ID

41304

Beschreibung

Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Stichworte

Versionen (1)
  1. 13.08.20 13.08.20 -
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GlaxoSmithKline

Hochgeladen am

13. August 2020

DOI

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Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275

Englisch

Logs/Repeats

1 Formulare  
  1. StudyEvent: ODM
    1. Logs/Repeats
Logs and Repeats
Beschreibung

Logs and Repeats

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0205341
Date of visit/assessment
Beschreibung

Event Log, Repeat, Date of visit, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1708728
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C1320303
UMLS CUI [1,4]
C2985720
Were there any concomitant medications taken by the subject during the study?
Beschreibung

Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any adverse events during the study?
Beschreibung

Adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Did the subject experience any serious adverse events during the study?
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Were any repeat or unscheduled vital signs recorded?
Beschreibung

Vital signs, Repeat; Vital signs, Unscheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C0518766
UMLS CUI [2,2]
C3854240
Was any unscheduled study medication taken?
Beschreibung

Experimental drug, Unscheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3854240
Were any repeat or unscheduled PK blood samples taken?
Beschreibung

Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Repeat; Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Unscheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0005834
UMLS CUI [2,3]
C3854240
Were there an unscheduled or repeat ECHO/MUGA examinations performed?
Beschreibung

Echocardiography, Multiple gated acquisition scanning, Repeat; Echocardiography, Multiple gated acquisition scanning, Unscheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0013516
UMLS CUI [2,2]
C0521317
UMLS CUI [2,3]
C3854240
Were any unscheduled or repeat ECGs performed?
Beschreibung

Electrocardiography, Repeat; Electrocardiography, Unscheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C1623258
UMLS CUI [2,2]
C3854240
Were the liver event criteria met for this subject as defined by the protocol?
Beschreibung

Liver, Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
ECHO/MUGA
Beschreibung

ECHO/MUGA

Alias
UMLS CUI-1
C0013516
UMLS CUI-2
C0521317
Ejection fraction range lower limit
Beschreibung

Echocardiography, Multiple gated acquisition scanning, Ejection fraction (finding), Lower Limit of Normal

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C2700378
UMLS CUI [1,4]
C1518030
%
Scan Type
Beschreibung

Echocardiography, Multiple gated acquisition scanning

Datentyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
Date and Time of Scan
Beschreibung

Echocardiography, Multiple gated acquisition scanning, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Left ventricular ejection fraction (LVEF)
Beschreibung

Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C0428772
%
Left ventricular ejection fraction (LVEF)
Beschreibung

Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C0428772
%
Scan results
Beschreibung

Echocardiography, Multiple gated acquisition scanning, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C1274040
Describe abnormality
Beschreibung

Echocardiography, Multiple gated acquisition scanning, Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C1704258
Vital Signs - Repeating Form
Beschreibung

Vital Signs - Repeating Form

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0205341
Actual date/time
Beschreibung

Vital signs, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Sitting heart rate
Beschreibung

Heart rate while sitting

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2029904
Sitting blood pressure measurement - Systolic
Beschreibung

Systolic Pressure, Sitting position

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting blood pressure measurement - Diastolic
Beschreibung

Diastolic blood pressure, Sitting position

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Unscheduled 12-Lead ECG - Repeating Form
Beschreibung

Unscheduled 12-Lead ECG - Repeating Form

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3854240
UMLS CUI-3
C0205341
Date and Time of ECG
Beschreibung

12 lead ECG, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Heart rate
Beschreibung

12 lead ECG, Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Beschreibung

12 lead ECG, Electrocardiogram: P-R interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschreibung

12 lead ECG, QRS complex duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschreibung

12 lead ECG, QT interval - finding

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschreibung

12 lead ECG, Electrocardiogram QT corrected interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
Result of the ECG
Beschreibung

12 lead ECG, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
12-Lead ECG Abnormalities
Beschreibung

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Date and Time of ECG
Beschreibung

12 lead ECG, Abnormality, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Record clinically significant abnormalities
Beschreibung

12 lead ECG, Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
Unscheduled Pharmacokinetics Samples (PK) - Repeating Form
Beschreibung

