ID

39861

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 (1)
  1. 24/02/2020 24/02/2020 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24 février 2020

DOI

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Lizenz

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

Englisch

Subject Logs - Log Status; Concomitant Medications; Non-Serious Adverse Event; Serious Adverse Events

1 Formulare  
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Log Status
Beschreibung

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Were any concomitant medications taken by the subject during the study?
Beschreibung

Were any concomitant medications taken by the subject during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Did the subject experience any non-serious adverse events during the study?
Beschreibung

Did the subject experience any non-serious adverse events during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Did the subject experience a serious adverse event during the study?
Beschreibung

Did the subject experience a serious adverse event during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Did the subject receive any medical/surgical procedures during the study?
Beschreibung

Did the subject receive any medical/surgical procedures during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C1948041
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Did the subject experience an incident with GSK medical devices provided for use during this study?
Beschreibung

If Yes, complete the paper Medical Device Incident Report Form

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C1551358
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications - Sequence Number
Beschreibung

Concomitant Medications - Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C2348184
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Concomitant Medications - Modified reported term
Beschreibung

Concomitant Medications - Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschreibung

GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Beschreibung

GSK Drug Collection code

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Unit Dose
Beschreibung

Unit Dose

Datentyp

text

Alias
UMLS CUI [1]
C0869039
Medication Units
Beschreibung

Medication Units

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
Medication Frequency
Beschreibung

Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschreibung

Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Is this drug being taken for an ophthalmic indication?
Beschreibung

Is this drug being taken for an ophthalmic indication?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0029087
If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
Beschreibung

If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0029087
UMLS CUI [2]
C0015392
UMLS CUI [3]
C2348235
Reason for medication
Beschreibung

Reason for medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Medication start date
Beschreibung

Medication start date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Is medication ongoing?
Beschreibung

Is medication ongoing?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
If medication is not ongoing, specify end date
Beschreibung

If medication is not ongoing, specify end date

Datentyp

date

Alias
UMLS CUI [1]
C2826666
UMLS CUI [2]
C2826744
Medication type
Beschreibung

Medication type

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
Non-Serious Adverse Event
Beschreibung

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Non-Serious Adverse Event Sequence Number
Beschreibung

Non-Serious Adverse Event Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Non-Serious Adverse Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event - Modified Reported
Beschreibung

Non-Serious Adverse Event - Modified Reported

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
Non-Serious Adverse Event MedDRA synonym
Beschreibung

Non-Serious Adverse Event MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1140263
Non-Serious Adverse Event MedDRA lower level term code
Beschreibung

Non-Serious Adverse Event MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C3898442
Non-Serious Adverse Event - Failed coding
Beschreibung

Non-Serious Adverse Event - Failed coding

Datentyp

text

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Non-Serious Adverse Event - Start Date
Beschreibung

Non-Serious Adverse Event - Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Outcome
Beschreibung

Non-Serious Adverse Event Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious Adverse Event End Date
Beschreibung

Non-Serious Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event Frequency
Beschreibung

Non-Serious Adverse Event Frequency

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-Serious Adverse Event - Maximum Intensity
Beschreibung

Record maximum intensity throughout duration of event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event - Intensity at onset of event
Beschreibung

Record intensity at the onset of the event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0332162
Non-Serious Adverse Event - Maximum Grade
Beschreibung

Record maximum grade throughout duration of event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event - Grade at onset of event
Beschreibung

Record grade at the onset of the event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
Non-Serious Adverse Event - Maximum Grade or Intensity
Beschreibung

Record maximum grade or intensity throughout duration of event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0806909
Non-Serious Adverse Event - Grade or Intensity at onset of event
Beschreibung

Record grade or intensity at the onset of the event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C0332162
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the AE

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Non-Serious Adverse Event - Was the subject taking eye drops?
Beschreibung

Non-Serious Adverse Event - Was the subject taking eye drops?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0015399
Record Action Taken with Double Masked Product as a Result of the AE
Beschreibung

Double masked product = Eye drops

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Use best judgment at initial entry. May be amended when additional information becomes available. Double masked product = Eye drops

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
Beschreibung

If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1548787
Duration of AE if < 24 hours
Beschreibung

Duration of AE if < 24 hours

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
h
Duration of AE if < 24 hours
Beschreibung

