ID

24804

Description

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

Keywords

Versions (3)
  1. 8/18/17 8/18/17 -
  2. 9/8/17 9/8/17 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 18, 2017

DOI

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License

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

English

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

1 forms  
General information
Description

General information

Protocol indentifier
Description

Protocol indentifier

Data type

text

Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre
Description

Centre

Data type

date

Randomization number
Description

Randomization number

Data type

text

Serious adverse events
Description

Serious adverse events

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

If Yes, record details below.

Data type

boolean

Section 1
Description

Section 1

Event
Description

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.

Data type

text

Start date
Description

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

Data type

date

Outcome
Description

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.

Data type

integer

End Date
Description

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’.

Data type

date

Maximum Intensity
Description

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).

Data type

text

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

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).

Data type

text

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

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

Data type

boolean

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

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.

Data type

boolean

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

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

Data type

boolean

Section 2: Seriousness
Description

Section 2: Seriousness

[A] Results in death
Description

SAE results in death

Data type

boolean

[B] Is life-threatening
Description

SAE is life-threatening

Data type

boolean

[C] Requires hospitalisation or prolongation of existing hospitalisation
Description

SAE requires hospitalisation

Data type

boolean

[D] Results in disability/incapacity
Description

SAE results in disability/incapacity

Data type

boolean

[E] Congenital anomaly/birth defect
Description

Congenital anomaly/birth defect

Data type

boolean

[F] Other
Description

Óther SAE

Data type

boolean

Other, specify
Description

Other SAE specificationn

Data type

text

Section 3: Demography data
Description

Section 3: Demography data

Date of birth
Description

Date of birth

Data type

date

Sex
Description

Sex

Data type

text

Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
Section 4
Description

Section 4

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

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

Data type

text

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

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

Disease under study
Description

Disease under study

Data type

boolean

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

Medical condition

Data type

boolean

Lack of efficacy
Description

Lack of efficacy

Data type

boolean

Withdrawal of investigational product(s)
Description

Withdrawal of investigational product

Data type

boolean

Concomitant medication (record in Section 8)
Description

Concomitant medication

Data type

boolean

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

Activity related to study participation

Data type

boolean

Other
Description

Other cause of SAE

Data type

boolean

Other, specify
Description

Other cause of SAE specification

Data type

text

Section 6: Relevant medical conditions
Description

Section 6: Relevant medical conditions

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

Medical conditions relevant to SAE

Data type

text

Date of onset
Description

Date of onset

Data type

date

Condition Present at Time of the SAE?
Description

Condition Present at time of SAE

Data type

boolean

If No, Date of Last Occurrence
Description

Date of Last Occurrence

Data type

date

Section 7
Description

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)
Description

Other risk factors relevant to SAE

Data type

text

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

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

Drug name
Description

(Trade Name preferred)

Data type

text

Dose
Description

Dose

Data type

float

Unit
Description

Unit

Data type

text

Frequency
Description

Frequency

Data type

text

Route
Description

Route

Data type

text

Taken prior to study?
Description

medication taken prior to study

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Start date
Description

Start date

Data type

date

Stop Date
Description

Stop Date

Data type

date

Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Reason for Medication
Description

Reason for Medication

Data type

text

Section 9: Details of Investigational Product(s)
Description

Section 9: Details of Investigational Product(s)

Dose level (randomization)
Description

Dose level randomization

Data type

text

Start date (randomization)
Description

Start date randomization

Data type

date

Stop date (randomization)
Description

Stop date randomization

Data type

date

Continuing (randomization)
Description

Continuation randomization

Data type

boolean

Dose level (At time of SAE)
Description

Dose level At time of SAE

Data type

text

Start date (At time of SAE)
Description

Start date At time of SAE

Data type

date

Stop date (At time of SAE)
Description

Stop date At time of SAE

Data type

date

Continuing (At time of SAE)
Description

Continuation At time of SAE

Data type

boolean

Was randomisation code broken at investigational site?
Description

randomisation code broken

Data type

text

Section 10
Description

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)
Description

Details of relevant assessments

Data type

text

Section 11
Description

Section 11

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

Narrative Remarks

Data type

text

Investigator information
Description

Investigator information

Investigator’s signature
Description

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

Data type

text

Date
Description

Date

Data type

date

Investigator’s name (print)
Description

Investigator’s name

Data type

text

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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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