Unscheduled Pharmacokinetics Samples (PK) - Repeating Form

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C3854240
UMLS CUI-3
C0205341
PK Sample ID
Beschreibung

Pharmacokinetic aspects, Sample identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1299222
Actual date/time
Beschreibung

Pharmacokinetic aspects, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Investigational Product - GSK1120212 Unscheduled (Study Drug) - Repeating Form
Beschreibung

Investigational Product - GSK1120212 Unscheduled (Study Drug) - Repeating Form

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3854240
UMLS CUI-3
C0205341
Unscheduled Dose - Date/Time
Beschreibung

Experimental drug, Unscheduled, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Adverse Event (AE) - Repeating Form
Beschreibung

Adverse Event (AE) - Repeating Form

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0205341
Sequence number
Beschreibung

Adverse event, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348184
Was the event serious?
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Yes, Seriousness Reason(s)
Beschreibung

Serious Adverse Event, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0566251
Event
Beschreibung

Adverse event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Modified term
Beschreibung

Adverse Event Modified Reported Term

Datentyp

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Beschreibung

Adverse event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1140263
MedDRA lower level term code
Beschreibung

Adverse event, MedDRA Low Level Term Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3898442
Failed coding
Beschreibung

Adverse event, Code, Failed

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Start date
Beschreibung

Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Did the event occur prior to rollover?
Beschreibung

Adverse event, Before

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0332152
Outcome/End date
Beschreibung

Adverse Event Outcome, Adverse Event End Date

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C2697886
End Date and Time
Beschreibung

Adverse Event End Date Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Date and Time of Death
Beschreibung

Adverse event, Date of death, Time of death

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1148348
UMLS CUI [1,3]
C1301931
Frequency
Beschreibung

Adverse event, Frequencies

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Intensity at onset of event
Beschreibung

Adverse event, Symptom intensity, Onset

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0332162
Maximum intensity
Beschreibung

Adverse event, Symptom intensity, Maximum

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Grade at onset of event
Beschreibung

Adverse event, Grade, Onset

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
Maximum grade
Beschreibung

Adverse event, Grade, Maximum

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Grade or intensity at onset of event
Beschreibung

Adverse event, Grade, Symptom intensity, Onset

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0332162
Maximum Grade or intensity
Beschreibung

Adverse event, Grade, Symptom intensity, Maximum

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0806909
Were any actions taken with investigational product(s) as a result of the AE?
Beschreibung

Adverse event, Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
Yes, tick all that apply
Beschreibung

Adverse event, Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
Most clinically significant action taken with investigational product(s) as a Result of the AE
Beschreibung

Adverse Event, Action Taken with Study Treatment, Clinical Significance

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
UMLS CUI [1,3]
C2826293
Did the subject withdraw from study as a result of this AE?
Beschreibung

Adverse event, Withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Adverse event, Causations, Experimental drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0304229
Yes, Check all that apply
Beschreibung

Adverse event, Causations, Experimental drug

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0304229
Duration of AE if < 24 hours
Beschreibung

Adverse event, Duration

Datentyp

time

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2926735
Time to onset since last dose
Beschreibung

Adverse event, Time of onset, Date last dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C1762893
Is this adverse event a dose-limiting toxicity during the determinative period?
Beschreibung

Adverse event, dose-limiting, Drug toxicity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1512043
UMLS CUI [1,3]
C0013221
Were concomitant medications taken to treat this adverse event?
Beschreibung

Adverse event, Therapeutic procedure, Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2347852
Start Date of Event Segment
Beschreibung

Adverse event, Part, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0808070
Intensity of event segment
Beschreibung

Adverse event, Part, Symptom intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
Grade of event segment
Beschreibung

Adverse event, Part, Grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
Grade or Intensity of event segment
Beschreibung

Adverse event, Part, Grade, Symptom intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C0518690
Start Date of Action(s)
Beschreibung

Adverse event, Therapeutic procedure, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0808070
Action taken with investigational product
Beschreibung

Adverse event, Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
Investigational product action is taken with
Beschreibung

Adverse event, Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
Date event became serious (Date event met serious criteria)
Beschreibung

Serious Adverse Event, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Date event ceased to be serious
Beschreibung

