ID

24368

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2017-07-30 2017-07-30 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 juli 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Serious Adverse Events Ropinirole NCT00632736

Engelsk

Serious Adverse Events

1 Formulär  
  1. StudyEvent: ODM
    1. Serious Adverse Events
SERIOUS ADVERSE EVENT (SAE)
Beskrivning

SERIOUS ADVERSE EVENT (SAE)

Alias
UMLS CUI-1
C1519255
Subject ID
Beskrivning

Subject ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

integer

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

Randomisation Number

Datatyp

text

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

Serious Adverse Events

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
SECTION 1
Beskrivning

SECTION 1

Alias
UMLS CUI-1
C1828479
Event
Beskrivning

Event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
End date
Beskrivning

End date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beskrivning

Maximum Intensity

Datatyp

text

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

Action Taken

Datatyp

text

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

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

Datatyp

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?
Beskrivning

causations adverse events

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0004398
SECTION 2 Seriousness
Beskrivning

SECTION 2 Seriousness

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

Death

Datatyp

boolean

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

life-threatening

Datatyp

boolean

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

hospitalisation

Datatyp

boolean

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

disability

Datatyp

boolean

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

Congenital anomaly

Datatyp

boolean

Alias
UMLS CUI [1]
C2826727
Other, specify
Beskrivning

Other

Datatyp

text

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

SECTION 3 Demography Data

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

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
kg
SECTION 4
Beskrivning

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?
Beskrivning

Adverse event Recurrence

Datatyp

text

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

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
Beskrivning

Disease

Datatyp

boolean

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

Medical condition

Datatyp

boolean

Alias
UMLS CUI [1]
C1699700
Lack of efficacy
Beskrivning

Lack of efficacy

Datatyp

boolean

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

Withdrawal of investigational product

Datatyp

boolean

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

Concomitant medication

Datatyp

boolean

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

study participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Beskrivning

other

Datatyp

text

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

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
Beskrivning

Medical Conditions Hypersensitivity surgeries

Datatyp

text

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

Date of Onset

Datatyp

date

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

Medical Conditions SAE

Datatyp

boolean

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

Date of Last Occurrence

Datatyp

date

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

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)
Beskrivning

Risk Factors substance use disorder occupational hazard

Datatyp

text

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

SECTION 8 RELEVANT Concomitant Medications

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

Drug Name

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beskrivning

Dose

Datatyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beskrivning

Unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beskrivning

Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

Route

Datatyp

text

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

Taken Prior to Study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beskrivning

Ongoing Medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

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

SECTION 9 Details of Investigational Product(s)

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

lnvestigational Product

Datatyp

text

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

SECTION 10 Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1828479
Details of RELEVANT Assessments
Beskrivning

(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)

Datatyp

text

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

SECTION 11 Narrative Remarks

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

comment SAE

Datatyp

text

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

Investigator signature

Datatyp

text

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

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Events

1 Formulär
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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