AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites

The study consisted of:

A 30-day screening phase prior to Day 1
Day 1 registration and pre-treatment paracentesis
Aflibercept administration within 1-day of registration
Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
A 60-day post-treatment follow-up phase

During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation:

Participant (or legal representative) chose to withdraw from treatment
The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being
Participant had intercurrent illness that prevented further administration of investigational product (IP)
Participant had more than 2 IP dose reductions
Participant had unacceptable adverse events (AEs)
Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina
Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation