ID

39955

Beschreibung

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Stichworte

Versionen (1)
  1. 05.03.20 05.03.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. März 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

Englisch

Week 4 - Investigational Product (Eye Drops) Returned, Dispensed; Ranibizumab Re-Injection; Monthly Ranibizumab Injection; Treatment Preference Questionnaire

1 Formulare  
Investigational Product (Eye Drops) - Returned
Beschreibung

Investigational Product (Eye Drops) - Returned

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0015399
UMLS CUI-3
C0332156
Date returned
Beschreibung

Date returned

Datentyp

date

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0011008
Investigational product container number - Returned
Beschreibung

Investigational product container number - Returned

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
UMLS CUI [2]
C0332156
Vials - Returned
Beschreibung

Vials - Returned

Alias
UMLS CUI-1
C0184301
UMLS CUI-2
C0332156
Opened vials returned
Beschreibung

Opened vials returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0175566
UMLS CUI [2]
C2699071
Unopened vials returned
Beschreibung

Unopened vials returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0587267
UMLS CUI [2]
C2699071
Foils - Returned
Beschreibung

Foils - Returned

Alias
UMLS CUI-1
C1551385
UMLS CUI-2
C0332156
Opened number 1 foils returned
Beschreibung

Opened number 1 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 1 foils returned
Beschreibung

Unopened number 1 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Opened number 2 foils returned
Beschreibung

Opened number 2 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 2 foils returned
Beschreibung

Unopened number 2 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Opened number 3 foils returned
Beschreibung

Opened number 3 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 3 foils returned
Beschreibung

Unopened number 3 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Opened number 4 foils returned
Beschreibung

Opened number 4 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 4 foils returned
Beschreibung

Unopened number 4 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Investigational Product (Eye Drops) - Dispensed
Beschreibung

Investigational Product (Eye Drops) - Dispensed

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0015399
UMLS CUI-3
C0947323
Date dispensed
Beschreibung

Date dispensed

Datentyp

date

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0011008
Investigational product container number - Dispesed
Beschreibung

Investigational product container number - Dispesed

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
UMLS CUI [2]
C0947323
Ranibizumab Re-Injection
Beschreibung

Ranibizumab Re-Injection

Alias
UMLS CUI-1
C1566537
UMLS CUI-2
C1272883
Did the subject receive a ranibizumab re-injection?
Beschreibung

Did the subject receive a ranibizumab re-injection?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C1272883
Date/Time of ranibizumab injection in the study eye
Beschreibung

Date/Time of ranibizumab injection in the study eye

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C1272883
UMLS CUI [2]
C0011008
UMLS CUI [3]
C0040223
Reason for re-injection
Beschreibung

Check all that apply

Datentyp

text

Alias
UMLS CUI [1,1]
C1272883
UMLS CUI [1,2]
C0392360
If other reason for re-injection, specify
Beschreibung

If other reason for re-injection, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1272883
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Monthly Ranibizumab Injection
Beschreibung

Monthly Ranibizumab Injection

Alias
UMLS CUI-1
C1566537
UMLS CUI-2
C1272883
UMLS CUI-3
C0332177
Date and Time of ranibizumab injection in the study eye
Beschreibung

Date and Time of ranibizumab injection in the study eye

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C1272883
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C0015392
Have you observed any of the following findings?
Beschreibung

Select all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0243095
Treatment Preference Questionnaire
Beschreibung

Treatment Preference Questionnaire

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0558295
UMLS CUI-3
C0034394
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Question 1. Overall, with respect to ease of treatment, which treatment do you prefer?
Beschreibung

Question 1. Overall, with respect to ease of treatment, which treatment do you prefer?

Datentyp

integer

Alias
UMLS CUI [1]
C1522634
UMLS CUI [2,1]
C1272700
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C0558295
Question 2. Overall, with respect to comfort of treatment (e.g., pain, discomfort, irritation or other physical distress) which treatment do you prefer?
Beschreibung

Question 2. Overall, with respect to comfort of treatment (e.g., pain, discomfort, irritation or other physical distress) which treatment do you prefer?

Datentyp

integer

Alias
UMLS CUI [1]
C1522634
UMLS CUI [2,1]
C1331418
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C0030193
UMLS CUI [4]
C2364135
UMLS CUI [5]
C1706307
UMLS CUI [6]
C4061283
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0558295
Question 3. Overall, with respect to your feelings associated with treatment (e.g., nervousness, fear, anxiety or other emotional distress) which treatment do you prefer?
Beschreibung

Question 3. Overall, with respect to your feelings associated with treatment (e.g., nervousness, fear, anxiety or other emotional distress) which treatment do you prefer?

