ID

39433

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

Versions (2)
  1. 17/12/19 17/12/19 -
  2. 9/1/20 9/1/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

9 de enero de 2020

DOI

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License

Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)

English

Adverse Events

1 forms  
  1. StudyEvent: ODM
    1. Adverse Events
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Description

Study Name

Data type

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Event
Description

Diagnosis only, otherwise sign/symptom

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse Event start date - Complete Date Unknown
Description

Adverse Event start date - Complete Date Unknown

Data type

integer

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C0439673
Adverse Event - Start date and time
Description

Adverse Event - Start date and time

Data type

datetime

Alias
UMLS CUI [1]
C2826806
Adverse Event - Outcome, End date and time
Description

Adverse Event - Outcome, End date and time

Data type

integer

Alias
UMLS CUI [1]
C1705586
UMLS CUI [2]
C2826793
Adverse Event end date - Complete Date Unknown
Description

Adverse Event end date - Complete Date Unknown

Data type

text

Alias
UMLS CUI [1,1]
C2826793
UMLS CUI [1,2]
C0439673
Adverse Event - End date/ time
Description

Adverse Event - End date/ time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Adverse Event - Frequency
Description

Adverse Event - Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Adverse Event - Maximum Intensity
Description

Record maximum intensity throughout duration of event

Data type

integer

Alias
UMLS CUI [1]
C1710066
Action taken with Investigational Product(s) as a result of the AE
Description

Action taken with Investigational Product(s) as a result of the AE

Data type

integer

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

Please complete the Study Completion Form and Early Withdrawal forms if applicable.

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Use best judgement at initial entry. May be amended when additional information becomes available.

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Adverse Event - Intensity Changes
Description

Adverse Event - Intensity Changes

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0518690
UMLS CUI-3
C0392747
Start date and time of event segment change
Description

Start date and time of event segment change

Data type

datetime

Alias
UMLS CUI [1,1]
C2826806
UMLS CUI [1,2]
C0443172
Intensity of event segment
Description

Intensity of event segment

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Was this event serious?
Description

Was this event serious?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Was this event determined by the investigator to be possibly suicidality-related?
Description

Please complete a Possible Suicidality-Related Adverse Event Form

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0332149
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE number
Description

SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Description

Did SAE occur after initiation of study medication?

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Intensity at onset of event
Description

Record intensity at the onset of event

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0332162
Action taken with Investigational Product(s) as a result of the SAE
Description

Action taken with Investigational Product(s) as a result of the SAE

Data type

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Description

Please complete the Study Completion Form and Early Withdrawal forms if applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Description

Use best judgement at initial entry. May be amended when additional information becomes available

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if <24 hours
Description

Duration of AE if <24 hours

Data type

integer

Measurement units
  • hr(s)
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0877248
hr(s)
Duration of AE if <24 hours
Description

Duration of AE if <24 hours

Data type

integer

Measurement units
  • min(s)
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0877248
min(s)
Time to onset since last dose
Description

Time to onset since last dose

Data type

integer

Measurement units
  • hr(s)
Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1517741
hr(s)
Time to onset since last dose
Description

Time to onset since last dose

Data type

integer

Measurement units
  • min(s)
Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1517741
min(s)
Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
Description

Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0304229
UMLS CUI [4]
C2700391
UMLS CUI [5]
C0005834
UMLS CUI [6]
C1710661
UMLS CUI [7]
C0439849
Adverse Event - Seriousness
Description

Adverse Event - Seriousness

Alias
UMLS CUI-1
C1710056
Specify the reason for considering this an SAE
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
Specify reason for considering this an SAE with general narrative comment
Description

Specify reason for considering this an SAE with general narrative comment

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348235
UMLS CUI [2]
C0947611
Relevant Concomitant/Treatment Medications
Description

Relevant Concomitant/Treatment Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2347946
UMLS CUI-3
C0013227
Relevant Concomitant/Treatment Medications - Drug Name
Description

(Trade name preferred)

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2347946
Relevant Concomitant/Treatment Medications - Total daily dose
Description

Relevant Concomitant/Treatment Medications - Total daily dose

Data type

float

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2347946
UMLS CUI [3,1]
C2348070
UMLS CUI [3,2]
C0439810
Relevant Concomitant/Treatment Medications - Unit
Description

Relevant Concomitant/Treatment Medications - Unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2347946
UMLS CUI [3]
C0439148
Relevant Concomitant/Treatment Medications - Indication
Description

Relevant Concomitant/Treatment Medications - Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2347946
UMLS CUI [3]
C3146298
Relevant Concomitant/Treatment Medications - Start date/time
Description

Relevant Concomitant/Treatment Medications - Start date/time

Data type

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C2347852
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0808070
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1301880
Relevant Concomitant/Treatment Medications - Drug type
Description

Relevant Concomitant/Treatment Medications - Drug type

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2347946
UMLS CUI [3]
C0457591
Lab Sequence Number
Description

Lab Sequence Number

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C2348184
Lab Sequence Number
Description

Lab Sequence Number

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Relevant Diagnostic Results
Description

Relevant Diagnostic Results

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
Test name
Description

Test name

Data type

text

Alias
UMLS CUI [1]
C0022885
Test date
Description

Test date

Data type

date

Alias
UMLS CUI [1]
C2826247
Test results
Description

Test results

Data type

text

Alias
UMLS CUI [1]
C0456984
Test units
Description

Test units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal low range
Description

Normal low range

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal high range
Description

Normal high range

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Description

Relevant diagnostic results not noted above

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Adverse Events - Rechallenge
Description

Adverse Events - Rechallenge

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Description

If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0034897
UMLS CUI [2,3]
C0580673
General Narrative Comments
Description

General Narrative Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1135957
General Narrative Comments
Description

Provide a brief narrative description of SAE, possible other causes of the event e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions and details of the treatment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1135957
Possible suicidality-related adverse event - Section 1
Description

Possible suicidality-related adverse event - Section 1

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Event
Description

Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Possible suicidality-related adverse event - Section 2
Description

Possible suicidality-related adverse event - Section 2

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Provide a brief description of the possible suicidality-related AE/SAE
Description

Provide a brief description of the possible suicidality-related AE/SAE

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0678257
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3166387
UMLS CUI [2,3]
C0678257
Possible suicidality-related adverse event - Section 3
Description

Possible suicidality-related adverse event - Section 3

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Disease under study
Description

Disease under study

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Concomitant medication(s)
Description

Record in Section 8

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Comorbid psychiatric condition(s)
Description

Record in Section 8

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0009488
Medical condition(s)
Description

Record in Section 8

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Psycho-social stressors
Description

Record in Section 8

Data type

boolean

Alias
UMLS CUI [1]
C0748073
Withdrawal of investigational product(s)
Description

Withdrawal of investigational product(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Investigational product dose change
Description

Investigational product dose change

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707811
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

Alias
UMLS CUI [1]
C0235828
Investigational product(s)
Description

Investigational product(s)

Data type

boolean

Alias
UMLS CUI [1]
C0304229
Other cause
Description

Other cause

Data type

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0205394
Specify other cause
Description

Specify other cause

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Possible suicidality-related adverse event - Section 4
Description

Possible suicidality-related adverse event - Section 4

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Has the subject had any psychiatric conditions in the past (other than the one under study)?
Description

Has the subject had any psychiatric conditions in the past (other than the one under study)?

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205394
If subject has had any psychiatric conditions in the past, provide informations
Description

If subject has had any psychiatric conditions in the past, provide informations

Data type

text

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C1533716
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
Description

Has the subject had any suicidal ideation, behaviour or self-harm in the past?