Duration of AE if < 24 hours

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
min
Non-Serious Adverse Event - Is this an Ocular Event?
Beschreibung

Non-Serious Adverse Event - Is this an Ocular Event?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1299003
Non-Serious Adverse Event - If this is an Ocular Event, sepcify
Beschreibung

Non-Serious Adverse Event - If this is an Ocular Event, sepcify

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1299003
UMLS CUI [2]
C2348235
Serious Adverse Event - Type of Report
Beschreibung

Serious Adverse Event - Type of Report

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C0332307
Initial Report
Beschreibung

Initial Report

Datentyp

integer

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0205265
Follow-Up Report
Beschreibung

Follow-Up Report

Datentyp

integer

Alias
UMLS CUI [1]
C1704685
Serious Adverse Event - Randomisation
Beschreibung

Serious Adverse Event - Randomisation

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0034656
Did SAE occur after initiation of study medication?
Beschreibung

Did SAE occur after initiation of study medication?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Beschreibung

SAE Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Modified Term
Beschreibung

Serious Adverse Event - Modified Term

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
Serious Adverse Event - MedDRA synonym
Beschreibung

Serious Adverse Event - MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
Serious Adverse Event - MedDRA lower level term code
Beschreibung

Serious Adverse Event - MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Serious Adverse Event - Failed coding
Beschreibung

Serious Adverse Event - Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Serious Adverse Event - Start Date
Beschreibung

Serious Adverse Event - Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Serious Adverse Event - Outcome
Beschreibung

Serious Adverse Event - Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event - End Date
Beschreibung

Serious Adverse Event - End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Serious Adverse Event - Maximum Intensity
Beschreibung

Record maximum intensity throughout duration of event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Serious Adverse Event - Intensity at onset of event
Beschreibung

Record intensity at the onset of the event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0332162
Serious Adverse Event - Maximum Grade
Beschreibung

Record maximum grade throughout duration of event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Serious Adverse Event - Grade at onset of event
Beschreibung

Record grade at the onset of the event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
Serious Adverse Event - Maximum Grade or Intensity
Beschreibung

Record maximum grade or intensity throughout duration of event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0806909
Serious Adverse Event - Grade or Intensity at onset of event
Beschreibung

Record grade or intensity at the onset of the event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C0332162
Action Taken with Investigational Product(s) as a Result of the SAE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Serious Adverse Event - Was the subject taking eye drops?
Beschreibung

Serious Adverse Event - Was the subject taking eye drops?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015399
Action Taken with ranibizumab as a Result of the SAE
Beschreibung

Action Taken with ranibizumab as a Result of the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1566537
Serious Adverse Event - Is this an Ocular Event?
Beschreibung

Serious Adverse Event - Is this an Ocular Event?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1299003
Serious Adverse Event - If this is an Ocular Event, sepcify
Beschreibung

Serious Adverse Event - If this is an Ocular Event, sepcify

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1299003
UMLS CUI [2]
C2348235
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Beschreibung

Serious Adverse Event - Did the subject withdraw from study as a result of this AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

Use best judgment at initial entry. May be amended when additional information becomes available. Double masked product = Eye drops + boolean

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
Beschreibung

If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1548787
Duration of SAE if < 24 hours
Beschreibung

Duration of SAE if < 24 hours

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
h
Duration of SAE if < 24 hours
Beschreibung

Duration of SAE if < 24 hours

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
min
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Beschreibung

Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439849
Was the event serious?
Beschreibung

Was the event serious?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Related Investigational Product
Beschreibung

Serious Adverse Event - Related Investigational Product

Datentyp

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0304229
Serious Adverse Event - Intensity Changes
Beschreibung

Serious Adverse Event - Intensity Changes

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0518690
UMLS CUI-3
C0392747
Serious Adverse Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date and Time of event segment
Beschreibung

Start Date and Time of event segment

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0808070
UMLS CUI [1,4]
C1301880
Intensity of event segment
Beschreibung

Intensity of event segment

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
Grade of event segment
Beschreibung

Grade of event segment

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
Grade or Intensity of event segment
Beschreibung

Grade or Intensity of event segment

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0441800
Serious Adverse Event - Seriousness
Beschreibung

Serious Adverse Event - Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness?
Beschreibung

Specify the reason for considering this an SAE. Check all that apply.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
Beschreibung

