ID

39878

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

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  1. 26.02.20 26.02.20 -
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GlaxoSmithKline

Hochgeladen am

26. Februar 2020

DOI

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

Englisch

Week 4 - Vital Signs; Electronically Transferred Lab Data; Liver event assessment; PK Tissue Sample; 12-Lead ECG

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Date of visit/ assessment
Beschreibung

Date of visit/ assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
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]
Electronically Transferred Lab Data
Beschreibung

Electronically Transferred Lab Data

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

Date sample taken

Datentyp

date

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

Sample taken - not done

Datentyp

integer

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

Haem Lab type code

Datentyp

text

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

Chem Lab type code

Datentyp

text

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

Urin Lab type code

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
Liver event assessment
Beschreibung

Liver event assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Beschreibung

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.

Datentyp

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
Specify type of liver chemistry event
Beschreibung

Specify type of liver chemistry event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2348235
PK Tissue Sample
Beschreibung

PK Tissue Sample

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0370003
Sample taken?
Beschreibung

If yes, complete details

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0370003
Start date and Actual start time
Beschreibung

Start date and Actual start time

Datentyp

datetime

Alias
UMLS CUI [1]
C3897500
Investigational product (Last Dose) date/time
Beschreibung

Investigational product = Eye drops

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1762893
Investigational product (2nd Last Dose) date/time
Beschreibung

Investigational product = Eye drops

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1762893
Investigational product (3rd Last Dose) date/time
Beschreibung

Investigational product = Eye drops

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1762893
PK Type Code
Beschreibung

PK Type Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0805701
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
Method of QTc Calculation
Beschreibung

Method of QTc Calculation

Datentyp

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
QTcB (Bazett)
Beschreibung

QTcB (Bazett)

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1882512
ms
QTcF (Fridericia)
Beschreibung

QTcF (Fridericia)

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1882513
ms
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
If abnormal ECG, specify
Beschreibung

If abnormal ECG, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2348235
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Ähnliche Modelle

Week 4 - Vital Signs; Electronically Transferred Lab Data; Liver event assessment; PK Tissue Sample; 12-Lead ECG

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Date of visit/ assessment
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (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
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])
Item Group
Liver event assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
Item
Specify type of liver chemistry event
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Specify type of liver chemistry event
Code List
Specify type of liver chemistry event
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria) (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria or has been monitored for 4 weeks and continues to meet liver chemistry event criteria) (3)
Item Group
PK Tissue Sample
C0201734 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Sample taken?
Item
Sample taken?
boolean
C0201734 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
Start date and Actual start time
Item
Start date and Actual start time
datetime
C3897500 (UMLS CUI [1])
Investigational product (Last Dose) date/time
Item
Investigational product (Last Dose) date/time
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
Investigational product (2nd Last Dose) date/time
Item
Investigational product (2nd Last Dose) date/time
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
Investigational product (3rd Last Dose) date/time
Item
Investigational product (3rd Last Dose) date/time
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
PK Type Code
Item
PK Type Code
text
C0031328 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (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; record QTc value(s) generated by the machine (1)
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTcB (Bazett)
Item
QTcB (Bazett)
integer
C1882512 (UMLS CUI [1])
QTcF (Fridericia)
Item
QTcF (Fridericia)
integer
C1882513 (UMLS CUI [1])
Item
Result of the ECG
integer
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)
Item
If abnormal ECG, specify
text
C0522055 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If abnormal ECG, specify
Code List
If abnormal ECG, specify
CL Item
Sinus bradycardia ([A1])
CL Item
Sinus tachycardia (heart rate > 100 beats/min) ([A2])
CL Item
Atrial fibrillation ([A8])
CL Item
Right bundle branch block ([C8])
CL Item
Left bundle branch block ([C9])
CL Item
Myocardial infarction, old ([D1])
CL Item
Enter comment ([E99])
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