ID

42267

Beschrijving

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Trefwoorden

Versies (2)
  1. 13-10-20 13-10-20 -
  2. 26-04-21 26-04-21 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

26 april 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073

Engels

Log

1 Formulieren  
  1. StudyEvent: ODM
    1. Log
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschrijving

Date of visit; Assessment Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Log Status
Beschrijving

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Were any (non corticosteroid ) concomitant medications taken by the subject prior to screening and/or during the study?
Beschrijving

Concomitant Agent

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Were any (corticosteroid ) concomitant medications taken by the subject prior to screening and/or during the study?
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
Did the subject experience any non-serious adverse events during the study?
Beschrijving

Non-serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience a serious adverse event during the study?
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Were any blood products or blood supportive care products drawn during the study?
Beschrijving

Blood product; Blood product, Supportive care

Datatype

boolean

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
Was pharmacogenetic whole blood sample collected?
Beschrijving

Collection of blood specimen for laboratory procedure, Pharmacogenetics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
Non-Serious Adverse Event (AE) - Repeating Form
Beschrijving

Non-Serious Adverse Event (AE) - Repeating Form

Alias
UMLS CUI-1
C1518404
Sequence Number
Beschrijving

Non-serious Adverse Event, Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2348184
Event
Beschrijving

Non-serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1518404
Modified term
Beschrijving

Non-serious Adverse Event, Adverse Event Modified Reported Term

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
MedDRA synonym
Beschrijving

Non-serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1140263
MedDRA lower level term code
Beschrijving

Non-serious Adverse Event, MedDRA Low Level Term Code

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C3898442
Failed coding
Beschrijving

Non-serious Adverse Event, Code, Failed

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Start Date
Beschrijving

Non-serious Adverse Event, Start DateStart Date

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Outcome
Beschrijving

Non-serious Adverse Event, Adverse Event Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date
Beschrijving

Non-serious Adverse Event, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Frequency
Beschrijving

Non-serious Adverse Event, Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Beschrijving

Non-serious Adverse Event, Symptom intensity, Maximum

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Maximum Grade
Beschrijving

Non-serious Adverse Event, Grade, Maximum

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Maximum Grade or Intensity
Beschrijving

Non-serious Adverse Event, Grade, Maximum; Non-serious Adverse Event, Symptom intensity, Maximum

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Non-serious Adverse Event, Action Taken with Study Treatment

Datatype

text

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

Non-serious Adverse Event, Withdraw

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Non-serious Adverse Event, Relationships, Experimental drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Duration of the AE if < 24 hours
Beschrijving

Non-serious Adverse Event, Duration

Datatype

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2926735
Time to Onset Since Last Dose
Beschrijving

Non-serious Adverse Event, Time of onset, Time last dose

Datatype

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
Serious Adverse Events (SAE) - Repeating Form
Beschrijving

Serious Adverse Events (SAE) - Repeating Form

Alias
UMLS CUI-1
C1519255
Type of Report
Beschrijving

Serious Adverse Event Report, Type

Datatype

text

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Did the SAE occur after initiation of study medication?
Beschrijving

Serious Adverse Event, Experimental drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
SAE Sequence Number
Beschrijving

Serious Adverse Event, Sequence Number

Datatype

integer

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

Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1519255
Modified term
Beschrijving

Serious Adverse Event, Adverse Event Modified Reported Term

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
MedDRA synonym
Beschrijving

Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

Datatype

text

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

Serious Adverse Event, MedDRA Low Level Term Code

Datatype

text

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

Serious Adverse Event, Code, Failed

Datatype

text

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

Serious Adverse Event, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Outcome
Beschrijving

Serious Adverse Event, Adverse Event Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date/Date of Death
Beschrijving

Serious Adverse Event, End Date; Serious Adverse Event, Date of death

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1148348
Maximum Intensity
Beschrijving

Serious Adverse Event, Symptom intensity, Maximum

Datatype

text

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

Serious Adverse Event, Grade, Maximum

Datatype

text

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

Serious Adverse Event, Grade, Maximum; Serious Adverse Event, Symptom intensity, Maximum

Datatype

text

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
Beschrijving

Serious Adverse Event, Action Taken with Study Treatment

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from from study as a result of this AE?
Beschrijving