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1760428
UMLS CUI [1,4]
C0424366
If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
Description

If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information

Data type

text

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1760428
UMLS CUI [1,4]
C0424366
UMLS CUI [2]
C1533716
Subject's current use of illicit drugs?
Description

Subject's current use of illicit drugs?

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0521116
If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
Description

If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained

Data type

text

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0521116
UMLS CUI [2]
C1533716
UMLS CUI [3,1]
C0373483
UMLS CUI [3,2]
C1274040
Subject's current use of alcohol?
Description

Subject's current use of alcohol?

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0521116
If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
Description

If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.

Data type

text

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0521116
UMLS CUI [2]
C1533716
UMLS CUI [3,1]
C0202304
UMLS CUI [3,2]
C1274040
Family history of suicidality?
Description

Family history of suicidality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C3166387
If family history of suicidality, provide information
Description

If family history of suicidality, provide information

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C3166387
UMLS CUI [2]
C1533716
Family history of psychiatric disorders?
Description

Family history of psychiatric disorders?

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0004936
If family history of psychiatric disorders, provide information
Description

If family history of psychiatric disorders, provide information

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0004936
Possible suicidality-related adverse event - Section 5
Description

Possible suicidality-related adverse event - Section 5

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Provide information on the subject's current psycho-social stressors. For example, isolation, problems with family, relationships, work, finances, stress, etc.
Description

Provide information on the subject's current psycho-social stressors

Data type

text

Alias
UMLS CUI [1]
C0748073
UMLS CUI [2]
C0205409
UMLS CUI [3]
C0424960
UMLS CUI [4]
C0439849
UMLS CUI [5]
C0043227
UMLS CUI [6]
C0557159
UMLS CUI [7]
C0038435
Possible suicidality-related adverse event - Section 6
Description

Possible suicidality-related adverse event - Section 6

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event. For example, suicidal thoughts, associated frequency, severity and duration as well as likelihood of the subject acting upon these thoughts.
Description

Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event

Data type

text

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C1760428
UMLS CUI [3]
C0439603
UMLS CUI [4]
C0439793
UMLS CUI [5]
C0449238
UMLS CUI [6]
C0033204
Possible suicidality-related adverse event - Section 7
Description

Possible suicidality-related adverse event - Section 7

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
Description

For example: Details of any suicidal behaviour, including any plan, preparations, and/or attempt Description of the associated frequencs, severity and duration of these behaviours Likelihood of the subject action upon plans and preparations If possible, description of the subject's intent (or evidence of attention seeking behaviour) Description of the degree of impulsivity or premeditation Description on the subject's mood and thoughts before and after the behaviour

Data type

text

Alias
UMLS CUI [1,1]
C1760428
UMLS CUI [1,2]
C1533716
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Possible suicidality-related adverse event - Section 8
Description

Possible suicidality-related adverse event - Section 8

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.
Description

Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.

Data type

text

Alias
UMLS CUI [1]
C1830770
UMLS CUI [2,1]
C0681841
UMLS CUI [2,2]
C1524062
UMLS CUI [3]
C0237726
UMLS CUI [4]
C0204523
UMLS CUI [5]
C1547647
UMLS CUI [6]
C1522577
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Similar models

