Serious Adverse Event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event Specification
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms (e.g., Anaphylaxis) Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. A seperate form should be used for each SAE however if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Outcome All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Recovered/Resolved" or "Recovered/Resolved with sequelae". If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not recovered/Not resolved" or "Recovering/Resolving". Also enter "Not recovered/Not resolved" if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.
integer
C1705586 (UMLS CUI [1])
Code List
Outcome All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Recovered/Resolved" or "Recovered/Resolved with sequelae". If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not recovered/Not resolved" or "Recovering/Resolving". Also enter "Not recovered/Not resolved" if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.
CL Item
Results in death (Results in death)
CL Item
Is life-threatening (Is life-threatening)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (Requires hospitalisation or prolongation of existing hospitalisation)
CL Item
Results in disability/incapacity (Results in disability/incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
Item
Maximum Intensity Record the maximum intensity that occured over the duration of the event. Amend the intensity if it increases. Mild= An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everday activities. Moderate= An event that is sufficiently discomforting to interfere with normal everday activities. Severe= An event that prevents normal everyday activities. Not applicable= those event(s) where intensity is meaningless or impossible to determine (i.e. blindness and coma)
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum Intensity Record the maximum intensity that occured over the duration of the event. Amend the intensity if it increases. Mild= An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everday activities. Moderate= An event that is sufficiently discomforting to interfere with normal everday activities. Severe= An event that prevents normal everyday activities. Not applicable= those event(s) where intensity is meaningless or impossible to determine (i.e. blindness and coma)
CL Item
Results in death (Results in death)
CL Item
Is life-threatening (Is life-threatening)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (Requires hospitalisation or prolongation of existing hospitalisation)
CL Item
Resutls in disablity/incapacity (Resutls in disablity/incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
Withdrawal
Item
Withdrawal Indicate "Yes" if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate "No". If "Yes", complete Study Conclusion page and tick Adverse Event as reason for withdrawal. Did the subject withdraw from study as a result of this AE?
boolean
C2349954 (UMLS CUI [1])
Autopsy
Item
IF fatal, was a post-mortem/autopsy perfomed? (If "Yes", summarise findings in Section 11 Narrative Remarks on this SAE form.)
boolean
C0004398 (UMLS CUI [1])
Serious Adverse Event: Seriousness Specification
Item
Specify reason(s) for considering this a SAE, tick all that apply: If "Other", specify (see definition of SAE):
text
C1710056 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
If Investigational Product was stopped, did the reported Event(s) recur after further Investigational Product(s) were administered? If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occured, did the reported adverse event recur?
text
C0580798 (UMLS CUI [1])
Code List
If Investigational Product was stopped, did the reported Event(s) recur after further Investigational Product(s) were administered? If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occured, did the reported adverse event recur?
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Date of Onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Date of Last Occurrence
Item
If "No", Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Drug Name
Item
Drug Name (Trade Name preferred) (e.g. Zantac)
text
C2360065 (UMLS CUI [1])
Unit
Item
Unit (e.g. mg)
text
C1519795 (UMLS CUI [1])
Route
Item
Route (e.g. PO)
text
C0013153 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Assessment
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
C1516048 (UMLS CUI [1])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Investigator's Signature
Item
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
text
C2346576 (UMLS CUI [1])