Serious Adverse Event, End date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Serious Adverse Events (SAE)
Beschreibung

Serious Adverse Events (SAE)

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Beschreibung

Serious Adverse Event, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Report
Beschreibung

Serious Adverse Event Report

Datentyp

text

Alias
UMLS CUI [1]
C3897642
SAE form started
Beschreibung

Serious Adverse Event, Report, Start Date, Start time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0808070
UMLS CUI [1,4]
C1301880
Seriousness Reason(s)
Beschreibung

Serious Adverse Event, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0566251
Was SAE caused by activities related to study participation (e.g. procedures)?
Beschreibung

Serious Adverse Event, Causations, Activities, Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
Serious Adverse Event
Beschreibung

Serious Adverse Event

Datentyp

text

Modified term copied from adverse event form
Beschreibung

Serious Adverse Event, Adverse Event Modified Reported Term

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
Start date
Beschreibung

Serious Adverse Event, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Outcome / End date
Beschreibung

Serious Adverse Event, Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date and Time
Beschreibung

Serious Adverse Event, End date, End Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Date and Time of Death
Beschreibung

Serious Adverse Event, Date of death, Time of death

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C1148348
UMLS CUI [1,4]
C1301931
Frequency
Beschreibung

Serious Adverse Event, Frequencies

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439603
Maximum Intensity
Beschreibung

Serious Adverse Event, Symptom intensity, Maximum

Datentyp

text

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

Serious Adverse Event, Grade, Maximum

Datentyp

text

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

Serious Adverse Event, Grade, Symptom intensity, Maximum

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0806909
Toxicity/Intensity History
Beschreibung

Serious Adverse Event, Toxicity aspects, Patient History

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0040539
UMLS CUI [1,3]
C0679831
Most clinically significant action taken with investigational product(s) as a Result of the AE
Beschreibung

Serious Adverse Event, Action Taken with Study Treatment, Clinical Significance

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
UMLS CUI [1,3]
C2826293
Action(s) taken with Investigational Product
Beschreibung

Serious Adverse Event, Action Taken with Study Treatment

Datentyp

text

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

Serious Adverse Event, Withdraw

Datentyp

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?
Beschreibung

Serious Adverse Event, Investigational New Drugs, Relationships

Datentyp

text

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

Serious Adverse Event, Duration

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2926735
Time to onset since last dose
Beschreibung

Serious Adverse Event, Time of onset, Time last dose

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
Is this adverse event a dose-limiting toxicity during the determinative period?
Beschreibung

Serious Adverse Event, Dose-limiting, Drug toxicity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1512043
UMLS CUI [1,3]
C0013221
Date segments adverse event was serious
Beschreibung

Serious Adverse Event, Part

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
Are there any relevant concomitant medications associated with this serious adverse event?
Beschreibung

Serious Adverse Event, Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
Concomitant Medication - Sequence Number
Beschreibung

Serious Adverse Event, Concomitant Agent, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2348184
Concomitant Medication - Drug Name
Beschreibung

Serious Adverse Event, Concomitant Agent, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Concomitant Medication - Modified reported term
Beschreibung

Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826819
Concomitant Medication - Drug Name
Beschreibung

Serious Adverse Event, Concomitant Agent, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Concomitant Medication - Unit Dose
Beschreibung

Serious Adverse Event, Concomitant Agent, Dosage

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0178602
Concomitant Medication - Units
Beschreibung

Serious Adverse Event, Concomitant Agent, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Concomitant Medication - Frequency
Beschreibung

Serious Adverse Event, Concomitant Agent, Frequencies

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Concomitant Medication - Route
Beschreibung

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Concomitant Medication - Reason for Medication
Beschreibung

Serious Adverse Event, Concomitant Agent, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0566251
Concomitant Medication - Reason for Medication Modified Report Term
Beschreibung

Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826819
UMLS CUI [1,4]
C0566251
Concomitant Medication - Start Date
Beschreibung

Serious Adverse Event, Concomitant Agent, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Concomitant Medication - Ongoing?
Beschreibung

Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826666
Concomitant Medication - No, End Date
Beschreibung

Serious Adverse Event, Concomitant Agent, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Concomitant Medication - Total Duration
Beschreibung

