ID

24368

Descrizione

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

versioni (1)
  1. 30/07/17 30/07/17 -
Titolare del copyright

GlaxoSmithKline

Caricato su

30 luglio 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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Serious Adverse Events Ropinirole NCT00632736

Inglese

Serious Adverse Events

1 moduli  
  1. StudyEvent: ODM
    1. Serious Adverse Events
SERIOUS ADVERSE EVENT (SAE)
Descrizione

SERIOUS ADVERSE EVENT (SAE)

Alias
UMLS CUI-1
C1519255
Subject ID
Descrizione

Subject ID

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrizione

Centre Number

Tipo di dati

integer

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

Randomisation Number

Tipo di dati

text

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

Serious Adverse Events

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1519255
SECTION 1
Descrizione

SECTION 1

Alias
UMLS CUI-1
C1828479
Event
Descrizione

Event

Tipo di dati

text

Alias
UMLS CUI [1]
C0877248
Start Date
Descrizione

Start Date

Tipo di dati

date

Alias
UMLS CUI [1]
C0808070
Outcome
Descrizione

Outcome

Tipo di dati

integer

Alias
UMLS CUI [1]
C1705586
End date
Descrizione

End date

Tipo di dati

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Descrizione

Maximum Intensity

Tipo di dati

text

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

Action Taken

Tipo di dati

text

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

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

Tipo di dati

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?
Descrizione

causations adverse events

Tipo di dati

boolean

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

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004398
SECTION 2 Seriousness
Descrizione

SECTION 2 Seriousness

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

Death

Tipo di dati

boolean

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

life-threatening

Tipo di dati

boolean

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

hospitalisation

Tipo di dati

boolean

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

disability

Tipo di dati

boolean

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

Congenital anomaly

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826727
Other, specify
Descrizione

Other

Tipo di dati

text

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

SECTION 3 Demography Data

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

Date of birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrizione

Sex

Tipo di dati

text

Alias
UMLS CUI [1]
C0079399
Weight
Descrizione

Weight

Tipo di dati

float

Unità di misura
  • kg
kg
SECTION 4
Descrizione

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?
Descrizione

Adverse event Recurrence

Tipo di dati

text

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

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
Descrizione

Disease

Tipo di dati

boolean

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

Medical condition

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1699700
Lack of efficacy
Descrizione

Lack of efficacy

Tipo di dati

boolean

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

Withdrawal of investigational product

Tipo di dati

boolean

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

Concomitant medication

Tipo di dati

boolean

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

study participation status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Descrizione

other

Tipo di dati

text

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

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
Descrizione

Medical Conditions Hypersensitivity surgeries

Tipo di dati

text

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

Date of Onset

Tipo di dati

date

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

Medical Conditions SAE

Tipo di dati

boolean

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

Date of Last Occurrence

Tipo di dati

date

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

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)
Descrizione

Risk Factors substance use disorder occupational hazard

Tipo di dati

text

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

SECTION 8 RELEVANT Concomitant Medications

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

Drug Name

Tipo di dati

text

Alias
UMLS CUI [1]
C0013227
Dose
Descrizione

Dose

Tipo di dati

integer

Alias
UMLS CUI [1]
C3174092
Unit
Descrizione

Unit

Tipo di dati

text

Alias
UMLS CUI [1]
C1519795
Frequency
Descrizione

Frequency

Tipo di dati

text

Alias
UMLS CUI [1]
C3476109
Route
Descrizione

Route

Tipo di dati

text

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

Taken Prior to Study?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Descrizione

Start Date

Tipo di dati

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Descrizione

Stop Date

Tipo di dati

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Descrizione

Ongoing Medication?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Descrizione

Reason for Medication

Tipo di dati

text

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

SECTION 9 Details of Investigational Product(s)

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

lnvestigational Product

Tipo di dati

text

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

SECTION 10 Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1828479
Details of RELEVANT Assessments
Descrizione

(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)

Tipo di dati

text

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

SECTION 11 Narrative Remarks

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

comment SAE

Tipo di dati

text

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

Investigator signature

Tipo di dati

text

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

Investigator name

Tipo di dati

text

Alias
UMLS CUI [1]
C2826892
Date
Descrizione

Date

Tipo di dati

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Events

1 moduli
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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