Serious Adverse Event - Relevant Concomitant/ Treatment Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C2347946
UMLS CUI-4
C0304229
CM Sequence Number
Beschreibung

CM Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Concomitant medication - Drug name
Beschreibung

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Concomitant medication - Modified reported term
Beschreibung

Concomitant medication - Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Concomitant medication dose
Beschreibung

Concomitant medication dose

Datentyp

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Concomitant medication unit
Beschreibung

Concomitant medication unit

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Concomitant medication frequency
Beschreibung

Concomitant medication frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Concomitant medication route
Beschreibung

Medication Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Concomitant medication start date
Beschreibung

Concomitant medication start date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medication ongoing?
Beschreibung

Concomitant Medication ongoing?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
If concomitant medication is not ongoing, specify end date.
Beschreibung

If concomitant medication is not ongoing, specify end date.

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Concomitant medication - Primary Indication
Beschreibung

Enter a medical diagnosis not description

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Concomitant medication - Drug type
Beschreibung

Concomitant medication - Drug type

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0457591
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
Beschreibung

Serious Adverse Events - Relevant Medical Conditions/ Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0262926
UMLS CUI-3
C0035648
MHx Sequence Number
Beschreibung

MHx Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
Specific Condition Name
Beschreibung

Specific Condition Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Medical History - Modified reported term
Beschreibung

Medical History - Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826728
Medical Condition - Date of onset
Beschreibung

Medical Condition - Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Medical Condition - Continuing?
Beschreibung

If no, specify date of last occurrence

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Medical Condition - Date of last occurence
Beschreibung

Medical Condition - Date of last occurence

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1517741
Serious Adverse Event - Relevant Diagnostic Results
Beschreibung

Serious Adverse Event - Relevant Diagnostic Results

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
Lab Sequence Number
Beschreibung

Lab Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test Name
Beschreibung

Test Name

Datentyp

integer

Alias
UMLS CUI [1]
C0022885
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Test Units
Beschreibung

Test Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Beschreibung

Normal Low Range

Datentyp

integer

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Beschreibung

Normal High Range

Datentyp

integer

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Beschreibung

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Serious Adverse Event - Rechallenge
Beschreibung

Serious Adverse Event - Rechallenge

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Beschreibung

If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C2745955
Serious Adverse Event - Investigational Product
Beschreibung

Serious Adverse Event - Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Study Drug
Beschreibung

Study Drug

Datentyp

integer

Alias
UMLS CUI [1]
C0304229
Study Drug
Beschreibung

Study Drug

Datentyp

integer

Alias
UMLS CUI [1]
C0304229
Study Drug
Beschreibung

Study Drug

Datentyp

integer

Alias
UMLS CUI [1]
C0304229
Investigational Product - Start Date
Beschreibung

Investigational Product - Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Investigational Product - Stop Date
Beschreibung

Investigational Product - Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Regimen
Beschreibung

Regimen

Datentyp

text

Alias
UMLS CUI [1]
C1276413
Investigational Product - Dose
Beschreibung

Investigational Product - Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
Investigational Product - Cumulative Dose
Beschreibung

Investigational Product - Cumulative Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2986497
General narrative comments
Beschreibung

General narrative comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Serious Adverse Event - Non clinical
Beschreibung

Serious Adverse Event - Non clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0205210
Send incomplete SAE data to GSK Safety
Beschreibung

Send incomplete SAE data to GSK Safety

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0205257
Receipt by GSK date
Beschreibung

Receipt by GSK date

Datentyp

datetime

Alias
UMLS CUI [1]
C2985846
Was the event serious?
Beschreibung

Was the event serious?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Beschreibung

SAE Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Beschreibung

Version Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0333052
UMLS CUI [1,2]
C0237753
Case ID
Beschreibung