Serious Adverse Event, Concomitant Agent, Duration

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0449238
Concomitant Medication - Duration Unit
Beschreibung

Serious Adverse Event, Concomitant Agent, Duration, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C1519795
Did SAE occur after initiation of study medication?
Beschreibung

Serious Adverse Event, Experimental drug, Initiation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1704686
Randomization Number
Beschreibung

Serious Adverse Event, Randomization, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0237753
Relevant Medical Conditions - MHx Sequence Number
Beschreibung

Serious Adverse Event, Disease, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2348184
Relevant Medical Conditions - Specific Condition Name
Beschreibung

Serious Adverse Event, Disease

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2348184
Relevant Medical Conditions - Modified reported term
Beschreibung

Serious Adverse Event, Disease, Adverse Event Modified Reported Term

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2826798
Relevant Medical Conditions - Date of onset
Beschreibung

Serious Adverse Event, Disease, Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0574845
Relevant Medical Conditions - Continuing?
Beschreibung

Serious Adverse Event, Disease, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0549178
Relevant Medical Conditions - No, specify date of last occurrence
Beschreibung

Serious Adverse Event, Disease, End date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
Relevant Diagnostic Results - Lab Sequence Number
Beschreibung

Serious Adverse Event, diagnostic procedure, Sequence Number

Datentyp

integer

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

Serious Adverse Event, diagnostic procedure, Test Name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C2826273
Relevant Diagnostic Results - Test Date
Beschreibung

Serious Adverse Event, diagnostic procedure, Date in time

Datentyp

date

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

Serious Adverse Event, diagnostic procedure, Result

Datentyp

text

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

Serious Adverse Event, diagnostic procedure, Unit of Measure

Datentyp

text

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

Serious Adverse Event, diagnostic procedure, Normal Range, Low

Datentyp

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
Beschreibung

Serious Adverse Event, diagnostic procedure, Normal Range, High

Datentyp

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
Beschreibung

Serious Adverse Event, diagnostic procedure, Result, Other

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0205394
Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Beschreibung

Serious Adverse Event, Relationships, Experimental drug

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Investigational Product - Study Drug
Beschreibung

Serious Adverse Event, Experimental drug

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
Investigational Product - Start Date
Beschreibung

Serious Adverse Event, Experimental drug, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
Investigational Product - Stop Date
Beschreibung

Serious Adverse Event, Experimental drug, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0806020
Investigational Product - Dose
Beschreibung

Serious Adverse Event, Experimental drug, Dosage

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
Investigational Product - Cumulative Dose
Beschreibung

Serious Adverse Event, Experimental drug, Cumulative Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2986497
General Narrative Comments
Beschreibung

Serious Adverse Event, Comment

Datentyp

text

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

Concomitant Medications - Repeating Form

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschreibung

Concomitant Agent, Sequence Number

Datentyp

integer

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

Concomitant Agent, Medication name

Datentyp

text

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

Concomitant Agent, Concomitant Medication Modified Reported Term

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826819
Failed coding
Beschreibung

Concomitant Agent, Code, Failed

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Unit Dose
Beschreibung

Concomitant Agent, Dosage

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178602
Units
Beschreibung

Concomitant Agent, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Frequency
Beschreibung

Concomitant Agent, Frequencies

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Route
Beschreibung

Concomitant Agent, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Reason for Medication
Beschreibung

Concomitant Agent, Reason and justification

Datentyp

text

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

Concomitant Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Taken Prior to Study?
Beschreibung

Concomitant Medication Previous Occurrence

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Beschreibung

Concomitant Medication Ongoing

Datentyp

boolean

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

Concomitant Medication End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Device Used to Administer Medication
Beschreibung

Concomitant Agent, Devices, Medication administered

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0699733
UMLS CUI [1,3]
C0806914
Total Daily Dose
Beschreibung

Concomitant Agent, Daily Dose, Total

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Was drug administered for an exacerbation?
Beschreibung

Concomitant Agent, Disease Exacerbation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0235874
Was drug administered as a rescue medication?
Beschreibung

Concomitant Agent, Rescue remedy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0884980
Cumulative Dose Used?
Beschreibung

