ID

29110

Beschreibung

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

Stichworte

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gsk

Hochgeladen am

25. Februar 2018

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Ropinirole Case Report Form GSK RRL100013

Englisch

Subject diary

4 Formulare  
Subject diary
Beschreibung

Subject diary

Subject Diary
Beschreibung

Subject Diary

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0035258
1. Enter the date and time your RLs symptoms started.
Beschreibung

Date

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C0332189
2. Severity of RLS episode
Beschreibung

Severity of RLS episode

Datentyp

text

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0332189
3. Did your RLS symptoms disrupt your routine evening activity?
Beschreibung

Did your RLS symptoms disrupt your routine evening activity?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332453
UMLS CUI [1,2]
C0001288
UMLS CUI [1,3]
C0035258
4. How severe were your RLS symptoms 2 hours after taking the study medication?
Beschreibung

Severity two hours after medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0035258
UMLS CUI [2]
C0013227
5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
Beschreibung

Read the following and complete the questions when you wake up next morning.

Datentyp

text

Alias
UMLS CUI [1,1]
C1515926
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0035258
UMLS CUI [2]
C0013227
6. Overall, did your RLS symptoms affect your sleep last night?
Beschreibung

Sleep affected by RLS symptoms?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037313
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0035258
If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
Beschreibung

Specification of RLS symptoms affecting sleep

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393760
UMLS CUI [1,2]
C0037317
UMLS CUI [1,3]
C0035258
Subject Instructions
Beschreibung

Subject Instructions

Diary Completion Instructions
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0034394
Patient global improvement scale instrucitons
Beschreibung

Patient global improvement scale instrucitons

Datentyp

text

Alias
UMLS CUI [1]
C3639888
Dosing Instructions
Beschreibung

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.

Datentyp

text

Dosing information
Beschreibung

Dosing information

Alias
UMLS CUI-1
C0678766
Dosage given:
Beschreibung

Dosage given:___________ Tablet x ___________ mg

Datentyp

text

Alias
UMLS CUI [1]
C0178602
Date and time of dosing:
Beschreibung

Date and time of dosing

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Beschreibung

dose administered by

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

Dose checked and witnessed by

Datentyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C1283174
UMLS CUI [1,3]
C0178602
Comments:
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Patient rated scale
Beschreibung

Patient rated scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C1578483
RLS Quality of Live Questionnaire
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C0035258
SF36 Health Status Survey
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C3640521
Medical Outcome Study Sleep Scale
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0349674
UMLS CUI [1,2]
C0037313
Work Productivity and Activity Impairment Questionnaire
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C3639722
DOSING DETAILS
Beschreibung

DOSING DETAILS

Alias
UMLS CUI-1
C0678766
Dosing Instructions
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1442085
UMLS CUI [1,2]
C0678766
Dosage given:
Beschreibung

Dosage given:___________ Tablet x ___________ mg

Datentyp

text

Alias
UMLS CUI [1]
C0178602
Date and time of dosing:
Beschreibung

Date and time of dosing

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Beschreibung

dose administered by

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

Dose checked and witnessed by

Datentyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C1283174
UMLS CUI [1,3]
C0178602
Comments:
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Actigraphy Information
Beschreibung

Actigraphy Information

Alias
UMLS CUI-1
C1171301
Night of Week
Beschreibung

(to be completed by study coordinator prior to giving diary to patient e.g. Monday, Tuesday)

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C0677547
UMLS CUI [1,2]
C0240526
UMLS CUI [1,3]
C0442592
Day Month Year
Was the device with the "Right" label worn on Right leg
Beschreibung

Was the device with the "Right" label worn on Right leg Actigraphy Information

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0230442
Was the device with the "Left" label worn on Left leg Actigraphy Information
Beschreibung

Was the device with the "Left" label worn on Left leg Actigraphy Information

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0230443
Time you went to bed
Beschreibung

AM or PM (circle one)

Datentyp

time

Alias
UMLS CUI [1]
C4289366
Time you got up for the day the next morning
Beschreibung

____ AM or PM (circle one)

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1170730
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Ähnliche Modelle

