AusPAR: Cabazitaxel - Therapeutic Goods Administration
AusPAR: Cabazitaxel - Therapeutic Goods Administration
AusPAR: Cabazitaxel - Therapeutic Goods Administration
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Other studies<br />
<strong>AusPAR</strong> Jevtana <strong>Cabazitaxel</strong> Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4<br />
Final 9 February 2012<br />
<strong>Therapeutic</strong> <strong>Goods</strong> <strong>Administration</strong><br />
In the Phase I/II studies, the incidence of TEAEs was similar to that in the pivotal study<br />
(Table 10). The incidence of neutropenia in these studies was lower (2.2%, 9.3% and 9.1%<br />
in the ≤ 25 mg/m 2, ≥ 25 mg/m 2 and weekly cabazitaxel). The pattern for the other TEAEs<br />
was similar to that in the pivotal study (Table 11). The pattern of distribution of Grade ≥3<br />
TEAEs in these studies was similar to that in the pivotal study, with diarrhoea, fatigue,<br />
asthenia, neutropenia and febrile neutropenia being the most frequent.<br />
Table 10: Overview of safety - by study and treatment group (Phase III study EFC<br />
6193 and Phase I/Phase II studies<br />
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