Concomitant Agent, Cumulative Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2986497
Was drug ever used?
Beschreibung

Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Total Duration
Beschreibung

Concomitant Agent, Duration, Total

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0439810
Duration Unit
Beschreibung

Concomitant Agent, Duration, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1519795
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Ähnliche Modelle

Logs/Repeats

1 Formulare
  1. StudyEvent: ODM
    1. Logs/Repeats
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Logs and Repeats
C1708728 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Event Log, Repeat, Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1708728 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,4])
Concomitant Agent
Item
Were there any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Adverse event
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Serious Adverse Event
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Vital signs, Repeat; Vital signs, Unscheduled
Item
Were any repeat or unscheduled vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C3854240 (UMLS CUI [2,2])
Experimental drug, Unscheduled
Item
Was any unscheduled study medication taken?
boolean
C0304229 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Repeat; Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Unscheduled
Item
Were any repeat or unscheduled PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0031328 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
C3854240 (UMLS CUI [2,3])
Echocardiography, Multiple gated acquisition scanning, Repeat; Echocardiography, Multiple gated acquisition scanning, Unscheduled
Item
Were there an unscheduled or repeat ECHO/MUGA examinations performed?
boolean
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0013516 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C3854240 (UMLS CUI [2,3])
Electrocardiography, Repeat; Electrocardiography, Unscheduled
Item
Were any unscheduled or repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C3854240 (UMLS CUI [2,2])
Liver, Adverse Event
Item
Were the liver event criteria met for this subject as defined by the protocol?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
ECHO/MUGA
C0013516 (UMLS CUI-1)
C0521317 (UMLS CUI-2)
Echocardiography, Multiple gated acquisition scanning, Ejection fraction (finding), Lower Limit of Normal
Item
Ejection fraction range lower limit
integer
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C2700378 (UMLS CUI [1,3])
C1518030 (UMLS CUI [1,4])
Item
Scan Type
text
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
Echocardiography, Multiple gated acquisition scanning
Code List
Scan Type
CL Item
ECHO (1)
CL Item
MUGA (2)
Echocardiography, Multiple gated acquisition scanning, Date in time, Time
Item
Date and Time of Scan
datetime
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction
Item
Left ventricular ejection fraction (LVEF)
integer
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [1,3])
Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction
Item
Left ventricular ejection fraction (LVEF)
integer
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [1,3])
Item
Scan results
text
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Echocardiography, Multiple gated acquisition scanning, Result
Code List
Scan results
CL Item
Normal (1)
CL Item
Abnormal, describe abnormality (2)
Echocardiography, Multiple gated acquisition scanning, Abnormality
Item
Describe abnormality
text
C0013516 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item Group
Vital Signs - Repeating Form
C0518766 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Vital signs, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Sitting heart rate
integer
C2029904 (UMLS CUI [1])
Gender
Code List
Sitting heart rate
Systolic Pressure, Sitting position
Item
Sitting blood pressure measurement - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
Sitting blood pressure measurement - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Unscheduled 12-Lead ECG - Repeating Form
C0430456 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
12 lead ECG, Date in time, Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram: P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT interval - finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method
Code List
QTc Interval
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
12 lead ECG, Abnormality, Date in time, Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Record clinically significant abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Code List
Record clinically significant abnormalities
CL Item
No abnormalities (1)
CL Item
Sinus bradycardia (50-59 beats/min) (2)
CL Item
Sinus bradycardia (40-49 beats/min) (3)
CL Item
Sinus bradycardia (30-39 beats/min) (4)
CL Item
Sinus bradycardia (<30 beats/min) (5)
CL Item
Sinus pause (6)
CL Item
Sinus tachycardia (>100 beats/min) (7)
CL Item
Ectopic supraventricular beats (8)
CL Item
Ectopic supraventricular rhythm (9)
CL Item
Wandering atrial pacemaker (10)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)
CL Item
Atrial flutter (14)
CL Item
Atrial fibrillation (15)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
CL Item
Junctional tachycardia (>100 beats/min) (17)
CL Item
Ventricular premature deplorisation (18)
CL Item
Ventricular couplets (19)
CL Item
Bigeminy (20)
CL Item
Trigeminy (21)
CL Item
Electrical alternans (22)
CL Item
R on T phenomenon (23)
CL Item
Ventricular fibrillation (24)
CL Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
CL Item
Wide QRS tachycardia (diagnosis unknown (28)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)
CL Item
Torsades de Pointes (TdP) (33)
CL Item
Pacemaker (34)
CL Item
First degree AV block (PR interval >200msec) (35)
CL Item
Short PR Intervak (36)
CL Item
Second degree AV block (Mobitz type 1) (37)
