Serious Adverse Event, Experimental Drug
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, Diagnosis; Serious Adverse Event, Symptoms
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Serious Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (Recovered/Resolved)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae (Recovered/Resolved with sequelae)
Serious Adverse Event, Recovered or Resolved, End date, End time
Item
Outcome Resolved/Recovered, give End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Serious Adverse Event, Recovered or Resolved with sequelae, End date, End time
Item
Outcome Resolved/Recovered with sequelae, give End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C1709862 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Serious Adverse Event, Fatal, Death Date, Time of death
Item
Outcome Fatal, give 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
Maximum Intensity
text
C1710056 (UMLS CUI [1])
Code List
Maximum Intensity
CL Item
Moderate (Moderate)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
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])
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
3xULN and bilirubin >= 2xULN (Yes, ALT >)
CL Item
5xULN (Yes, ALT >)
CL Item
3xULN if associated with the appearance or worsening of rash or hepatitis symptoms (fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash or eosinophilia) (Yes, ALT >)
CL Item
3xULN persists for >=4 weeks (Yes, ALT >)
CL Item
3xULN and cannot be monitored weekly for 4 weeks (Yes, ALT >)
Serious Adverse Event; Relationship; Clinical Research
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
CL Item
Results in death (Results in death)
CL Item
Is life-threatening (Is life-threatening)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (Requires hospitalisation or prolongation of existing hospitalisation)
CL Item
Results in disability/incapacity (Results in disability/incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Other, specify within general narrative comment (Other, specify within general narrative comment)
Serious Adverse Event, Medication name
Item
Drug name
text
C1519255 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Serious Adverse Event, Medication Dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Dose Unit
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2826646 (UMLS CUI [1,2])
Serious Adverse Event, Medication Frequency
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Serious Adverse Event, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Serious Adverse Event, Pharmaceutical Preparation, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, Continuous
Item
Ongoing
boolean
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, Indication
Item
Primary Indication
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, Types of Drugs
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,3])
Disease
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1])
Disease, Date of Onset
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Ongoing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
CL Item
Unknown (Unknown)
Disease, Occurrence, Date in time
Item
Date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Medical History, Risk Factors
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Diagnostic Procedure, Test Name
Item
Test Name
text
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Diagnostic Procedure, Date in time
Item
Test Date
date
C0430022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Diagnostic Procedure, Result
Item
Test Result
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Diagnostic Procedure, Unit of measure
Item
Test Units
text
C0430022 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Diagnostic Procedure, Normal Range, Low
Item
Normal Low Range
text
C0430022 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
Diagnostic Procedure, Normal Range, High
Item
Normal High Range
text
C0430022 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Diagnostic Procedure, Results
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1519255 (UMLS CUI [1,1])
C2347900 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Experimental Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Experimental Drug, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1])
Experimental Drug, End Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, Comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])