Item
time of documentation, check one.
text
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Code List
time of documentation, check one.
CL Item
Initial Report (Inital Report)
CL Item
Follow-Up Report (Follow-Up Report)
date of documentation
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
CL Item
Life-threatening (Life-threatening)
CL Item
Hospitalization/prolonged hospitalization (Hospitalization/prolonged hospitalization)
CL Item
Disabling/incapacitating (Disabling/incapacitating)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Important medical event (please explain below) (Important medical event (please explain below))
CL Item
Other, specify (Other, specify)
Item
Was the patient an in-patient when the adverse event occurred?
integer
C0021562 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Was the patient an in-patient when the adverse event occurred?
date of report
Item
Date of Report
date
C1302584 (UMLS CUI [1])
start date and time of adverse event
Item
Start Date and Time
datetime
C2697888 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
stop date and time of adverse event
Item
Stop Date and Time
datetime
C2697886 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Severity of Event
text
C1710066 (UMLS CUI [1])
Code List
Severity of Event
CL Item
Moderare (Moderate)
describe adverse event
Item
DESCRIBE EVENT
text
C0877248 (UMLS CUI [1])
dose frequency of study drug
Item
Dose Frequency
integer
C2982514 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
drug administration route
Item
Route
text
C0013153 (UMLS CUI [1])
indication of medication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
start date of study drug
Item
Therapy Start Date
date
C3173309 (UMLS CUI [1])
stop date of study drug
Item
Therapy StopDate
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
DRUG/EVENT RELATIONSHIP
text
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
DRUG/EVENT RELATIONSHIP
CL Item
Not related (Not related)
CL Item
Suspected (Suspected)
CL Item
Unlikely (Unlikely)
CL Item
Probable (Probable)
Item
Did event resolve after study treatment stopped?
text
C1514893 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1531784 (UMLS CUI [1,3])
Code List
Did event resolve after study treatment stopped?
CL Item
Not applicable (Not applicable)
Item
Did reaction reappear after reintroduction?
text
C0376495 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Did reaction reappear after reintroduction?
CL Item
Not applicable (Not applicable)
medical history
Item
MEDICAL HISTORY/ COEXISTING DISEASES
text
C0262926 (UMLS CUI [1])
relevant laboratory data/ diagnosis/ concomitant medication/ autopsy finding
Item
RELEVANT TESTS/LABORATORY DATA (including dates)/DIAGNOSIS/TREATMENT/AUTOPSY FINDINGS
text
C1115972 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
C1706864 (UMLS CUI [4])
Item
FINAL OUTCOME
text
C1705586 (UMLS CUI [1])
CL Item
Resolved, no residual effects (Resolved, no residual effects)
CL Item
Resolved, residual effects (Resolved, residual effects)
CL Item
Continuing (Continuing)
Item
Patient Death
text
C1306577 (UMLS CUI [1])
CL Item
Disease for which the patient was given study treatment (e.g. disease progression, treatment failure) (Disease for which the patient was given study treatment (e.g. disease progression, treatment failure))
CL Item
Other pre-existing condition/disease (Other pre-existing condition/disease)
CL Item
SAE not related to study drug (SAE not related to study drug)
CL Item
SAE related to study drug (SAE related to study drug)
CL Item
Unknown (further information will be requested) (Unknown (further information will be requested))
Item
AUTOPSY
text
C0004398 (UMLS CUI [1])
CL Item
Yes (provide report if possible) (Yes (provide report if possible))
CL Item
Planned (Planned)
code broken
Item
CODE BROKEN
boolean
C3846431 (UMLS CUI [1])
cause of death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
name of principal investigator
Item
Name
text
C1547383 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
address of principal investigator
Item
Address
text
C1442065 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
telephone number of principal investigator
Item
Telephone Number
integer
C1515258 (UMLS CUI [1,1])
principal investigator's signature
Item
Principal Investigator's Signature
text
C1519316 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
date of signature
Item
Date
date
C0807937 (UMLS CUI [1])