{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"190"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"}],"units":"Participants"}],"description":"In this study, number of participants who experienced at least one adverse event (AE) or one serious adverse event (SAE) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and terminology for AEs was chosen according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term. Also, intensity, seriousness, onset of AEs, and interventions for management of the adverse events were documented in the booklet. For each AE, data was summarized using system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done based on the World health organization-Uppsala Monitoring Centre (WHO-UMC) system.","groups":[{"description":"500 mg/m\\^2 pemetrexed, IV infusion\n\nPemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\\^2","id":"OG000","title":"NanoAlvand Pemetrexed"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population is defined as all patients who received at least one dose of the study drug. In this study, a total of 199 patients with non-squamous non-Small cell lung cancer (NSCLC) or malignant pleural mesothelioma (MPM) were enrolled. However, one patient was excluded from the safety analysis due to the absence of a recorded diagnosis, resulting in a safety population of 198 individuals.","reportingStatus":"POSTED","timeFrame":"This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition","title":"Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE))","type":"PRIMARY","unitOfMeasure":"Participants"}