SAE

1 forms
  1. StudyEvent: ODM
    1. SAE
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Treatment Number
Item
Treatment Number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
SAE Report No
Item
SAE Report No
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Sponsor receipt date
Item
Sponsor receipt date
date
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Item
Type of report
integer
C0585733 (UMLS CUI [1])
Type of report
Code List
Type of report
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Item Group
Section 1: General SAE information
C1508263 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
SAE Start Date
Item
SAE Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
SAE Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
SAE Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
SAE End date
Item
SAE End date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
SAE maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
SAE maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Dose interrupted (3)
CL Item
Not applicable (X)
subject withdraw from study as a result of SAE
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE causation
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Item
Medically attended visit for SAE
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit for SAE
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Doctor (MD)
autopsy if fatal SAE
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Section 2: Seriousness
C1710056 (UMLS CUI-1)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization/ prolongation of existing hospitalization
Item
Requires hospitalization or prolongation of existing hospitalization
boolean
C0019993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect in the offspring
Item
Congenital anomaly/birth defect in the offspring
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other seriousness
Item
Other seriousness
boolean
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Other SAE seriousness specification
Item
Other SAE seriousness specification
text
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Hospital date of admission
Item
Hospital date of admission
date
C0806429 (UMLS CUI [1])
Hospital date of discharge
Item
Hospital date of discharge
date
C2361123 (UMLS CUI [1])
Item Group
Section 3: Demography Data
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Seriousness
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item Group
Section 4: SAE reccurence
C1519255 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
Item
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
If Investigational Product(s) was stopped, did the reported event(s) recur after further Investigational Product(s) were administered?
Code List
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No  (N)
CL Item
Yes  (Y)
CL Item
Unknown at this time  (U)
CL Item
Not applicable (NA)
Item Group
Section: 5 Possible Causes of SAE Other Than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Medical condition(s)
Item
Medical condition(s)
boolean
C0009488 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational product
boolean
C2349954 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Concomitant medication(s)
Item
Concomitant medication(s) (record in Section 8)
boolean
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation
boolean
C2348568 (UMLS CUI [1])
Other SAE causation
Item
Other SAE causation
boolean
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Specify other SAE causation
Item
Specify other SAE causation
text
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Section 6: Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C1519255 (UMLS CUI [3,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Condition present at time of the SAE
Item
Condition present at time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of Last Occurrence
Item
Date of last occurrence
date
C1517741 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Section 7: Other Relevant Risk Factors
C0205394 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Other relevant risk factors
Item
Other Relevant Risk Factors
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 8: Relevant Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1])
Concomitant Medication Dose
Item
Dose
integer
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Unit
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Ongoing Concomitant Medication ?
Item
Ongoing Concomitant Medication ?
boolean
C2826666 (UMLS CUI [1])
Reason for Concomitant Medication
Item
Reason for Concomitant Medication
text
C0392360 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Section 9: Details of investigational product(s)
C0013230 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Dose number
Item
Dose No
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Lot number
Item
Lot No
integer
C1115660 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route / site
Item
Route / site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Was randomization code broken on investigational site's request?
integer
C0034656 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Randomization code
Code List
Was randomization code broken on investigational site's request?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
Item Group
Section 10: Details of Relevant Assessments
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 11: Narrative Remarks
C0947611 (UMLS CUI-1)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 12: SAE additional / follow-up information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
SAE additional / follow-up information
Item
SAE additional / follow-up information
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Item
Type of report
integer
C0585733 (UMLS CUI [1])
Type of report
Code List
Type of report
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Date of investigator's signature
Item
Date of investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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