First results of the Phase II TITAN trial: anti-von Willebrand ... - Ablynx
First results of the Phase II TITAN trial: anti-von Willebrand ... - Ablynx
First results of the Phase II TITAN trial: anti-von Willebrand ... - Ablynx
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Serious adverse events<br />
• 2 SAEs reported in 2/5 subjects during treatment phase:<br />
– metrorrhagia with severe anaemia<br />
o1 subject in perimenopausal period<br />
oresolved<br />
ostudy drug discontinued, subject withdrew consent<br />
oconsidered possibly related to study drug by <strong>the</strong> Investigator → but in<br />
perimenopausal age, <strong>the</strong> most common cause <strong>of</strong> abnormal vaginal bleeding<br />
is anovulation (Nesse RE, Am Fam Physician 1999, James A et al. Eur J Obstet Gynecol Reprod Biol<br />
2011)<br />
– Urinary tract infection<br />
o1 subject<br />
oresulting in hospitalisation<br />
oresolved<br />
oconsidered unlikely/not related to study drug by <strong>the</strong> Investigator<br />
31
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