Serious Adverse Event, Withdraw

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Serious Adverse Event, Relationships, Experimental drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Duration of the AE if < 24 hours
Beschrijving

Serious Adverse Event, Duration

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2926735
Time to Onset Since Last Dose
Beschrijving

Serious Adverse Event, Time of onset, Time last dose

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
Was SAE caused by activities related to study participation (e.g. procedures)?
Beschrijving

Serious Adverse Event, Relationships, Study Subject Participation Status

Datatype

boolean

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

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Seriousness?
Beschrijving

Serious Adverse Event, Seriousness of Adverse Event

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
CM Sequence Number
Beschrijving

Serious Adverse Event, Concomitant Medication, Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2348184
Drug Name
Beschrijving

Serious Adverse Event, Concomitant Agent, Medication name

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Beschrijving

Serious Adverse Event, Concomitant Agent, Dosage

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0178602
Unit
Beschrijving

Serious Adverse Event, Concomitant Agent, Unit of Measure

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Frequency
Beschrijving

Serious Adverse Event, Concomitant Agent, Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Beschrijving

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Start Date
Beschrijving

Serious Adverse Event, Concomitant Medication, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Ongoing?
Beschrijving

Serious Adverse Event, Concomitant Medication Ongoing

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
No, specify End Date
Beschrijving

Serious Adverse Event, Concomitant Agent, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Relevant Medical Conditions/Risk Factors - MHx Sequence Number
Beschrijving

Serious Adverse Event, Disease, Risk factor, Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0035648
UMLS CUI [1,4]
C2348184
Relevant Medical Conditions/Risk Factors - Specific Condition Name
Beschrijving

Serious Adverse Event, Disease

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
Relevant Medical Conditions/Risk Factors - Date of onset
Beschrijving

Serious Adverse Event, Disease, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0808070
Relevant Medical Conditions/Risk Factors - Continuing?
Beschrijving

Serious Adverse Event, Disease, Continuous

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0549178
Relevant Medical Conditions/Risk Factors - No, specify Date of last occurrence
Beschrijving

Serious Adverse Event, Disease, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
Relevant Medical History/Risk factors not noted above
Beschrijving

Serious Adverse Event, Disease, Risk factor, Other

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0035648
UMLS CUI [1,4]
C0205394
Relevant Diagnostic Results - Lab Sequence Number
Beschrijving

Serious Adverse Event, Diagnostic procedures, Result, Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C2348184
Relevant Diagnostic Results - Test Name
Beschrijving

Serious Adverse Event, Diagnostic procedures

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
Relevant Diagnostic Results - Test Date
Beschrijving

Serious Adverse Event, Diagnostic procedures, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0011008
Relevant Diagnostic Results - Test Result
Beschrijving

Serious Adverse Event, Diagnostic procedures, Result

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
Relevant Diagnostic Results - Test Units
Beschrijving

Serious Adverse Event, Diagnostic procedures, Unit of Measure

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1519795
Relevant Diagnostic Results - Normal Low Range
Beschrijving

Serious Adverse Event, Diagnostic procedures, Normal Range, Low

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0086715
UMLS CUI [1,4]
C0205251
Relevant Diagnostic Results - Normal High Range
Beschrijving

Serious Adverse Event, Diagnostic procedures, Normal Range, High

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0086715
UMLS CUI [1,4]
C0205250
Relevant Diagnostic Results - Relevant diagnostic results not noted above
Beschrijving

Serious Adverse Event, Diagnostic procedures, Result, Other

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0205394
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Beschrijving

Serious Adverse Event, Relationships, Experimental drug

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
General Narrative Comments - Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
Beschrijving

Serious Adverse Event, Comment

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Concomitant Medications - Repeating Form
Beschrijving

Concomitant Medications - Repeating Form

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschrijving

Concomitant Agent, Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Drug Name
Beschrijving

Concomitant Agent, Medication name

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Beschrijving

Concomitant Medication Modified Reported Term

Datatype

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschrijving

Concomitant Agent, Synonym

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Beschrijving

Concomitant Agent, Code

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
Failed coding
Beschrijving

Concomitant Agent, Code, Failed

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Reason for Medication
Beschrijving

Concomitant Agent, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0566251
Start Date
Beschrijving

Concomitant Agent, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Taken Prior to Study?
Beschrijving

