Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Protocol Treatment Arm, Numbers
Item
Treatment number
integer
C1522541 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Serious Adverse Event, During, Clinical Trials
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event, Diagnosis, Symptoms
Item
Serious adverse events - Diagnosis only (if known) or signs / symptoms
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Serious Adverse Event, Start Date
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start Time
Item
Time of onset
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Maximum intensity
CL Item
Not applicable (4)
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Resolved with sequelae (2)
Serious Adverse Event, End Date
Item
Date of resolution or death
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Time
Item
Time of resolution or death
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the SAE
text
C1519255 (UMLS CUI [1,1])
C1704758 (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)
Serious Adverse Event, Withdraw
Item
Did subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event
Item
Does the AE meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])
Item
Possible Causes of SAE other than Investigational Product(s), check all that apply
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Code List
Possible Causes of SAE other than Investigational Product(s), check all that apply
CL Item
Disease under study (1)
CL Item
Treatment failure (2)
CL Item
Withdrawal of investigational product(s) (3)
CL Item
Concomitant disorder, specify (4)
CL Item
Concomitant medication, specify (5)
CL Item
Activity related to study participation (e.g. procedures), specify (6)
CL Item
Other, specify (7)
Item
Specification
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item
Seriousness, check all that apply
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Code List
Seriousness, check all that apply
CL Item
Life threatening (2)
CL Item
Hospitalization required or prolonged (3)
CL Item
Disabling or incapacitating (4)
CL Item
Congenital anomaly (5)
CL Item
Other (see definition) (6)
Item
Specification
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Fatal, Autopsy
Item
If fatal, was an autopsy done/to be performed?
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Serious Adverse Event, Disease
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Start Date
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Disease, During
Item
Condition present at time of the SAE
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Serious Adverse Event, Disease, End Date
Item
If NO, date of last occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Risk Factors, Other
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Serious Adverse Event, Experiment drug, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Experiment drug, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Experiment drug, Medication dose, Time
Item
Time of dose
time
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug (Trade name preferred)
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication dose
Item
Dose
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Date started
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Before, Clinical Trial Period
Item
Check if started Pre-study
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Serious Adverse Event, Concomitant Agent, End Date
Item
Date stopped
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Continuous
Item
Check if continued Post-SAE
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Indication
Item
Conditions treated / indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Serious Adverse Event, Comment
Item
Provide a textual description of the serious adverse event (including treatment of the event).
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Serious Adverse Event, Evaluation, Details
Item
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Investigator Name
Item
Name
text
C2826892 (UMLS CUI [1])
Clinical Investigator, Address
Item
Address
text
C0008961 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Serious Adverse Event, Additional Information
Item
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages.
text
C1519255 (UMLS CUI [1,1])
C1546922 (UMLS CUI [1,2])
Investigator Name
Item
Name
text
C2826892 (UMLS CUI [1])
Clinical Investigator, Address
Item
Address
text
C0008961 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])