ID

24368

Description

Study part: Serious Adverse Events.An Open-Label Extension phase 3 Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169 Patient Level Data. Study ID:101468/248, Clinical Study ID: 101468/248.

Keywords

Versions (1)
  1. 7/30/17 7/30/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 30, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Serious Adverse Events Ropinirole NCT00632736

English

Serious Adverse Events

1 forms  
  1. StudyEvent: ODM
    1. Serious Adverse Events
SERIOUS ADVERSE EVENT (SAE)
Description

SERIOUS ADVERSE EVENT (SAE)

Alias
UMLS CUI-1
C1519255
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0475309
UMLS CUI [1,2]
C0019994
Randomisation Number
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Did the subject experience a serious adverse event during the study?
Description

Serious Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C1519255
SECTION 1
Description

SECTION 1

Alias
UMLS CUI-1
C1828479
Event
Description

Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
End date
Description

End date

Data type

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Description

Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the SAE
Description

Action Taken

Data type

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this SAE?
Description

Complete Study Conclusion page and Adverse event as reason for withdrawal.

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Description

causations adverse events

Data type

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
If fatal, was a post-mortem/autopsy performed?
Description

If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

Data type

boolean

Alias
UMLS CUI [1]
C0004398
SECTION 2 Seriousness
Description

SECTION 2 Seriousness

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1710056
Results in death
Description

Death

Data type

boolean

Alias
UMLS CUI [1]
C0011065
Is life-threatening
Description

life-threatening

Data type

boolean

Alias
UMLS CUI [1]
C2826244
Requires hospitalisation or prolongation of existing hospitalisation
Description

hospitalisation

Data type

boolean

Alias
UMLS CUI [1]
C0019993
Results in disability/incapacity
Description

disability

Data type

boolean

Alias
UMLS CUI [1]
C0231170
Congenital anomaly/birth defect
Description

Congenital anomaly

Data type

boolean

Alias
UMLS CUI [1]
C2826727
Other, specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
SECTION 3 Demography Data
Description

SECTION 3 Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
SECTION 4
Description

SECTION 4

Alias
UMLS CUI-1
C1828479
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Description

Adverse event Recurrence

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
Description

SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0085978
UMLS CUI-3
C1710056
Disease under study
Description

Disease

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Medical condition(s) (record in Section 6)
Description

Medical condition

Data type

boolean

Alias
UMLS CUI [1]
C1699700
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational product(s)
Description

Withdrawal of investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant medication (record in Section 8)
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Activity related to study participation (e.g., procedures)
Description

study participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Description

other

Data type

text

Alias
UMLS CUI [1]
C0205394
SECTION 6 RELEVANT Medical Conditions
Description

SECTION 6 RELEVANT Medical Conditions

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0012634
Specify any RELEVANT past or current medical disorders, allergies,surgeries, etc. that can help explain the SAE
Description

Medical Conditions Hypersensitivity surgeries

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0543467
Date of Onset
Description

Date of Onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Condition Present at Time of the SAE?
Description

Medical Conditions SAE

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Description

Date of Last Occurrence

Data type

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
SECTION 7 Other RELEVANT Risk Factors
Description

SECTION 7 Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0035648
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Description

Risk Factors substance use disorder occupational hazard

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0038586
UMLS CUI [1,3]
C0337074
SECTION 8 RELEVANT Concomitant Medications
Description

SECTION 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug Name
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose
Description

Dose

Data type

integer

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Description

Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

Ongoing Medication?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9 Details of Investigational Product(s)
Description

SECTION 9 Details of Investigational Product(s)

Alias
UMLS CUI-1
C1828479
Details of lnvestigational Product(s)
Description

lnvestigational Product

Data type

text

Alias
UMLS CUI [1]
C0304229
SECTION 10 Details of RELEVANT Assessments
Description

SECTION 10 Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1828479
Details of RELEVANT Assessments
Description

(provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)

Data type

text

Alias
UMLS CUI [1]
C0220825
SECTION 11 Narrative Remarks
Description

SECTION 11 Narrative Remarks

Alias
UMLS CUI-1
C1828479
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Description

comment SAE

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator’s signature
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Events

1 forms
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SERIOUS ADVERSE EVENT (SAE)
C1519255 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0475309 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Serious Adverse Events
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Item Group
SECTION 1
C1828479 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
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)
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
subject withdraw from study as a result of SAE
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
causations adverse events
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Item Group
SECTION 2 Seriousness
C1828479 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Death
Item
Results in death
boolean
C0011065 (UMLS CUI [1])
life-threatening
Item
Is life-threatening
boolean
C2826244 (UMLS CUI [1])
hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
disability
Item
Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Congenital anomaly
Item
Congenital anomaly/birth defect
boolean
C2826727 (UMLS CUI [1])
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
Item Group
SECTION 3 Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
Item Group
SECTION 4
C1828479 (UMLS CUI-1)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Adverse event Recurrence
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
C1828479 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C1710056 (UMLS CUI-3)
Disease
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
Medical condition
Item
Medical condition(s) (record in Section 6)
boolean
C1699700 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication (record in Section 8)
boolean
C2347852 (UMLS CUI [1])
study participation status
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1])
other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
Item Group
SECTION 6 RELEVANT Medical Conditions
C1828479 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Medical Conditions Hypersensitivity surgeries
Item
Specify any RELEVANT past or current medical disorders, allergies,surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Medical Conditions SAE
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
SECTION 7 Other RELEVANT Risk Factors
C1828479 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Risk Factors substance use disorder occupational hazard
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
C0035648 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
C0337074 (UMLS CUI [1,3])
Item Group
SECTION 8 RELEVANT Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
SECTION 9 Details of Investigational Product(s)
C1828479 (UMLS CUI-1)
lnvestigational Product
Item
Details of lnvestigational Product(s)
text
C0304229 (UMLS CUI [1])
Item Group
SECTION 10 Details of RELEVANT Assessments
C1828479 (UMLS CUI-1)
Assessments
Item
Details of RELEVANT Assessments
text
C0220825 (UMLS CUI [1])
Item Group
SECTION 11 Narrative Remarks
C1828479 (UMLS CUI-1)
comment SAE
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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