ID

26886

Description

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome Documentation part (Visit Description): Serious Adverse Event

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Versions (1)
  1. 27/10/2017 27/10/2017 -
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GlaxoSmithKline

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27 octobre 2017

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Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Serious Adverse Event 101468/199

Anglais

Serious Adverse Event

1 Formulaires  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0244821
Did the subject experience any serious adverse events during the study?
Description

If Yes, record details below.

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
Event
Description

Diagnosis Only (if known). Otherwise Sign/Symptom

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Start date Serious Adverse Event
Description

Start date Serious Adverse Event

Type de données

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Start Time Serious Adverse Event
Description

Start Time Serious Adverse Event

Type de données

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697889
Outcome Serious Adverse Event
Description

Outcome Serious Adverse Event

Type de données

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date Serious Adverse Event
Description

End Date Serious Adverse Event

Type de données

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
End Time Serious Adverse Event
Description

End Time Serious Adverse Event

Type de données

time

Alias
UMLS CUI [1,1]
C2826658
UMLS CUI [1,2]
C1519255
Frequency of Serious Adverse Event
Description

Frequency of Serious Adverse Event

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439603
Maximum Intensity
Description

Serious Adverse Event

Type de données

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the Serious AE
Description

Action Taken

Type de données

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this AE?
Description

withdrawal

Type de données

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

AE caused by the investigational product

Type de données

boolean

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

autopsy performed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Specify reason(s) for considering this a SAE, check all that apply:
Description

Seriousness of Serious Adverse Event

Type de données

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
If other reason, please specify
Description

Seriousness of Serious Adverse Event

Type de données

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Description

Recurrence of Serious Adverse Event

Type de données

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
Date of birth
Description

Date of birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Type de données

integer

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
Description

Causes of SAE

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
If other cause of SAE, please specify
Description

Causes of SAE

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
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 Assessments

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0431080
UMLS CUI [1,3]
C0220825
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Description

Narrative Remarks

Type de données

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Relevant Medical Conditions
Description

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
Description

medical disorders, allergies, surgeries

Type de données

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
Date of Onset of medical condition/allergies/surgeries
Description

Date of Onset

Type de données

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0808070
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
Condition Present at Time of the SAE?
Description

Condition Present at Time of the SAE

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
Date of Last Occurrence
Description

Date of Last Occurrence

Type de données

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
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)
Description

Risk Factors

Type de données

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Details of Investigational Product(s)
Description

Details of Investigational Product(s)

Alias
UMLS CUI-1
C0304229
Date of Dose
Description

Date of Dose

Type de données

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Description

Time of Dose

Type de données

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Was treatment blind broken at investigational site?
Description

treatment blind broken

Type de données

boolean

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
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Similar models

Serious Adverse Event

1 Formulaires
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Event
Item
Event
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start date Serious Adverse Event
Item
Start date Serious Adverse Event
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
Start Time Serious Adverse Event
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Item
Outcome Serious Adverse Event
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome Serious Adverse Event
CL Item
Recovered/Resolved (1)
C2826210 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C0521108 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved withsequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal (5)
End Date Serious Adverse Event
Item
End Date Serious Adverse Event
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time Serious Adverse Event
Item
End Time Serious Adverse Event
time
C2826658 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Frequency of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency of Non-Serious Adverse Event
Code List
Frequency of Serious Adverse Event
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1710066 (UMLS CUI [1,1])
C1519255 (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 (4)
Item
Action Taken with Investigational Product(s) as a Result of the Serious AE
integer
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the Serious AE
CL Item
Investigational product(s) withdrawn (1)
C1875319 (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)
C0443172 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (6)
withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AE caused by the investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a SAE, check all that apply:
integer
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Seriousness of Serious Adverse Event
Code List
Specify reason(s) for considering this a SAE, check 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 (6)
Seriousness of Serious Adverse Event
Item
If other reason, please specify
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Recurrence of Serious Adverse Event
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Causes of SAE
Code List
Possible Causes of SAE Other Than Investigational Product(s), check 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 (7)
Causes of SAE
Item
If other cause of SAE, please specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Details of 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
C1519255 (UMLS CUI [1,1])
C0431080 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
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
Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
medical disorders, allergies, surgeries
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Date of Onset
Item
Date of Onset of medical condition/allergies/surgeries
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [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])
Date of Last Occurrence
Item
Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
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
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
treatment blind broken
Item
Was treatment blind broken at investigational site?
boolean
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
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