ID

24804

Beschreibung

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 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 : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Serious adverse events

Stichworte

Versionen (3)
  1. 18.08.17 18.08.17 -
  2. 08.09.17 08.09.17 -
  3. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

18. August 2017

DOI

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Creative Commons BY-NC 3.0
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Serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

Englisch

Serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulare  
General information
Beschreibung

General information

Protocol indentifier
Beschreibung

Protocol indentifier

Datentyp

text

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre
Beschreibung

Centre

Datentyp

date

Randomization number
Beschreibung

Randomization number

Datentyp

text

Serious adverse events
Beschreibung

Serious adverse events

Did the subject experience a serious adverse event during the study?
Beschreibung

If Yes, record details below.

Datentyp

boolean

Section 1
Beschreibung

Section 1

Event
Beschreibung

Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE however if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.

Datentyp

text

Start date
Beschreibung

Record the start date of the first occurrence of the SAE.

Datentyp

date

Outcome
Beschreibung

All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

Datentyp

integer

End Date
Beschreibung

Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/ Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Datentyp

date

Maximum Intensity
Beschreibung

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Datentyp

text

Action Taken with Investigational Product(s) as a Result of the SAE
Beschreibung

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced =Dose is reduced for one or more investigational product(s). Dose increased =Dose increased for one or more investigational product(s). Dose not changed=Investigational product(s) continues even though an adverse event has occurred. Dose interrupted=Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable=Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

Datentyp

text

Did the subject withdraw from study as a result of this SAE?
Beschreibung

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Datentyp

boolean

Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Datentyp

boolean

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

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

Datentyp

boolean

Section 2: Seriousness
Beschreibung

Section 2: Seriousness

[A] Results in death
Beschreibung

SAE results in death

Datentyp

boolean

[B] Is life-threatening
Beschreibung

SAE is life-threatening

Datentyp

boolean

[C] Requires hospitalisation or prolongation of existing hospitalisation
Beschreibung

SAE requires hospitalisation

Datentyp

boolean

[D] Results in disability/incapacity
Beschreibung

SAE results in disability/incapacity

Datentyp

boolean

[E] Congenital anomaly/birth defect
Beschreibung

Congenital anomaly/birth defect

Datentyp

boolean

[F] Other
Beschreibung

Óther SAE

Datentyp

boolean

Other, specify
Beschreibung

Other SAE specificationn

Datentyp

text

Section 3: Demography data
Beschreibung

Section 3: Demography data

Date of birth
Beschreibung

Date of birth

Datentyp

date

Sex
Beschreibung

Sex

Datentyp

text

Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
kg
Section 4
Beschreibung

Section 4

If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

If deliberate or inadvertant administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?

Datentyp

text

Section 5: Possible Causes of SAE Other Than Investigational Product(s)
Beschreibung

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

Disease under study
Beschreibung

Disease under study

Datentyp

boolean

Medical condition(s) (record in Section 6)
Beschreibung

Medical condition

Datentyp

boolean

Lack of efficacy
Beschreibung

Lack of efficacy

Datentyp

boolean

Withdrawal of investigational product(s)
Beschreibung

Withdrawal of investigational product

Datentyp

boolean

Concomitant medication (record in Section 8)
Beschreibung

Concomitant medication

Datentyp

boolean

Activity related to study participation (e.g., procedures)
Beschreibung

Activity related to study participation

Datentyp

boolean

Other
Beschreibung

Other cause of SAE

Datentyp

boolean

Other, specify
Beschreibung

Other cause of SAE specification

Datentyp

text

Section 6: Relevant medical conditions
Beschreibung

Section 6: Relevant medical conditions

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschreibung

Medical conditions relevant to SAE

Datentyp

text

Date of onset
Beschreibung

Date of onset

Datentyp

date

Condition Present at Time of the SAE?
Beschreibung

Condition Present at time of SAE

Datentyp

boolean

If No, Date of Last Occurrence
Beschreibung

Date of Last Occurrence

Datentyp

date

Section 7
Beschreibung

Section 7

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 risk factors relevant to SAE

Datentyp

text

Section 8: RELEVANT Concomitant Medications (include details of any concomitant medication(s) which may have contributed to the event)
Beschreibung

Section 8: RELEVANT Concomitant Medications (include details of any concomitant medication(s) which may have contributed to the event)

Drug name
Beschreibung

(Trade Name preferred)

Datentyp

text

Dose
Beschreibung

Dose

Datentyp

float

Unit
Beschreibung

Unit

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Taken prior to study?
Beschreibung

medication taken prior to study

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Start date
Beschreibung

Start date

Datentyp

date

Stop Date
Beschreibung

Stop Date

Datentyp

date

Ongoing Medication?
Beschreibung

Ongoing Medication

Datentyp

boolean

Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Section 9: Details of Investigational Product(s)
Beschreibung