CL Item
Second degree AV block (Mobitz type 2) (38)
CL Item
2:1 AV block (39)
CL Item
Third degree AV block (40)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (41)
CL Item
Right axis deviation (QRS axis more positive than +100 degrees) (42)
CL Item
Incomplete left bundle branch block (43)
CL Item
Incomplete left bundle branch block (44)
CL Item
Right bundle branch block (45)
CL Item
Left anterior hemiblock (46)
CL Item
Left posterior hemiblock (47)
CL Item
Left bundle branch block (48)
CL Item
Bifascicular block (49)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (50)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)
CL Item
QTc prolongation >=500 msec (52)
CL Item
AV dissociation (53)
CL Item
Myocardial infarction, old (54)
CL Item
Myocardial infarction, non Q-wave (55)
CL Item
Non-specific ST-T changes (56)
CL Item
J point elevation (57)
CL Item
ST elevation (58)
CL Item
ST depression (59)
CL Item
ST segment abnormality (60)
CL Item
U waves (61)
CL Item
T wave inversion (62)
CL Item
T wave peaked (63)
CL Item
T waves biphasic (64)
CL Item
T waves flat (65)
CL Item
66)Notched T-waves (66)Notched T-waves)
CL Item
Low QRS voltage (67)
CL Item
T wave abnormality (68)
CL Item
Other abnormal rhythm (69)
CL Item
Other morphology (70)
CL Item
Other conduction (71)
CL Item
Other myocardial infarction (72)
CL Item
Other depolarization/repolarisation (73)
CL Item
Other abnormality/Cardiologist comments (74)
Item Group
Unscheduled Pharmacokinetics Samples (PK) - Repeating Form
C0031328 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Pharmacokinetic aspects, Sample identification number
Item
PK Sample ID
integer
C0031328 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Pharmacokinetic aspects, Date in time, Time
Item
Actual date/time
datetime
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Investigational Product - GSK1120212 Unscheduled (Study Drug) - Repeating Form
C0304229 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Experimental drug, Unscheduled, Date in time, Time
Item
Unscheduled Dose - Date/Time
datetime
C0304229 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Adverse Event (AE) - Repeating Form
C0877248 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Adverse event, Sequence Number
Item
Sequence number
integer
C0877248 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Yes, Seriousness Reason(s)
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Serious Adverse Event, Reason and justification
Code List
Yes, Seriousness Reason(s)
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalization or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
CL Item
Serious Protocol Defined Liver Chemistry Stopping/Interruption Criteria Met (7)
Adverse event
Item
Event
text
C0877248 (UMLS CUI [1])
Adverse Event Modified Reported Term
Item
Modified term
text
C2826798 (UMLS CUI [1])
Adverse event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA synonym
text
C0877248 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Adverse event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C0877248 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Adverse event, Code, Failed
Item
Failed coding
text
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Adverse Event Start Date
Item
Start date
date
C2697888 (UMLS CUI [1])
Adverse event, Before
Item
Did the event occur prior to rollover?
boolean
C0877248 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Item
Outcome/End date
text
C1705586 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Adverse Event Outcome, Adverse Event End Date
Code List
Outcome/End date
CL Item
Recovered/Resolved, prove End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Recovered with sequelae, prove End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Adverse Event End Date Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Adverse event, Date of death, Time of death
Item
Date and Time of Death
datetime
C0877248 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
C1301931 (UMLS CUI [1,3])
Item
Frequency
text
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Adverse event, Frequencies
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Intensity at onset of event
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Adverse event, Symptom intensity, Onset
Code List
Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum intensity
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Adverse event, Symptom intensity, Onset
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Grade at onset of event
text
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Adverse event, Grade, Onset
Code List
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
Maximum grade
text
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Adverse event, Grade, Onset
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)
Item
Grade or intensity at onset of event
text
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
Adverse event, Grade, Symptom intensity, Onset
Code List
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 (6)
Item
Maximum Grade or intensity
text
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Adverse event, Grade, Symptom intensity, Onset
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
Were any actions taken with investigational product(s) as a result of the AE?
text
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Adverse event, Action Taken with Study Treatment
Code List
Were any actions taken with investigational product(s) as a result of the AE?
CL Item
No action taken with investigational product(s) (1)
CL Item
Yes, actions were taken with investigational product(s) (2)
CL Item
Not applicable, AE occurred when not receiving investigational product(s) (3)
Item
Yes, tick all that apply
text
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Adverse event, Action Taken with Study Treatment
Code List
Yes, tick all that apply
