This improved efficacy was at the expense of increased toxicity which was manageable, as the incidence of grade 3 or 4 toxicity did not exceed 20% 7– 9. Nevertheless, infusional chemotherapy requires a central venous catheter with its associated complications, frequent hospital visits (every 2 weeks) and the need to carry a pump.
The data also suggest that nintedanib has a manageable safety profile, with incidences of the AEs of hypertension, hypothyroidism, cardiac disorders, HFS and haematological abnormalities being lower than typically expected with the use of a TKI.
Conclusion: Local AEs with hylan G-F 20 were of low incidence, were clinically manageable, and did not affect treatment efficacy.
NCI-CTC grades 3 or 4 nonhaematologic toxicities were minimal in incidence and all manageable (diarrhoea in 3% and vomiting in 3%).
In contrast to the incidence of the manageable hemorrhage, the life-threatening postoperative hemorrhage after Le Fort osteotomy is rare and varies between an incidence of 0 and 0.7 % [ 21].
Toxicity profiles for the other two cohorts were more manageable (Table 3), and the incidence and types of adverse events were similar to those in previous phase II studies of gemcitabine plus doxorubicin in patients with breast cancer (Pérez-Manga et al, 2000; Gomez et al, 2001; El Serafy et al, 2003; Bensalem and Bouzid, 2006).
The most frequently reported grade 3 4 adverse events in phase III trials of bevacizumab plus IFN include fatigue and asthaenia, hypertension, anorexia, bleeding, pyrexia and proteinuria; the majority of these are mild to moderate and manageable, and only a low incidence of grade 3 4 events is observed (Escudier et al, 2007; Rini et al, 2008).
Although there are not yet published results on this MRX34 treatment, a recent update revealed that MRX34 has a manageable safety profile with only one incidence of a dose-limiting toxicity [ 109].
28 Therefore, a goal of future development of antiangiogenic agents in HCC is a manageable side-effect profile with a low incidence of liver-related toxicity.
All bleeding incidents were easily manageable.
Most of the treatment-related adverse events, although high in incidence, were grade ≤2 and clinically manageable.
