ID

38669

Beschreibung

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Stichworte

Versionen (3)
  1. 26.05.19 26.05.19 -
  2. 27.05.19 27.05.19 - Julian Varghese
  3. 30.10.19 30.10.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30. Oktober 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328

Englisch

Non-Serious Adverse Event; Serious Adverse Events; Concomitant Medications

1 Formulare  
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]
C1518404
UMLS CUI [1,2]
C2348184
Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign,iSymptom

Datentyp

text

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

Non-Serious Adverse Event Modified term

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826302
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-Seroius Adverse Event MedDRA lower level term code
Beschreibung

Non-Seroius 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 [1,1]
C1518404
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
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 - Provide End Date if Recovered/ Resolved
Beschreibung

Non-Serious Adverse Event - Provide End Date if Recovered/ Resolved

Datentyp

date

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C1709863
UMLS CUI [2,2]
C0806020
Non-Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
Beschreibung

Non-Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae

Datentyp

date

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C1709862
UMLS CUI [2,2]
C0806020
Non-Serious Adverse Event Maximum Intensity
Beschreibung

Non-Serious Adverse Event Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event Maximum Grade
Beschreibung

Non-Serious Adverse Event Maximum Grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
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

integer

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

Did the subject withdraw from study including all follow up as a result of this AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1522577
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C1274040
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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
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
SAE Modified term
Beschreibung

SAE Modified term

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826302
SAE MedDRA synonym
Beschreibung

SAE MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
SAE MedDRA lower level term code
Beschreibung

SAE MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
SAE Failed coding
Beschreibung

SAE Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
SAE Start Date
Beschreibung

SAE Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
SAE Outcome
Beschreibung

SAE Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event - Provide End Date if Recovered/ Resolved
Beschreibung

Serious Adverse Event - Provide End Date if Recovered/ Resolved

Datentyp

date

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C1709863
UMLS CUI [2,2]
C0806020
Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
Beschreibung

Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae

Datentyp

date

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C1709862
UMLS CUI [2,2]
C0806020
Serious Adverse Event - Provide Date of Death if fatal Outcome
Beschreibung

Serious Adverse Event - Provide Date of Death if fatal Outcome

Datentyp

date

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1148348
UMLS CUI [3]
C0206277
SAE Maximum Intensity
Beschreibung

SAE Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
SAE Maximum Grade
Beschreibung

SAE Maximum Grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
SAE Maximum Grade or Intensity
Beschreibung

SAE Maximum Grade or Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
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

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study including all follow up as a result of this AE?
Beschreibung

Did the subject withdraw from study including all follow up as a result of this AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1522577
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1274040
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.

Datentyp

boolean

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

Duration of AE if < 24 hours

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
Time to Onset of SAE Since Last Dose
Beschreibung

Time to Onset of SAE Since Last Dose

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0449244
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?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C2700391
UMLS CUI [3]
C0005834
UMLS CUI [4]
C1710661
Was the event serious?
Beschreibung

Was the event serious?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Related Investigational Product
Beschreibung

Related Investigational Product

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439849
SAE - Type of Report
Beschreibung

SAE - Type of Report

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0585733
Serious Adverse Event Initial Report
Beschreibung

Serious Adverse Event Initial Report

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205265
Serious Adverse Event Follow-Up Report
Beschreibung

Serious Adverse Event Follow-Up Report

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704685
SAE- Randomisation
Beschreibung

SAE- 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]
C1519255
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1704686
SAE - Seriousness
Beschreibung

SAE - Seriousness

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

Seriousness of SAE?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
SAE - Relevant Concomitant Medications
Beschreibung

SAE - Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C2347852
CM Sequence Number
Beschreibung

CM Sequence Number

Datentyp

text

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

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

Datentyp

text

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

Concomitant Mediacation Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Concomitant Medication Dose
Beschreibung

Concomitant Medication Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3174092
Concomitant Medication Unit
Beschreibung

Concomitant Medication Unit

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Concomitant Medication Frequency
Beschreibung

Concomitant Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C2826654
Concomitant Medication Route
Beschreibung

Concomitant Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C2826730
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 not Ongoing, specify End Date.
Beschreibung

If Concomitant Medication not Ongoing, specify End Date.