Case ID

Datentyp

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Beschreibung

OCEANS Code

Datentyp

text

Alias
UMLS CUI [1]
C0805701
Email Flag
Beschreibung

Email Flag

Datentyp

text

Alias
UMLS CUI [1]
C0013849
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Subject Logs - Log Status; Concomitant Medications; Non-Serious Adverse Event; Serious Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject receive any medical/surgical procedures during the study?
Item
Did the subject receive any medical/surgical procedures during the study?
boolean
C1948041 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject experience an incident with GSK medical devices provided for use during this study?
Item
Did the subject experience an incident with GSK medical devices provided for use during this study?
boolean
C0025080 (UMLS CUI [1,1])
C1551358 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications - Sequence Number
Item
Concomitant Medications - Sequence Number
integer
C2347852 (UMLS CUI [1])
C2348184 (UMLS CUI [2])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Concomitant Medications - Modified reported term
Item
Concomitant Medications - Modified reported term
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
text
C0869039 (UMLS CUI [1])
Item
Medication Units
text
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Medication Units
Code List
Medication Units
CL Item
Actuation  (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (APP)
CL Item
Area under curve  (AUC)
CL Item
Bottle  (BOT)
CL Item
Capsule  (CAP)
CL Item
Cubic centimeter  (CC)
CL Item
Cup  (CUP)
CL Item
Drops  (GTT)
CL Item
Finger tip unit  (FTU)
CL Item
Gamma per kilogram per minute  (GA/KG/MIN)
CL Item
Gram  (G)
CL Item
Grams per kilogram  (G/KG)
CL Item
Grams per litre  (G/L)
CL Item
Grams per metre squared  (G/M2)
CL Item
Grams per metre squared per 12 hours  (G/M2/12HR)
CL Item
G/M2/DAYGrams per metre squared per day (G/M2/DAYGrams per metre squared per day)
CL Item
Grams per millilitre  (G/ML)
CL Item
Inhalation  (INH)
CL Item
100 International units/ml  (100IU/ML)
CL Item
International units  (IU)
CL Item
International units per kilogram  (IU/KG)
CL Item
IU/KG/HRInternational units per kilogram per hour (IU/KG/HRInternational units per kilogram per hour)
CL Item
International units per millilitre  (IU/ML)
CL Item
Litre  (L)
CL Item
Litres per minute  (L/MIN)
CL Item
Lozenge  (LOZ)
CL Item
Mega becquerels (MBq)  (MBQ)
CL Item
Megaunits (million units)  (MU)
CL Item
Microgram (MCG)  (MCG)
CL Item
Microgram (UG) (Microgram (UG))
CL Item
Micrograms per gram  (MCG/G)
CL Item
Micrograms per hour  (MCG/HR)
CL Item
Microgram per kilogram  (MCG/KG)
CL Item
Microgram per kilogram per minute  (MCG/KG/MIN)
CL Item
Micrograms per millitre  (MCG/ML)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Microlitre  (MCL)
CL Item
Micromoles  (UMOL)
CL Item
Micromoles per 24 hours  (UMOL/24HR)
CL Item
Millicurie  (MCI)
CL Item
Milliequivalent  (MEQ)
CL Item
Milliequivalents per 24 hours  (MEQ)
CL Item
Milligram  (MG)
CL Item
Milligram per day  (MG/DAY)
CL Item
Milligram per hour  (MG/HR)
CL Item
Milligram per kilogram  (MG/KG)
CL Item
Milligram per kilogram per hour  (MG/KG/HR)
CL Item
Milligram per kilogram per minute  (MG/KG/MIN)
CL Item
Milligrams per metre squared  (MG/M2)
CL Item
Milligrams per metre squared per day  (MG/M2/DAY)
CL Item
Milligrams per millilitre  (MG/ML)
CL Item
Milligram per week  (MG/WK)
CL Item
Milligrams percent  (MG%)
CL Item
Millilitre  (ML)
CL Item
Millilitres per hour  (ML/HR)
CL Item
Millilitres per minute  (ML/MIN)
CL Item
Millimole  (MMOL)
CL Item
Millimoles per kilogram  (MMOL/KG)
CL Item
Millimoles per millilitre  (MMOL/ML)
CL Item
Million international units  (MIU)
CL Item
Minimum alveolar concentration  (MAC)
CL Item
Nanogram per kilogram per minute  (NG/KG/MIN)
CL Item
Nebule  (NEB)
CL Item
Ounce  (OZ)
CL Item
Pack  (PACK)
CL Item
Patch  (PATCH)
CL Item
Percent  (%)
CL Item
Puff  (PUFF)
CL Item
Ring  (RING)
CL Item
Sachet  (SACH)
CL Item
Spray  (SPR)
CL Item
Suppository  (SUPP)
CL Item
Tablet  (TAB)
CL Item
Tablespoon  (TBLSP)
CL Item
Teaspoon  (TSP)
CL Item
Units  (U)
CL Item
Units per gram  (U/G)
CL Item
Units per hour  (U/HR)
CL Item
Units per kilogram per minute  (U/KG/MIN)
CL Item
Units per minute  (U/MIN)
CL Item
Unknown  (UNK)
CL Item
Vial (VIAL)
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Frequency
Code List
Medication Frequency
CL Item
2 times per week  (2XWK)
CL Item
3 times per week (3XWK)
CL Item
4 times per week  (4XWK)
CL Item
5 times per day  (5XD)
CL Item
5 times per week  (5XWK)
CL Item
AC  (AC)
CL Item
BID  (BID)
CL Item
Continuous infusion  (CINF)