Adverse Events

1 forms
  1. StudyEvent: ODM
    1. Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Item
Adverse Event start date - Complete Date Unknown
integer
C2697888 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Adverse event start date - Complete Date Unknown
Code List
Adverse Event start date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Adverse Event - Start date and time
Item
Adverse Event - Start date and time
datetime
C2826806 (UMLS CUI [1])
Item
Adverse Event - Outcome, End date and time
integer
C1705586 (UMLS CUI [1])
C2826793 (UMLS CUI [2])
Adverse Event - Outcome, End date and time
Code List
Adverse Event - Outcome, End date and time
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Item
Adverse Event end date - Complete Date Unknown
text
C2826793 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Adverse event end date - Complete Date Unknown
Code List
Adverse Event end date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Adverse Event - End date/ time
Item
Adverse Event - End date/ time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Event - Frequency
integer
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Adverse Event - Frequency
Code List
Adverse Event - Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Adverse Event - Maximum Intensity
integer
C1710066 (UMLS CUI [1])
Adverse Event - Maximum Intensity
Code List
Adverse Event - 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
integer
C1704758 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Action taken with Investigational Product(s) as a result of the AE
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)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item Group
Adverse Event - Intensity Changes
C0877248 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
Start date and time of event segment change
Item
Start date and time of event segment change
datetime
C2826806 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
Intensity of event segment
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of event segment
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Was this event serious?
Item
Was this event serious?
boolean
C1519255 (UMLS CUI [1])
Was this event determined by the investigator to be possibly suicidality-related?
Item
Was this event determined by the investigator to be possibly suicidality-related?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE number
Item
SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Intensity at onset of event
integer
C0518690 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Randomisation - Intensity at onset of event
Code List
Intensity at onset of event
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 SAE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with Investigational Product(s) as a result of the SAE
Code List
Action taken with Investigational Product(s) as a result of the SAE
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)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if <24 hours
Item
Duration of AE if <24 hours
integer
C0449238 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Duration of AE if <24 hours
Item
Duration of AE if <24 hours
integer
C0449238 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Time to onset since last dose
Item
Time to onset since last dose
integer
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Time to onset since last dose
Item
Time to onset since last dose
integer
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
Item
Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
boolean
C1519255 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
C2700391 (UMLS CUI [4])
C0005834 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
C0439849 (UMLS CUI [7])
Item Group
Adverse Event - Seriousness
C1710056 (UMLS CUI-1)
Item
Specify the reason for considering this an SAE
integer
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Specify the reason for considering this an SAE
Code List
Specify the reason for considering this an SAE
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other (6)
CL Item
Possible drug-induced liver injury (see definition in SAE section of protocol) (7)
Specify reason for considering this an SAE with general narrative comment
Item
Specify reason for considering this an SAE with general narrative comment
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item Group
Relevant Concomitant/Treatment Medications
C2347852 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
Relevant Concomitant/Treatment Medications - Drug Name
Item
Relevant Concomitant/Treatment Medications - Drug Name
text
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
Relevant Concomitant/Treatment Medications - Total daily dose
Item
Relevant Concomitant/Treatment Medications - Total daily dose
float
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C2348070 (UMLS CUI [3,1])
C0439810 (UMLS CUI [3,2])
Relevant Concomitant/Treatment Medications - Unit
Item
Relevant Concomitant/Treatment Medications - Unit
text
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0439148 (UMLS CUI [3])
Relevant Concomitant/Treatment Medications - Indication
Item
Relevant Concomitant/Treatment Medications - Indication
text
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3])
Relevant Concomitant/Treatment Medications - Start date/time
Item
Relevant Concomitant/Treatment Medications - Start date/time
datetime
C2826734 (UMLS CUI [1])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0808070 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C1301880 (UMLS CUI [4,2])
Item
Relevant Concomitant/Treatment Medications - Drug type
integer
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0457591 (UMLS CUI [3])
Relevant Concomitant/Treatment Medications - Drug type
Code List
Relevant Concomitant/Treatment Medications - Drug type
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Lab Sequence Number
C0022885 (UMLS CUI-1)
C2348184 (UMLS CUI-2)
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item Group
Relevant Diagnostic Results
C2347946 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Test name
Item
Test name
text
C0022885 (UMLS CUI [1])
Test date
Item
Test date