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose interrupted (3)
CL Item
Dose delayed (4)
CL Item
Cycle interrupted (5)
CL Item
Cycle delayed (6)
CL Item
Infusion interrupted (7)
CL Item
Infusion delayed (8)
Item
Most clinically significant action taken with investigational product(s) as a Result of the AE
text
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Adverse Event, Action Taken with Study Treatment, Clinical Significance
Code List
Most clinically significant 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)
Adverse event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0877248 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Adverse event, Causations, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Yes, Check all that apply
text
C0877248 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Adverse event, Causations, Experimental drug
Code List
Yes, Check all that apply
CL Item
Lapatinib (1)
CL Item
Esomeprazole (2)
Adverse event, Duration
Item
Duration of AE if < 24 hours
time
C0877248 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Adverse event, Time of onset, Date last dose
Item
Time to onset since last dose
time
C0877248 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Adverse event, dose-limiting, Drug toxicity
Item
Is this adverse event a dose-limiting toxicity during the determinative period?
boolean
C0877248 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
Adverse event, Therapeutic procedure, Concomitant Agent
Item
Were concomitant medications taken to treat this adverse event?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Adverse event, Part, Start Date
Item
Start Date of Event Segment
date
C0877248 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
Intensity of event segment
text
C0877248 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Adverse event, Part, Symptom intensity
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
text
C0877248 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Adverse event, Part, Symptom intensity
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
text
C0877248 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
Adverse event, Part, Symptom intensity
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)
Adverse event, Therapeutic procedure, Start Date
Item
Start Date of Action(s)
date
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
Action taken with investigational product
text
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Adverse event, Action Taken with Study Treatment
Code List
Action taken with investigational product
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose interrupted (3)
CL Item
Dose delayed (4)
Item
Investigational product action is taken with
text
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Adverse event, Action Taken with Study Treatment
Code List
Investigational product action is taken with
CL Item
Lapatinib (1)
CL Item
Esomeprazole (2)
Serious Adverse Event, Start Date
Item
Date event became serious (Date event met serious criteria)
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, End date
Item
Date event ceased to be serious
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Serious Adverse Events (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event, Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Report
text
C3897642 (UMLS CUI [1])
Serious Adverse Event Report
Code List
Report
CL Item
Initial (1)
CL Item
Follow-Up (2)
Serious Adverse Event, Report, Start Date, Start time
Item
SAE form started
datetime
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Item
Seriousness Reason(s)
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
undefined item
Code List
Seriousness Reason(s)
CL Item
Results in death  (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalization or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect  (5)
CL Item
Other, specify with general narrative comment (6)
Serious Adverse Event, Causations, Activities, Study Subject Participation Status
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Serious Adverse Event
Item
Serious Adverse Event
text
Serious Adverse Event, Adverse Event Modified Reported Term
Item
Modified term copied from adverse event form
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event, Start Date
Item
Start date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome / End date
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Outcome / End date
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time  (4)
CL Item
Fatal, record Date and Time of Death (5)
Serious Adverse Event, End date, End Time
Item
End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Serious Adverse Event, Date of death, Time of death
Item
Date and Time of Death
datetime
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,3])
C1301931 (UMLS CUI [1,4])
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (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)
Item
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, Grade, 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)
Serious Adverse Event, Toxicity aspects, Patient History
Item
Toxicity/Intensity History
text
C1519255 (UMLS CUI [1,1])
C0040539 (UMLS CUI [1,2])
C0679831 (UMLS CUI [1,3])
Item
Most clinically significant action taken with investigational product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Serious Adverse Event, Action Taken with Study Treatment, Clinical Significance
Code List
Most clinically significant 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)
Serious Adverse Event, Action Taken with Study Treatment
Item
Action(s) taken with Investigational Product
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Investigational New Drugs, Relationships
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Serious Adverse Event, Duration
Item
Duration of 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, Dose-limiting, Drug toxicity
Item