CL Item
HS  (HS)
CL Item
Once daily  (OD)
CL Item
Once only  (ONE)
CL Item
PC  (PC)
CL Item
PRN  (PRN)
CL Item
Q12H  (Q12H)
CL Item
Q2H  (Q2H)
CL Item
Every 2 weeks (Q2WK)
CL Item
Q3D  (Q3D)
CL Item
Every 3 months (Q3M)
CL Item
Every 3 weeks  (Q3WK)
CL Item
Q4D  (Q4D)
CL Item
Q4H  (Q4H)
CL Item
Q6H  (Q6H)
CL Item
Q8H  (Q8H)
CL Item
QAM  (QAM)
CL Item
QH  (QH)
CL Item
QID  (QID)
CL Item
Once a month  (QM)
CL Item
Every other day  (QOD)
CL Item
QPM  (QPM)
CL Item
Once a week  (QWK)
CL Item
TID  (TID)
CL Item
Unknown (UNK)
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
CL Item
Intra-arterial  (IA)
CL Item
Intra-articular  (IART)
CL Item
Intra-bursa  (IB)
CL Item
Intradermal  (ID)
CL Item
Inhalation  (IH)
CL Item
Intramuscular  (IM)
CL Item
Injection  (INJ)
CL Item
Intravenous  (IV)
CL Item
Nasal  (NS)
CL Item
Otic  (OT)
CL Item
Other  (OTH)
CL Item
Oral  (PO)
CL Item
Rectal  (PR)
CL Item
Subcutaneous  (SC)
CL Item
Sublingual  (SL)
CL Item
Transdermal  (TD)
CL Item
Topical  (TP)
CL Item
Unknown  (UNK)
CL Item
Vaginal (VG)
Is this drug being taken for an ophthalmic indication?
Item
Is this drug being taken for an ophthalmic indication?
boolean
C0013227 (UMLS CUI [1,1])
C0029087 (UMLS CUI [1,2])
Item
If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
text
C0013227 (UMLS CUI [1,1])
C0029087 (UMLS CUI [1,2])
C0015392 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
Code List
If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
CL Item
Left (OS) (L)
CL Item
Right (OD) (R)
CL Item
Both eyes (B)
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication start date
Item
Medication start date
date
C2826734 (UMLS CUI [1])
Is medication ongoing?
Item
Is medication ongoing?
boolean
C2826666 (UMLS CUI [1])
If medication is not ongoing, specify end date
Item
If medication is not ongoing, specify end date
date
C2826666 (UMLS CUI [1])
C2826744 (UMLS CUI [2])
Medication type
Item
Medication type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event Sequence Number
Item
Non-Serious Adverse Event Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-Serious Adverse Event
Item
Non-Serious Adverse Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event - Modified Reported
Item
Non-Serious Adverse Event - Modified Reported
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Non-Serious Adverse Event MedDRA synonym
Item
Non-Serious Adverse Event MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Non-Serious Adverse Event MedDRA lower level term code
Item
Non-Serious Adverse Event MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-Serious Adverse Event - Failed coding
Item
Non-Serious Adverse Event - Failed coding
text
C1518404 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Non-Serious Adverse Event - Start Date
Item
Non-Serious Adverse Event - Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event Outcome
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
Non-Serious Adverse Event End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event Frequency
Code List
Non-Serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event - Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event - Maximum Intensity
Code List
Non-Serious Adverse Event - Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Non-Serious Adverse Event - Intensity at onset of event
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Non-Serious Adverse Event - Intensity at onset of event
Code List
Non-Serious Adverse Event - Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Non-Serious Adverse Event - Maximum Grade
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event - Maximum Grade
Code List
Non-Serious Adverse Event - Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Non-Serious Adverse Event - Grade at onset of event
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Non-Serious Adverse Event - Grade at onset of event
Code List
Non-Serious Adverse Event - Grade at onset of event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Non-Serious Adverse Event - Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Non-Serious Adverse Event - Maximum Grade or Intensity
Code List
Non-Serious Adverse Event - Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Non-Serious Adverse Event - Grade or Intensity at onset of event
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
Non-Serious Adverse Event - Grade or Intensity at onset of event
Code List
Non-Serious Adverse Event - Grade or Intensity at onset of event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Non-Serious Adverse Event - Was the subject taking eye drops?
Item
Non-Serious Adverse Event - Was the subject taking eye drops?