Subject diary

4 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject diary
Item Group
Subject Diary
C3890583 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
Date
Item
1. Enter the date and time your RLs symptoms started.
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,4])
Item
2. Severity of RLS episode
text
C0439793 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
Severity of RLS episode
Code List
2. Severity of RLS episode
CL Item
very severe (4)
CL Item
severe (3)
CL Item
moderate (2)
CL Item
mild (1)
Did your RLS symptoms disrupt your routine evening activity?
Item
3. Did your RLS symptoms disrupt your routine evening activity?
boolean
C0332453 (UMLS CUI [1,1])
C0001288 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item
4. How severe were your RLS symptoms 2 hours after taking the study medication?
text
C0439793 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
Severity two hours after medication
Code List
4. How severe were your RLS symptoms 2 hours after taking the study medication?
CL Item
Very Severe (6)
CL Item
Severe (5)
CL Item
Moderate (4)
CL Item
Mild (3)
CL Item
None (2)
CL Item
I was asleep at 2 hours after taking the last dose  (1)
Item
5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
text
C1515926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
Change in RLS symptoms after dosing the night before
Code List
5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
CL Item
Very much improved (Complete symptom relief) (1)
CL Item
Very much worse (Symptoms very much worse) (7)
CL Item
Much worse (Symptoms much worse) (6)
CL Item
Minimally worse (Symptoms minimally worse) (5)
CL Item
No change (4)
CL Item
Minimally improved (Some symptom relief) (3)
CL Item
Much improved (Good symptom relief) (2)
Sleep affected by RLS symptoms?
Item
6. Overall, did your RLS symptoms affect your sleep last night?
boolean
C0037313 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Specification of RLS symptoms affecting sleep
Item
If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
boolean
C0393760 (UMLS CUI [1,1])
C0037317 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item Group
Subject Instructions
Diary Completion Instructions
Item
text
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
Patient global improvement scale instrucitons
Item
Patient global improvement scale instrucitons
text
C3639888 (UMLS CUI [1])
Dosing Instructions
Item
Dosing Instructions
text
Item Group
Dosing information
C0678766 (UMLS CUI-1)
Dosage
Item
Dosage given:
text
C0178602 (UMLS CUI [1])
Date and time of dosing
Item
Date and time of dosing:
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered by
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose checked and witnessed by
Item
Dose checked and witnessed by:
text
C0682356 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Patient rated scale
C0681889 (UMLS CUI-1)
C1578483 (UMLS CUI-2)
RLS Quality of Live Questionnaire
Item
RLS Quality of Live Questionnaire
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
SF36 Health Status Survey
Item
SF36 Health Status Survey
text
C3640521 (UMLS CUI [1])
Medical Outcome Study Sleep Scale
Item
Medical Outcome Study Sleep Scale
text
C0349674 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Work Productivity and Activity Impairment Questionnaire
Item
Work Productivity and Activity Impairment Questionnaire
text
C3639722 (UMLS CUI [1])
Item Group
DOSING DETAILS
C0678766 (UMLS CUI-1)
Dosing Instructions
Item
Dosing Instructions
text
C1442085 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
Dosage
Item
Dosage given:
text
C0178602 (UMLS CUI [1])
Date and time of dosing
Item
Date and time of dosing:
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered by
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose checked and witnessed by
Item
Dose checked and witnessed by:
text
C0682356 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Actigraphy Information
C1171301 (UMLS CUI-1)
Night of Week
Item
Night of Week
date
C0677547 (UMLS CUI [1,1])
C0240526 (UMLS CUI [1,2])
C0442592 (UMLS CUI [1,3])
Was the device with the "Right" label worn on Right leg Actigraphy Information
Item
Was the device with the "Right" label worn on Right leg
boolean
C1171301 (UMLS CUI [1,1])
C0230442 (UMLS CUI [1,2])
Was the device with the "Left" label worn on Left leg Actigraphy Information
Item
Was the device with the "Left" label worn on Left leg Actigraphy Information
boolean
C1171301 (UMLS CUI [1,1])
C0230443 (UMLS CUI [1,2])
Time you went to bed
Item
Time you went to bed
time
C4289366 (UMLS CUI [1])
Time you got up for the day the next morning
Item
Time you got up for the day the next morning
time
C0040223 (UMLS CUI [1,1])
C1170730 (UMLS CUI [1,2])
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