who have less than one-third of the hemithorax occupied by pleural fluid, the primary physician should discuss with another local physician who is blinded to inhibitor Rucaparib the treatment arm whether pleural intervention is required. Data management Clinical Record Forms (CRF) will be completed by the trial team at recruiting centres and sent to the ORTU. Data will then be entered onto the trial database (OpenClinica clinical trials software). Missing data and data queries will be highlighted to the trial teams on a monthly basis. The CRFs will only identify patients using their personal trial identification number (no identifiable patient information). Primary outcome The primary outcome is the number of patients who experience pleurodesis failure up to 3 months (90 days)
postrandomisation. A patient is defined as experiencing pleurodesis failure if they undergo any of the following procedures on the side ipsilateral to their trial intervention: Therapeutic pleural aspiration of ≥100 mL; or Insertion of an intercostal drain for fluid drainage; or Insertion of an indwelling pleural catheter; or Medical or surgical thoracoscopy. A patient is also deemed to have failed pleurodesis if their primary physician decides that they require one of the above pleural interventions, but the intervention is not performed. The primary physician is not blind to the treatment arm; however, all decisions to intervene or not in effusions which occupy less than or equal to one-third of the hemithorax will be discussed with a second clinician who is blind to treatment allocation. Secondary outcomes The trial’s secondary outcomes are: The number of patients with pleurodesis failure up to 30 days postrandomisation. The number of patients with pleurodesis failure up to 180 days postrandomisation. Requirement for further pleural procedures up to 180 days postrandomisation, based on an independent assessment performed
by two adjudicators who are blind to the treatment outcome and clinical course. Percentage pleural opacification (on CXR) at 1-month, 3-month and 6-month postrandomisation follow-up visits, and after initial drain AV-951 removal. Self-reported health-related quality of life at 1-month, 3-month and 6-month follow-up postrandomisation visits, measured using SF-36 and EQ-5D questionnaires. Self-reported thoracic pain and breathlessness (postrandomisation) at 7, 30, 90 and 180 days, measured using VAS scores. All-cause mortality up to 180 days postrandomisation. Time to pleurodesis failure, censored at 180 days postrandomisation. Number of nights spent in the hospital up to 90 days postrandomisation, including length of initial hospital stay.