under study)?
Description

psychiatric conditions

Type de données

integer

Alias
UMLS CUI [1]
C0004936
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
Description

Suicidal ideation

Type de données

integer

Alias
UMLS CUI [1]
C0424000
Subject's current use of llicit drugs?
Description

Illicit drugs

Type de données

integer

Alias
UMLS CUI [1]
C0086190
Subject's current use of alcohol?
Description

Alcohol consumption

Type de données

integer

Alias
UMLS CUI [1]
C0001948
Family history of suicidality?
Description

Family history of suicidality

Type de données

integer

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0438696
Family history of psychiatric disorders?
Description

Family history of psychiatric disorders

Type de données

integer

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0004936
Provide information on the subject's current psycho-social stressors
Description

psycho-social stressors

Type de données

text

Alias
UMLS CUI [1]
C0748073
Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event
Description

suicidal ideation

Type de données

text

Alias
UMLS CUI [1]
C0424000
Provide information on any suicidal behaviour present during the study, as assessed by the investigator, for this index event
Description

suicidal behaviour

Type de données

text

Alias
UMLS CUI [1]
C1760428
Provide any additional comments or explanation, including, but not limited to, both medical and psychiatric treatment, outcome and follow-up
Description

additional comments

Type de données

text

Alias
UMLS CUI [1]
C1830770
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Similar models

Suicidality Galafold (migalastat) AT1001-012 NCT01218659

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
Item Group
Suicidality
C0438696 (UMLS CUI-1)
Item
In the investigator's judgement, were there any possible suicidality-related adverse events?
integer
C0438696 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
Suicidality
Code List
In the investigator's judgement, were there any possible suicidality-related adverse events?
CL Item
Yes; please fill out adverse events form (1)
CL Item
No (2)
Adverse Event number
Item
Please insert adverse event number
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse Event start date
Item
Adverse Event date
date
C2697888 (UMLS CUI [1])
Adverse Event Description
Item
Provide a brief description of the possible suicidality-related adverse event
text
C2699044 (UMLS CUI [1])
Item
Possible causes of possible suicidality-related adverse event: Disease under study
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
Adverse Event Cause
Code List
Possible causes of possible suicidality-related adverse event: Disease under study
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Concomitant medications
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Concomitant medications
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Medical condition(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Medical condition(s)
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0748073 (UMLS CUI [2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Withdrawal of investigationalproduct(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Withdrawal of investigationalproduct(s)
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Investigational product dose change
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1707811 (UMLS CUI [2,2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Investigational product dose change
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Lack of efficacy
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0235828 (UMLS CUI [2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Lack of efficacy
CL Item
Yes (1)
CL Item
No (2)
Item
Possible causes of possible suicidality-related adverse event: Investigational product(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2])
undefined item
Code List
Possible causes of possible suicidality-related adverse event: Investigational product(s)
CL Item
Yes (1)
CL Item
No (2)
undefined item
Item
Possible causes of possible suicidality-related adverse event: Other, please specify
text
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Has the subject had any psychiatric conditions in the past (other than the one under study)?
integer
C0004936 (UMLS CUI [1])
psychiatric conditions
Code List
Has the subject had any psychiatric conditions in the past (other than the one under study)?
CL Item
Yes, provide Information (1)
CL Item
No (2)
Item
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
integer
C0424000 (UMLS CUI [1])
Suicidal ideation
Code List
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
CL Item
Yes, provide information (1)
CL Item
No (2)
Item
Subject's current use of llicit drugs?
integer
C0086190 (UMLS CUI [1])
Illicit drugs
Code List
Subject's current use of llicit drugs?
CL Item
Yes, provide information, including results of a drug screen test if one has been obtained (1)
CL Item
No (2)
Item
Subject's current use of alcohol?
integer
C0001948 (UMLS CUI [1])
Alcohol consumption
Code List
Subject's current use of alcohol?
CL Item
Yes, provide information, including test results of an alcohol level test if one has been obtained (1)
CL Item
No (2)
Item
Family history of suicidality?
integer
C0241889 (UMLS CUI [1,1])
C0438696 (UMLS CUI [1,2])
Family history of suicidality
Code List
Family history of suicidality?
CL Item
Yes, provide information (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Family history of psychiatric disorders?
integer
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Family history of psychiatric disorders
Code List
Family history of psychiatric disorders?
CL Item
Yes, provide information (1)
CL Item
No (2)
CL Item
Unknown (3)
psycho-social stressors
Item
Provide information on the subject's current psycho-social stressors
text
C0748073 (UMLS CUI [1])
suicidal ideation
Item
Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event
text
C0424000 (UMLS CUI [1])
suicidal behaviour
Item
Provide information on any suicidal behaviour present during the study, as assessed by the investigator, for this index event
text
C1760428 (UMLS CUI [1])
additional comments
Item
Provide any additional comments or explanation, including, but not limited to, both medical and psychiatric treatment, outcome and follow-up
text
C1830770 (UMLS CUI [1])
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