English

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

1 forms  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Data type

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre
Description

Centre

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomization number
Description

Randomization number

Data type

integer

Alias
UMLS CUI [1]
C2986235
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

Alias
UMLS CUI [1]
C1519255
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

boolean

Alias
UMLS CUI [1]
C0877248
Start date
Description

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

Data type

date

Alias
UMLS CUI [1]
C0808070
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

Alias
UMLS CUI [1]
C1705586
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

Alias
UMLS CUI [1]
C0806020
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

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
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

Alias
UMLS CUI [1]
C2826626
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

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
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

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Section 2: Seriousness
Description

Section 2: Seriousness

[A] Results in death
Description

SAE results in death

Data type

boolean

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

SAE is life-threatening

Data type

boolean

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

SAE requires hospitalisation

Data type

boolean

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

SAE results in disability/incapacity

Data type

boolean

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

Congenital anomaly/birth defect

Data type

boolean

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

Óther SAE

Data type

boolean

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

Other SAE specificationn

Data type

text

Alias
UMLS CUI [1]
C3845569
Section 3: Demography data
Description

Section 3: Demography data

Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
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

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
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

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

Medical condition

Data type

boolean

Alias
UMLS CUI [1]
C1699700
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

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

Withdrawal of investigational product

Data type

boolean

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

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
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

Alias
UMLS CUI [1]
C0205394
Other, specify
Description

Other cause of SAE specification

Data type

text

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C3840932
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

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
Date of onset
Description

Date of onset

Data type

date

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

Condition Present at time of SAE

Data type

boolean

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

Date of Last Occurrence

Data type

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1519255
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

integer

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
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

Alias
UMLS CUI [1]
C0013227
Dose
Description

Dose

Data type

float

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

float

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
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

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2347852
Section 9: Details of Investigational Product(s)
Description

Section 9: Details of Investigational Product(s)

Dose level randomization
Description

Dose level randomization

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0034656
Start date (randomization)
Description

Start date randomization

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0808070
Stop date (randomization)
Description

Stop date randomization

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C2598418
Continuing (randomization)
Description

Continuation randomization

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1553904
Dose level At time of SAE
Description

Dose level At time of SAE

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1519255
Start date (At time of SAE)
Description

Start date At time of SAE

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Stop date (At time of SAE)
Description

Stop date At time of SAE

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2598418
Continuing (At time of SAE)
Description

Continuation At time of SAE

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1553904
Was randomisation code broken at investigational site?
Description

randomisation code broken

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C3846431
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

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
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

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator information
Description

Investigator information

Investigator’s signature
Description

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

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator’s name
Description

Investigator’s name

Data type

text

Alias
UMLS CUI [1]
C2826892
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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 identifier
Item
Protocol identifier
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre
Item
Centre
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
Item Group
Serious adverse events
serious adverse events
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Event
Item
Event
boolean
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)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
(Comment:en)
CL Item
Recovered/Resolved with sequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal (5)
C1705586 (UMLS CUI-1)
C0004398 (UMLS CUI-2)
(Comment:en)
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 (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
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 (1)
C0013230 (UMLS CUI-1)
(Comment:en)
CL Item
Dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
Dose not changed (4)
C0178602 (UMLS CUI-1)
C0442739 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C0178602 (UMLS CUI-1)
C0443239 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
post-mortem/autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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])
Óther SAE
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Other SAE specificationn
Item
Other, specify
text
C3845569 (UMLS CUI [1])
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)
C0086582 (UMLS CUI-1)
(Comment:en)
CL Item
Female (Female)
C0086287 (UMLS CUI-1)
(Comment:en)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
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
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
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)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (No)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown at this time (Unknown at this time)
(Comment:en)
CL Item
Not applicable (Not applicable)
C1272460 (UMLS CUI-1)
(Comment:en)
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) (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])
Activity related to study participation
Item
Activity related to study participation (e.g., procedures)
boolean
Other cause of SAE
Item
Other
boolean
C0205394 (UMLS CUI [1])
Other cause of SAE specification
Item
Other, specify
text
C1707811 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
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
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Condition Present at time of 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])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
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)
integer
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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
C0013227 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
float
C3476109 (UMLS CUI [1])
Route
Item
Route
integer
C0013153 (UMLS CUI [1])
medication 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
integer
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Item Group
Section 9: Details of Investigational Product(s)
Dose level randomization
Item
Dose level randomization
integer
C0178602 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Start date randomization
Item
Start date (randomization)
date
C0034656 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date randomization
Item
Stop date (randomization)
date
C0034656 (UMLS CUI [1,1])
C2598418 (UMLS CUI [1,2])
Continuation randomization
Item
Continuing (randomization)
boolean
C0034656 (UMLS CUI [1,1])
C1553904 (UMLS CUI [1,2])
Dose level At time of SAE
Item
Dose level At time of SAE
integer
C0178602 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start date At time of SAE
Item
Start date (At time of SAE)
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date At time of SAE
Item
Stop date (At time of SAE)
date
C1519255 (UMLS CUI [1,1])
C2598418 (UMLS CUI [1,2])
Continuation At time of SAE
Item
Continuing (At time of SAE)
boolean
C1519255 (UMLS CUI [1,1])
C1553904 (UMLS CUI [1,2])
Item
Was randomisation code broken at investigational site?
text
C0034656 (UMLS CUI [1,1])
C3846431 (UMLS CUI [1,2])
randomisation code broken
Code List
Was randomisation code broken at investigational site?
CL Item
Yes (Yes)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (No)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (Not applicable)
C1272460 (UMLS CUI-1)
(Comment:en)
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
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 11
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 information
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator’s name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
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