Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
DATE OF REPORT
Item
DATE OF REPORT
date
C1302584 (UMLS CUI [1])
SERIOUS ADVERSE EVENTS
Item
EVENT / ILLNESS
text
C1519255 (UMLS CUI [1])
ONSET DATE
Item
ONSET DATE
date
C0574845 (UMLS CUI [1])
Resolution adverse event
Item
EVENT RESOLVED?
boolean
C1514893 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Resolution Date
Item
RESOLVED DATE
date
C2985858 (UMLS CUI [1])
Item
FREQUENCY
integer
C0439603 (UMLS CUI [1])
Item
SEVERITY
integer
C1710066 (UMLS CUI [1])
Item
RELATIONSHIP TO DISEASE
integer
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
RELATIONSHIP TO DISEASE
Item
RELATIONSHIP TO STUDY DRUG
integer
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
RELATIONSHIP TO STUDY DRUG
Item
ACTION TAKEN STUDY DRUG ADMINISTRATION
integer
C2826626 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
ACTION TAKEN STUDY DRUG ADMINISTRATION
CL Item
DOSE MODIFIED (2)
ACTION TAKEN
Item
ACTION TAKEN TREATMENT- NONE
boolean
C2826626 (UMLS CUI [1])
ACTION TAKEN MEDICATION
Item
ACTION TAKEN TREATMENT- MEDICATION
boolean
C2826626 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
ACTION TAKEN SURGERY
Item
ACTION TAKEN TREATMENT- PROCEDURE/ SURGERY (COMMENT BELOW)
boolean
C2826626 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
ACTION TAKEN OTHER
Item
ACTION TAKEN TREATMENT- OTHER
boolean
C2826626 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other
Item
OTHER
text
C0205394 (UMLS CUI [1])
comment
Item
COMMENT
text
C0947611 (UMLS CUI [1])
Hospitalization
Item
HOSPITALIZATION?
boolean
C0019993 (UMLS CUI [1])
Admission date
Item
ADMIT DATE
date
C1302393 (UMLS CUI [1])
Discharge Date
Item
DISCHARGE DATE
date
C2361123 (UMLS CUI [1])
Chronology Severity of Adverse Event
Item
EVENT CHRONOLOGY: (DESCRIBE ASSOCIATED SIGNS AND SYMPTOMS, CLINICAL COURSE AND OUTCOME)
text
C0008717 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
therapy Severity of Adverse Event
Item
TREATMENT(S) (OTHER THAN MEDICATIONS) FOR THE SERIOUS ADVERSE EVENT, IF RENDERED:
text
C0087111 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
diagnostic test Severity of Adverse Event
Item
DIAGNOSTIC TEST(S) RESULTS PERTAINING TO THE SERIOUS ADVERSE EVENT
text
C0086143 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
medical history Severity of Adverse Event
Item
MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO THE SERIOUS ADVERSE EVENT
text
C0262926 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Item
IF THE STUDY DRUG WAS HELD AND LATER RESTARTED, DID THE SAME ADVERSE EVENT RECUR?
integer
C0034897 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Code List
IF THE STUDY DRUG WAS HELD AND LATER RESTARTED, DID THE SAME ADVERSE EVENT RECUR?
CL Item
NOT APPLICABLE (3)