Safety Reporting: Serious Adverse Events (SAEs)

Reporting procedures

Depending on the nature of the event, the reporting procedures outlined in this protocol should be followed. Any queries concerning serious adverse event reporting should be directed to the trial coordination centre in the first instance.

  • Non-serious AEs potentially attributable to antibiotics prescribed for AECOPD will be collected as part of routine follow-up on the week 1, week 2 and week 4 follow-up CRF
  • Other non-serious AEs will not be collected
  • Pre-planned hospitalisation e.g. for pre-existing conditions which have not worsened or elective procedures for a pre-existing condition will not be classed as an SAE
  • Hospitalisation is expected within this patient population and will be collected and reported as part of routine follow-up (self-reported by patients and recorded on the week 1, week 2 and week 4 follow-up CRFs and by case note review at 6 months) and not subject to expedited reporting on a SAE form
  • All other events fulfilling the definition of an SAE , including death, that occur between the time of consent and the 4 week follow-up should be reported to SEWTU by completing and faxing a SAE form to the PACE Trial Manager within 24 hours of the site becoming aware of the event
  • Any death occurring after the 4 week follow-up should be reported by telephoning SEWTU (02920 687620) and not subject to expedited reporting on a SAE form
  • Any other SAE occurring after the 4 week follow up will not be reported

SEWTU will notify the Sponsor and main REC of all related and unexpected SAEs occurring during the trial within 15 calendar days of the Chief Investigator becoming aware of the event.

All Investigators will be informed of all related SAEs occurring throughout the trial. Local Investigators should report any SAEs as required by their Local Research Committee and/or Research and Development Office.

Definitions:

Adverse Event (AE):

Any untoward medical occurrence in a trial participant which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom, or disease.

Serious Adverse Event (SAE): Any adverse event that:

  • Results in death
  • Is life-threatening*
  • Required hospitalisation or prolongation of existing hospitalisation**
  • Results in persistent or significant disability or incapacity
  • Consists of a congenital anomaly or birth defect
  • Other medically important condition ***

* Note: The term “life-threatening” in the definition of serious refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.

** Note: Hospitalisation is defined as an inpatient admission, regardless of the length of stay, even if the hospitalisation is a precautionary measure, for continued observation. Pre-planned hospitalisation e.g. for pre-existing conditions which have not worsened or elective procedures does not constitute an adverse event.

*** Note: other events that may not result in death are not life-threatening, or do not require hospitalisation may be considered as a serious adverse event when, based upon appropriate medical judgement, the event may jeopardise the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.