SAE initial report
Item
1. Initial Report
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
SAE follow-up report
Item
2. Follow-Up Report
boolean
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
SAE After Experimental Drug Initiation
Item
3. Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1704686 (UMLS CUI [1,4])
SAE Diagnosis | SAE Sign/Symptom
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])
C0037088 (UMLS CUI [2,2])
Serious Adverse Event Start Date/Time
Item
Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C2826806 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
CL Item
Fatal, record Date and Time of Death (Fatal, record Date and Time of Death)
SAE End Date Time
Item
End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
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
Moderate (Moderate)
CL Item
Not applicable (Not applicable)
Item
Actions taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Actions 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Investigational product(s) withdrawn (Investigational product(s) withdrawn)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)
Patient withdrawn from trial because of SAE
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship of Experimental Drug to Investigational Product(s)
Item
Is there a reasonable possibility the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
SAE Caused by Activiteies related to Study participation
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])
SAE results in death
Item
Results in death
boolean
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE requires hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE: Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE, other
Item
Other, specify within general narrative comment
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Name of concomitant medication or investigational agent
Item
Drug Name
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Dose of concomitant medication or investigational agent
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Unit of concomitant medication or investigational agent
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Frequency of concomitant medication or investigational agent
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Route of concomitant medication or investigational agent admission
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Start Date of concomitant medication or investigational agent
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
CL Item
No, specify End Date (No, specify End Date)
End Date of concomitant medication or investigational agent
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Indication of concomitant medication or investigational agent
Item
Primary Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Drug Type of concomitant medication or investigational agent
Item
Drug Type
text
C0457591 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0457591 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Relevant Medical Conditions
Item
7. Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
CL Item
No, specify date of last occurence (No, specify date of last occurence)
CL Item
Unknown (Unknown)
Date of Last Occurrence of Disease or Risk Factors
Item
Date of Last Occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0035648 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,4])
Relevance of Other Medical History/Risk Factors
Item
8. Relevant Medical History / Risk Factors not noted above
text
C2347946 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
Diagnostic Procedure Name
Item
Test Name
text
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Test Date
Item
Test Date
text
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0456984 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C1272773 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
text
C1299400 (UMLS CUI [1])
Other Diagnostic procedure Result
Item
10. Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
11. If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
C0231290 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1512900 (UMLS CUI [2,3])
Code List
11. If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Comment on SAE
Item
12. General narrative comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])