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])
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])
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])
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])
CL Item
Single Episode (1)
Item
Intensity at onset of event
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Code List
Intensity at onset of event
CL Item
Not applicable (4)
Item
Maximum intensity
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Maximum intensity
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])
Code List
Grade at onset of event
Item
Maximum grade
text
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
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
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])
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
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])
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])
Code List
Yes, tick all that apply
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose interrupted (3)
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])
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 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])
Code List
Yes, Check all that apply
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])
Code List
Intensity of event segment
Item
Grade of event segment
text
C0877248 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Code List
Grade of event segment
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])
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)
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])
Code List
Action taken with investigational product
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose interrupted (3)
Item
Investigational product action is taken with
text
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
Investigational product action is taken with
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])
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, 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])
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])
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])
CL Item
Single Episode (1)
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Maximum grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
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
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])
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 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])
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])