ID

39454

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. 1/11/20 1/11/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 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 - Electronically Transferred Lab Data; 12-LEad ECG; Neovascular AMD history and prior AMD medications

1 forms  
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample taken - not done
Description

Sample taken - not done

Data type

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1272696
Haem Lab type code
Description

Haem Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Chem Lab type code
Description

Chem Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Urin Lab type code
Description

Urin Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Record QTc value(s) generated by the machine - Bazett
Description

Record QTc value(s) generated by the machine - Bazett

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
ms
Record QTc value(s) generated by the machine - Fridericia
Description

Record QTc value(s) generated by the machine - Fridericia

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0855331
ms
Result of the ECG
Description

Result of the ECG

Data type

text

Alias
UMLS CUI [1]
C0438154
If other ECG result, enter comment
Description

If other ECG result, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Neovascular AMD history and prior AMD medications - Right Eye
Description

Neovascular AMD history and prior AMD medications - Right Eye

Alias
UMLS CUI-1
C0242383
UMLS CUI-2
C4068891
UMLS CUI-3
C0013227
UMLS CUI-4
C0229089
Neovascular AMD (wet) diagnosis
Description

Neovascular AMD (wet) diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C3888896
UMLS CUI [1,2]
C4068891
UMLS CUI [1,3]
C0011900
If neovascular AMD (wet) diagnosis, record date
Description

If neovascular AMD (wet) diagnosis, record date

Data type

date

Alias
UMLS CUI [1,1]
C3888896
UMLS CUI [1,2]
C4068891
UMLS CUI [1,3]
C2316983
Has the subject received any anti-VEGF intravitreal injections for the treatment of neovascular AMD?
Description

If yes, provide details.

Data type

boolean

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C0242383
UMLS CUI [2,2]
C4068891
Which anti-VEGF intravitreal injections has the subject ever received?
Description

Which anti-VEGF intravitreal injections has the subject ever received?

Data type

integer

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
First anti-VEGF intravitreal treatment date
Description

First anti-VEGF intravitreal treatment date

Data type

date

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2]
C3173309
Last anti-VEGF intravitreal treatment date
Description

i.e. most recent treatment prior to Screening Visit

Data type

date

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [1,3]
C1531784
Last anti-VEGF intravitreal treatment
Description

i.e. most recent treatment prior to Screening Visit

Data type

text

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1517741
Approximate total lifetime anti-VEGF intravitreal injections
Description

Approximate total lifetime anti-VEGF intravitreal injections

Data type

integer

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C1265611
UMLS CUI [2,2]
C4071830
Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit
Description

Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit

Data type

integer

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C1265611
UMLS CUI [2,2]
C0220908
UMLS CUI [2,3]
C0332152
Has the subject received any other neovascular AMD treatments?
Description

More than one response may be ticked. Represent each drug or device only once (e.g. radiation device represent under device)

Data type

text

Alias
UMLS CUI [1,1]
C0242383
UMLS CUI [1,2]
C4068891
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205394
Neovascular AMD history and prior AMD medications - Left Eye
Description

Neovascular AMD history and prior AMD medications - Left Eye

Alias
UMLS CUI-1
C0242383
UMLS CUI-2
C4068891
UMLS CUI-3
C0013227
UMLS CUI-4
C0229090
Neovascular AMD (wet) diagnosis
Description

Neovascular AMD (wet) diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C3888896
UMLS CUI [1,2]
C4068891
UMLS CUI [1,3]
C0011900
If neovascular AMD (wet) diagnosis, record date
Description

If neovascular AMD (wet) diagnosis, record date

Data type

date

Alias
UMLS CUI [1,1]
C3888896
UMLS CUI [1,2]
C4068891
UMLS CUI [1,3]
C2316983
Has the subject received any anti-VEGF intravitreal injections for the treatment of neovascular AMD?
Description

If yes, provide details.

