Alvopem® (Pemetrexed) Safety Assessment

Status Completed

Clinical Trial Summary

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. No control groups were included in the study design. The primary objective of this study was safety assessment, including the incidence of AEs.

Clinical Trial Description

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 SAEs . This study was single arm and the sample size of this study was 199 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04843007
Study type	Observational
Source	NanoAlvand
Contact
Status	Completed
Phase
Start date	October 5, 2016
Completion date	January 22, 2020

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