Datentyp

integer

Alias
UMLS CUI [1]
C1522634
UMLS CUI [2,1]
C1527305
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0004083
UMLS CUI [3]
C0027769
UMLS CUI [4]
C4054984
UMLS CUI [5]
C0003467
UMLS CUI [6]
C0700361
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0558295
Question 4. Overall, with respect to the impact on your day-to-day activities before, during and after treatment, which treatment do you prefer?
Beschreibung

Question 4. Overall, with respect to the impact on your day-to-day activities before, during and after treatment, which treatment do you prefer?

Datentyp

integer

Alias
UMLS CUI [1]
C1522634
UMLS CUI [2]
C4049986
UMLS CUI [3]
C0871707
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0558295
Question 5a. If you could only have one treatment, which would you choose?
Beschreibung

Question 5a. If you could only have one treatment, which would you choose?

Datentyp

integer

Alias
UMLS CUI [1]
C1522634
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1707391
Question 5b. What is the single most important reason for your choice?
Beschreibung

Question 5b. What is the single most important reason for your choice?

Datentyp

text

Alias
UMLS CUI [1]
C1522634
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C1707391
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Week 4 - Investigational Product (Eye Drops) Returned, Dispensed; Ranibizumab Re-Injection; Monthly Ranibizumab Injection; Treatment Preference Questionnaire

