Event data collection and adjudication
cancer, death, Cancer
CANCER, EVENT, DISEASE, METASTATIC DISEASE, NONMELANOMA SKIN CANCER, EVENTS, PATHOLOGY, PRIMARY CANCER, CANCER
Cancer was defined as diagnosis of any new primary cancer, excluding nonmelanoma skin cancer, that had been histopathologically confirmed or clinically evident on imaging. Cancer mortality was defined as death where the primary cause was attributable to cancer. Participants completed a questionnaire designed to record new cancer events at 6-month intervals, and clinical records were searched annually for new cancer diagnoses. All in-trial event reports (cancer and death) triggered the collection of clinical evidentiary documentation (eg, histopathology, specialist letters, imaging, and death certificates) from hospitals, pathology services, and responsible physicians. These clinical documents were compiled into an event summary and presented to a committee of international clinical experts specializing in oncology, for adjudication. Where histopathological confirmation was not undertaken clinically (eg, in the setting of diffuse metastatic disease or patient refusal of surgical intervention of any kind), cancer cases were considered to reach the cancer endpoint only if strong clinical evidence of disease was present on imaging (computed tomography, positron emission tomography, magnetic resonance imaging, or bone scans showing clear primary or diffuse metastatic disease) or blood biomarkers. Alternatively, clinically documented treatment for metastatic disease was considered sufficient to confirm the cancer endpoint. If the results of imaging investigations were unclear, suspicious, or inconclusive imaging, the cancer case was not considered a cancer endpoint. Further details of the cancer and cause-of-death adjudication processes have been published elsewhere (