Information:
Fel:
ID
24234
Beskrivning
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus
Nyckelord
Versioner (2)
- 2017-06-08 2017-06-08 -
- 2017-07-27 2017-07-27 -
Uppladdad den
27 juli 2017
DOI
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Creative Commons BY-NC 3.0
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VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382
VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382
Similar models
VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1])
Item Group
VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0)
ADMINISTRATION_DT [ADDT]
Item
Date Administered:
date
C1302393 (UMLS CUI [1])
Item
1. In general, would you say your overall health is:
integer
C3174572 (UMLS CUI [1])
CL Item
1 - Excellent (1)
CL Item
2 - Very Good (2)
CL Item
3 - Good (3)
CL Item
4 - Fair (4)
CL Item
5 - Poor (5)
Item
2. At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?
integer
C3174874 (UMLS CUI [1])
Code List
2. At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?
CL Item
1 - Excellent (1)
CL Item
2 - Good (2)
CL Item
3 - Fair (3)
CL Item
4 - Poor (4)
CL Item
5 - Very poor (5)
Item
3. How much of the time do you worry about your eyesight?
integer
C3174914 (UMLS CUI [1])
CL Item
1 - None of the time (1)
CL Item
2 - A little of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - Most of the time (4)
CL Item
5 - All of the time (5)
Item
4. How much pain or discomfort have you had in and around your eyes (for example, burning, itching, or aching)? Would you say it is:
integer
C3174916 (UMLS CUI [1])
Code List
4. How much pain or discomfort have you had in and around your eyes (for example, burning, itching, or aching)? Would you say it is:
CL Item
1 - None (1)
CL Item
2 - Mild (2)
CL Item
3 - Moderate (3)
CL Item
4 - Severe, or (4)
Item
5. How much difficulty do you have reading ordinary print in newspapers? Would you say you have:
integer
C3174916 (UMLS CUI [1])
Code List
5. How much difficulty do you have reading ordinary print in newspapers? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
6. How much difficulty do you have doing work or hobbies that require you to see well up close, such as cooking, sewing, fixing things around the house, or using hand tools? Would you say:
integer
C3176685 (UMLS CUI [1])
Code List
6. How much difficulty do you have doing work or hobbies that require you to see well up close, such as cooking, sewing, fixing things around the house, or using hand tools? Would you say:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7. Because of your eyesight, how much difficulty do you have finding something on a crowded shelf?
integer
C3176687 (UMLS CUI [1])
Code List
7. Because of your eyesight, how much difficulty do you have finding something on a crowded shelf?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7a. Wearing glasses, how much difficulty do you have reading the small print in a telephone book, on a medicine bottle, or on legal forms? Would you say:
integer
C3166557 (UMLS CUI [1])
Code List
7a. Wearing glasses, how much difficulty do you have reading the small print in a telephone book, on a medicine bottle, or on legal forms? Would you say:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7b. Because of your eyesight, how much difficulty do you have figuring out whether bills you receive are accurate?
integer
C3176641 (UMLS CUI [1])
Code List
7b. Because of your eyesight, how much difficulty do you have figuring out whether bills you receive are accurate?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7c. Because of your eyesight, how much difficulty do you have doing things like shaving, styling your hair, or putting on makeup?
integer
C3176643 (UMLS CUI [1])
Code List
7c. Because of your eyesight, how much difficulty do you have doing things like shaving, styling your hair, or putting on makeup?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
8. How much difficulty do you have reading street signs or the names of stores?
integer
C3176689 (UMLS CUI [1])
Code List
8. How much difficulty do you have reading street signs or the names of stores?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
9. Because of your eyesight, how much difficulty do you have going down steps, stairs, or curbs in dim light or at night?
integer
C3176691 (UMLS CUI [1])
Code List
9. Because of your eyesight, how much difficulty do you have going down steps, stairs, or curbs in dim light or at night?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10. Because of your eyesight, how much difficulty do you have noticing objects off to the side while you are walking along?
integer
C3176693 (UMLS CUI [1])
Code List
10. Because of your eyesight, how much difficulty do you have noticing objects off to the side while you are walking along?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10a. Because of your eyesight, how much difficulty do you have recognizing people you know from across a room?
integer
C3176645 (UMLS CUI [1,1])
Code List
10a. Because of your eyesight, how much difficulty do you have recognizing people you know from across a room?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10b. Because of your eyesight, how much difficulty do you have taking part in active sports or other outdoor activities that you enjoy (like golf, bowling, jogging, or walking)?
integer
C3176647 (UMLS CUI [1])
Code List
10b. Because of your eyesight, how much difficulty do you have taking part in active sports or other outdoor activities that you enjoy (like golf, bowling, jogging, or walking)?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10c. Because of your eyesight, how much difficulty do you have seeing and enjoying programs on TV?
