A multicenter, randomized phase III study of bortezomib and ...

HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012
12.2.2 Follow up of adverse events
All adverse events will be followed clinically until they have been resolved, or until a stable situation
has been reached. Depending on the event, follow up may require additional tests or medical
procedures as indicated, and/or referral to the general physician or a medical specialist.
On the AE CRF only the incidence of adverse events is recorded. Any ongoing adverse event that
increases in severity is to be reported as a new adverse event on the CRF. Other follow up
information is not collected on the CRF.
12.3 Serious Adverse Events
12.3.1 Reporting of serious adverse events
Serious Adverse Events (SAEs) will be reported from the first study-related procedure until 30 days
following the last dose of any drug from the protocol treatment schedule or until the start of
subsequent systemic therapy for the disease under study, if earlier.
Serious Adverse events occurring after 30 days should also be reported if considered at least possibly
related to the investigational medicinal product by the investigator.
SAEs must be reported to the HOVON Data Center by fax within 24 hours after the event was
known to the investigator, using the SAE report form provided. This initial report should contain a
minimum amount of information regarding the event, associated treatment and patient identification,
as described in the detail in the instructions for the SAE report form. Complete detailed information
should be provided in a follow-up report within a further 2 business days, if necessary.
The following events are not considered to be a Serious Adverse Event:
1. Hospitalization for protocol therapy administration. Hospitalization or prolonged hospitalization
for a complication of therapy administration will be reported as a Serious Adverse Event.
2. Hospitalization for diagnostic investigations (e.g., scans, endoscopy, sampling for laboratory
tests, bone marrow sampling) that are not related to an adverse event. Hospitalization or
prolonged hospitalization for a complication of such procedures remains a reportable serious
adverse event.
3. Prolonged hospitalization for technical, practical, or social reasons, in absence of an adverse
event.
4. Hospitalization for a procedure that was planned prior to study participation (i.e. prior to
registration or randomization). This should be recorded in the source documents. Prolonged
hospitalization for a complication of such procedures remains a reportable serious adverse
event.
Page 36 of 75 EudraCT-No: 2010-021445-42