Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Serious Adverse Event
Item
Event - Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start Time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
Serious Adverse Event, End Date
Item
End Date (If fatal, record date of death)
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (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
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
Investigational product(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Serious Adverse Event, Withdraw
Item
Did the 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?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Autopsy
Item
If fatal, was a post-mortem/autopsy performed
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item
Specify reason(s) for considering this a SAE
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a SAE
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify (6)
Serious Adverse Event, Seriousness of Adverse Event
Item
Specify
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Patient date of birth
Item
Date of birth
date
C1519255 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
Item
Sex
text
C1519255 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
Serious Adverse Event, Body Weight
Item
Weight
float
C1519255 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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 (3)
CL Item
Not applicable (4)
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
Medical condition(s), specify (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s), specify (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Serious Adverse Event, Disease; Serious Adverse Event, Hypersensitivity; Serious Adverse Event, Operative Surgical Procedures
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])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Serious Adverse Event, Disease, Start Date; Serious Adverse Event, Hypersensitivity, Start Date; Serious Adverse Event, Operative Surgical Procedures, Start Date
Item
Date of Onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0808070 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0808070 (UMLS CUI [3,3])
Serious Adverse Event, Disease, End Date; Serious Adverse Event, Hypersensitivity, End Date; Serious Adverse Event, Operative Surgical Procedures, 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])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0806020 (UMLS CUI [3,3])
Serious Adverse Event, Risk factors
Item
Provide any family or 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])
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Dosage
Item
Dose
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (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 Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Reason and justification
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item
Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Investigational Product
CL Item
Citalopram (C) (1)
CL Item
WELLBUTRIN XL (2)
Serious Adverse Event, Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Serious Adverse Event, Experimental drug, Dosage, Time
Item
Time of Dose
time
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Was treatment blind broken at investigational site?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Code List
Was treatment blind broken at investigational site?
CL Item
Not applicable (3)
Serious Adverse Event, Diagnostic Procedure
Item
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
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Serious Adverse Event, Comment
Item
Provide a brief narrative description of the SAE and details of treatment given
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Serious Adverse Event, Investigator Signature
Item
Investigator’s signature (confirming that the data on the SAE pages are accurate and complete)
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Serious Adverse Event, Investigator Signature, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Name
Item
Investigator’s name
text
C1519255 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])