ID
39878
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)
- 2/26/20 2/26/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 26, 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
Week 4 - Vital Signs; Electronically Transferred Lab Data; Liver event assessment; PK Tissue Sample; 12-Lead ECG
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
First sitting BP reading
Alias
- UMLS CUI-1
- C0005823
- UMLS CUI-2
- C0277814
- UMLS CUI-3
- C0205435
Description
Assessment Time
Data type
date
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C0040223
Description
Systolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Second sitting BP reading
Alias
- UMLS CUI-1
- C0005823
- UMLS CUI-2
- C0277814
- UMLS CUI-3
- C0205436
Description
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Sample taken - not done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1272696
Description
Haem Lab type code
Data type
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Description
Chem Lab type code
Data type
text
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Description
Urin Lab type code
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
Description
Liver event assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Description
Note: If a subject has been monitored for 4 weeks and continues to meet liver chemistry monitoring criteria, subject must be identified as a liver event. If Yes and type of liver chemistry event is Liver Monitoring, obtain tests as per protocol.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0545082
Description
Specify type of liver chemistry event
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C2348235
Description
PK Tissue Sample
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0370003
Description
If yes, complete details
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0370003
Description
Start date and Actual start time
Data type
datetime
Alias
- UMLS CUI [1]
- C3897500
Description
Investigational product = Eye drops
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1762893
Description
Investigational product = Eye drops
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1762893
Description
Investigational product = Eye drops
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1762893
Description
PK Type Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0805701
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Date of ECG
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
Method of QTc Calculation
Data type
text
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
QTcB (Bazett)
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1882512
Description
QTcF (Fridericia)
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1882513
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
If abnormal ECG, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2348235
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Week 4 - Vital Signs; Electronically Transferred Lab Data; Liver event assessment; PK Tissue Sample; 12-Lead ECG
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C0277814 (UMLS CUI-2)
C0205435 (UMLS CUI-3)
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C0205436 (UMLS CUI-3)
C1705822 (UMLS CUI-2)
C1272696 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
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C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
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C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0370003 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
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