Is this adverse event a dose-limiting toxicity during the determinative period?
boolean
C1519255 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
Serious Adverse Event, Part
Item
Date segments adverse event was serious
date
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent
Item
Are there any relevant concomitant medications associated with this serious adverse event?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Sequence Number
Item
Concomitant Medication - 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
Concomitant Medication - Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term
Item
Concomitant Medication - Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication name
Item
Concomitant Medication - 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
Concomitant Medication - Unit 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
Concomitant Medication - Units
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Concomitant Medication - 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
Concomitant Medication - Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Reason and justification
Item
Concomitant Medication - Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term, Reason and justification
Item
Concomitant Medication - Reason for Medication Modified Report Term
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Concomitant Medication - Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing
Item
Concomitant Medication - Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, End Date
Item
Concomitant Medication - No, End Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Duration
Item
Concomitant Medication - Total Duration
time
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Duration, Unit of Measure
Item
Concomitant Medication - Duration Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Serious Adverse Event, Experimental drug, Initiation
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
Serious Adverse Event, Randomization, Numbers
Item
Randomization Number
integer
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Sequence Number
Item
Relevant Medical Conditions - MHx Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Disease
Item
Relevant Medical Conditions - Specific Condition Name
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Adverse Event Modified Reported Term
Item
Relevant Medical Conditions - Modified reported term
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Date of onset
Item
Relevant Medical Conditions - Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Continuous
Item
Relevant Medical Conditions - Continuing?
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Disease, End date
Item
Relevant Medical Conditions - 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, diagnostic procedure, Sequence Number
Item
Relevant Diagnostic Results - Lab Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, diagnostic procedure, Test Name
Item
Relevant Diagnostic Results - Test Name
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C2826273 (UMLS CUI [1,3])
Serious Adverse Event, diagnostic procedure, 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 procedure, 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 procedure, 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 procedure, 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 procedure, 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 procedure, 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])
Serious Adverse Event, Relationships, Experimental drug
Item
Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug
Item
Investigational Product - Study Drug
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Start Date
Item
Investigational Product - Start Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, End Date
Item
Investigational Product - Stop Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Dosage
Item
Investigational Product - Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Cumulative Dose
Item
Investigational Product - Cumulative Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Serious Adverse Event, Comment
Item
General Narrative Comments
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 Agent, Concomitant Medication Modified Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C2826819 (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, Dosage
Item
Unit Dose
text
C2347852 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Concomitant Agent, Unit of Measure
Item
Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent, Reason and justification
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Concomitant Medication Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
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 Medication End Date
Item
No, specify End Date
date
C2826744 (UMLS CUI [1])
Concomitant Agent, Devices, Medication administered
Item
Device Used to Administer Medication
text
C2347852 (UMLS CUI [1,1])
C0699733 (UMLS CUI [1,2])
C0806914 (UMLS CUI [1,3])
Concomitant Agent, Daily Dose, Total
Item
Total Daily Dose
text
C2347852 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Concomitant Agent, Disease Exacerbation
Item
Was drug administered for an exacerbation?
boolean
C2347852 (UMLS CUI [1,1])
C0235874 (UMLS CUI [1,2])
Concomitant Agent, Rescue remedy
Item
Was drug administered as a rescue medication?
boolean
C2347852 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Concomitant Agent, Cumulative Dose
Item
Cumulative Dose Used?
boolean
C2347852 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Concomitant Agent
Item
Was drug ever used?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent, Duration, Total
Item
Total Duration
text
C2347852 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Concomitant Agent, Duration, Unit of Measure
Item
Duration Unit
text
C2347852 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
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