Data type

boolean

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C0242383
UMLS CUI [2,2]
C4068891
Which anti-VEGF intravitreal injections has the subject ever received?
Description

Which anti-VEGF intravitreal injections has the subject ever received?

Data type

integer

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
First anti-VEGF intravitreal treatment date
Description

First anti-VEGF intravitreal treatment date

Data type

date

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2]
C3173309
Last anti-VEGF intravitreal treatment date
Description

i.e. most recent treatment prior to Screening Visit

Data type

date

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [1,3]
C1531784
Last anti-VEGF intravitreal treatment
Description

i.e. most recent treatment prior to Screening Visit

Data type

text

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1517741
Approximate total lifetime anti-VEGF intravitreal injections
Description

Approximate total lifetime anti-VEGF intravitreal injections

Data type

integer

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C1265611
UMLS CUI [2,2]
C4071830
Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit
Description

Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit

Data type

integer

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [2,1]
C1265611
UMLS CUI [2,2]
C0220908
UMLS CUI [2,3]
C0332152
Has the subject received any other neovascular AMD treatments?
Description

More than one response may be ticked. Represent each drug or device only once (e.g. radiation device represent under device)

Data type

text

Alias
UMLS CUI [1,1]
C0242383
UMLS CUI [1,2]
C4068891
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205394
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Similar models

