ID
29110
Descrição
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
Palavras-chave
Versões (4)
- 22/02/2018 22/02/2018 -
- 24/02/2018 24/02/2018 -
- 25/02/2018 25/02/2018 -
- 17/09/2021 17/09/2021 -
Titular dos direitos
gsk
Transferido a
25 de fevereiro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
Subject diary
Descrição
Subject Instructions
Descrição
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 de dados
text
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0034394
Descrição
Patient global improvement scale instrucitons
Tipo de dados
text
Alias
- UMLS CUI [1]
- C3639888
Descrição
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 de dados
text
Descrição
Dosing information
Alias
- UMLS CUI-1
- C0678766
Descrição
Dosage given:___________ Tablet x ___________ mg
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0178602
Descrição
Date and time of dosing
Tipo de dados
datetime
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Descrição
dose administered by
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2348343
Descrição
Dose checked and witnessed by
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C1283174
- UMLS CUI [1,3]
- C0178602
Descrição
Comments
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0947611
Descrição
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Descrição
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 de dados
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Descrição
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 de dados
text
Alias
- UMLS CUI [1]
- C3640521
Descrição
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 de dados
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Descrição
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 de dados
text
Alias
- UMLS CUI [1]
- C3639722
Descrição
DOSING DETAILS
Alias
- UMLS CUI-1
- C0678766
Descrição
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 de dados
text
Alias
- UMLS CUI [1,1]
- C1442085
- UMLS CUI [1,2]
- C0678766
Descrição
Dosage given:___________ Tablet x ___________ mg
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0178602
Descrição
Date and time of dosing
Tipo de dados
datetime
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Descrição
dose administered by
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2348343
Descrição
Dose checked and witnessed by
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C1283174
- UMLS CUI [1,3]
- C0178602
Descrição
Comments
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0947611
Descrição
Actigraphy Information
Alias
- UMLS CUI-1
- C1171301
Descrição
(to be completed by study coordinator prior to giving diary to patient e.g. Monday, Tuesday)
Tipo de dados
date
Unidades de medida
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0677547
- UMLS CUI [1,2]
- C0240526
- UMLS CUI [1,3]
- C0442592
Descrição
Was the device with the "Right" label worn on Right leg Actigraphy Information
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1171301
- UMLS CUI [1,2]
- C0230442
Descrição
Was the device with the "Left" label worn on Left leg Actigraphy Information
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1171301
- UMLS CUI [1,2]
- C0230443
Descrição
AM or PM (circle one)
Tipo de dados
time
Alias
- UMLS CUI [1]
- C4289366
Descrição
____ AM or PM (circle one)
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1170730
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Subject diary
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C0332189 (UMLS CUI [1,4])
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C0332189 (UMLS CUI [1,3])
C0001288 (UMLS CUI [1,2])
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C1457887 (UMLS CUI [1,2])
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C0037317 (UMLS CUI [1,2])
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C0205197 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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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])
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