Outcomes
ascites, death, SADRs, PD, increasing bowel dysfunction
ASCITES, PERITONEAL CARCINOMATOSIS, ADVERSE EVENTS, EVENT, BOWEL OBSTRUCTION, ADVERSE EVENT, EVENTS, ADVERSE DRUG REACTIONS
The primary endpoint was OS which was measured from the date of randomisation up to the date of death due to any cause or, for living patients, the date of the last contact.Secondary endpoints included progression-free survival (PFS), PFS after subsequent therapy (PFS-ST), PFS at second progression (PFS2), safety profile and HRQoL. PFS was measured from the date of randomisation to the date of documented PD or death due to any cause, whichever came first. If a patient received further antitumor therapy before PD, PFS was censored on the date of this anti-tumour therapy. The objective clinical progression that did not require radiological confirmation was peritoneal carcinomatosis with increasing bowel dysfunction, increased ascites requiring drainage, emerging surgical procedures due to bowel obstruction. PFS-ST was defined as the time from the first dose of subsequent treatment (ST) until progression or death due to any cause and analysed on patients receiving a ST after INOVATYON. PFS2, which was not planned in the original protocol but recommended by the IDMC, was taken as the time from the date of randomisation until the second progression or death due to any cause and analysed on randomised patients.Safety endpoints were: for each drug-related adverse event, the maximum grade experienced by each patient; for each drug-related adverse event, patients experiencing grade 3–4 events. If the same drug-related adverse event occurred two or more times in the same patient, this was counted as a single event and the worst grade was considered.Type, frequency and nature of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) were also described.