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SAE Reporting Reminder

  • Any SAEs that occur following the first dose of IMP until up to 30 days following the last dose of IMP must be reported via the SPIRIT 2 SAE reporting form and followed by entry of an AE page in the eCRF
  • SAE reporting is still required for patients who complete 5 years on SPIRIT 2 but remain on Dasatinib IMP provided through the study (as the patients continue to take IMP)
  • SAEs occurring more than 30 days after the last dose of IMP do not need to be reported unless they are believed to be caused by the IMP treatment (i.e. SARs). SARs must be reported regardless of the length of time since the last IMP dose
  • Please ensure that any serious adverse events are reported to the Trial Office within 24 hours of site awarenes

The SPIRIT 2 protocol states the criteria for SAEs are:

  •  An event that is fatal or life threatening (life threatening is anything that would result in the patient’s death if left untreated)
  • An event that results in significant or persistent disability
  • An event that leads to the hospitalisation of the patient (any overnight inpatient stay) or prolongs existing hospitalisation. This includes any elective (planned) admission (for example knee replacement etc.)
  • Adverse pregnancy outcomes in a patient or partner of a male patient (including spontaneous abortion). Pregnancy itself is not an SAE however should be reported to the trial office via the Pregnancy Reporting Form (downloadable from: http://www.spirit-cml.org/isf/studyspecificdocuments-part1). This includes pregnancies in the partners of male patients
  • Any other significant medical event (in the opinion of the Principal or Co-Investigator)
  • A diagnosis of any malignancy (other than Chronic Myeloid Leukaemia (CML)) – as included in Protocol version 2.0
  • Progression of CML to accelerated phase or blast crisis

If you have any queries relating to SAE reporting please contact the Trial Office on 0191 241 8668.

 

Last modified: Thu, 08 Jun 2017 09:54:31 BST