ID

26476

Beskrivning

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety 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 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Screening Repeat Tests form.

Nyckelord

Versioner (2)
  1. 2017-10-03 2017-10-03 -
  2. 2017-10-18 2017-10-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 oktober 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

Engelsk

Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 Formulär  
General Information
Beskrivning

General Information

Alias
UMLS CUI-1
C1508263
UMLS CUI-2
C1955348
UMLS CUI-3
C0035258
Centre Number
Beskrivning

Centre Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beskrivning

Patient Number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
ONLY COMPLETE THE FOLLOWING IF THERE WERE ABNORMAL FINDINGS AT THE SCREENING VISIT
Beskrivning

ABNORMAL FINDINGS

Datatyp

boolean

Alias
UMLS CUI [1]
C1704258
ELECTROCARDIOGRAM (12 LEAD)
Beskrivning

ELECTROCARDIOGRAM (12 LEAD)

Alias
UMLS CUI-1
C0013798
Date of ECG
Beskrivning

Date of ECG

Datatyp

date

Alias
UMLS CUI [1]
C2826640
Were any clinically significant abnormalities detected?
Beskrivning

ecg abnormalities

Datatyp

integer

Alias
UMLS CUI [1]
C0522055
PHYSICAL EXAMINATION
Beskrivning

PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
If any abnormality was present at screening please perform a physical examination. If there are any significant abnormal findings record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.
Beskrivning

abnormal findings

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
LABORATORY EVALUATION
Beskrivning

LABORATORY EVALUATION

Alias
UMLS CUI-1
C0022885
Date of sample
Beskrivning

Date of sample

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beskrivning

Were any clinically significant abnormalities detected?

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
URINE DIPSTICK
Beskrivning

URINE DIPSTICK

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beskrivning

urine dipstick

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1274040
Tillbaka till toppen

Similar models

Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
ABNORMAL FINDINGS
Item
ONLY COMPLETE THE FOLLOWING IF THERE WERE ABNORMAL FINDINGS AT THE SCREENING VISIT
boolean
C1704258 (UMLS CUI [1])
Item Group
ELECTROCARDIOGRAM (12 LEAD)
C0013798 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0522055 (UMLS CUI [1])
ecg abnormalities
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes - If ’Yes’, please record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
Item Group
PHYSICAL EXAMINATION
C0031809 (UMLS CUI-1)
abnormal findings
Item
If any abnormality was present at screening please perform a physical examination. If there are any significant abnormal findings record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
LABORATORY EVALUATION
C0022885 (UMLS CUI-1)
Date of sample
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Were any clinically significant abnormalities detected?
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes - If ‘Yes’, please record the findings and/or diagnosis in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
Item Group
URINE DIPSTICK
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
urine dipstick
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive - If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and send a sample to Quest Diagnostics for further evaluation. (2)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial