Spots Global Cancer Trial Database for Alvopem® (Pemetrexed) Safety Assessment
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Trial Identification
Brief Title: Alvopem® (Pemetrexed) Safety Assessment
Official Title: Alvopem® (Pemetrexed) Safety Assessment in Patients With Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma
Study ID: NCT04843007
Interventions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Adnan Khosravi, Associate Professor
Affiliation: National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
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