MRC Clinical Trials Unit at UCL
90 High Holborn
Yes – However the SAE report should be updated once you have confirmed the date. A partial date e.g MM/YYYY is acceptable if an exact date cannot be provided.
No – Please update the changes on the original report, crossing through and initial all changes. This is especially important where the main diagnosis changes, and ensures MRCCTU does not record duplicate events.
All second primary cancers should be reported as a notable event using the SAE CRF. Any subsequent non-elective admissions will remain reportable until 30 days after stopping of research treatment. All elective admissions e.g. planned treatment visits or elective surgeries remain exempt.
The event description should be a brief overview of what happened including any relevant signs and symptoms, treatment for the event and rationale for the causality and expectedness given. This may be replaced by a discharge summary if available.
Yes - If you are short of time or experiencing problems with faxing then you may email it via galaxkey or password protected. However in general fax submission is recommended.
Acknowledgement emails should be received within 1-3 working days of receipt. Please contact us if you are yet to receive one after 3 working days.
No – please send the SAE report within 24 hours of becoming aware of the event. Please submit an updated report once the clinician has countersigned.
Please follow the SAE reporting flowchart below.
Please see the table below
The STAMPEDE trial is comparing new treatment strategies with the current standard approach. To make a fair comparison we are collecting SAEs in the same way on the control arm and all research arms.
SAEs should be reported until disease progression or until 30 days after the last exposure to hormone therapy e.g. 30 days after the expiration date of the depot.
No, once the original comparison closure has taken place we no longer require you to report SAEs for patients on these arms.
This should be used to record any other treatments being taken for prostate cancer and any other medications that may be related to the event. It is not necessary to provide details of any treatments given as part of treatment for the serious adverse event or reaction.
If research metformin continues post progression then this should be reported. However, after protocol treatment (1st line ADT and all STAMPEDE research treatments) has stopped for more than 30 days, only late reactions to STAMPEDE research treatments and notable events (second primary cancers) are reportable.
Yes, in patients who remain on ADT alone the same rules apply as for Arm A patients. SAEs should be reported until disease progression or until 30 days after the last exposure to hormone therapy e.g. 30 days after the expiration date of the depot. In addition, any late reactions to research treatment should always be reported.
Hospitalisation is defined as an inpatient admission, regardless of length of stay, even if the hospitalisation is a precautionary measure for continued observation. Hospitalisations for a pre-existing condition (including elective procedures that have not worsened) do not constitute an SAE
It depends – If the patient was discharged and immediately came back feeling unwell then this could be recorded on the initial report. However if the event is > 1 day after the initial admission a separate report should be submitted.
As the admission for the hip replacement was elective (planned) then is this exempt from reporting as a SAE. However, as the myocardial infarction prolonged the hospital admission this does meet the definition of serious and so should be reported as an SAE.
A&E attendances do not fulfil the definition of a serious event however all inpatient admissions do, regardless of the length of stay. Therefore a 4 hour admission following A&E attendance is reportable as a SAE.
Yes – please submit a SAE report within 24 hours of discovering the event, regardless of when it occurred. Please include in the event narrative an explanation for the late reporting.
It depends; some treatments such as metformin may continue post progression. If research treatment has been received in the last 30 days then all SAEs are reportable. If research treatment stopped more than 30 days ago, the SAE is only reportable if is possibly related to research treatment (i.e. a late reaction) or it’s a notable event i.e. a second primary cancer.
Yes – if you are unsure whether the event is progression or not then please submit an SAE. Please then update the CTU when the results of tests are known. If progression is confirmed then we will ask you to nullify the SAE and provide an updated progression log instead. Please remember that spinal cord compression is a skeletal related event which should be reported on the follow-up form.
If progressive disease is confirmed please update the initial SAE report event description and re-submit to MRCCTU.
Metformin should still be regarded as a protocol treatment following progression until it is stopped.
Yes, serious adverse events occurring after disease progression that are unrelated (i.e: not SARs or SUSARs) to protocol treatment are exempt, providing protocol treatment stopped at least 30 days ago
Yes – Please submit the SAE report and update once the cause of death is known. Deaths occurring as a result of disease progression are exempt from reporting as SAEs but where this is uncertain both an SAE and death form should be reported.
Have another question or looking for more information? why not check out the STAMPEDE Training Suite for the training slides detailing information on STAMPEDE.
MRC Clinical Trials Unit at UCL
90 High Holborn
Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy
See the latest News in STAMPEDE through the link to the right.