Concomitant Medication Previous Occurrence

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Beschrijving

Concomitant Medication Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
No, specify End Date
Beschrijving

Concomitant Agent, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
Corticosteroid Concomitant Medications - Repeating Form
Beschrijving

Corticosteroid Concomitant Medications - Repeating Form

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0001617
Sequence Number
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C2348184
Drug Name
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Medication name

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C2360065
Modified reported term
Beschrijving

Concomitant Medication Modified Reported Term, Adrenal Cortex Hormones

Datatype

text

Alias
UMLS CUI [1,1]
C2826819
UMLS CUI [1,2]
C0001617
GSK Drug synonym
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Synonym

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0871468
GSK Drug Collection code
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Code

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0805701
Failed coding
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Code, Failed

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Total Daily Dose
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Daily Dose, Total

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0439810
Units
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Unit of Measure

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C1519795
Frequency
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0439603
Route
Beschrijving

Concomitant Agent,Adrenal Cortex Hormones, Drug Administration Routes

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0013153
Reason for Medication
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0566251
Other, specify
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0566251
Start Date
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0808070
Taken Prior to Study?
Beschrijving

Concomitant Medication Previous Occurrence, Adrenal Cortex Hormones

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826667
UMLS CUI [1,2]
C0001617
Ongoing?
Beschrijving

Concomitant Medication Ongoing,Adrenal Cortex Hormones

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0001617
No, specify End Date
Beschrijving

Concomitant Agent, Adrenal Cortex Hormones, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0806020
Blood Products and Blood Supportive Care Products
Beschrijving

Blood Products and Blood Supportive Care Products

Alias
UMLS CUI-1
C0456388
UMLS CUI-2
C0344211
Sequence Number
Beschrijving

Blood product, Sequence Number; Blood product, Supportive care, Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C2348184
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [2,3]
C2348184
Blood Products and Blood Supportive Care Products
Beschrijving

Blood product; Blood product, Supportive care

Datatype

text

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
Other, specify
Beschrijving

Blood product; Blood product, Supportive care

Datatype

text

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
Cumulative Quantity or Dose
Beschrijving

Blood product, Cumulative Dose; Blood product, Supportive care, Cumulative Dose

Datatype

text

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C2986497
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [2,3]
C2986497
Units
Beschrijving

Blood product, Unit of Measure; Blood product, Supportive care, Unit of Measure

Datatype

text

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C1519795
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [2,3]
C1519795
Start Date
Beschrijving

Blood product, Start Date; Blood product, Supportive care, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [2,3]
C0808070
Stop Date
Beschrijving

Blood product, End Date; Blood product, Supportive care, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [2,3]
C0806020
Pharmacogenetic (PGx) Research Consent / Whole Blood Sample Collection
Beschrijving

Pharmacogenetic (PGx) Research Consent / Whole Blood Sample Collection

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C2347500
UMLS CUI-3
C0021430
Has informed consent been obtained for PGx research?
Beschrijving

Pharmacogenetic Test, Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
Yes, record Date informed consent obtained for PGx research
Beschrijving

Pharmacogenetic Test, Informed Consent, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
Yes, record Has Whole Blood sample been collected for PGx research?
Beschrijving

Pharmacogenetic Test, Collection of blood specimen for laboratory procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
Yes, record: Yes, record date sample taken
Beschrijving

Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
No, check reason
Beschrijving

Pharmacogenetic Test, Informed Consent, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Other, specify
Beschrijving

Pharmacogenetic Test, Informed Consent, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Pharmacogenetic (PGx) Research Withdrawal of Consent
Beschrijving

Pharmacogenetic (PGx) Research Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx research?
Beschrijving

Pharmacogenetic Test, Informed Consent, Withdraw (activity)

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Yes, date informed consent withdrawn
Beschrijving

Pharmacogenetic Test, Informed Consent, Withdraw (activity), Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
UMLS CUI [1,4]
C0011008
Has a request been made for whole blood sample destruction?
Beschrijving

Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
Yes, check reason
Beschrijving

Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
Other, specify
Beschrijving

Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
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Similar models

