ID

40760

Beschreibung

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Stichworte

Versionen (5)
  1. 24.04.20 24.04.20 -
  2. 24.04.20 24.04.20 -
  3. 30.04.20 30.04.20 -
  4. 06.05.20 06.05.20 -
  5. 08.05.20 08.05.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Mai 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Englisch

Laboratory Collections; Urinalysis Test Results; Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Laboratory Collections - Clinical Chemistry & Haematology (Screening)
Beschreibung

Laboratory Collections - Clinical Chemistry & Haematology (Screening)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0018941
UMLS CUI-4
C0220908
Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
Beschreibung

Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling

Datentyp

datetime

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0008000
UMLS CUI [3]
C0018941
UMLS CUI [4,1]
C0005834
UMLS CUI [4,2]
C0011008
UMLS CUI [4,3]
C0040223
Laboratory Collections - Clinical Chemistry & Haematology - Comments
Beschreibung

Laboratory Collections - Clinical Chemistry & Haematology - Comments

Datentyp

text

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0008000
UMLS CUI [3]
C0018941
UMLS CUI [4]
C0947611
Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschreibung

If YES, please record diagnosis on Baseline Signs and Symptom page.

Datentyp

boolean

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0008000
UMLS CUI [3]
C0018941
UMLS CUI [4,1]
C1853129
UMLS CUI [4,2]
C2826293
Laboratory Collections - Clinical Chemistry & Haematology (Follow-Up)
Beschreibung

Laboratory Collections - Clinical Chemistry & Haematology (Follow-Up)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0018941
UMLS CUI-4
C1522577
Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
Beschreibung

Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling

Datentyp

datetime

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0008000
UMLS CUI [3]
C0018941
UMLS CUI [4,1]
C0005834
UMLS CUI [4,2]
C0011008
UMLS CUI [4,3]
C0040223
Laboratory Collections - Clinical Chemistry & Haematology - Comments
Beschreibung

Laboratory Collections - Clinical Chemistry & Haematology - Comments

Datentyp

text

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0008000
UMLS CUI [3]
C0018941
UMLS CUI [4]
C0947611
Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at baseline?
Beschreibung

If YES, please record diagnosis on Adverse Event page.

Datentyp

boolean

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0008000
UMLS CUI [3]
C0018941
UMLS CUI [4,1]
C1853129
UMLS CUI [4,2]
C2826293
UMLS CUI [5]
C1442488
Laboratory Collections - Drug Screening (Urine)
Beschreibung

Laboratory Collections - Drug Screening (Urine)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0202274
Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling
Beschreibung

Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling

Datentyp

datetime

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0202274
UMLS CUI [3,1]
C0870078
UMLS CUI [3,2]
C0011008
UMLS CUI [3,3]
C0040223
Were there any contra-indicated drugs detected?
Beschreibung

If YES, please record all the relevant contra-indicated drugs below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C4036061
UMLS CUI [1,3]
C1301624
Laboratory Collections - Drug Screening (Urine) - Type of drug
Beschreibung

Laboratory Collections - Drug Screening (Urine) - Type of drug

Datentyp

text

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0202274
UMLS CUI [3]
C0457591
Laboratory Collections - Drug Screening (Urine) - Comment
Beschreibung

Laboratory Collections - Drug Screening (Urine) - Comment

Datentyp

text

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0202274
UMLS CUI [3]
C0947611
Urinalysis Test Results (Screening)
Beschreibung

Urinalysis Test Results (Screening)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0587081
Urinalysis Test Results - Exact date and time of urine sampling
Beschreibung

Urinalysis Test Results - Exact date and time of urine sampling

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
UMLS CUI [2,1]
C0200354
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Urinalysis Test Results - Comments
Beschreibung

Urinalysis Test Results - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0947611
Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschreibung

If YES, please record diagnosis on Baseline Signs and Symptom page.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C2826293
Urinalysis Test Results (Follow-Up)
Beschreibung

Urinalysis Test Results (Follow-Up)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0587081
Urinalysis Test Results - Exact date and time of urine sampling
Beschreibung

Urinalysis Test Results - Exact date and time of urine sampling

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
UMLS CUI [2,1]
C0200354
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Urinalysis Test Results - Comments
Beschreibung

Urinalysis Test Results - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0947611
Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at at baseline?
Beschreibung

If YES, please record diagnosis on Baseline Signs and Symptom page.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C2826293
UMLS CUI [3]
C1442488
Urinalysis Test Results - Results for dip stick test:
Beschreibung

Urinalysis Test Results - Results for dip stick test:

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0587081
UMLS CUI-3
C1160927
Results for dip stick - Parameter
Beschreibung

Results for dip stick - Parameter

Datentyp

integer

Alias
UMLS CUI [1]
C1160927
UMLS CUI [2]
C0549193
Result for dip stick test
Beschreibung

Result for dip stick test

Datentyp

text

Alias
UMLS CUI [1,1]
C1160927
UMLS CUI [1,2]
C1274040
Result for dip stick test - Clinically Significant
Beschreibung

Result for dip stick test - Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1160927
UMLS CUI [1,2]
C2826293
Result for dip stick test - Comments
Beschreibung

Result for dip stick test - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1160927
UMLS CUI [1,2]
C0947611
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies
Beschreibung

Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

Alias
UMLS CUI-1
C0019168
UMLS CUI-2
C0166049
UMLS CUI-3
C0019683
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling
Beschreibung

Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling

Datentyp

datetime

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0019683
UMLS CUI [4,1]
C0005834
UMLS CUI [4,2]
C0011008
UMLS CUI [4,3]
C0040223
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments
Beschreibung

Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments

Datentyp

text

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0019683
UMLS CUI [4]
C0947611
Hepatitis B Surface Antigen - Was the result positive?
Beschreibung

Hepatitis B Surface Antigen - Was the result positive?

