Time to Repeat Paracentesis (TRP)
TRP is the number of days between the date of registration and the date of the first postregistration paracentesis. Median TRP was estimated from Kaplan-Meier curves. For participants who did not undergo a postregistration paracentesis while on study, TRP was censored at the end of the treatment period (last dose + 1 cycle), at the last visit known without repeat paracentesis, at 6 months postregistration, or at death, whichever was earlier.
Time frame: up to 6 months from registration
60-day Frequency of Paracentesis (FOP)
FOP was the total number of paracenteses performed within the first 60 days postregistration. For participants who had withdrawn after registration but prior to the 60-day cutoff date, the withdrawal would have been regarded as a paracentesis event and the 60-day FOP normalized and calculated as the nearest integer of the value corresponding to 60 × number of paracenteses / x, where x represents the number of days on study.
Time frame: up to 60 days post-registration
Progression-free Survival (PFS) Time
According to the Response Evaluation Criteria in Solid Tumors \[RECIST\], progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.
PFS time was interval from the date of registration to the date of tumor progression or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.
If participants were alive and progression-free at 6 months postregistration, they were censored for PFS.
Time frame: up to 6 months post-registration
Overall Survival (OS) Time
OS time was the time interval between the date of registration to the date of death from any cause. Median OS was estimated from Kaplan-Meier curves. Participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.
Time frame: up to 6 months post-registration
Number of Participants With a Positive Anti-drug Antibody Response
Anti-drug antibodies in participant's serum were measured using 2 different methods
* an Enzyme Linked Immunosorbent Assay (ELISA) in which the lower limit of detection (LLOD) was 238.4 ng/mL; and
* an Electrochemiluminescence-based, Bridging Assay in which the validated LLOD was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.
Participants with detectable anti-drug antibodies by either method were considered to have a positive anti-drug antibody response.
Time frame: up to 60 days after the last dose of treatment
Safety - Number of Participants With Adverse Events (AE)
All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.
Time frame: up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized
