ID

39445

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 (2)
  1. 1/10/20 1/10/20 -
  2. 1/10/20 1/10/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 10, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

Screen - Medical / surgical procedures; Risk Factors; Vital Signs; History of Tobacco Use; Alcohol intake

1 forms  
Medical/ surgical procedures - Right Eye
Description

Medical/ surgical procedures - Right Eye

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C1299003
UMLS CUI-3
C0229089
Ocular surgeries and procedures - Right Eye
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1299003
UMLS CUI [2]
C0229089
If intraocular lens implant in right eye, specify
Description

If intraocular lens implant in right eye, specify

Data type

text

Alias
UMLS CUI [1,1]
C0023319
UMLS CUI [1,2]
C0229089
UMLS CUI [1,3]
C2348235
Medical/ surgical procedures - Left Eye
Description

Medical/ surgical procedures - Left Eye

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C1299003
UMLS CUI-3
C0229090
Ocular surgeries and procedures - Left Eye
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1299003
UMLS CUI [2]
C0229090
If intraocular lens implant in left eye, specify
Description

If intraocular lens implant in left eye, specify

Data type

text

Alias
UMLS CUI [1,1]
C0023319
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C2348235
Other ocular surgeries and procedures
Description

Other ocular surgeries and procedures

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C1299003
UMLS CUI-3
C0205394
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Specific Procedure
Description

Specific Procedure

Data type

text

Alias
UMLS CUI [1,1]
C1948041
UMLS CUI [1,2]
C2348235
Eye
Description

Eye

Data type

integer

Alias
UMLS CUI [1]
C0015392
Risk Factors
Description

Risk Factors

Alias
UMLS CUI-1
C0035648
Does the subject have diabetes mellitus?
Description

Does the subject have diabetes mellitus?

Data type

text

Alias
UMLS CUI [1]
C0011849
Does the subject have hyperlipidemia?
Description

Does the subject have hyperlipidemia?

Data type

text

Alias
UMLS CUI [1]
C0020473
Does the subject live with a person who smokes?
Description

Does the subject live with a person who smokes?

Data type

text

Alias
UMLS CUI [1]
C0037370
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

integer

Alias
UMLS CUI [1]
C1305855
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
First sitting BP reading
Description

First sitting BP reading

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0277814
UMLS CUI-3
C0205435
Assessment Time
Description

Assessment Time

Data type

date

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0040223
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Second sitting BP reading
Description

Second sitting BP reading

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0277814
UMLS CUI-3
C0205436
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Third sitting BP reading
Description

Third sitting BP reading

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0277814
UMLS CUI-3
C0205437
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Calculated Subject position
Description

Calculated Subject position

Data type

text

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0444686
History of Tobacco Use
Description

History of Tobacco Use

Alias
UMLS CUI-1
C0841002
What is the subject's history of smoking use?
Description

What is the subject's history of smoking use?

Data type

integer

Alias
UMLS CUI [1]
C0841002
If former smoker, when did the subject last smoke?
Description

If former smoker, when did the subject last smoke?

Data type

date

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C0037369
UMLS CUI [1,3]
C1517741
Substance Use Type
Description

Substance Use Type

Data type

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
Average number of cigarettes smoked per day?
Description

CONVERTER FOR CIGARS AND TOBACCO 1 cigar = 7 cigarettes. 1 gram (or 0.03 oz.) of tobacco = 1 cigarette.

Data type

integer

Measurement units
  • cigarettes per day
Alias
UMLS CUI [1,1]
C1608325
UMLS CUI [1,2]
C3694146
cigarettes per day
Number of years during which the subject has smoked/used tobacco?
Description

Number of years during which the subject has smoked/used tobacco?

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
years
Number of pack years?
Description

Number of pack years?

