ID

36392

Beschreibung

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the non serious AE form. It has to be filled in if the subject experiences non serious AE during the study.

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Versionen (2)
  1. 05.09.17 05.09.17 -
  2. 10.05.19 10.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Mai 2019

DOI

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Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Englisch

Non- Serious Adverse Experiences (non serious AE)

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
ADVERSE EXPERIENCES (Non-serious)
Beschreibung

ADVERSE EXPERIENCES (Non-serious)

Alias
UMLS CUI-1
C1518404
Did adverse experiences occurr?
Beschreibung

Record any adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: “Do you feel different in any way since starting the treatment or since the last visit?” Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box and sign form below.

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Onset Date of AE
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2985916
Onset Time of AE
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C0877248
End Date of AE
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2697886
End Time of AE
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Outcome of AE
Beschreibung

Outcome of AE

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Event course of AE
Beschreibung

Experience Course of AE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If AE is interemittent, please specify number of episodes
Beschreibung

Number of episodes

Datentyp

integer

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

INTENSITY (Maximum) Definition: MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to Investigational Drug
Beschreibung

Action Taken with Respect to Investigational Drug

Datentyp

integer

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

Definition: NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Beschreibung

If ‘Yes’, please record on Concomitant Medication form.

Datentyp

text

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

Patient withdrawn due to this specific AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Investigator signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Non- Serious Adverse Experiences (non serious AE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
ADVERSE EXPERIENCES (Non-serious)
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Did adverse experiences occurr?
boolean
C1518404 (UMLS CUI [1])
Onset Date of AE
Item
Onset Date of AE
date
C2985916 (UMLS CUI [1])
Onset Time of AE
Item
Onset Time of AE
time
C0449244 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
End Date of AE
Item
End Date of AE
date
C2697886 (UMLS CUI [1])
End Time of AE
Item
End Time of AE
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome of AE
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome of AE
CL Item
Resolved (1)
CL Item
Ongoing (2)
Item
Event course of AE
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Event course of AE
CL Item
Intermittent (1)
CL Item
Constant (2)
Number of episodes
Item
If AE is interemittent, please specify number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Not related  (1)
CL Item
Unlikely  (2)
CL Item
Suspected  (3)
CL Item
Probable  (4)
Item
Corrective Therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective Therapy
Code List
Corrective Therapy
CL Item
Yes (Y)
CL Item
No (N)
Item
Was patient withdrawn due to this specific AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Patient withdrawn due to this specific AE
Code List
Was patient withdrawn due to this specific AE?
CL Item
Yes (Y)
CL Item
No (N)
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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