Patient-Reported Outcomes. Patient reported outcomes will be captured using an electronic device. All patients enrolled in the study will complete the self-administered questionnaires for the FACIT-Fatigue (Version 4), EuroQoL 5 Dimensions, 3-Level version (EQ-5D-3L) scales and European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire-Core 30 scale (QLQ-C30), Version 3.0, as indicated in Section 1.3. PROs should be administered as early as possible during clinic visits.
Patient-Reported Outcomes. The EORTC QLQ-C30, EORTC QLQ-OV28, EQ-5D-5L, and PGIS questionnaires will be used to collect data on the patient’s functioning, health-related QOL, disease symptoms and health status. The primary PRO endpoint is the number of patients achieving at least a 15% ( ≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at the Week 8/9 assessment (Xxxxxxxx 2014). Patients with missing week 8/9 questionnaires will be excluded from analysis unless they have PD or death prior to week 8/9 assessment in which case they will be included as unimproved. Results will be summarized and presented by each treatment arm. Comparison between the two treatment arms will be carried out using appropriate statistical tests. Details of the analysis methods for PRO endpoints will be described in a PRO Statistical Analysis Plan.
Patient-Reported Outcomes. The abdominal/GI scale of EORTC QLQ-OV28 PRO will be a key secondary endpoint and will include the number of patients achieving at least a 15 point absolute improvement at Week 8/9 assessment.
