ID

35978

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Significant Medical/Surgical History and Physical examination. Both has to be filled in for screening. Physical examination has to be filled in for Follow-up too.

Keywords

Versions (1)
  1. 4/8/19 4/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 8, 2019

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License

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Significant Medical/Surgical History, Physical examination

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID:
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

Fill in "Physical examination" for both screening and follow-up. "Medical hitory" is only for sceening mandatory.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Significant Medical/Surgical History
Description

Significant Medical/Surgical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Is the subject suffering from or has he/she ever suffered from any SIGNIFICANT medical or surgical condition?
Description

If Yes, list below one diagnosis per line. (Please print clearly) Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

Data type

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0489540
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
GSK Use
Description

Investigator Use

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Year of first diagnosis
Description

Month/Year

Data type

partialDate

Alias
UMLS CUI [1]
C2316983
Past
Description

Diagnosis from past

Data type

boolean

Alias
UMLS CUI [1]
C0455458
Ongoing
Description

Ongoing disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Any findings?
Description

"Physical Examination should be performed and any relevant findings must be described on the Medical History form (for findings of the past), or on the Baseline Sign/Symptom form (for findings presently occurring, events existing prior to drug administration). IMPORTANT: these findings, or events, must have a complete starting date that is at, or before, the date of the assessment (so that these are clearly pre-treatment findings, or events)." If any clinically significant abnormalities are present, DO NOT INCLUDE the subject.

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
If there are any findings, please speficy the region
Description

Findings, specification

Data type

integer

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C2348235
If other findings, please specify
Description

Other findings

Data type

text

Alias
UMLS CUI [1]
C1335151
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Similar models

Significant Medical/Surgical History, Physical examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID:
text
C3846158 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
Follow-up (2)
Item Group
Significant Medical/Surgical History
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
Item
Is the subject suffering from or has he/she ever suffered from any SIGNIFICANT medical or surgical condition?
text
C0262926 (UMLS CUI [1])
C0489540 (UMLS CUI [2])
Significant Medical/Surgical History
Code List
Is the subject suffering from or has he/she ever suffered from any SIGNIFICANT medical or surgical condition?
CL Item
No (N)
CL Item
Yes (Y)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Investigator Use
Item
GSK Use
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C2316983 (UMLS CUI [1])
Diagnosis from past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing disease
Item
Ongoing
boolean
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Any findings?
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Findings
Code List
Any findings?
CL Item
No (N)
CL Item
Yes (Y)
Item
If there are any findings, please speficy the region
integer
C0243095 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Findings, specification
Code List
If there are any findings, please speficy the region
CL Item
Head, ears, eyes, nose, throat (1)
CL Item
Cardiovascular (2)
CL Item
Respiratory (3)
CL Item
Lymph nodes (major lymph glands only) (4)
CL Item
Abdominal (5)
CL Item
Musculo-skeletal (6)
CL Item
Neurologic (7)
CL Item
Skin (8)
CL Item
Other (9)
Other findings
Item
If other findings, please specify
text
C1335151 (UMLS CUI [1])
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