boolean
C1518404 (UMLS CUI [1,1])
C0015399 (UMLS CUI [1,2])
Item
Record Action Taken with Double Masked Product as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Record Action Taken with Double Masked Product as a Result of the AE
Code List
Record Action Taken with Double Masked Product as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
Code List
If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
CL Item
Ranibizumab (113)
CL Item
Double masked product (114)
CL Item
Ranibizumab/Double masked product (115)
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-Serious Adverse Event - Is this an Ocular Event?
Item
Non-Serious Adverse Event - Is this an Ocular Event?
boolean
C1518404 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event - If this is an Ocular Event, sepcify
text
C1518404 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
If this is an Ocular Event, sepcify
Code List
Non-Serious Adverse Event - If this is an Ocular Event, sepcify
CL Item
Right Eye (R)
CL Item
Left Eye (L)
Item Group
Serious Adverse Event - Type of Report
C3897642 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Initial Report
integer
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Initial Report
Code List
Initial Report
CL Item
Initial (1)
Item
Follow-Up Report
integer
C1704685 (UMLS CUI [1])
Follow-Up Report
Code List
Follow-Up Report
CL Item
Follow-Up (2)
Item Group
Serious Adverse Event - Randomisation
C1519255 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event - Modified Term
Item
Serious Adverse Event - Modified Term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA synonym
Item
Serious Adverse Event - MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA lower level term code
Item
Serious Adverse Event - MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event - Failed coding
Item
Serious Adverse Event - Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event - Start Date
Item
Serious Adverse Event - Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Serious Adverse Event - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event - Outcome
Code List
Serious Adverse Event - Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
Serious Adverse Event - End Date
Item
Serious Adverse Event - End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Serious Adverse Event - Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Intensity
Code List
Serious Adverse Event - Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (X)
Item
Serious Adverse Event - Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Serious Adverse Event - Intensity at onset of event
Code List
Serious Adverse Event - Intensity at onset of event
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (X)
Item
Serious Adverse Event - Maximum Grade
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Grade
Code List
Serious Adverse Event - Maximum Grade
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4 (4)
Item
Serious Adverse Event - Grade at onset of event
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Serious Adverse Event - Grade at onset of event
Code List
Serious Adverse Event - Grade at onset of event
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5 (5)
Item
Serious Adverse Event - Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Serious Adverse Event - Maximum Grade or Intensity
Code List
Serious Adverse Event - Maximum Grade or Intensity
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5  (5)
CL Item
Not applicable (X)
Item
Serious Adverse Event - Grade or Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
Serious Adverse Event - Grade or Intensity at onset of event
Code List
Serious Adverse Event - Grade or Intensity at onset of event
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5  (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the SAE
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed  (4)
CL Item
Dose interrupted  (5)
CL Item
Not applicable (X)
Serious Adverse Event - Was the subject taking eye drops?
Item
Serious Adverse Event - Was the subject taking eye drops?
boolean
C1519255 (UMLS CUI [1,1])
C0015399 (UMLS CUI [1,2])
Item
Action Taken with ranibizumab as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1566537 (UMLS CUI [1,3])
Action Taken with ranibizumab as a Result of the SAE
Code List
Action Taken with ranibizumab as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Serious Adverse Event - Is this an Ocular Event?
Item
Serious Adverse Event - Is this an Ocular Event?
boolean
C1519255 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
Item
Serious Adverse Event - If this is an Ocular Event, sepcify
text
