ID

24368

Beschreibung

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.

Stichworte

Versionen (1)
  1. 30.07.17 30.07.17 -
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GlaxoSmithKline

Hochgeladen am

30. Juli 2017

DOI

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Serious Adverse Events Ropinirole NCT00632736

Englisch

Serious Adverse Events

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Events
SERIOUS ADVERSE EVENT (SAE)
Beschreibung

SERIOUS ADVERSE EVENT (SAE)

Alias
UMLS CUI-1
C1519255
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

integer

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

Randomisation Number

Datentyp

text

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

Serious Adverse Events

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
SECTION 1
Beschreibung

SECTION 1

Alias
UMLS CUI-1
C1828479
Event
Beschreibung

Event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

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

Action Taken

Datentyp

text

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

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

Datentyp

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?
Beschreibung

causations adverse events

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0004398
SECTION 2 Seriousness
Beschreibung

SECTION 2 Seriousness

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

Death

Datentyp

boolean

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

life-threatening

Datentyp

boolean

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

hospitalisation

Datentyp

boolean

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

disability

Datentyp

boolean

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

Congenital anomaly

Datentyp

boolean

Alias
UMLS CUI [1]
C2826727
Other, specify
Beschreibung

Other

Datentyp

text

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

SECTION 3 Demography Data

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
kg
SECTION 4
Beschreibung

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?
Beschreibung

Adverse event Recurrence

Datentyp

text

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

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
Beschreibung

Disease

Datentyp

boolean

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

Medical condition

Datentyp

boolean

Alias
UMLS CUI [1]
C1699700
Lack of efficacy
Beschreibung

Lack of efficacy

Datentyp

boolean

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

Withdrawal of investigational product

Datentyp

boolean

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

Concomitant medication

Datentyp

boolean

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

study participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Beschreibung

other

Datentyp

text

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

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
Beschreibung

Medical Conditions Hypersensitivity surgeries

Datentyp

text

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

Date of Onset

Datentyp

date

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

Medical Conditions SAE

Datentyp

boolean

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

Date of Last Occurrence

Datentyp

date

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

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)
Beschreibung

Risk Factors substance use disorder occupational hazard

Datentyp

text

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

SECTION 8 RELEVANT Concomitant Medications

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

Drug Name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

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

Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

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

SECTION 9 Details of Investigational Product(s)

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

lnvestigational Product

Datentyp

text

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

SECTION 10 Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1828479
Details of RELEVANT Assessments
Beschreibung

(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)

Datentyp

text

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

SECTION 11 Narrative Remarks

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

comment SAE

Datentyp

text

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

Investigator signature

Datentyp

text

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

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Serious Adverse Events

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