Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
SERIOUS ADVERSE EVENT (SAE)
C1519255 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0475309 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Serious Adverse Events
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Item Group
SECTION 1
C1828479 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Moderate (Moderate)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C2826626 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
subject withdraw from study as a result of SAE
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
causations adverse events
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Item Group
SECTION 2 Seriousness
C1828479 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Death
Item
Results in death
boolean
C0011065 (UMLS CUI [1])
life-threatening
Item
Is life-threatening
boolean
C2826244 (UMLS CUI [1])
hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
disability
Item
Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Congenital anomaly
Item
Congenital anomaly/birth defect
boolean
C2826727 (UMLS CUI [1])
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
Item Group
SECTION 3 Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Item Group
SECTION 4
C1828479 (UMLS CUI-1)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
C1828479 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C1710056 (UMLS CUI-3)
Disease
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
Medical condition
Item
Medical condition(s) (record in Section 6)
boolean
C1699700 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication (record in Section 8)
boolean
C2347852 (UMLS CUI [1])
study participation status
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1])
other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
Item Group
SECTION 6 RELEVANT Medical Conditions
C1828479 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Medical Conditions Hypersensitivity surgeries
Item
Specify any RELEVANT past or current medical disorders, allergies,surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Medical Conditions SAE
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
SECTION 7 Other RELEVANT Risk Factors
C1828479 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Risk Factors substance use disorder occupational hazard
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
C0035648 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
C0337074 (UMLS CUI [1,3])
Item Group
SECTION 8 RELEVANT Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
SECTION 9 Details of Investigational Product(s)
C1828479 (UMLS CUI-1)
SAE Screening Study
Item
Did the SAE occur during the Screening Period?
boolean
C1519255 (UMLS CUI [1,1])
C2348164 (UMLS CUI [1,2])
Date of First Dose
Item
Date of First Dose
date
C3173309 (UMLS CUI [1])
Date of Most Recent Dose
Item
Date of Most Recent Dose
date
C0011008 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
Number of Doses
Item
Number of Doses Completed to Date
integer
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item
Was randomisation code broken at investigational site?
text
C0034656 (UMLS CUI [1])
Code List
Was randomisation code broken at investigational site?
CL Item
Not applicable (Not applicable)
Item Group
SECTION 10 Details of RELEVANT Assessments
C1828479 (UMLS CUI-1)
Procedures related to diagnosis SAE laboratory
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g.,laboratory data with units and normal range)
text
C2939431 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Item Group
SECTION 11 Narrative Remarks
C1828479 (UMLS CUI-1)
comment SAE
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])