serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Diagnosis or serious signs/symptoms of SAE
Item
Diagnosis or serious signs/symptoms
text
C0011900 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset SAE
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of onset SAE
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Resolved with Sequelae (2)
Date of resolution or death
Item
Date of resolution or death
date
C2985918 (UMLS CUI [1])
C1148348 (UMLS CUI [2])
Time of resolution or death
Item
Time of resolution or death
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
Item
Action taken with investigational product(s) as a result of the SAE
integer
C0013230 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
Dose adjusted (2)
CL Item
Temporarily interrupted (3)
CL Item
Permanently discontinued (4)
CL Item
Not applicable (5)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to investigational product
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Definition of Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1704788 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item
Possible causes of SAE other than lnvestigational Product(s):
integer
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Code List
Possible causes of SAE other than lnvestigational Product(s):
CL Item
Disease under study (1)
CL Item
Treatment failure (2)
CL Item
Withdrawal of investigational product(s) (3)
CL Item
Concomitant disorder (4)
CL Item
Concomitant medication (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
Item
Seriousness of SAE
integer
C1710056 (UMLS CUI [1])
Code List
Seriousness of SAE
CL Item
Life threatening (2)
CL Item
Hospitalization required or prolonged (3)
CL Item
Disabling or incapacitating (4)
CL Item
Congenital anomaly (5)
SAE fatal, autopsy
Item
lf fatal, was an autopsy done/to be performed?
boolean
C1705232 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Narrative / Comments
Item
Narrative / Comments: Provide a textual description of the serious adverse event (including treatment of the event).
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Details of Relevant Assessments
Item
Details of Relevant Assessments: Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
text
C1519255 (UMLS CUI [1,1])
C0431080 (UMLS CUI [1,2])
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
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 [1,1])
C0012634 (UMLS CUI [1,2])
Condition present at time of the SAE
Item
Condition present at time of the SAE
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of last occurrence
Item
If 'No', date of last occurrence:
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Other relevant risk factors
Item
Other Relevant Risk Factors: Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Treatment period
integer
C3161471 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Code List
Treatment period
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Start time of dose
Item
Start time of dose
time
C1301880 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
event during washout period
Item
Did the event occur during the washout period?
boolean
C1519255 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1710661 (UMLS CUI [1,3])
event during screening
Item
Did the event occur during screening?
boolean
C1519255 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
event during follow-up
Item
Did the event occur during follow-up?
boolean
C1519255 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Dose
Item
Dose
float
C2826638 (UMLS CUI [1])
Unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Start Date
Item
Date started
date
C2826734 (UMLS CUI [1])
Started pre-study
Item
Started pre-study
boolean
C2981448 (UMLS CUI [1])
Stop Date
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Ongoing Medication
Item
Medication continued post-SAE
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Conditions treated/indication
text
C2826696 (UMLS CUI [1])
Reporting lnvestigator
Item
Reporting lnvestigator: Name
text
C2826892 (UMLS CUI [1])
Reporting lnvestigator: Address
Item
Reporting lnvestigator: Address
text
C2986286 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Reporting lnvestigator: Signature
Item
Reporting lnvestigator: Signature
text
C2986286 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Date of report
Item
Date
date
C1302584 (UMLS CUI [1])
Additional or follow-up information
Item
Provide any additional details on the serious adverse event not already captured in the previous questions.
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])