ID

39442

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. 1/10/20 1/10/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 10, 2020

DOI

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License

Creative Commons BY-NC 3.0
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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

English

Screen - Administrative; Demography; Cardiovascular medical conditions; Medical Conditions; Ocular Medical Conditions

1 forms  
Inform Screening
Description

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject initials
Description

Subject initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Description

Enter subject’s date of birth, if you are unable to provide a full date of birth, enter a partial date of birth.

Data type

date

Alias
UMLS CUI [1]
C0421451
Inform Enrollment
Description

Inform Enrollment

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C4041024
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Subject identification
Description

Subject identification

Alias
UMLS CUI-1
C2348585
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Enter subject’s date of birth, if you are unable to provide a full date of birth, enter a partial date of birth.

Data type

date

Alias
UMLS CUI [1]
C0421451
Date of birth - Complete
Description

Date of birth - Complete

Data type

date

Alias
UMLS CUI [1,1]
C0421451
UMLS CUI [1,2]
C0205197
Date of birth - Imputed
Description

Date of birth - Imputed

Data type

date

Alias
UMLS CUI [1,1]
C0421451
UMLS CUI [1,2]
C2825504
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1]
C3841890
Subject Status
Description

Subject Status

Data type

text

Alias
UMLS CUI [1]
C2348568
Cardiovascular medical conditions
Description

Cardiovascular medical conditions

Alias
UMLS CUI-1
C0007222
Specific cardiovascular medical condition
Description

Specific cardiovascular medical condition

Data type

integer

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2348235
Cardiovascular medical condition status
Description

Cardiovascular medical condition status

Data type

integer

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0449438
Specify other cardiovascular medical condition
Description

Specify other cardiovascular medical condition

Data type

text

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Medical conditions
Description

Medical conditions

Alias
UMLS CUI-1
C0012634
Specific medical condition
Description

Specific medical condition

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Medical condition status
Description

Medical condition status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Ocular medical conditions - Right Eye
Description

Ocular medical conditions - Right Eye

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C1299003
UMLS CUI-3
C0229089
Specific ocular medical condition - Right Eye
Description

Specific ocular medical condition - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1299003
UMLS CUI [1,3]
C2348235
UMLS CUI [2]
C0229089
Ocular medical condition status - Right Eye
Description

Ocular medical condition status - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1299003
UMLS CUI [1,3]
C0449438
UMLS CUI [2]
C0229089
Ocular medical conditions - Left Eye
Description

Ocular medical conditions - Left Eye

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C1299003
UMLS CUI-3
C0229090
Specific ocular medical condition - Left Eye
Description

Specific ocular medical condition - Left Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1299003
UMLS CUI [1,3]
C2348235
UMLS CUI [2]
C0229090
Ocular medical condition status - Left Eye
Description

Ocular medical condition status - Left Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1299003
UMLS CUI [1,3]
C0449438
UMLS CUI [2]
C0229090
Other ocular conditions
Description

Other ocular conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C1299003
UMLS CUI-3
C0205394
Sequence number
Description

Sequence number

Data type

text

Alias
UMLS CUI [1]
C2348184
Specific other ocular condition
Description

Specific other ocular condition

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1299003
UMLS CUI [1,3]
C0205394
Other ocular condition status
Description

Other ocular condition status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1299003
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C0205394
Eye
Description

Eye

Data type

integer

Alias
UMLS CUI [1]
C0015392
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Similar models

Screen - Administrative; Demography; Cardiovascular medical conditions; Medical Conditions; Ocular Medical Conditions

