ID

40120

Description

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

Keywords

Versions (1)
  1. 3/12/20 3/12/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 12, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

English

Status of Treatment Mask; Investigational Product Discontinuation; Pregnancy Information; Investigational Product (Eye Drops) - Last Dose Date; Study Conclusion

1 forms  
Status of Treatment Mask
Description

Status of Treatment Mask

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment mask broken during the study?
Description

If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Date mask broken
Description

Date mask broken

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason mask broken
Description

Reason mask broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason for mask broken, specify
Description

If other reason for mask broken, specify

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the scheduled end of the treatment period?
Description

Yes, complete primary reason

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0205539
UMLS CUI [2,4]
C0444930
UMLS CUI [2,5]
C0332152
Select primary reason the investigational product was stopped
Description

Select primary reason the investigational product was stopped

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0457454
If reason is Adverse Event, specify
Description

Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Check all that apply. If none, select "No Subreasons":

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
If Investigator discretion, specify
Description

Select this reason if none of the other primary reasons are appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
If decision by subject or proxy, specify
Description

Select this reason if none of the other primary reasons are appropriate. Check all that apply. If none, select "No Subreasons":

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0600420
UMLS CUI [1,4]
C2348235
If other decision by subject or proxy, specify
Description

If other decision by subject or proxy, specify

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0600420
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form

Data type

boolean

Alias
UMLS CUI [1]
C3828490
Investigational Product (Eye Drops) - Last Dose Date
Description

Investigational Product (Eye Drops) - Last Dose Date

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0015399
UMLS CUI-3
C1762893
Last Dose Date
Description

Last Dose Date

Data type

date

Alias
UMLS CUI [1]
C1762893
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Data type

text

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Description

Primary reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If reason for withdrawal is Adverse Event, specify
Description

Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Check all that apply. If none, select "No Subreasons":

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2349954
Investigator discretion, specify
Description

Select this reason if none of the other primary reasons are appropriate

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
Withdrew consent, specify
Description

Select this reason if none of the other primary reasons are appropriate. Check all that apply. If none, select "No Subreasons":

Data type

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235
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Similar models

Status of Treatment Mask; Investigational Product Discontinuation; Pregnancy Information; Investigational Product (Eye Drops) - Last Dose Date; Study Conclusion

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Status of Treatment Mask
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment mask broken during the study?
Item
Was the treatment mask broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date mask broken
Item
Date mask broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason mask broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason mask broken
Code List
Reason mask broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
If other reason for mask broken, specify
Item
If other reason for mask broken, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Was the investigational product stopped permanently before the scheduled end of the treatment period?
Item
Was the investigational product stopped permanently before the scheduled end of the treatment period?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0444930 (UMLS CUI [2,4])
C0332152 (UMLS CUI [2,5])
Item
Select primary reason the investigational product was stopped
text
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Select primary reason the investigational product was stopped
Code List
Select primary reason the investigational product was stopped
CL Item
Other, specify (OT)
CL Item
Adverse Event, specify (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol Deviation (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Investigator discretion, specify (6)
CL Item
Decision by subject or proxy (7)
Item
If reason is Adverse Event, specify
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If reason is Adverse Event, specify
Code List
If reason is Adverse Event, specify
CL Item
Exclusionary blood pressure (006)
CL Item
Subject met GSK defined liver chemistry stopping criteria (055)
CL Item
No subreasons (-99)
If Investigator discretion, specify
Item
If Investigator discretion, specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
If decision by subject or proxy, specify
text
C0679006 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0600420 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If decision by subject or proxy, specify
Code List
If decision by subject or proxy, specify
CL Item
Burden of procedures (39)
CL Item
Other, specify (OT)
CL Item
No subreasons (-99)
If other decision by subject or proxy, specify
Item
If other decision by subject or proxy, specify
text
C0679006 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0600420 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
Investigational Product (Eye Drops) - Last Dose Date
C0304229 (UMLS CUI-1)
C0015399 (UMLS CUI-2)
C1762893 (UMLS CUI-3)
Last Dose Date
Item
Last Dose Date
date
C1762893 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes, complete primary reason for withdrawal (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event, specify (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol Deviation (3)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion, specify  (7)
CL Item
Withdrew consent, specify (8)
Item
If reason for withdrawal is Adverse Event, specify
text
C0877248 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
If reason for withdrawal is Adverse Event, specify
Code List
If reason for withdrawal is Adverse Event, specify
CL Item
Exclusionary blood pressure (006)
CL Item
Liver function test abnormality (017)
CL Item
No subreasons (-99)
Investigator discretion, specify
Item
Investigator discretion, specify
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Item
Withdrew consent, specify
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Withdrew consent, specify
Code List
Withdrew consent, specify
CL Item
Burden of procedures (38)
CL Item
Other, specify (OT)
CL Item
No subreasons (-99)
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