date
C2826247 (UMLS CUI [1])
Test results
Item
Test results
text
C0456984 (UMLS CUI [1])
Test units
Item
Test units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal low range
Item
Normal low range
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal high range
Item
Normal high range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Adverse Events - Rechallenge
C0877248 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
integer
C0304229 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0580673 (UMLS CUI [2,3])
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
General Narrative Comments
C0947611 (UMLS CUI-1)
C1135957 (UMLS CUI-2)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1,1])
C1135957 (UMLS CUI [1,2])
Item Group
Possible suicidality-related adverse event - Section 1
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Item Group
Possible suicidality-related adverse event - Section 2
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Provide a brief description of the possible suicidality-related AE/SAE
Item
Provide a brief description of the possible suicidality-related AE/SAE
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C3166387 (UMLS CUI [2,2])
C0678257 (UMLS CUI [2,3])
Item Group
Possible suicidality-related adverse event - Section 3
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Concomitant medication(s)
Item
Concomitant medication(s)
boolean
C2347852 (UMLS CUI [1])
Comorbid psychiatric condition(s)
Item
Comorbid psychiatric condition(s)
boolean
C0004936 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Medical condition(s)
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
Psycho-social stressors
Item
Psycho-social stressors
boolean
C0748073 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Investigational product dose change
Item
Investigational product dose change
boolean
C0304229 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Investigational product(s)
Item
Investigational product(s)
boolean
C0304229 (UMLS CUI [1])
Other cause
Item
Other cause
boolean
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Specify other cause
Item
Specify other cause
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Possible suicidality-related adverse event - Section 4
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Has the subject had any psychiatric conditions in the past (other than the one under study)?
Item
Has the subject had any psychiatric conditions in the past (other than the one under study)?
boolean
C0004936 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
If subject has had any psychiatric conditions in the past, provide informations
Item
If subject has had any psychiatric conditions in the past, provide informations
text
C0004936 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
Item
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
boolean
C0424000 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1760428 (UMLS CUI [1,3])
C0424366 (UMLS CUI [1,4])
If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
Item
If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
text
C0424000 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1760428 (UMLS CUI [1,3])
C0424366 (UMLS CUI [1,4])
C1533716 (UMLS CUI [2])
Subject's current use of illicit drugs?
Item
Subject's current use of illicit drugs?
boolean
C0281875 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
Item
If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
text
C0281875 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
C0373483 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
Subject's current use of alcohol?
Item
Subject's current use of alcohol?
boolean
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
Item
If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
text
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
C0202304 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
Family history of suicidality?
Item
Family history of suicidality?
boolean
C0241889 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
If family history of suicidality, provide information
Item
If family history of suicidality, provide information
text
C0241889 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
Family history of psychiatric disorders?
Item
Family history of psychiatric disorders?
boolean
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
If family history of psychiatric disorders, provide information
Item
If family history of psychiatric disorders, provide information
text
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Item Group
Possible suicidality-related adverse event - Section 5
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Provide information on the subject's current psycho-social stressors
Item
Provide information on the subject's current psycho-social stressors. For example, isolation, problems with family, relationships, work, finances, stress, etc.
text
C0748073 (UMLS CUI [1])
C0205409 (UMLS CUI [2])
C0424960 (UMLS CUI [3])
C0439849 (UMLS CUI [4])
C0043227 (UMLS CUI [5])
C0557159 (UMLS CUI [6])
C0038435 (UMLS CUI [7])
Item Group
Possible suicidality-related adverse event - Section 6
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event
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. For example, suicidal thoughts, associated frequency, severity and duration as well as likelihood of the subject acting upon these thoughts.
text
C0424000 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2])
C0439603 (UMLS CUI [3])
C0439793 (UMLS CUI [4])
C0449238 (UMLS CUI [5])
C0033204 (UMLS CUI [6])
Item Group
Possible suicidality-related adverse event - Section 7
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
Item
Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
text
C1760428 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Item Group
Possible suicidality-related adverse event - Section 8
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.
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])
C0681841 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0237726 (UMLS CUI [3])
C0204523 (UMLS CUI [4])
C1547647 (UMLS CUI [5])
C1522577 (UMLS CUI [6])
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