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Investigational Product (Eye Drops) - Returned
C0304229 (UMLS CUI-1)
C0015399 (UMLS CUI-2)
C0332156 (UMLS CUI-3)
Date returned
Item
Date returned
date
C0332156 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational product container number - Returned
Item
Investigational product container number - Returned
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0332156 (UMLS CUI [2])
Item Group
Vials - Returned
C0184301 (UMLS CUI-1)
C0332156 (UMLS CUI-2)
Opened vials returned
Item
Opened vials returned
integer
C0184301 (UMLS CUI [1,1])
C0175566 (UMLS CUI [1,2])
C2699071 (UMLS CUI [2])
Unopened vials returned
Item
Unopened vials returned
integer
C0184301 (UMLS CUI [1,1])
C0587267 (UMLS CUI [1,2])
C2699071 (UMLS CUI [2])
Item Group
Foils - Returned
C1551385 (UMLS CUI-1)
C0332156 (UMLS CUI-2)
Opened number 1 foils returned
Item
Opened number 1 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 1 foils returned
Item
Unopened number 1 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Opened number 2 foils returned
Item
Opened number 2 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 2 foils returned
Item
Unopened number 2 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Opened number 3 foils returned
Item
Opened number 3 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 3 foils returned
Item
Unopened number 3 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Opened number 4 foils returned
Item
Opened number 4 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 4 foils returned
Item
Unopened number 4 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Item Group
Investigational Product (Eye Drops) - Dispensed
C0304229 (UMLS CUI-1)
C0015399 (UMLS CUI-2)
C0947323 (UMLS CUI-3)
Date dispensed
Item
Date dispensed
date
C0947323 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational product container number - Dispesed
Item
Investigational product container number - Dispesed
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0947323 (UMLS CUI [2])
Item Group
Ranibizumab Re-Injection
C1566537 (UMLS CUI-1)
C1272883 (UMLS CUI-2)
Did the subject receive a ranibizumab re-injection?
Item
Did the subject receive a ranibizumab re-injection?
boolean
C1566537 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
Date/Time of ranibizumab injection in the study eye
Item
Date/Time of ranibizumab injection in the study eye
datetime
C1566537 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Item
Reason for re-injection
text
C1272883 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for re-injection
Code List
Reason for re-injection
CL Item
Evidence of intraretinal fluid or subretinal fluid (subfoveal and extrafoveal accumulations) (9)
CL Item
A serous retinal pigment epithelial detachment (PED) that would benefit from re-injection  (10)
CL Item
Notable decline in VA (a decrease of > 5 letters from any earlier maximum VA during the study if, in the opinion of the investigator, the VA decline is due to neovascular AMD) (3)
CL Item
New subretinal or intraretinal macular hemorrhage (11)
CL Item
Increased lesion size on FA relative to the last angiogram (5)
CL Item
Leakage on FA that would benefit from re-injection (12)
CL Item
Other, specify (OT)
If other reason for re-injection, specify
Item
If other reason for re-injection, specify
text
C1272883 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Monthly Ranibizumab Injection
C1566537 (UMLS CUI-1)
C1272883 (UMLS CUI-2)
C0332177 (UMLS CUI-3)
Date and Time of ranibizumab injection in the study eye
Item
Date and Time of ranibizumab injection in the study eye
datetime
C1566537 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0008972 (UMLS CUI [2,1])
C0015392 (UMLS CUI [2,2])
Item
Have you observed any of the following findings?
integer
C0243095 (UMLS CUI [1])
Have you observed any of the following findings?
Code List
Have you observed any of the following findings?
CL Item
Evidence of intraretinal fluid or subretinal fluid (subfoveal and extrafoveal accumulations) (9)
CL Item
A serous retinal pigment epithelial detachment (PED) that would benefit from ongoing injections  (13)
CL Item
Notable decline in VA (a decrease of > 5 letters from any earlier maximum VA during the study if, in the opinion of the investigator, the VA decline is due to neovascular AMD) (3)
CL Item
New subretinal or intraretinal macular hemorrhage (11)
CL Item
Increased lesion size relative to last angiogram (if FA was performed) (5)
CL Item
Leakage that would benefit from ongoing injections (if FA was performed) (14)
CL Item
None (8)
Item Group
Treatment Preference Questionnaire
C0087111 (UMLS CUI-1)
C0558295 (UMLS CUI-2)
C0034394 (UMLS CUI-3)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Question 1. Overall, with respect to ease of treatment, which treatment do you prefer?
integer
C1522634 (UMLS CUI [1])
C1272700 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0558295 (UMLS CUI [3])
Question 1. Overall, with respect to ease of treatment, which treatment do you prefer?
Code List
Question 1. Overall, with respect to ease of treatment, which treatment do you prefer?
CL Item
I prefer intravitreal injections (1)
CL Item
I prefer eye drops (2)
CL Item
I have no preference (3)
Item
Question 2. Overall, with respect to comfort of treatment (e.g., pain, discomfort, irritation or other physical distress) which treatment do you prefer?
integer
C1522634 (UMLS CUI [1])
C1331418 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0030193 (UMLS CUI [3])
C2364135 (UMLS CUI [4])
C1706307 (UMLS CUI [5])
C4061283 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0558295 (UMLS CUI [7,2])
Question 2. Overall, with respect to comfort of treatment (e.g., pain, discomfort, irritation or other physical distress) which treatment do you prefer?
Code List
Question 2. Overall, with respect to comfort of treatment (e.g., pain, discomfort, irritation or other physical distress) which treatment do you prefer?
CL Item
I prefer intravitreal injections (1)
CL Item
I prefer eye drops (2)
CL Item
I have no preference (3)
Item
Question 3. Overall, with respect to your feelings associated with treatment (e.g., nervousness, fear, anxiety or other emotional distress) which treatment do you prefer?
integer
C1522634 (UMLS CUI [1])
C1527305 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0004083 (UMLS CUI [2,3])
C0027769 (UMLS CUI [3])
C4054984 (UMLS CUI [4])
C0003467 (UMLS CUI [5])
C0700361 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0558295 (UMLS CUI [7,2])
Question 3. Overall, with respect to your feelings associated with treatment (e.g., nervousness, fear, anxiety or other emotional distress) which treatment do you prefer?
Code List
Question 3. Overall, with respect to your feelings associated with treatment (e.g., nervousness, fear, anxiety or other emotional distress) which treatment do you prefer?
CL Item
I prefer intravitreal injections (1)
CL Item
I prefer eye drops (2)
CL Item
I have no preference (3)
Item
Question 4. Overall, with respect to the impact on your day-to-day activities before, during and after treatment, which treatment do you prefer?
integer
C1522634 (UMLS CUI [1])
C4049986 (UMLS CUI [2])
C0871707 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0558295 (UMLS CUI [4,2])
Question 4. Overall, with respect to the impact on your day-to-day activities before, during and after treatment, which treatment do you prefer?
Code List
Question 4. Overall, with respect to the impact on your day-to-day activities before, during and after treatment, which treatment do you prefer?
CL Item
I prefer intravitreal injections (1)
CL Item
I prefer eye drops (2)
CL Item
I have no preference (3)
Item
Question 5a. If you could only have one treatment, which would you choose?
integer
C1522634 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1707391 (UMLS CUI [2,2])
Question 5a. If you could only have one treatment, which would you choose?
Code List
Question 5a. If you could only have one treatment, which would you choose?
CL Item
Intravitreal injections (4)
CL Item
Eye drops (5)
Question 5b. What is the single most important reason for your choice?
Item
Question 5b. What is the single most important reason for your choice?
text
C1522634 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C1707391 (UMLS CUI [2,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video