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Inform Enrollment
C1552002 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Subject identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Date of birth - Complete
Item
Date of birth - Complete
date
C0421451 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Date of birth - Imputed
Item
Date of birth - Imputed
date
C0421451 (UMLS CUI [1,1])
C2825504 (UMLS CUI [1,2])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female, record child-bearing potential (F)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Subject Status
Item
Subject Status
text
C2348568 (UMLS CUI [1])
Item Group
Cardiovascular medical conditions
C0007222 (UMLS CUI-1)
Item
Specific cardiovascular medical condition
integer
C0007222 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Disease
Code List
Specific cardiovascular medical condition
CL Item
Myocardial infarction (1)
CL Item
Stroke (2)
CL Item
Heart failure (3)
CL Item
Hypertension (4)
CL Item
Atrial Fibrillation (5)
CL Item
Coronary Artery Disease (6)
CL Item
Other Condition (7)
Item
Cardiovascular medical condition status
integer
C0007222 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease status
Code List
Cardiovascular medical condition status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Specify other cardiovascular medical condition
Item
Specify other cardiovascular medical condition
text
C0007222 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Medical conditions
C0012634 (UMLS CUI-1)
Item
Specific medical condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specific medical condition
Code List
Specific medical condition
CL Item
Blood and lymphatic system disorders (1)
CL Item
Ear and labyrinth disorders (2)
CL Item
Endocrine disorders (3)
CL Item
Gastrointestinal disorders (4)
CL Item
Hepatobiliary disorders (5)
CL Item
Immune system disorders (6)
CL Item
Metabolism and nutrition disorders (7)
CL Item
Musculoskeletal and connective tissue disorders (8)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (9)
CL Item
Nervous system disorders (10)
CL Item
Psychiatric disorders (11)
CL Item
Renal and urinary disorders (12)
CL Item
Reproductive system and breast disorders (13)
CL Item
Respiratory, thoracic and mediastinal disorders (14)
CL Item
Skin and subcutaneous tissue disorders (15)
Item
Medical condition status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease status
Code List
Medical condition status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Ocular medical conditions - Right Eye
C0012634 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
C0229089 (UMLS CUI-3)
Item
Specific ocular medical condition - Right Eye
integer
C0012634 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0229089 (UMLS CUI [2])
Specific ocular medical condition
Code List
Specific ocular medical condition - Right Eye
CL Item
Non-exudative senile macular degeneration of retina (Dry) (1)
CL Item
Geographic Atrophy (Atrophic age related macular degeneration (2)
CL Item
Exudative senile macular degeneration of retina (Wet, neovascular (3)
CL Item
Glaucoma (4)
CL Item
Ocular hypertension (5)
CL Item
Non-proliferative diabetic retinopathy (6)
CL Item
Proliferative diabetic retinopathy (7)
CL Item
Diabetic macular edema (8)
CL Item
Uveitis (including ocular histoplasmosis) (9)
CL Item
Rhegmatogenous retinal detachment (10)
CL Item
Macular hole (11)
CL Item
Endophthalmitis (12)
CL Item
Dry eye (13)
CL Item
Pterygium (14)
CL Item
Corneal neovascularization (15)
CL Item
Ophthalmic herpes simplex (16)
CL Item
Ophthalmic herpes zoster (17)
CL Item
Corneal scar (18)
CL Item
Corneal dystrophy (19)
CL Item
Retinal vein occlusion (i.e. BRVO, CRVO) (20)
CL Item
Optic nerve disorder (other than glaucoma e.g., inflammation, atrophy, edema) (21)
Item
Ocular medical condition status - Right Eye
integer
C0012634 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0229089 (UMLS CUI [2])
Ocular medical condition status
Code List
Ocular medical condition status - Right Eye
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Ocular medical conditions - Left Eye
C0012634 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
C0229090 (UMLS CUI-3)
Item
Specific ocular medical condition - Left Eye
integer
C0012634 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0229090 (UMLS CUI [2])
Specific ocular medical condition - Left Eye
Code List
Specific ocular medical condition - Left Eye
CL Item
Non-exudative senile macular degeneration of retina (Dry) (1)
CL Item
Geographic Atrophy (Atrophic age related macular degeneration (2)
CL Item
Exudative senile macular degeneration of retina (Wet, neovascular (3)
CL Item
Glaucoma (4)
CL Item
Ocular hypertension (5)
CL Item
Non-proliferative diabetic retinopathy (6)
CL Item
Proliferative diabetic retinopathy (7)
CL Item
Diabetic macular edema (8)
CL Item
Uveitis (including ocular histoplasmosis) (9)
CL Item
Rhegmatogenous retinal detachment (10)
CL Item
Macular hole (11)
CL Item
Endophthalmitis (12)
CL Item
Dry eye (13)
CL Item
Pterygium (14)
CL Item
Corneal neovascularization (15)
CL Item
Ophthalmic herpes simplex (16)
CL Item
Ophthalmic herpes zoster (17)
CL Item
Corneal scar (18)
CL Item
Corneal dystrophy (19)
CL Item
Retinal vein occlusion (i.e. BRVO, CRVO) (20)
CL Item
Optic nerve disorder (other than glaucoma e.g., inflammation, atrophy, edema) (21)
Item
Ocular medical condition status - Left Eye
integer
C0012634 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0229090 (UMLS CUI [2])
Ocular medical condition status - Left Eye
Code List
Ocular medical condition status - Left Eye
CL Item
Current  (1)
CL Item
Past  (2)
CL Item
No Medical Condition (3)
Item Group
Other ocular conditions
C0012634 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Sequence number
Item
Sequence number
text
C2348184 (UMLS CUI [1])
Specific other ocular condition
Item
Specific other ocular condition
text
C0012634 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Other ocular condition status
integer
C0012634 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Other ocular condition status
Code List
Other ocular condition status
CL Item
Current (1)
CL Item
Past (2)
Item
Eye
integer
C0015392 (UMLS CUI [1])
Eye
Code List
Eye
CL Item
Right (1)
CL Item
Left (2)
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