Section 9: Details of Investigational Product(s)

Dose level (randomization)
Beschreibung

Dose level randomization

Datentyp

text

Start date (randomization)
Beschreibung

Start date randomization

Datentyp

date

Stop date (randomization)
Beschreibung

Stop date randomization

Datentyp

date

Continuing (randomization)
Beschreibung

Continuation randomization

Datentyp

boolean

Dose level (At time of SAE)
Beschreibung

Dose level At time of SAE

Datentyp

text

Start date (At time of SAE)
Beschreibung

Start date At time of SAE

Datentyp

date

Stop date (At time of SAE)
Beschreibung

Stop date At time of SAE

Datentyp

date

Continuing (At time of SAE)
Beschreibung

Continuation At time of SAE

Datentyp

boolean

Was randomisation code broken at investigational site?
Beschreibung

randomisation code broken

Datentyp

text

Section 10
Beschreibung

Section 10

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

Section 11
Beschreibung

Section 11

Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beschreibung

Narrative Remarks

Datentyp

text

Investigator information
Beschreibung

Investigator information

Investigator’s signature
Beschreibung

confirming that the data on the SAE pages are accurate and complete

Datentyp

text

Date
Beschreibung

Date

Datentyp

date

Investigator’s name (print)
Beschreibung

Investigator’s name

Datentyp

text

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Ähnliche Modelle

Serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General information
Protocol indentifier
Item
Protocol indentifier
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre
Item
Centre
date
Randomization number
Item
Randomization number
text
Item Group
Serious adverse events
serious adverse events
Item
Did the subject experience a serious adverse event during the study?
boolean
Event
Item
Event
text
Start date
Item
Start date
date
Item
Outcome
integer
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
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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 (X)
withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
Relationship to Investigational Product
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
post-mortem/autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
Item Group
Section 2: Seriousness
SAE results in death
Item
[A] Results in death
boolean
SAE is life-threatening
Item
[B] Is life-threatening
boolean
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
Óther SAE
Item
[F] Other
boolean
Other SAE specificationn
Item
Other, specify
text
Item Group
Section 3: Demography data
Date of birth
Item
Date of birth
date
Item
Sex
text
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
Item Group
Section 4
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
Recurrence of SAE
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)
Disease under study
Item
Disease under study
boolean
Medical condition
Item
Medical condition(s) (record in Section 6)
boolean
Lack of efficacy
Item
Lack of efficacy
boolean
Withdrawal of investigational product
Item
Withdrawal of investigational product(s)
boolean
Concomitant medication
Item
Concomitant medication (record in Section 8)
boolean
Activity related to study participation
Item
Activity related to study participation (e.g., procedures)
boolean
Other cause of SAE
Item
Other
boolean
Other cause of SAE specification
Item
Other, specify
text
Item Group
Section 6: Relevant medical conditions
Medical conditions relevant to SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
Date of onset
Item
Date of onset
date
Condition Present at time of SAE
Item
Condition Present at Time of the SAE?
boolean
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
Item Group
Section 7
Other risk factors relevant to SAE
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
Section 8: RELEVANT Concomitant Medications (include details of any concomitant medication(s) which may have contributed to the event)
Drug name
Item
Drug name
text
Dose
Item
Dose
float
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
medication taken prior to study
Item
Taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Start date
Item
Start date
date
Stop Date
Item
Stop Date
date
Ongoing Medication
Item
Ongoing Medication?
boolean
Reason for Medication
Item
Reason for Medication
text
Item Group
Section 9: Details of Investigational Product(s)
Dose level randomization
Item
Dose level (randomization)
text
Start date randomization
Item
Start date (randomization)
date
Stop date randomization
Item
Stop date (randomization)
date
Continuation randomization
Item
Continuing (randomization)
boolean
Dose level At time of SAE
Item
Dose level (At time of SAE)
text
Start date At time of SAE
Item
Start date (At time of SAE)
date
Stop date At time of SAE
Item
Stop date (At time of SAE)
date
Continuation At time of SAE
Item
Continuing (At time of SAE)
boolean
Item
Was randomisation code broken at investigational site?
text
randomisation code broken
Code List
Was randomisation code broken at investigational site?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Item Group
Section 10
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
Item Group
Section 11
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
Item Group
Investigator information
Investigator’s signature
Item
Investigator’s signature
text
Date
Item
Date
date
Investigator’s name
Item
Investigator’s name (print)
text
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