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Informações:
Falhas:
ID
20030
Descrição
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.
Palavras-chave
Versões (3)
- 19/12/2016 19/12/2016 -
- 04/02/2017 04/02/2017 -
- 20/09/2021 20/09/2021 -
Transferido a
4 de fevereiro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584
Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584
- StudyEvent: ODM
Similar models
Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Item Group
1. Over the past two weeks, how bothered have you been by...
Item
a. ...the amount of home monitoring (blood sugar testing) required as a part of using your medication(s)?
text
C0005803 (UMLS CUI [1])
Code List
a. ...the amount of home monitoring (blood sugar testing) required as a part of using your medication(s)?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item
b. ... the number of times you need to take your medication(s)?
text
C3476109 (UMLS CUI [1])
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item
c. ...the need to adjust the dosing (amount) of your medication(s)?
text
C1735490 (UMLS CUI [1])
Code List
c. ...the need to adjust the dosing (amount) of your medication(s)?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item
d. ...how your medication(s) interferes with with your daily life?
text
C0013216 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
Code List
d. ...how your medication(s) interferes with with your daily life?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item Group
2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
Item
e. Symptoms of low blood sugar (such as trembling, sweating, dizziness or blurred vision)
text
C0020615 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Code List
e. Symptoms of low blood sugar (such as trembling, sweating, dizziness or blurred vision)
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
Item Group
3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to....
Item
a. ...keep your blood sugar levels stable (avoid highs and lows)?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C0005802 (UMLS CUI [1,5])
C0205360 (UMLS CUI [1,6])
C0011849 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C0005802 (UMLS CUI [1,5])
C0205360 (UMLS CUI [1,6])
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item
b. ...help you from feeling tired and lacking energy?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C0557875 (UMLS CUI [1,5])
C0011849 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C0557875 (UMLS CUI [1,5])
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item Group
4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with....
Item
a. ...the ease and convenience of your diabetes medication(s)?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0242428 (UMLS CUI [1,3])
C1331418 (UMLS CUI [1,4])
C0011849 (UMLS CUI [1,2])
C0242428 (UMLS CUI [1,3])
C1331418 (UMLS CUI [1,4])
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item
b. ...the impact of your diabetes medication(s) on your physical well-being?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0517226 (UMLS CUI [1,4])
C0011849 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0517226 (UMLS CUI [1,4])
Code List
b. ...the impact of your diabetes medication(s) on your physical well-being?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item
c. ...the impact of your diabetes medication(s) on your emotional well-being?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0424578 (UMLS CUI [1,4])
C0011849 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0424578 (UMLS CUI [1,4])
Code List
c. ...the impact of your diabetes medication(s) on your emotional well-being?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item Group
5. Thinking about your diabetes medication(s) over the past two weeks....
Item
a. ...how difficult has it been for you to plan your daily activities around your medication(s)?
text
C0441655 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
Code List
a. ...how difficult has it been for you to plan your daily activities around your medication(s)?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item
b. ...how much of a burden has it been for you to take your medication(s) as prescribed?
text
C2828008 (UMLS CUI [1,1])
C1515187 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1515187 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
b. ...how much of a burden has it been for you to take your medication(s) as prescribed?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item
c. ...how embarrased or awkward have you felt because of taking your medication(s)?
text
C0557910 (UMLS CUI [1,1])
C1515187 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1515187 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
c. ...how embarrased or awkward have you felt because of taking your medication(s)?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item
d. ...how worried have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
text
C0233481 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
C0009566 (UMLS CUI [1,4])
C0013216 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
C0009566 (UMLS CUI [1,4])
Code List
d. ...how worried have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item Group
6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to...
Item
a. ...be flexible with planning meals (when you eat and what you are able to eat)?
text
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,3])
Code List
a. ...be flexible with planning meals (when you eat and what you are able to eat)?
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
All the time (5)
Item
b. ...do your recommended physical activity or exercise?
text
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
C0521102 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
Code List
b. ...do your recommended physical activity or exercise?
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
All the time (5)
Item
c. ...follow your recommended diet?
text
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0012155 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0012155 (UMLS CUI [1,3])
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
All the time (5)
Item Group
7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ....
Item
...your current diabetes medication(s)?
text
C0242428 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item Group
8. Overall, based on your current experiences with your diabetes medications...
Item
..how interested would you be to change the type of medication(s) you take or the way you take it, if it was possible?
text
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0543488 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,2])
C0543488 (UMLS CUI [1,3])
Code List
..how interested would you be to change the type of medication(s) you take or the way you take it, if it was possible?
CL Item
Not at all interested (1)
CL Item
Slightly interested (2)
CL Item
Somewhat interested (3)
CL Item
Very interested (4)
CL Item
Extremely interested (5)