ID

25762

Beschreibung

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome AE Section

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Versionen (1)
  1. 18.09.17 18.09.17 -
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GlaxoSmithKline

Hochgeladen am

18. September 2017

DOI

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AE Section GSK Ropinirole Restless Legs Syndrome 101468

Englisch

AE Section GSK Ropinirole Restless Legs Syndrome 101468

1 Formulare  
Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Adverse Event - Please note any SERIOUS events should NOT be recorded on this page, but on the SERIOUS ADVERSE EVENT pages provided. Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient 'How are you feeling' (pre-dose) and at subsequent schedules intervals post dose: 'Since you were last asked have you felt unwell or different from usual?'
Beschreibung

Adverse Event - Please note any SERIOUS events should NOT be recorded on this page, but on the SERIOUS ADVERSE EVENT pages provided. Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient 'How are you feeling' (pre-dose) and at subsequent schedules intervals post dose: 'Since you were last asked have you felt unwell or different from usual?'

Alias
UMLS CUI-1
C0877248
If no adverse events, please mark box and sign form below.
Beschreibung

Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Event
Beschreibung

Adverse Event: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
Onset Date
Beschreibung

Onset Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0574845
dd-mmm-yyyy
Onset Time
Beschreibung

Onset Time

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1]
C0449244
24hr:min
End Date (If ongoing, please leave blank)
Beschreibung

End Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
End Time (If ongoing, please leave blank)
Beschreibung

End Time

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1]
C1522314
24hr:min
Outcome
Beschreibung

Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Event Course
Beschreibung

Event Course

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Event Course If Intermittent, specify No. of episodes
Beschreibung

Number of Episodes

Datentyp

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschreibung

Intensity

Datentyp

text

Action Taken with Respect to Investigational Drug
Beschreibung

Action Taken

Datentyp

text

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Beschreibung

Relationship

Datentyp

text

Alias
UMLS CUI [1]
C0439849
Corrective Therapy. If 'YES', please record on Concomitant Medication form.
Beschreibung

Corrective Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject due to this AE?
Beschreibung

Withdrawal due to Adverse Event

Datentyp

boolean

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

Adverse Event Date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
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Ähnliche Modelle

AE Section GSK Ropinirole Restless Legs Syndrome 101468

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Adverse Event - Please note any SERIOUS events should NOT be recorded on this page, but on the SERIOUS ADVERSE EVENT pages provided. Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient 'How are you feeling' (pre-dose) and at subsequent schedules intervals post dose: 'Since you were last asked have you felt unwell or different from usual?'
C0877248 (UMLS CUI-1)
Adverse Event
Item
If no adverse events, please mark box and sign form below.
boolean
C0877248 (UMLS CUI [1])
Adverse Event: Specification
Item
Adverse Event
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1])
End Date
Item
End Date (If ongoing, please leave blank)
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time (If ongoing, please leave blank)
time
C1522314 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
Number of Episodes
Item
Event Course If Intermittent, specify No. of episodes
float
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
Intensity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
Non (Non)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Drug interrupted/restarted (Drug interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
Item
Relationship to Investigational Drug
text
C0439849 (UMLS CUI [1])
Relationship
Code List
Relationship to Investigational Drug
CL Item
Related (Related)
CL Item
Possibly related (Possibly related)
CL Item
Probably related (Probably related)
CL Item
Unrelated (Unrelated)
Corrective Therapy
Item
Corrective Therapy. If 'YES', please record on Concomitant Medication form.
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal due to Adverse Event
Item
Was subject due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Adverse Event Date
Item
Date
date
C2697888 (UMLS CUI [1])
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