Data type

integer

Alias
UMLS CUI [1]
C1277691
Alcohol intake
Description

Alcohol intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Description

1 unit of alcohol = 1.5 ounces of hard liquor; 1 beer; 4 ounces of wine

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Record the average number of units of alcohol consumed per week
Description

Record the average number of units of alcohol consumed per week

Data type

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Substance Use Type
Description

Substance Use Type

Data type

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
Back to the top of the page

Similar models

Screen - Medical / surgical procedures; Risk Factors; Vital Signs; History of Tobacco Use; Alcohol intake

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical/ surgical procedures - Right Eye
C0543467 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
C0229089 (UMLS CUI-3)
Item
Ocular surgeries and procedures - Right Eye
integer
C0543467 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C0229089 (UMLS CUI [2])
Ocular surgeries and procedures
Code List
Ocular surgeries and procedures - Right Eye
CL Item
Contact lens wearer (1)
CL Item
Eyeglasses wearer (2)
CL Item
Cataract extraction (3)
CL Item
Intraocular lens implant (4)
CL Item
Vitrectomy (5)
CL Item
Detached retina repair (e.g., scleral buckle, pneumatic retinopexy, vitrectomy) (6)
CL Item
Glaucoma surgery (7)
CL Item
LASIK eye surgery (8)
CL Item
Photorefractive keratectomy (9)
CL Item
Keratotomy (10)
CL Item
Corneal transplant (11)
CL Item
Punctal plug insertion (current) (12)
Item
If intraocular lens implant in right eye, specify
text
C0023319 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
If intraocular lens implant in right eye, specify
Code List
If intraocular lens implant in right eye, specify
CL Item
Cataract (1)
CL Item
Other (OT)
Item Group
Medical/ surgical procedures - Left Eye
C0543467 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
C0229090 (UMLS CUI-3)
Item
Ocular surgeries and procedures - Left Eye
integer
C0543467 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C0229090 (UMLS CUI [2])
Ocular surgeries and procedures - Left Eye
Code List
Ocular surgeries and procedures - Left Eye
CL Item
Contact lens wearer (1)
CL Item
Eyeglasses wearer (2)
CL Item
Cataract extraction (3)
CL Item
Intraocular lens implant (4)
CL Item
Vitrectomy (5)
CL Item
Detached retina repair (e.g., scleral buckle, pneumatic retinopexy, vitrectomy) (6)
CL Item
Glaucoma surgery (7)
CL Item
LASIK eye surgery (8)
CL Item
Photorefractive keratectomy (9)
CL Item
Keratotomy (10)
CL Item
Corneal transplant (11)
CL Item
Punctal plug insertion (current) (12)
Item
If intraocular lens implant in left eye, specify
text
C0023319 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
If intraocular lens implant in left eye, specify
Code List
If intraocular lens implant in left eye, specify
CL Item
Cataract  (1)
CL Item
Other (OT)
Item Group
Other ocular surgeries and procedures
C0543467 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Procedure
Item
Specific Procedure
text
C1948041 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Eye
integer
C0015392 (UMLS CUI [1])
Eye
Code List
Eye
CL Item
Right (1)
CL Item
Left (2)
Item Group
Risk Factors
C0035648 (UMLS CUI-1)
Item
Does the subject have diabetes mellitus?
text
C0011849 (UMLS CUI [1])
Does the subject have diabetes mellitus?
Code List
Does the subject have diabetes mellitus?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Does the subject have hyperlipidemia?
text
C0020473 (UMLS CUI [1])
Does the subject have hyperlipidemia?
Code List
Does the subject have hyperlipidemia?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Does the subject live with a person who smokes?
text
C0037370 (UMLS CUI [1])
Does the subject live with a person who smokes?
Code List
Does the subject live with a person who smokes?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
integer
C1305855 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
First sitting BP reading
C0005823 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
C0205435 (UMLS CUI-3)
Assessment Time
Item
Assessment Time
date
C1516048 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Second sitting BP reading
C0005823 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
C0205436 (UMLS CUI-3)
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Third sitting BP reading
C0005823 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
C0205437 (UMLS CUI-3)
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Item Group
History of Tobacco Use
C0841002 (UMLS CUI-1)
Item
What is the subject's history of smoking use?
integer
C0841002 (UMLS CUI [1])
What is the subject's history of smoking use?
Code List
What is the subject's history of smoking use?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
If former smoker, when did the subject last smoke?
Item
If former smoker, when did the subject last smoke?
date
C0337671 (UMLS CUI [1,1])
C0037369 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Average number of cigarettes smoked per day?
Item
Average number of cigarettes smoked per day?
integer
C1608325 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Number of years during which the subject has smoked/used tobacco?
Item
Number of years during which the subject has smoked/used tobacco?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of pack years?
Item
Number of pack years?
integer
C1277691 (UMLS CUI [1])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Record the average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial