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

HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012
The HOVON Data Center will ensure that a six-monthly line listing of all reported SAE’s is provided to
the Ethics Committee(s) if this is required by national laws or regulations or by the procedures of the
Ethics Committee.
Once every 3 months a safety report listing serious adverse events, serious adverse reactions and
SUSARS, and a tabulation of all adverse events CTCAE grade ≥ 2 will be sent to the DSMB.
12.4 Reporting Suspected Unexpected Serious Adverse Reactions
The HDC Safety Desk, on behalf of the sponsor, will ensure the reporting of any SUSARs to the
Ethics Committees (EC), the Competent Authorities (CA), the manufacturer of the investigational
product and the investigators in compliance with applicable laws and regulations, and in accordance
with any trial specific agreements between the sponsor and a co-sponsor or the manufacturer.
Expedited reporting of SUSARs will occur no later than 15 days after the HOVON Data Center had
first knowledge of the serious adverse event. For fatal or life-threatening cases this will be no later
than 7 days for a preliminary report, with another 8 days for a complete report.
The manner of SUSAR reporting will be in compliance with the procedures of the Ethics Committees
and Health Authorities involved.
12.5 Pregnancies
Pregnancies of a female subject or the female partner of a male subject, occurring while the subject is
on protocol treatment or within 30 days following the last dose of any drug from the protocol treatment
schedule, should be reported to the sponsor. Pregnancies must be reported to the HOVON Data
Center by fax within 24 hours after the event was known to the investigator, using the pregnancy
report form provided. The HOVON Data Center will forward all pregnancy reports to the manufacturer
of the investigational product.
The investigator will follow the female subject until completion of the pregnancy, and must notify the
sponsor of the outcome of the pregnancy within 5 days or as specified below. The investigator will
provide this information as a follow-up to the initial pregnancy report. If the outcome of the pregnancy
meets the criteria for immediate classification as a SAE (i.e., spontaneous or therapeutic abortion,
stillbirth, neonatal death, or congenital anomaly – including that in an aborted fetus), the investigator
should follow the procedures for reporting SAEs. In the case of a live “normal” birth, the sponsor
should be informed as soon as the information is available. All neonatal deaths that occur within 30
days of birth should be reported, without regard to causality, as SAEs. In addition, any infant death
Page 38 of 75 EudraCT-No: 2010-021445-42