Datentyp

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0806020
Primary Indication for Concomitant Medication
Beschreibung

Enter a medical diagnosis not description

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication Modified reported term
Beschreibung

Concomitant Medication Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Drug Type
Beschreibung

Drug Type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
SAE - Relevant Medical Conditions/ Risk Factors
Beschreibung

SAE - Relevant Medical Conditions/ Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0262926
UMLS CUI-3
C0035648
Relevant medical Conditions/ Risk Factors Sequence Number
Beschreibung

Relevant medical Conditions/ Risk Factors Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C2348184
Specific Condition Name
Beschreibung

Enter a medical diagnosis not description.

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Relevant Medical Conditions/ Risk Factors Modified reported term
Beschreibung

Relevant Medical Conditions/ Risk Factors Modified reported term

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C2826302
Relevant Medical Conditions/ Risk Factors Date of onset
Beschreibung

Relevant Medical Conditions/ Risk Factors Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0574845
Relevant Medical Conditions/ Risk Factors Continuing?
Beschreibung

Relevant Medical Conditions/ Risk Factors Continuing?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0549178
If Relevant Medical Conditions/ Risk Factors not Continuing, specify date of last occurence.
Beschreibung

If Relevant Medical Conditions/ Risk Factors not Continuing, specify date of last occurence.

Datentyp

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C2745955
UMLS CUI [1,5]
C1517741
UMLS CUI [1,6]
C0011008
Relevant Medical History / Risk Factors not noted above
Beschreibung

Relevant Medical History / Risk Factors not noted above

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0205394
SAE - Relevant Diagnostic Results
Beschreibung

SAE - 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
Lab Test Name
Beschreibung

Lab Test Name

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Lab Test Date
Beschreibung

Lab Test Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Lab Test Result
Beschreibung

Lab Test Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1274040
Lab Test Units
Beschreibung

Lab Test Units

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1519795
Lab Normal Low Range
Beschreibung

Lab Normal Low Range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C0205251
Lab Normal High Range
Beschreibung

Lab Normal High Range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C0205250
Relevant diagnostic results not noted above
Beschreibung

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
SAE - Rechallenge
Beschreibung

SAE - 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

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C2745955
SAE - Investigational Product
Beschreibung

SAE - Investigational Product

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

Study Drug

Datentyp

text

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
SAE - Investigational Product
Beschreibung

SAE - Investigational Product

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

Study Drug

Datentyp

text

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
SAE - Investigational Product
Beschreibung

SAE - Investigational Product

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

Study Drug

Datentyp

text

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
Investigational Product Dose
Beschreibung

Investigational Product Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3174092
Investigational Product Cumulative Dose
Beschreibung

Investigational Product Cumulative Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0304229
SAE - General Narrative Comments
Beschreibung

SAE - General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General narrative comments
Beschreibung

General narrative comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
SAE - Non clinical
Beschreibung

SAE - Non clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0205210
UMLS CUI-3
C1298908
Send incomplete SAE data to GSK Safety
Beschreibung

Send incomplete SAE data to GSK Safety

Datentyp

integer

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

integer

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

integer

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
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications Sequence Number
Beschreibung

Concomitant Medications Sequence Number

Datentyp

integer

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

(Trade Name preferred)

Datentyp

text

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

Concomitant Medication Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Concomitant Medication GSK Drug synonym
Beschreibung

Concomitant Medication GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0871468
Concomitant Medication GSK Drug Collection code
Beschreibung

Concomitant Medication GSK Drug Collection code

Datentyp

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C1516698
UMLS CUI [2,2]
C0805701
Concomitant Medication Failed coding
Beschreibung

