ID

25748

Beschreibung

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the SAE form.

Stichworte

Versionen (1)
  1. 17.09.17 17.09.17 -
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GlaxoSmithKline

Hochgeladen am

17. September 2017

DOI

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GSK Ropinirole in Patients Suffering from Parkinsons Disease SAE 101468/169 NCT00381472

Englisch

GSK Ropinirole in Patients Suffering from Parkinsons Disease SAE 101468/169 NCT00381472

1 Formulare  
SERIOUS ADVERSE EVENTS
Beschreibung

SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse events during the study? If Yes, record details below.
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date
Beschreibung

If fatal, record date of death.

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the Serious AE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE

Datentyp

integer

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

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

Relationship to Investigational Product(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
If fatal, was a post-mortem/autopsy performed?
Beschreibung

If fatal, was a post-mortem/autopsy performed?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C1710056
(specify reason(s) for considering this a SAE, ✔ all that apply:
Beschreibung

Seriousness

Datentyp

integer

Alias
UMLS CUI [1]
C1710056
(specify reason(s) for considering this a SAE, all that apply: Other, specify:
Beschreibung

Seriousness

Datentyp

text

Alias
UMLS CUI [1]
C1710056
Demography Data
Beschreibung

Demography Data

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C1519255
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Section 4
Beschreibung

Section 4

Alias
UMLS CUI-1
C1519255
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

Adverse event Recurrence

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
Possible Causes of SAE
Beschreibung

Possible Causes of SAE

Alias
UMLS CUI-1
C3828190
UMLS CUI-2
C1519255
Possible Causes of SAE Other Than Investigational Product(s), ✔ all that apply:
Beschreibung

Possible Causes of SAE Other Than Investigational Product(s), ✔ all that apply:

Datentyp

integer

Alias
UMLS CUI [1,1]
C3828190
UMLS CUI [1,2]
C1519255
Possible Causes of SAE Other Than Investigational Product(s), Other, specify:
Beschreibung

Possible Causes of SAE Other Than Investigational Product(s), ✔ all that apply:

Datentyp

text

Alias
UMLS CUI [1,1]
C3828190
UMLS CUI [1,2]
C1519255
RELEVANT Medical Conditions
Beschreibung

RELEVANT Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
UMLS CUI-3
C1519255
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschreibung

RELEVANT Medical Conditions

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332162
Condition Present at Time of the SAE?
Beschreibung

Condition Present at Time of the SAE?

Datentyp

boolean

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

If No, Date of Last Occurrence

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1519255
Other RELEVANT Risk Factors
Beschreibung

Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C1519255
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Beschreibung

Other RELEVANT Risk Factors

Datentyp

text

RELEVANT Concomitant Medications
Beschreibung

RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
Drug Name
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Taken Prior to Study?
Beschreibung

Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826667
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1519255
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2347852
UMLS CUI [1,4]
C1519255
Details of Investigational Product(s)
Beschreibung

Details of Investigational Product(s)

Alias
UMLS CUI-1
C0304229
Details of Investigational Product(s)
Beschreibung

Details of Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Was randomisation code broken at investigational site?
Beschreibung

randomisation

Datentyp

integer

Alias
UMLS CUI [1]
C0034656
Details of RELEVANT Assessments
Beschreibung

Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
Details of RELEVANT Assessments (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)
Beschreibung

Details of RELEVANT Assessments

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
Narrative Remarks
Beschreibung

Narrative Remarks

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beschreibung

Narrative Remarks

Datentyp

text

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

Investigator’s signature

Alias
UMLS CUI-1
C2346576
Investigator’s signature
Beschreibung

Investigator’s signature

Datentyp

text

Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

GSK Ropinirole in Patients Suffering from Parkinsons Disease SAE 101468/169 NCT00381472

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
SERIOUS ADVERSE EVENTS
C1519255 (UMLS CUI-1)
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study? If Yes, record details below.
boolean
C1519255 (UMLS CUI [1])
Event
Item
Event
text
C1519255 (UMLS CUI [1])
Start date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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 [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
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 Serious AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Code List
Action Taken with Investigational Product(s) as a Result of the Serious 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)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If fatal, was a post-mortem/autopsy performed?
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Seriousness
C1710056 (UMLS CUI-1)
Item
(specify reason(s) for considering this a SAE, ✔ all that apply:
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
(specify reason(s) for considering this a SAE, ✔ all that apply:
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, specify (6)
Seriousness
Item
(specify reason(s) for considering this a SAE, all that apply: Other, specify:
text
C1710056 (UMLS CUI [1])
Item Group
Demography Data
C0011298 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item Group
Section 4
C1519255 (UMLS CUI-1)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
integer
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
No (1)
CL Item
Not applicable (2)
CL Item
Unknown at this time (3)
CL Item
Yes (4)
Item Group
Possible Causes of SAE
C3828190 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s), ✔ all that apply:
integer
C3828190 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Possible Causes of SAE Other Than Investigational Product(s), ✔ all that apply:
Code List
Possible Causes of SAE Other Than Investigational Product(s), ✔ all that apply:
CL Item
Disease under study (1)
CL Item
Medical condition(s) (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (record in Section 8) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Possible Causes of SAE Other Than Investigational Product(s), ✔ all that apply:
Item
Possible Causes of SAE Other Than Investigational Product(s), Other, specify:
text
C3828190 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
RELEVANT Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
RELEVANT Medical Conditions
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of Onset
Item
Date of Onset
date
C0011008 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
If No, Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
Other RELEVANT Risk Factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Other RELEVANT Risk Factors
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
Item Group
RELEVANT Concomitant Medications
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1])
Item
Was randomisation code broken at investigational site?
integer
C0034656 (UMLS CUI [1])
randomisation
Code List
Was randomisation code broken at investigational site?
CL Item
No (1)
CL Item
Not applicable (2)
CL Item
Yes (3)
Item Group
Details of RELEVANT Assessments
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments (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)
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Narrative Remarks
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Narrative Remarks
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])
Item Group
Investigator’s signature
C2346576 (UMLS CUI-1)
Investigator’s signature
Item
Investigator’s signature
text
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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