The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma.
Data was gathered in one booklet, which had 6 different periods. The patients' information assessed after each injection, every 3 weeks. These booklets were completed by designated physicians.
The primary objective of this study was safety assessment, including the incidence and intensity of AEs and serious adverse events (SAEs).
This study was single arm and the sample size of this study was 199 patients.