Item
Sex
integer
C0079399 (UMLS CUI [1])
Date of birth
Item
Date of birth (dd mon yy)
date
C0421451 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Race
text
C0034510 (UMLS CUI [1])
Pregnancy
Item
Pregnant
boolean
C0032961 (UMLS CUI [1])
weeks pregnant
Item
if yes, week
text
C1135241 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Date of Onset
Item
Date of event: Onset (dd mon yy)
date
C0574845 (UMLS CUI [1])
End Date
Item
Date of event: End (dd mon yy), if ongoing, record "cont" in the end column
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Onset
Item
Onset how long (hh:mm) after first admin. of trial drug. If tretm duration at onset is <24 hours
time
C0332162 (UMLS CUI [1])
Item
Intensity of event
integer
C0522510 (UMLS CUI [1])
Code List
Intensity of event
Therapeutic procedure
Item
Therapy for event
boolean
C0087111 (UMLS CUI [1])
Specification
Item
If yes, specify in description below
boolean
C2348235 (UMLS CUI [1])
Item
Action taken with trial drug due to event
integer
C2826626 (UMLS CUI [1])
Code List
Action taken with trial drug due to event
CL Item
completed acc. protocol (5)
CL Item
discont. & reintroduced (6)
CL Item
not applicable (7)
Item
Outcome of event
integer
C0085565 (UMLS CUI [1])
Code List
Outcome of event
CL Item
not yet recovered (1)
Autopsy
Item
*Autopsy (if yes, attach report)
boolean
C0004398 (UMLS CUI [1])
Item
Was event serious?
integer
C1710056 (UMLS CUI [1])
Code List
Was event serious?
CL Item
no, but sign. (3)
code
Item
if yes, enter appropriate code(s): 1=results in death, 2=immediately life-threatening, 3=persistent or significant disability/incapacity, 4=requires or prolongs patient hospitalization, 5=congenital anomaly/birth defect, 6=other comparable medical criteria (specify under description)
text
C0008902 (UMLS CUI [1])
Causal relationship
Item
Causal relationship, Indicate which test drug(s) is causally related to the event? (Medical judgement including kind and pattern of reaction, reasonableness of time relationship, patient´s clinical status, co-medication etc.)
text
C0013227 (UMLS CUI [1])
Item
Investigator
integer
C2826892 (UMLS CUI [1])
Item
Clin. Monitor
integer
C1521743 (UMLS CUI [1])
Clinical Monitor
Item
Was the event unlisted? (please see instruction) Clin. Monitor :
boolean
C1521743 (UMLS CUI [1])
Description
Item
Description of the above recorded event(s) if necessary (make reference to event by above line number):
text
C0678257 (UMLS CUI [1])