Serious Adverse Event; During; Clinical Trial Period
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
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
integer
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
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event; Adverse Event End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of SAE
integer
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of 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Investigational product(s) withdrawn (1)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Serious Adverse Event; Patient withdrawn from trial
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Serious Adverse Event; Investigational New Drugs; Relationships
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Serious Adverse Event; Autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C1519255 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Item
Seriousness
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
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; Patient date of birth
Item
Date of birth
date
C1519255 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
Item
Sex
integer
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])
C0034897 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
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
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Code List
Possible Causes of SAE Other Than Investigational Product(s)
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; Hypersensitivity; 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])
C0020517 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Serious Adverse Event, Disease, Date of onset; Serious Adverse Event, Hypersensitivity, Date of onset; Serious Adverse Event, Operative Surgical Procedures, Date of onset
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0574845 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0574845 (UMLS CUI [3,3])
Serious Adverse Event, Disease, Present; Serious Adverse Event, Hypersensitivity, Present; Serious Adverse Event, Operative Surgical Procedures, Present
Item
Condition Present at Time of the SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0150312 (UMLS CUI [3,3])
Serious Adverse Event, Disease, ; Serious Adverse Event, Hypersensitivity, Occurrence, Date in Time; Serious Adverse Event, Operative Surgical Procedures, Occurrence, Date in Time
Item
C0150312
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,4])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C2745955 (UMLS CUI [3,3])
C0011008 (UMLS CUI [3,4])
Serious Adverse Events; Risk Factors
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
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; Medication Dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (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; Medication frequency
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (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; Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; Concomitant Medication ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; Concomitant Medication Use Indication
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826696 (UMLS CUI [1,3])
Serious Adverse Events; Experimental Drugs; Timepoint; Planned
Item
Planned Timepoint
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Serious Adverse Events; Experimental Drugs; Injection of therapeutic agent; Date in time
Item
Date of Injection
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Serious Adverse Events; Experimental Drugs; Injection of therapeutic agent; Time
Item
Time of Injection
time
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Serious Adverse Events; Experimental Drugs; Medication Dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Events; Evaluation
Item
Details of relevant Assessments
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Serious Adverse Event; Comment
Item
Narrative Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])