ID

26549

Beskrivning

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Nyckelord

Versioner (1)
  1. 2017-10-18 2017-10-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Serious adverse events Ropinirole CR Ropinirole IR Monotherapy 101468/168

Engelsk

Serious adverse events Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Centre/Investigator Number
Beskrivning

Centre/Investigator Number

Datatyp

text

Randomisation Number
Beskrivning

Randomisation Number

Datatyp

text

Visit Description
Beskrivning

Visit Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
SERIOUS ADVERSE EVENT (SAE)
Beskrivning

SERIOUS ADVERSE EVENT (SAE)

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

If Yes, record details below.

Datatyp

text

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

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

Datatyp

text

SECTION 1: Serious adverse event
Beskrivning

SECTION 1: Serious adverse event

Event
Beskrivning

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.

Datatyp

text

Start Date
Beskrivning

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

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beskrivning

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.

Datatyp

integer

End Date
Beskrivning

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’.

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beskrivning

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 normal 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).

Datatyp

text

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

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).

Datatyp

text

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

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

Datatyp

text

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

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.

Datatyp

text

SECTION 2: Seriousness
Beskrivning

SECTION 2: Seriousness

[A] Results in death
Beskrivning

SAE results in death

Datatyp

boolean

Alias
UMLS CUI [1]
C0011065
[B] Is life-threatening
Beskrivning

Note: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.

Datatyp

boolean

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

Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE.

Datatyp

boolean

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

Note: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.

Datatyp

boolean

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

Congenital anomaly/birth defect

Datatyp

boolean

Alias
UMLS CUI [1]
C0000768
[F] Other
Beskrivning

Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
[F] Other, specify
Beskrivning

Other SAE specification

Datatyp

text

Alias
UMLS CUI [1]
C3845569
[G] Insert study specific item
Beskrivning

Insert study specific item

Datatyp

boolean

SECTION 3: Demography data
Beskrivning

SECTION 3: Demography data

Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4: Recurrence of SAE
Beskrivning

SECTION 4: Recurrence of SAE

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

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

Datatyp

text

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

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

Disease under study
Beskrivning

Disease under study

Datatyp

boolean

Alias
UMLS CUI [1]
C0012634
Medical condition(s)
Beskrivning

(record in Section 6)

Datatyp

boolean

Alias
UMLS CUI [1]
C1699700
Lack of efficacy
Beskrivning

Lack of efficacy

Datatyp

boolean

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

Withdrawal of investigational product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant Medication
Beskrivning

Concomitant Medication

Datatyp

boolean

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

Activity related to study participation

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Other
Beskrivning

Other possible Cause of SAE

Datatyp

boolean

Other, specify
Beskrivning

Other possible Cause of SAE specification

Datatyp

text

SECTION 6: RELEVANT Medical Conditions
Beskrivning

SECTION 6: RELEVANT Medical Conditions

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

Relevant Medical Conditions

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Beskrivning

Date of onset

Datatyp

date

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

Condition Present at Time of the SAE

Datatyp

text

If No, Date of Last Occurrence
Beskrivning

Date of Last Occurrence

Datatyp

date

SECTION 7: Other RELEVANT Risk Factors
Beskrivning

SECTION 7: Other RELEVANT Risk Factors

Other relevant risk factors
Beskrivning

Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.

Datatyp

text

SECTION 8: RELEVANT Concomitant Medications
Beskrivning

SECTION 8: RELEVANT Concomitant Medications

Drug name
Beskrivning

(Trade name preferred)

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beskrivning

Dose

Datatyp

float

Alias
UMLS CUI [1]
C3174092
Unit
Beskrivning

Unit

Datatyp

text

Frequency
Beskrivning

Frequency

Datatyp

text

Route
Beskrivning

Route

Datatyp

text

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

administration prior to study

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beskrivning

Ongoing Medication

Datatyp

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

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

SECTION 9: Details of Investigational Product(s)

Details of Investigational Product(s)
Beskrivning

Investigational Product

Datatyp

text

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

Randomisation code broken

Datatyp

text

Alias
UMLS CUI [1]
C0034656
SECTION 10: Details of RELEVANT Assessments
Beskrivning

SECTION 10: Details of RELEVANT Assessments

Details of Relevant Assessments
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11: Narrative Remarks
Beskrivning

SECTION 11: Narrative Remarks

Narrative Remarks
Beskrivning

Provide a brief narrative description of the SAE and details of treatment given.

Datatyp

text

Investigator information
Beskrivning

Investigator information

Investigator’s signature
Beskrivning

Confirming that the data on the SAE pages are accurate and complete.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name (print)
Beskrivning

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Serious adverse events Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Centre/Investigator Number
Item
Centre/Investigator Number
text
Randomisation Number
Item
Randomisation Number
text
Visit Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
SERIOUS ADVERSE EVENT (SAE)
Item
Did the subject experience a serious adverse event during the study?
text
non-serious adverse events
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed?
text
fatal SAE
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 1: Serious adverse event
Event
Item
Event
text
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
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
C0806020 (UMLS CUI [1])
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 with IP
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)
Item
Did the subject withdraw from study as a result of this SAE?
text
Withdrawal
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
text
Cause of Adverse event
Code List
Is there a reasonable possibility the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 2: Seriousness
SAE results in death
Item
[A] Results in death
boolean
C0011065 (UMLS CUI [1])
SAE is life-threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
Other SAE
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Other SAE specification
Item
[F] Other, specify
text
C3845569 (UMLS CUI [1])
Insert study specific item
Item
[G] Insert study specific item
boolean
Item Group
SECTION 3: Demography data
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
C0005910 (UMLS CUI [1])
Item Group
SECTION 4: Recurrence of SAE
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
C0012634 (UMLS CUI [1])
Medical condition
Item
Medical condition(s)
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
boolean
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation (e.g. procedures)
boolean
C2348568 (UMLS CUI [1])
Other possible Cause of SAE
Item
Other
boolean
Other possible Cause of SAE specification
Item
Other, specify
text
Item Group
SECTION 6: RELEVANT Medical Conditions
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
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
Condition Present at Time of the SAE
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
Item Group
SECTION 7: Other RELEVANT Risk Factors
Other relevant risk factors
Item
Other relevant risk factors
text
Item Group
SECTION 8: RELEVANT Concomitant Medications
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Item
Taken Prior to Study?
text
administration prior to study
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
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)
Investigational Product
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1])
Item
Was randomisation code broken at investigational site?
text
C0034656 (UMLS CUI [1])
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
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11: Narrative Remarks
Narrative Remarks
Item
Narrative Remarks
text
Item Group
Investigator information
Investigator Signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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