Log

1 Formulieren
  1. StudyEvent: ODM
    1. Log
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Concomitant Agent
Item
Were any (non corticosteroid ) concomitant medications taken by the subject prior to screening and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent, Adrenal Cortex Hormones
Item
Were any (corticosteroid ) concomitant medications taken by the subject prior to screening and/or during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Non-serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Serious Adverse Event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Blood product; Blood product, Supportive care
Item
Were any blood products or blood supportive care products drawn during the study?
boolean
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
Collection of blood specimen for laboratory procedure, Pharmacogenetics
Item
Was pharmacogenetic whole blood sample collected?
boolean
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Item Group
Non-Serious Adverse Event (AE) - Repeating Form
C1518404 (UMLS CUI-1)
Non-serious Adverse Event, Sequence Number
Item
Sequence Number
integer
C1518404 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-serious Adverse Event
Item
Event
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Adverse Event Modified Reported Term
Item
Modified term
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Non-serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Non-serious Adverse Event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-serious Adverse Event, Code, Failed
Item
Failed coding
text
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Non-serious Adverse Event, Start DateStart Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
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
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Symptom intensity, Maximum
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe  (3)
CL Item
Not applicable (4)
Item
Maximum Grade
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Grade, Maximum
Code List
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)
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Non-serious Adverse Event, Grade, Maximum; Non-serious Adverse Event, Symptom intensity, Maximum
Code List
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
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
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 changes (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Non-serious Adverse Event, Withdraw
Item
Did the subject withdraw from from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Non-serious Adverse Event, Duration
Item
Duration of the AE if < 24 hours
time
C1518404 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Non-serious Adverse Event, Time of onset, Time last dose
Item
Time to Onset Since Last Dose
time
C1518404 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Item Group
Serious Adverse Events (SAE) - Repeating Form
C1519255 (UMLS CUI-1)
Item
Type of Report
text
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Serious Adverse Event Report, Type
Code List
Type of Report
CL Item
Initial (1)
CL Item
Follow-up (2)
Serious Adverse Event, Experimental drug
Item
Did the SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, 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, Adverse Event Modified Reported Term
Item
Modified term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event, Code, Failed
Item
Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
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; Serious Adverse Event, Date of death
Item
End Date/Date of Death
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1148348 (UMLS CUI [2,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event, Symptom intensity, Maximum
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event, Grade, Maximum
Code List
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)
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity
text
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])
Serious Adverse Event, Grade, Maximum; Serious Adverse Event, Symptom intensity, Maximum
Code List
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
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Serious Adverse Event, Action Taken with Study Treatment
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 changes (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Duration
Item
Duration of the AE if < 24 hours
time
C1519255 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Serious Adverse Event, Time of onset, Time last dose
Item
Time to Onset Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Study Subject Participation Status
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Seriousness?
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)
Serious Adverse Event, Concomitant Medication, Sequence Number
Item
CM Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Dosage
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, End Date
Item
No, specify End Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Risk factor, Sequence Number
Item
Relevant Medical Conditions/Risk Factors - MHx Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Serious Adverse Event, Disease
Item
Relevant Medical Conditions/Risk Factors - Specific Condition Name
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Start Date
Item
Relevant Medical Conditions/Risk Factors - Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
Relevant Medical Conditions/Risk Factors - Continuing?
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Continuous
Code List
Relevant Medical Conditions/Risk Factors - Continuing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Serious Adverse Event, Disease, End Date
Item
Relevant Medical Conditions/Risk Factors - No, specify Date of last occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Risk factor, Other
Item
Relevant Medical History/Risk factors not noted above
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures, Result, Sequence Number
Item
Relevant Diagnostic Results - Lab Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures
Item
Relevant Diagnostic Results - Test Name
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Serious Adverse Event, Diagnostic procedures, Date in time
Item
Relevant Diagnostic Results - Test Date
date
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedures, Result
Item
Relevant Diagnostic Results - Test Result
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedures, Unit of Measure
Item
Relevant Diagnostic Results - Test Units
