Pharmacovigilance FAQs

 

SAE Completion

a. I don’t know the last date the patient had their SOC HT (they are administering it at home). Is it ok to put “unk” on the SAE form?

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.

 

b. need to submit an updated SAE report. Should I start a new report?

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.

 

c. My patient has developed a second cancer and the consultant wants to continue with Abiraterone/Metformin /any protocol research drug. How do I report SAEs for this patient?

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.

 

d. What should I write in the event description?

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.

 

 

 

Reporting Method

e. I am having trouble faxing the SAE report. Am I allowed to email it instead?

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.

 

f. I submitted a SAE report to MRCCTU yesterday but have not received an acknowledgement email. When should I expect this?

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.

 

g. I have completed a SAE report but the consultant is unable to review and sign it until next week. Should I wait until (s)he has signed to fax it?

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.

 

 

 

Reporting Tools

h. I have an event, which I’m not sure if it should be reported or not? What do I do?

Please follow the SAE reporting flowchart below.

 

i. What does the causality of an event to a drug mean?

Please see the table below

  

 

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Arm A/ Original comparisons

j. Why are we collecting SAEs in Arm A patients?

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.

 

k. When should I stop submitting SAE reports 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.

 

l. Do I need to submit SAEs for patients on arms BCDEF and arm A who were randomised before November 2011?

No, once the original comparison closure has taken place we no longer require you to report SAEs for patients on these arms.

 

 

Treatment related Questions

m. What “other medications” should I report on the SAE?

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. 

 

n. My patient has been admitted for neutropenia after receiving chemotherapy for a second cancer. Should I report this as an SAE?

If research metformin continues post progression then this should be reported. However, after protocol treatment (1^st 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.

 

 

LHRH

o. My patient stopped research treatment due to side effects and remains on androgen deprivation therapy alone (LHRH), do I still need to report SAEs?

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.

 

 

Hospital Admissions

p. My patient attended A&E but was discharged after a couple of hours, should I submit an SAE for this?

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

 

q. My patient has had recurring admissions for the same event. Should this be reported on one SAE report or several separate reports?

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.

 

r. My patient was electively admitted for a hip replacement, whilst in hospital he experienced a myocardial infarction which delayed his discharge. How should I report this?

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.

 

s. My patient was admitted for 4 hours after attending A&E but discharged same day. Should I report this as a 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.

 

t. I have been reviewing a patient’s notes and found they were hospitalised 18 months ago but no SAE was submitted. Do you still need to know about this admission?

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.

 

 

 

Patient Progression

u. My patient progressed last year but has been admitted to hospital recently. Should I report this as a SAE?

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.

 

v. My patient has been admitted for further tests for potential disease progression (worsening cancer symptoms or suspected spinal cord compression.) Should this be reported as a SAE?

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.

 

w. My patient has confirmed disease progression after an admission to hospital. How should I update the SAE report I previously submitted?

If progressive disease is confirmed please update the initial SAE report event description and re-submit to MRCCTU.

 

x. Should Post-progression Metformin still be classified as a protocol treatment, post progression or should it then be considered as SOC treatment or 2nd line?

Metformin should still be regarded as a protocol treatment following progression until it is stopped.

 

y. Are Arm K events post-progression still reportable, if the patient remains on Metformin?

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

 

 

Reporting Death

z. My patient died at home and I am unable to find out cause of death or obtain the death certificate. Should this be reported as a SAE?

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.