ID
29110
Description
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
Versions (4)
- 2/22/18 2/22/18 -
- 2/24/18 2/24/18 -
- 2/25/18 2/25/18 -
- 9/17/21 9/17/21 -
Copyright Holder
gsk
Uploaded on
February 25, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
Subject diary
Description
Subject Instructions
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0034394
Description
Patient global improvement scale instrucitons
Data type
text
Alias
- UMLS CUI [1]
- C3639888
Description
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.
Data type
text
Description
Dosing information
Alias
- UMLS CUI-1
- C0678766
Description
Dosage given:___________ Tablet x ___________ mg
Data type
text
Alias
- UMLS CUI [1]
- C0178602
Description
Date and time of dosing
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Description
dose administered by
Data type
text
Alias
- UMLS CUI [1]
- C2348343
Description
Dose checked and witnessed by
Data type
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C1283174
- UMLS CUI [1,3]
- C0178602
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Description
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
Data type
text
Alias
- UMLS CUI [1]
- C3640521
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Description
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
Data type
text
Alias
- UMLS CUI [1]
- C3639722
Description
DOSING DETAILS
Alias
- UMLS CUI-1
- C0678766
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C1442085
- UMLS CUI [1,2]
- C0678766
Description
Dosage given:___________ Tablet x ___________ mg
Data type
text
Alias
- UMLS CUI [1]
- C0178602
Description
Date and time of dosing
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Description
dose administered by
Data type
text
Alias
- UMLS CUI [1]
- C2348343
Description
Dose checked and witnessed by
Data type
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C1283174
- UMLS CUI [1,3]
- C0178602
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Actigraphy Information
Alias
- UMLS CUI-1
- C1171301
Description
(to be completed by study coordinator prior to giving diary to patient e.g. Monday, Tuesday)
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0677547
- UMLS CUI [1,2]
- C0240526
- UMLS CUI [1,3]
- C0442592
Description
Was the device with the "Right" label worn on Right leg Actigraphy Information
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1171301
- UMLS CUI [1,2]
- C0230442
Description
Was the device with the "Left" label worn on Left leg Actigraphy Information
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1171301
- UMLS CUI [1,2]
- C0230443
Description
AM or PM (circle one)
Data type
time
Alias
- UMLS CUI [1]
- C4289366
Description
____ AM or PM (circle one)
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1170730
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