Screen - Electronically Transferred Lab Data; 12-LEad ECG; Neovascular AMD history and prior AMD medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Sample taken - not done
integer
C0200345 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Sample taken - not done
Code List
Sample taken - not done
CL Item
Not done (1)
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Bazett (B)
CL Item
Fridericia (F)
Record QTc value(s) generated by the machine - Bazett
Item
Record QTc value(s) generated by the machine - Bazett
integer
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Record QTc value(s) generated by the machine - Fridericia
Item
Record QTc value(s) generated by the machine - Fridericia
integer
C1882513 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
Sinus bradycardia (A1)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Artrial fibrillation (A8)
CL Item
Right bundle branch block (C8)
CL Item
Left bundle branch block (C9)
CL Item
Myocardial infarction, old (D1)
CL Item
Other abnormalities (E99)
If other ECG result, enter comment
Item
If other ECG result, enter comment
text
C0438154 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Neovascular AMD history and prior AMD medications - Right Eye
C0242383 (UMLS CUI-1)
C4068891 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
C0229089 (UMLS CUI-4)
Neovascular AMD (wet) diagnosis
Item
Neovascular AMD (wet) diagnosis
boolean
C3888896 (UMLS CUI [1,1])
C4068891 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
If neovascular AMD (wet) diagnosis, record date
Item
If neovascular AMD (wet) diagnosis, record date
date
C3888896 (UMLS CUI [1,1])
C4068891 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
Has the subject received any anti-VEGF intravitreal injections for the treatment of neovascular AMD?
Item
Has the subject received any anti-VEGF intravitreal injections for the treatment of neovascular AMD?
boolean
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C0242383 (UMLS CUI [2,1])
C4068891 (UMLS CUI [2,2])
Item
Which anti-VEGF intravitreal injections has the subject ever received?
integer
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
Which anti-VEGF intravitreal injections has the subject ever received?
Code List
Which anti-VEGF intravitreal injections has the subject ever received?
CL Item
bevacizumab (Avastin) (1)
CL Item
pegaptanib (Macugen) (2)
CL Item
ranibizumab (Lucentis) (3)
CL Item
Other investigational product for CNV (19)
First anti-VEGF intravitreal treatment date
Item
First anti-VEGF intravitreal treatment date
date
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C3173309 (UMLS CUI [2])
Last anti-VEGF intravitreal treatment date
Item
Last anti-VEGF intravitreal treatment date
date
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C1531784 (UMLS CUI [1,3])
Item
Last anti-VEGF intravitreal treatment
text
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Last anti-VEGF intravitreal treatment
Code List
Last anti-VEGF intravitreal treatment
CL Item
Other investigational product for CNV (9)
CL Item
bevacizumab (Avastin) = bevacizumab (Avastin) (1)
CL Item
pegaptanib (Macugen) = pegaptanib (Macugen) (2)
CL Item
ranibizumab (Lucentis) = ranibizumab (Lucentis) (3)
Approximate total lifetime anti-VEGF intravitreal injections
Item
Approximate total lifetime anti-VEGF intravitreal injections
integer
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C1265611 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit
Item
Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit
integer
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C1265611 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item
Has the subject received any other neovascular AMD treatments?
text
C0242383 (UMLS CUI [1,1])
C4068891 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Has the subject received any other neovascular AMD treatments?
Code List
Has the subject received any other neovascular AMD treatments?
CL Item
No (N)
CL Item
Yes, select treatments (Y)
CL Item
photodynamic therapy with verteporfin (4)
CL Item
intravitreal steroids (5)
CL Item
radiation (6)
CL Item
laser (7)
CL Item
pazopanib (8)
CL Item
Other investigational product for CNV  (9)
CL Item
Other investigational devices for CNV (10)
Item Group
Neovascular AMD history and prior AMD medications - Left Eye
C0242383 (UMLS CUI-1)
C4068891 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
C0229090 (UMLS CUI-4)
Neovascular AMD (wet) diagnosis
Item
Neovascular AMD (wet) diagnosis
boolean
C3888896 (UMLS CUI [1,1])
C4068891 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
If neovascular AMD (wet) diagnosis, record date
Item
If neovascular AMD (wet) diagnosis, record date
date
C3888896 (UMLS CUI [1,1])
C4068891 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
Has the subject received any anti-VEGF intravitreal injections for the treatment of neovascular AMD?
Item
Has the subject received any anti-VEGF intravitreal injections for the treatment of neovascular AMD?
boolean
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C0242383 (UMLS CUI [2,1])
C4068891 (UMLS CUI [2,2])
Item
Which anti-VEGF intravitreal injections has the subject ever received?
integer
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
Which anti-VEGF intravitreal injections has the subject ever received?
Code List
Which anti-VEGF intravitreal injections has the subject ever received?
CL Item
bevacizumab (Avastin)  (1)
CL Item
pegaptanib (Macugen)  (2)
CL Item
ranibizumab (Lucentis)  (3)
CL Item
Other investigational product for CNV (19)
First anti-VEGF intravitreal treatment date
Item
First anti-VEGF intravitreal treatment date
date
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C3173309 (UMLS CUI [2])
Last anti-VEGF intravitreal treatment date
Item
Last anti-VEGF intravitreal treatment date
date
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C1531784 (UMLS CUI [1,3])
Item
Last anti-VEGF intravitreal treatment
text
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Last anti-VEGF intravitreal treatment
Code List
Last anti-VEGF intravitreal treatment
CL Item
bevacizumab (Avastin) = bevacizumab (Avastin) (1)
CL Item
pegaptanib (Macugen) = pegaptanib (Macugen) (2)
CL Item
ranibizumab (Lucentis) = ranibizumab (Lucentis) (3)
CL Item
Other investigational product for CNV (9)
Approximate total lifetime anti-VEGF intravitreal injections
Item
Approximate total lifetime anti-VEGF intravitreal injections
integer
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C1265611 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit
Item
Total anti-VEGF intravitreal injections in the 6 months prior to the Screening Visit
integer
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C1265611 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item
Has the subject received any other neovascular AMD treatments?
text
C0242383 (UMLS CUI [1,1])
C4068891 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Has the subject received any other neovascular AMD treatments?
Code List
Has the subject received any other neovascular AMD treatments?
CL Item
No (N)
CL Item
Yes, select treatments (Y)
CL Item
photodynamic therapy with verteporfin (4)
CL Item
intravitreal steroids (5)
CL Item
radiation (6)
CL Item
laser (7)
CL Item
pazopanib (8)
CL Item
Other investigational product for CNV  (9)
CL Item
Other investigational devices for CNV (10)
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