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedures, Normal Range, Low
Item
Relevant Diagnostic Results - Normal Low Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures, Normal Range, High
Item
Relevant Diagnostic Results - Normal High Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures, Result, Other
Item
Relevant Diagnostic Results - Relevant diagnostic results not noted above
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Experimental drug
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at the time (3)
CL Item
Not applicable (4)
Serious Adverse Event, Comment
Item
General Narrative Comments - Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Concomitant Medications - Repeating Form
C2347852 (UMLS CUI-1)
Concomitant Agent, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Agent, Medication name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Modified Reported Term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Agent, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
Concomitant Agent, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Concomitant Agent, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Agent, Reason and justification
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Concomitant Agent, Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Agent, End Date
Item
No, specify End Date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Corticosteroid Concomitant Medications - Repeating Form
C2347852 (UMLS CUI-1)
C0001617 (UMLS CUI-2)
Concomitant Agent, Adrenal Cortex Hormones, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Concomitant Agent, Adrenal Cortex Hormones, Medication name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Concomitant Medication Modified Reported Term, Adrenal Cortex Hormones
Item
Modified reported term
text
C2826819 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Concomitant Agent, Adrenal Cortex Hormones, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Concomitant Agent, Adrenal Cortex Hormones, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant Agent, Adrenal Cortex Hormones, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Concomitant Agent, Adrenal Cortex Hormones, Daily Dose, Total
Item
Total Daily Dose
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,4])
Concomitant Agent, Adrenal Cortex Hormones, Unit of Measure
Item
Units
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Concomitant Agent, Adrenal Cortex Hormones, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Concomitant Agent,Adrenal Cortex Hormones, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Concomitant Agent, Reason and justification
Code List
Reason for Medication
CL Item
Worsening of NSS due to metastatic brain lesions (1)
CL Item
Unrelated to brain metastases (2)
CL Item
Other, specify (Other, specify)
Concomitant Agent, Adrenal Cortex Hormones, Reason and justification
Item
Other, specify
text
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Concomitant Agent, Adrenal Cortex Hormones, Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Concomitant Medication Previous Occurrence, Adrenal Cortex Hormones
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Concomitant Medication Ongoing,Adrenal Cortex Hormones
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Concomitant Agent, Adrenal Cortex Hormones, End Date
Item
No, specify End Date
date
C2347852 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Blood Products and Blood Supportive Care Products
C0456388 (UMLS CUI-1)
C0344211 (UMLS CUI-2)
Blood product, Sequence Number; Blood product, Supportive care, Sequence Number
Item
Sequence Number
integer
C0456388 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2348184 (UMLS CUI [2,3])
Item
Blood Products and Blood Supportive Care Products
text
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
Blood product; Blood product, Supportive care
Code List
Blood Products and Blood Supportive Care Products
CL Item
Red Blood Cells  (1)
CL Item
Platelets (2)
CL Item
Whole Blood  (3)
CL Item
Plasma - FFP  (4)
CL Item
Factor VIII (5)
CL Item
Cryoprecipitate  (6)
CL Item
White Blood Cells (7)
CL Item
G-CSF  (8)
CL Item
G(M)CSF (9)
CL Item
Erythropoietin (10)
CL Item
Pegfilgrastim (Conjugated G-CSF/Neulasta) (11)
CL Item
Oprelvecin (IL-11) (12)
CL Item
Other, specify (13)
Item
Other, specify
text
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
Blood product; Blood product, Supportive care
Code List
Other, specify
Blood product, Cumulative Dose; Blood product, Supportive care, Cumulative Dose
Item
Cumulative Quantity or Dose
text
C0456388 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2986497 (UMLS CUI [2,3])
Blood product, Unit of Measure; Blood product, Supportive care, Unit of Measure
Item
Units
text
C0456388 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C1519795 (UMLS CUI [2,3])
Blood product, Start Date; Blood product, Supportive care, Start Date
Item
Start Date
date
C0456388 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0808070 (UMLS CUI [2,3])
Blood product, End Date; Blood product, Supportive care, End Date
Item
Stop Date
date
C0456388 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
Item Group
Pharmacogenetic (PGx) Research Consent / Whole Blood Sample Collection
C0005834 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C0021430 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent
Item
Has informed consent been obtained for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Pharmacogenetic Test, Informed Consent, Date in time
Item
Yes, record Date informed consent obtained for PGx research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Item
Yes, record Has Whole Blood sample been collected for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time
Item
Yes, record: Yes, record date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
No, check reason
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Reason and justification
Code List
No, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Pharmacogenetic Test, Informed Consent, Reason and justification
Item
Other, specify
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw (activity)
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Withdraw (activity), Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action
Item
Has a request been made for whole blood sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx  (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Item
Other, specify
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification
Code List
Other, specify
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