integer
C3176649 (UMLS CUI [1,1])
Code List
10c. Because of your eyesight, how much difficulty do you have seeing and enjoying programs on TV?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
11. Because of your eyesight, how much difficulty do you have seeing how people react to things you say?
integer
C3176695 (UMLS CUI [1])
Code List
11. Because of your eyesight, how much difficulty do you have seeing how people react to things you say?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
12. Because of your eyesight, how much difficulty do you have picking out and matching your own clothes?
integer
C3176697 (UMLS CUI [1])
Code List
12. Because of your eyesight, how much difficulty do you have picking out and matching your own clothes?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
13. Because of your eyesight, how much difficulty do you have visiting with people in their homes, at parties, or in restaurants?
integer
C3176699 (UMLS CUI [1])
Code List
13. Because of your eyesight, how much difficulty do you have visiting with people in their homes, at parties, or in restaurants?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
14. Because of your eyesight, how much difficulty do you have going out to see movies, plays or sports events?
integer
C3176701 (UMLS CUI [1])
Code List
14. Because of your eyesight, how much difficulty do you have going out to see movies, plays or sports events?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
15. Now, I’d like to ask about driving a car. Are you currently driving, at least once in a while?
integer
C3174918 (UMLS CUI [1])
Code List
15. Now, I’d like to ask about driving a car. Are you currently driving, at least once in a while?
CL Item
Yes (Skip to Q15c) (1)
CL Item
No (2)
Item
15a. If NO, ASK: Have you never driven a car or have you given up driving?
integer
C3174287 (UMLS CUI [1])
Code List
15a. If NO, ASK: Have you never driven a car or have you given up driving?
CL Item
1 - Never drove (Skip to Part 3, Q17) (1)
CL Item
2 - Gave up (2)
Item
IF GAVE UP DRIVING: Was that mainly because of your eyesight, mainly for some other reason, or because of both your eyesight and other reasons?
integer
C3166530 (UMLS CUI [1])
Code List
IF GAVE UP DRIVING: Was that mainly because of your eyesight, mainly for some other reason, or because of both your eyesight and other reasons?
CL Item
1 - Mainly eyesight (1)
CL Item
(Skip to Part 3, Q17) (2)
CL Item
2 - Mainly other reasons (3)
Item
15c. IF CURRENTLY DRIVING: How much difficulty do you have driving during the daytime in familiar places? Would you say you have:
integer
C3174290 (UMLS CUI [1])
Code List
15c. IF CURRENTLY DRIVING: How much difficulty do you have driving during the daytime in familiar places? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
Item
16. How much difficulty do you have driving at night? Would you say you have:
integer
C3174292 (UMLS CUI [1])
Code List
16. How much difficulty do you have driving at night? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
16a. How much difficulty do you have driving in difficult conditions, such as in bad weather, during rush hour, on the freeway, or in city traffic? Would you say you have:
integer
C3174294 (UMLS CUI [1])
Code List
16a. How much difficulty do you have driving in difficult conditions, such as in bad weather, during rush hour, on the freeway, or in city traffic? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
17. Do you accomplish less than you would like because of your vision?
integer
C3174296 (UMLS CUI [1])
CL Item
1 - All of the time (1)
CL Item
2 - Most of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - A little of the time (4)
CL Item
5 - None of the time (5)
Item
18. Are you limited in how long you can work or do other activities because of your vision?
integer
C3174298 (UMLS CUI [1])
Code List
18. Are you limited in how long you can work or do other activities because of your vision?
CL Item
1 - All of the time (1)
CL Item
2 - Most of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - A little of the time (4)
CL Item
5 - None of the time (5)
Item
19. How much does pain or discomfort in or around your eyes, for example, burning, itching, or aching, keep you from doing what you’d like to be doing? Would you say:
integer
C3174920 (UMLS CUI [1])
Code List
19. How much does pain or discomfort in or around your eyes, for example, burning, itching, or aching, keep you from doing what you’d like to be doing? Would you say:
CL Item
1 - All of the time (1)
CL Item
2 - Most of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - A little of the time (4)
CL Item
5 - None of the time (5)
Item
20. I stay home most of the time because of my eyesight...
integer
C3176629 (UMLS CUI [1])
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
21. I feel frustrated a lot of the time because of my eyesight...
integer
C3176631 (UMLS CUI [1])
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
22. I have much less control over what I do, because of my eyesight...
integer
C3176633 (UMLS CUI [1])
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
23. Because of my eyesight, I have to rely too much on what other people tell me...
integer
C3176633 (UMLS CUI [1])
Code List
23. Because of my eyesight, I have to rely too much on what other people tell me...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
24. I need a lot of help from others because of my eyesight...
integer
C3176637 (UMLS CUI [1])
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
25. I worry about doing things that will embarrass myself or others, because of my eyesight...
integer
C3176639 (UMLS CUI [1])
Code List
25. I worry about doing things that will embarrass myself or others, because of my eyesight...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)