Concomitant Medication Failed coding

Datentyp

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Concomitant Medication Units
Beschreibung

Concomitant Medication Units

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Concomitant Medication Route
Beschreibung

Concomitant Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Concomitant Medication Reason for Medication
Beschreibung

Concomitant Medication Reason for Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
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 not Ongoing, specify End Date
Beschreibung

If Concomitant Medication not Ongoing, specify End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826666
UMLS CUI [2]
C0806020
Concomitant Medication Total Daily Dose
Beschreibung

Concomitant Medication Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1]
C2826638
Concomitant Medication Type
Beschreibung

Concomitant Medication Type

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332307
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Ähnliche Modelle

Non-Serious Adverse Event; Serious Adverse Events; Concomitant Medications

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event Sequence Number
Item
Non-Serious Adverse Event Sequence Number
integer
C1518404 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Event
Item
Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event Modified term
Item
Non-Serious Adverse Event Modified term
text
C1518404 (UMLS CUI [1,1])
C2826302 (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-Seroius Adverse Event MedDRA lower level term code
Item
Non-Seroius 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 [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
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 - Provide End Date if Recovered/ Resolved
Item
Non-Serious Adverse Event - Provide End Date if Recovered/ Resolved
date
C1518404 (UMLS CUI [1])
C1709863 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Non-Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
Item
Non-Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
date
C1518404 (UMLS CUI [1])
C1709862 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Non-Serious Adverse Event Maximum Intensity
integer
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
Mode rate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
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)
CL Item
Grade 5 (5)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
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 (6)
Did the subject withdraw from study including all follow up as a result of this AE?
Item
Did the subject withdraw from study including all follow up as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
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 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])
SAE Modified term
Item
SAE Modified term
text
C1519255 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
SAE MedDRA synonym
Item
SAE MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
SAE MedDRA lower level term code
Item
SAE MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
SAE Failed coding
Item
SAE Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
SAE Start Date
Item
SAE Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
SAE Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
SAE Outcome
Code List
SAE 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 - Provide End Date if Recovered/ Resolved
Item
Serious Adverse Event - Provide End Date if Recovered/ Resolved
date
C1519255 (UMLS CUI [1])
C1709863 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
Item
Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
date
C1519255 (UMLS CUI [1])
C1709862 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Serious Adverse Event - Provide Date of Death if fatal Outcome
Item
Serious Adverse Event - Provide Date of Death if fatal Outcome
date
C1519255 (UMLS CUI [1])
C1148348 (UMLS CUI [2])
C0206277 (UMLS CUI [3])
Item
SAE Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
SAE Maximum Intensity
Code List
SAE Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
SAE Maximum Grade
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
SAE Maximum Grade
Code List
SAE Maximum Grade
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
SAE Maximum Grade or Intensity
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
SAE Maximum Grade or Intensity
Code List
SAE 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 (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (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 interru pted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study including all follow up as a result of this AE?
Item
Did the subject withdraw from study including all follow up as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
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
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
durationDatetime
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time to Onset of SAE Since Last Dose
Item
Time to Onset of SAE Since Last Dose
durationDatetime
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Was the SAE caused by activities related to study participation other than investigational product?
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2700391 (UMLS CUI [2])
C0005834 (UMLS CUI [3])
C1710661 (UMLS CUI [4])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Related Investigational Product
Item
Related Investigational Product
text
C0304229 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Item Group
SAE - Type of Report
C1519255 (UMLS CUI-1)
C0585733 (UMLS CUI-2)
Item
Serious Adverse Event Initial Report
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Serious Adverse Event Initial Report
Code List
Serious Adverse Event Initial Report
CL Item
Initial (1)
Item
Serious Adverse Event Follow-Up Report
integer
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
Serious Adverse Event Follow-Up Report
Code List
Serious Adverse Event Follow-Up Report
CL Item
Follow-Up Report (1)
Item Group
SAE- 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])
C0304229 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
Item Group
SAE - Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness of SAE?
