ID
29110
Descrizione
Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage
Keywords
versioni (4)
- 22/02/18 22/02/18 -
- 24/02/18 24/02/18 -
- 25/02/18 25/02/18 -
- 17/09/21 17/09/21 -
Titolare del copyright
gsk
Caricato su
25 febbraio 2018
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
Subject diary
Descrizione
Subject Instructions
Descrizione
Bring this diary and any unused study medication with you to your next clinic visit Enter the information in the diary every day as required Print neatly and legibly Use ink, preferably black, to complete the information in the diary If you make a mistake: Draw a single line through the incorrect entry and write the correct data nearby Do not "write over" or erase an incorrect entry Do not use correction materials, such as correction fluid or tape, on this diary Page 2 FINAL - 24 SEP 04 If you have questions or concerns, contact the study contact person listed on the front of the diary
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0034394
Descrizione
Patient global improvement scale instrucitons
Tipo di dati
text
Alias
- UMLS CUI [1]
- C3639888
Descrizione
You will take 2 doses of study medication every day. You should generally take your first dose 1 hour prior to when your RLS symptoms usually start. Your second dose should be taken at bedtime and at least 3 hours after the first dose. You should try to take your second dose within 6 hours of the first dose, as longer time frames between doses (e.g., 8 hours or more) may lead to the reoccurrence of RLS symptoms.
Tipo di dati
text
Descrizione
Dosing information
Alias
- UMLS CUI-1
- C0678766
Descrizione
Dosage given:___________ Tablet x ___________ mg
Tipo di dati
text
Alias
- UMLS CUI [1]
- C0178602
Descrizione
Date and time of dosing
Tipo di dati
datetime
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Descrizione
dose administered by
Tipo di dati
text
Alias
- UMLS CUI [1]
- C2348343
Descrizione
Dose checked and witnessed by
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C1283174
- UMLS CUI [1,3]
- C0178602
Descrizione
Comments
Tipo di dati
text
Alias
- UMLS CUI [1]
- C0947611
Descrizione
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Descrizione
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Descrizione
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Tipo di dati
text
Alias
- UMLS CUI [1]
- C3640521
Descrizione
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Descrizione
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Tipo di dati
text
Alias
- UMLS CUI [1]
- C3639722
Descrizione
DOSING DETAILS
Alias
- UMLS CUI-1
- C0678766
Descrizione
You will take 2 doses of study medication every day. You should generally take your first dose 1 hour prior to when your RLS symptoms usually start. Your second dose should be taken at bedtime and at least 3 hours after the first dose. You should try to take your second dose within 6 hours of the first dose, as longer time frames between doses (e.g., 8 hours or more) may lead to the reoccurrence of RLS symptoms
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1442085
- UMLS CUI [1,2]
- C0678766
Descrizione
Dosage given:___________ Tablet x ___________ mg
Tipo di dati
text
Alias
- UMLS CUI [1]
- C0178602
Descrizione
Date and time of dosing
Tipo di dati
datetime
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Descrizione
dose administered by
Tipo di dati
text
Alias
- UMLS CUI [1]
- C2348343
Descrizione
Dose checked and witnessed by
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C1283174
- UMLS CUI [1,3]
- C0178602
Descrizione
Comments
Tipo di dati
text
Alias
- UMLS CUI [1]
- C0947611
Descrizione
Actigraphy Information
Alias
- UMLS CUI-1
- C1171301
Descrizione
(to be completed by study coordinator prior to giving diary to patient e.g. Monday, Tuesday)
Tipo di dati
date
Unità di misura
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0677547
- UMLS CUI [1,2]
- C0240526
- UMLS CUI [1,3]
- C0442592
Descrizione
Was the device with the "Right" label worn on Right leg Actigraphy Information
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1171301
- UMLS CUI [1,2]
- C0230442
Descrizione
Was the device with the "Left" label worn on Left leg Actigraphy Information
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1171301
- UMLS CUI [1,2]
- C0230443
Descrizione
AM or PM (circle one)
Tipo di dati
time
Alias
- UMLS CUI [1]
- C4289366
Descrizione
____ AM or PM (circle one)
Tipo di dati
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1170730
Similar models
Subject diary
C0040223 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,4])
C0035258 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C0001288 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
C1457887 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
C0392760 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0037317 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0034380 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0240526 (UMLS CUI [1,2])
C0442592 (UMLS CUI [1,3])
C0230442 (UMLS CUI [1,2])
C0230443 (UMLS CUI [1,2])
C1170730 (UMLS CUI [1,2])