C1519255 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Serious Adverse Event - If this is an Ocular Event, sepcify
Code List
Serious Adverse Event - If this is an Ocular Event, sepcify
CL Item
Right Eye  (R)
CL Item
Left Eye (L)
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Item
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
Code List
If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
CL Item
Ranibizumab  (113)
CL Item
Double masked product  (114)
CL Item
Ranibizumab/Double masked product (115)
Duration of SAE if < 24 hours
Item
Duration of SAE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of SAE if < 24 hours
Item
Duration of SAE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event - Related Investigational Product
Item
Serious Adverse Event - Related Investigational Product
text
C1519255 (UMLS CUI [1])
C0304229 (UMLS CUI [2])
Item Group
Serious Adverse Event - Intensity Changes
C1519255 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Start Date and Time of event segment
Item
Start Date and Time of event segment
datetime
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Item
Intensity of event segment
integer
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity of event segment
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Grade of event segment
Code List
Grade of event segment
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade or Intensity of event segment
integer
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Grade or Intensity of event segment
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Serious Adverse Event - Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Seriousness?
Code List
Seriousness?
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify within general narrative comment (F)
CL Item
All events of possible drug-induced liver injury with hyperbilirubinaemia defined as ALT >= 3xULN and bilirubin >= 2xULN (>35% direct) (or ALT >= 3xULN and INR>1.5, if INR measured) termed 'Hy's Law' events. (G)
Item Group
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication - Drug name
Item
Concomitant medication - Drug name
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication - Modified reported term
Item
Concomitant medication - Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant medication dose
Item
Concomitant medication dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Concomitant medication unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Medication Unit
Code List
Concomitant medication unit
CL Item
Actuation  (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (AP)
CL Item
Bottle  (BT)
CL Item
Capsule  (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops  (031)
CL Item
Gram  (002)
CL Item
International units  (025)
CL Item
International units per kilogram  (028)
CL Item
International units per millilitre  (IUML)
CL Item
Litre  (011)
CL Item
Litre per minute  (LM)
CL Item
Lozenge  (LOZ)
CL Item
Megaunits (million units)  (MEGU)
CL Item
Microgram (UG)  (004)
CL Item
Microgram (UG)  (004)
CL Item
Microgram/kilogram  (008)
CL Item
Microgram/kilogram per minute  (MCG/KG/MIN)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Microlitre  (013)
CL Item
Milliequivalent  (029)
CL Item
Milliequivalent per 24 hours  (MEQ24)
CL Item
Milligram  (003)
CL Item
Milligrams percent  (MGPER)
CL Item
Milligram per hour  (MGH)
CL Item
Milligram/kilogram  (007)
CL Item
Milligram/kilogram per hour  (MGKH)
CL Item
Milligram/kilogram per minute  (MGKM)
CL Item
Milligram/metre squared  (009)
CL Item
Milligram/millilitre  (MGML)
CL Item
Millilitre  (012)
CL Item
Millilitre per hour  (MLH)
CL Item
Millilitre per minute  (MLM)
CL Item
Millimole  (023)
CL Item
Million international units  (027)
CL Item
Minimum alveolar concentration  (MAC)
CL Item
Nebule  (NEB)
CL Item
Patch  (PAT)
CL Item
Percent  (030)
CL Item
Puff  (PUFF)
CL Item
Sachet  (SAC)
CL Item
Spray  (SPR)
CL Item
Suppository  (SUP)
CL Item
Tablespoon  (TBS)
CL Item
Tablet  (TAB)
CL Item
Teaspoon  (TSP)
CL Item
Units  (UNT)
CL Item
Unknown  (U)
CL Item
Vial (VIA)
Item
Concomitant medication frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication Frequency
Code List
Concomitant medication frequency
CL Item
2 times per week  (2W)
CL Item
3 times per week  (3W)
CL Item
4 times per week  (4W)
CL Item
5 times per day  (5D)
CL Item
5 times per week  (5W)
CL Item
AC  (AC)
CL Item
Q12H  (2D)
CL Item
Continuous infusion  (CO)
CL Item
Every 2 weeks  (FO)
CL Item
Every 3 weeks  (Q3W)
CL Item
Every 3 months  (Q3M)
CL Item
Every other day  (AD)
CL Item
QPM  (1N)
CL Item
Once a month  (MO)
CL Item
Once a week  (WE)
CL Item
Once daily  (1D)
CL Item
Once only  (1S)
CL Item
PC  (PC)
CL Item
PRN  (PRN)
CL Item
Q2H  (12D)
CL Item
Q3D  (Q3D)
CL Item
Q4D  (Q4D)
CL Item
Q4H  (6D)
CL Item
QID  (4D)
CL Item
TID  (3D)
CL Item
Q12H  (2D)
CL Item
QAM  (1M)
CL Item
QH  (24D)
CL Item
QID  (4D)
CL Item
QPM  (1N)
CL Item
TID  (3D)
CL Item
Unknown (U)
Item
Concomitant medication route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication Route
Code List
Concomitant medication route
CL Item
Both eyes  (047)
CL Item
Epidural  (008)
CL Item
Gastrostomy tube  (GT)
CL Item
Inhalation  (055)
CL Item
Injection  (INJ)
CL Item
Intra-arterial  (013)
CL Item
Intra-bursa  (IBU)
CL Item
Intralesional  (026)
CL Item
Intramuscular  (030)
CL Item
Nasal  (045)
CL Item
Intraocular  (031)
CL Item
Intraosteal  (IOS)
CL Item
Intraperitoneal  (033)
CL Item
Intrathecal  (037)
CL Item
Intrauterine  (015)
CL Item
Intravenous  (042)
CL Item
Nasal  (045)
CL Item
Oral  (048)
CL Item
Rectal  (054)
CL Item
Subcutaneous  (058)
CL Item
Sublingual  (060)
CL Item
Topical  (061)
CL Item
Transdermal  (062)
CL Item
Unknown  (065)
CL Item
Vaginal (067)
Concomitant medication start date
Item
Concomitant medication start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication ongoing?
Item
Concomitant Medication ongoing?
boolean
C2826666 (UMLS CUI [1])
If concomitant medication is not ongoing, specify end date.
Item
If concomitant medication is not ongoing, specify end date.
date
C2826744 (UMLS CUI [1])
Concomitant medication - Primary Indication
Item
Concomitant medication - Primary Indication
text
C2826696 (UMLS CUI [1])
Item
Concomitant medication - Drug type
text
C2347852 (UMLS CUI [1,1])
C0457591 (UMLS CUI [1,2])
Concomitant medication - Drug type
Code List
Concomitant medication - Drug type
CL Item
Concomitant  (2)
CL Item
Treatment  (T)
CL Item
Cause of SAE (1)
Item Group
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
MHx Sequence Number
Item
MHx Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Medical History - Modified reported term
Item
Medical History - Modified reported term
text
C2826728 (UMLS CUI [1])
Medical Condition - Date of onset
Item
Medical Condition - Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Medical Condition - Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medical Condition - Continuing?
Code List
Medical Condition - Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Medical Condition - Date of last occurence
Item
Medical Condition - Date of last occurence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Item Group
Serious Adverse Event - Relevant Diagnostic Results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C0022885 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV 1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transferase (32)
CL Item
Glutamic-pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pCO2 (54)
CL Item
pH (55)
CL Item
Phosphate (56)
CL Item
Platelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
integer
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
integer
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Item Group
Serious Adverse Event - Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,4])
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
N0 (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Item
Study Drug
integer
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Double masked product (1)
CL Item
Ranibizumab (as needed) (2)
CL Item
Monthly IVT ranibizumab (3)
Item
Study Drug
integer
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Dose level 1 (1)
CL Item
Dose level 2 (2)
CL Item
Dose level 3 (3)
Item
Study Drug
integer
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Course 1 (1)
CL Item
Course 2 (2)
CL Item
Course 3 (3)
Investigational Product - Start Date
Item
Investigational Product - Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product - Stop Date
Item
Investigational Product - Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Regimen
Item
Regimen
text
C1276413 (UMLS CUI [1])
Investigational Product - Dose
Item
Investigational Product - Dose
text
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
Investigational Product - Cumulative Dose
Item
Investigational Product - Cumulative Dose
text
C0304229 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
General narrative comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Non clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
Item
Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Send incomplete SAE data to GSK Safety
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (3)
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
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