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness of SAE?
Code List
Seriousness of SAE?
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/ birth defect (5)
CL Item
Other, specify within general narrative comment (6)
Item Group
SAE - Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
CM Sequence Number
Item
CM Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Concomitant Mediacation Modified reported term
Item
Concomitant Mediacation Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medication Dose
Item
Concomitant Medication Dose
text
C2347852 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Concomitant Medication Unit
Item
Concomitant Medication Unit
text
C2826646 (UMLS CUI [1])
Concomitant Medication Frequency
Item
Concomitant Medication Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Medication Route
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
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 not Ongoing, specify End Date.
Item
If Concomitant Medication not Ongoing, specify End Date.
date
C2826666 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication for Concomitant Medication
Item
Primary Indication for Concomitant Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Modified reported term
Item
Concomitant Medication Modified reported term
text
C2826819 (UMLS CUI [1])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Item Group
SAE - Relevant Medical Conditions/ Risk Factors
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
Relevant medical Conditions/ Risk Factors Sequence Number
Item
Relevant medical Conditions/ Risk Factors Sequence Number
integer
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Relevant Medical Conditions/ Risk Factors Modified reported term
Item
Relevant Medical Conditions/ Risk Factors Modified reported term
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Relevant Medical Conditions/ Risk Factors Date of onset
Item
Relevant Medical Conditions/ Risk Factors Date of onset
date
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Item
Relevant Medical Conditions/ Risk Factors Continuing?
integer
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Relevant Medical Conditions/ Risk Factors Continuing?
Code List
Relevant Medical Conditions/ Risk Factors Continuing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
If Relevant Medical Conditions/ Risk Factors not Continuing, specify date of last occurence.
Item
If Relevant Medical Conditions/ Risk Factors not Continuing, specify date of last occurence.
date
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
Relevant Medical History / Risk Factors not noted above
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
SAE - 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])
Lab Test Name
Item
Lab Test Name
text
C0022885 (UMLS CUI [1])
Lab Test Date
Item
Lab Test Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lab Test Result
Item
Lab Test Result
text
C0022885 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Lab Test Units
Item
Lab Test Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Lab Normal Low Range
Item
Lab Normal Low Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
Lab Normal High Range
Item
Lab Normal High Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
SAE - 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?
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
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
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
SAE - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Study Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
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])
Item Group
SAE - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Study Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
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])
Item Group
SAE - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Study Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
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])
Investigational Product Dose
Item
Investigational Product Dose
text
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Investigational Product Cumulative Dose
Item
Investigational Product Cumulative Dose
text
C2986497 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
SAE - General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
SAE - Non clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
Item
Send incomplete SAE data to GSK Safety
integer
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 (1)
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
integer
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
integer
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])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications Sequence Number
Item
Concomitant Medications Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication Drug Name
Item
Concomitant Medication Drug Name
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant Medication Modified reported term
Item
Concomitant Medication Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medication GSK Drug synonym
Item
Concomitant Medication GSK Drug synonym
text
C2347852 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
Concomitant Medication GSK Drug Collection code
Item
Concomitant Medication GSK Drug Collection code
text
C2347852 (UMLS CUI [1])
C1516698 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Concomitant Medication Failed coding
Item
Concomitant Medication Failed coding
text
C2347852 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Concomitant Medication Units
Item
Concomitant Medication Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Medication Route
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Reason for Medication
Item
Concomitant Medication Reason for Medication
text
C2826696 (UMLS CUI [1])
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 not Ongoing, specify End Date
Item
If Concomitant Medication not Ongoing, specify End Date
date
C2826666 (UMLS CUI [1])
C0806020 (UMLS CUI [2])
Concomitant Medication Total Daily Dose
Item
Concomitant Medication Total Daily Dose
text
C2826638 (UMLS CUI [1])
Concomitant Medication Type
Item
Concomitant Medication Type
text
C2347852 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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