Did the subject experience a serious adverse event during the study?
Item
boolean
If YES, record details below
Item
If YES, record details below
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
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
End Time
Item
End Time
time
Item
Maximum Intensity
text
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
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Investigational product(s) withdrawn (1)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)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
Specify reasons for considering this a SAE
Item
Specify reasons for considering this a SAE
text
Results in death
Item
Results in death
boolean
Is life-threatening
Item
Is life-threatening
boolean
Requires hospitalisation or prolongation of existing hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
Other, specify
Item
Other, specify
text
Item
If Investigational Product(s) was stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were administered?
text
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 other than Investgational Product
integer
Code List
Possible Causes other than Investgational Product
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) (record details in Section 8 below) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
If MEDICAL CONDITIONS, specify
Item
If MEDICAL CONDITIONS, specify
text
If OTHER, specify
Item
If OTHER, specify
text
Relevant past or current medical conditions
Item
Relevant past or current medical conditions
text
Date of Onset
Item
Date of Onset
date
Condition present at Time of the SAE
Item
Condition present at Time of the SAE
boolean
If NO, Date of Last Occurrence
Item
If NO, Date of Last Occurrence
date
Record other relevant risk factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Item
Record other relevant risk factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
Record details of investigational product
Item
Record details of investigational product
text
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE
Item
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE
text
Provide a brief narrative description of the SAE and details of treatment given
Item
Provide a brief narrative description of the SAE and details of treatment given
text
Investigator's signature
Item
Investigator's signature
text
Investigator's name (print)
Item
Investigator's name (print)
text