Datentyp

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C1514241
Hepatitis C Antibodies - Was the result positive?
Beschreibung

Hepatitis C Antibodies - Was the result positive?

Datentyp

boolean

Alias
UMLS CUI [1]
C0166049
UMLS CUI [2]
C1514241
HIVI/II Antibodies - Was the result positive?
Beschreibung

HIVI/II Antibodies - Was the result positive?

Datentyp

boolean

Alias
UMLS CUI [1]
C0019683
UMLS CUI [2]
C1514241
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Ähnliche Modelle

Laboratory Collections; Urinalysis Test Results; Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Laboratory Collections - Clinical Chemistry & Haematology (Screening)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0018941 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
Item
Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
datetime
C0022885 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0005834 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
C0040223 (UMLS CUI [4,3])
Laboratory Collections - Clinical Chemistry & Haematology - Comments
Item
Laboratory Collections - Clinical Chemistry & Haematology - Comments
text
C0022885 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Item
Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0022885 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C1853129 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
Item Group
Laboratory Collections - Clinical Chemistry & Haematology (Follow-Up)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0018941 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
Item
Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
datetime
C0022885 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0005834 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
C0040223 (UMLS CUI [4,3])
Laboratory Collections - Clinical Chemistry & Haematology - Comments
Item
Laboratory Collections - Clinical Chemistry & Haematology - Comments
text
C0022885 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at baseline?
Item
Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at baseline?
boolean
C0022885 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C1853129 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C1442488 (UMLS CUI [5])
Item Group
Laboratory Collections - Drug Screening (Urine)
C0022885 (UMLS CUI-1)
C0202274 (UMLS CUI-2)
Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling
Item
Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling
datetime
C0022885 (UMLS CUI [1])
C0202274 (UMLS CUI [2])
C0870078 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C0040223 (UMLS CUI [3,3])
Were there any contra-indicated drugs detected?
Item
Were there any contra-indicated drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C4036061 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
Laboratory Collections - Drug Screening (Urine) - Type of drug
Item
Laboratory Collections - Drug Screening (Urine) - Type of drug
text
C0022885 (UMLS CUI [1])
C0202274 (UMLS CUI [2])
C0457591 (UMLS CUI [3])
Laboratory Collections - Drug Screening (Urine) - Comment
Item
Laboratory Collections - Drug Screening (Urine) - Comment
text
C0022885 (UMLS CUI [1])
C0202274 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Item Group
Urinalysis Test Results (Screening)
C0042014 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Urinalysis Test Results - Exact date and time of urine sampling
Item
Urinalysis Test Results - Exact date and time of urine sampling
datetime
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0200354 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Urinalysis Test Results - Comments
Item
Urinalysis Test Results - Comments
text
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Item
Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C1853129 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Item Group
Urinalysis Test Results (Follow-Up)
C0042014 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Urinalysis Test Results - Exact date and time of urine sampling
Item
Urinalysis Test Results - Exact date and time of urine sampling
datetime
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0200354 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Urinalysis Test Results - Comments
Item
Urinalysis Test Results - Comments
text
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at at baseline?
Item
Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at at baseline?
boolean
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C1853129 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1442488 (UMLS CUI [3])
Item Group
Urinalysis Test Results - Results for dip stick test:
C0042014 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
C1160927 (UMLS CUI-3)
Item
Results for dip stick - Parameter
integer
C1160927 (UMLS CUI [1])
C0549193 (UMLS CUI [2])
Parameter
Code List
Results for dip stick - Parameter
CL Item
PH (1)
CL Item
Protein (2)
CL Item
Glucose (3)
CL Item
Biliribin (4)
CL Item
Blood (5)
Result for dip stick test
Item
Result for dip stick test
text
C1160927 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result for dip stick test - Clinically Significant
Item
Result for dip stick test - Clinically Significant
boolean
C1160927 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Result for dip stick test - Comments
Item
Result for dip stick test - Comments
text
C1160927 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies
C0019168 (UMLS CUI-1)
C0166049 (UMLS CUI-2)
C0019683 (UMLS CUI-3)
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling
Item
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling
datetime
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
C0005834 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
C0040223 (UMLS CUI [4,3])
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments
Item
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments
text
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
Hepatitis B Surface Antigen - Was the result positive?
Item
Hepatitis B Surface Antigen - Was the result positive?
boolean
C0019168 (UMLS CUI [1])
C1514241 (UMLS CUI [2])
Hepatitis C Antibodies - Was the result positive?
Item
Hepatitis C Antibodies - Was the result positive?
boolean
C0166049 (UMLS CUI [1])
C1514241 (UMLS CUI [2])
HIVI/II Antibodies - Was the result positive?
Item
HIVI/II Antibodies - Was the result positive?
boolean
C0019683 (UMLS CUI [1])
C1514241 (UMLS CUI [2])
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