Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Item
Did the patient experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Code List
Did the patient experience any serious adverse events during the study?
Date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
Caucasian (Caucasian)
CL Item
Hispanic (Hispanic)
CL Item
Other (specify) (Other (specify))
Item
If other race, please specify:
text
C0034510 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Code List
If other race, please specify:
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight - unit
text
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item
Height - unit
text
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Sequential number
Item
Sequential number
integer
C2348184 (UMLS CUI [1])
SAE
Item
Serious Adverse Events
text
C1519255 (UMLS CUI [1])
Date of onset of SAE
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of onset of 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
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
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])
Item
Action Taken with Investigational Product as a Result of the SAE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product as a Result of the SAE
CL Item
Drug adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (4)
Item
Withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Item
Relationship to Investigational Product(s)
integer
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Relationship to Investigational Product(s)
Item
Seriousness?
integer
C1710056 (UMLS CUI [1])
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Treatment failure
Item
Treatment failure
boolean
C0162643 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational product
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant disorder
Item
Concomitant disorder (specify)
boolean
C0009488 (UMLS CUI [1])
Concomitant disorder - specify
Item
Concomitant disorder - specify:
text
C0009488 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication (specify)
boolean
C2347852 (UMLS CUI [1])
Concomitant medication - specify
Item
Concomitant medication - specify:
text
C2347852 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Activity related to study participation, procedures
Item
Activity related to study participation (e.g., procedures) (specify)
boolean
C2348568 (UMLS CUI [1])
C0199171 (UMLS CUI [2])
Activity related to study participation, procedures - specify
Item
Activity related to study participation (e.g., procedures) - specify:
text
C2348568 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0199171 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
Other cause of SAE
Item
Other (specify)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other cause of SAE - specify
Item
Other - specify:
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
SAE - Death
Item
Death
boolean
C1519255 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Item
If fatal, was an autopsy done/to be performed?
text
C1705232 (UMLS CUI [1])
C0004398 (UMLS CUI [2])
Code List
If fatal, was an autopsy done/to be performed?
Life threatening AE
Item
Life threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization required or prolonged
Item
Hospitalization required or prolonged
boolean
C2348993 (UMLS CUI [1])
Disabling AE
Item
Disabling or incapacitating
boolean
C3830477 (UMLS CUI [1])
AE seriousness due to congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Other SAE
Item
Other (SAE definition) (specify)
boolean
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other SAE - specify
Item
Other (SAE definition) - specify
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Sequential number
Item
Sequential number
integer
C2348184 (UMLS CUI [1])
Medical history, allergies, surgeries relevant to SAE
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1519255 (UMLS CUI [3,2])
Date of onset of SAE
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Condition Present at Time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Condition Present at Time of the SAE?
Date of last occurence of comorbidity
Item
If ‘NO’, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0009488 (UMLS CUI [1,4])
Risk factors relevant to SAE (social history, family history, smoking, alcohol, diet, drug abuse, occupational hazard)
Item
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])
C0205394 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
C3714536 (UMLS CUI [2])
C0241889 (UMLS CUI [3])
C0543414 (UMLS CUI [4])
C0001948 (UMLS CUI [5])
C0012155 (UMLS CUI [6])
C0013146 (UMLS CUI [7])
C0337074 (UMLS CUI [8])
Investigational product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Date of first dose of investigational product
Item
Date of First Dose
date
C0304229 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Date of last dose of investigational product
Item
Date of Last Dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Sequential number
Item
Sequential number
integer
C2348184 (UMLS CUI [1])
Concomitant medication name
Item
Drug
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant medication dose
Item
Dose
float
C2826811 (UMLS CUI [1])
Concomitant medication dose unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Concomitant medication dose frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant medication route of administration
Item
Route
text
C2826730 (UMLS CUI [1])
Concomitant medication date started
Item
Date Started
date
C2826734 (UMLS CUI [1])
Concomitant medication started pre-study
Item
Check if started Pre-study
boolean
C2981448 (UMLS CUI [1])
Concomitant medication stop date
Item
Date Stopped
date
C2826744 (UMLS CUI [1])
Concomitant medication continued post-SAE
Item
Check if continued Post-SAE
boolean
C2826666 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Concomintant medication indication
Item
Conditions treated / indication
text
C2826696 (UMLS CUI [1])
Description of SAE | description of AE treatment
Item
Provide a textual description of the serious adverse event (including treatment of the event).
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C2981656 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
Details of other evaluation of SAE, laboratory procedures
Item
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
text
C0220825 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,4])
C0022885 (UMLS CUI [2])
Item
Form section signed
text
C2346576 (UMLS CUI [1,1])
C1828479 (UMLS CUI [1,2])
Code List
Form section signed
CL Item
Sections 1-10 (Sections 1-10)
CL Item
Additional or Follow-Up Information (Additional or Follow-Up Information)
Investigator name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Additional or Follow-Up Information
Item
Use this field to provide any additional details on the serious adverse event not already captured on the previous forms. The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
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])