ID

39445

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 (2)
  1. 10.01.20 10.01.20 -
  2. 10.01.20 10.01.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Januar 2020

DOI

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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

Englisch

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

1 Formulare  
Medical/ surgical procedures - Right Eye
Beschreibung

Medical/ surgical procedures - Right Eye

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

Check all that apply

Datentyp

integer

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

If intraocular lens implant in right eye, specify

Datentyp

text

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

Medical/ surgical procedures - Left Eye

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

Check all that apply

Datentyp

integer

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

If intraocular lens implant in left eye, specify

Datentyp

text

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

Other ocular surgeries and procedures

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

Sequence Number

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Specific Procedure
Beschreibung

Specific Procedure

Datentyp

text

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

Eye

Datentyp

integer

Alias
UMLS CUI [1]
C0015392
Risk Factors
Beschreibung

Risk Factors

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

Does the subject have diabetes mellitus?

Datentyp

text

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

Does the subject have hyperlipidemia?

Datentyp

text

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

Does the subject live with a person who smokes?

Datentyp

text

Alias
UMLS CUI [1]
C0037370
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Body mass index

Datentyp

integer

Alias
UMLS CUI [1]
C1305855
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
First sitting BP reading
Beschreibung

First sitting BP reading

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

Assessment Time

Datentyp

date

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

Systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Second sitting BP reading
Beschreibung

Second sitting BP reading

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

Systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Third sitting BP reading
Beschreibung

Third sitting BP reading

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

Systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Calculated Subject position
Beschreibung

Calculated Subject position

Datentyp

text

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

History of Tobacco Use

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

What is the subject's history of smoking use?

Datentyp

integer

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

If former smoker, when did the subject last smoke?

Datentyp

date

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

Substance Use Type

Datentyp

text

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

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

Datentyp

integer

Maßeinheiten
  • 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?
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
years
Number of pack years?
Beschreibung

Number of pack years?

Datentyp

integer

Alias
UMLS CUI [1]
C1277691
Alcohol intake
Beschreibung

Alcohol intake

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

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

Datentyp

boolean

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

Record the average number of units of alcohol consumed per week

Datentyp

integer

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

Substance Use Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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