NCT04843007

Alvopem® (Pemetrexed) Safety Assessment

Alvopem® (Pemetrexed) Safety Assessment in Patients With Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 199 (actual)
• Sponsor: NanoAlvand · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 adverse events (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 serious adverse events (SAEs). This study was single arm and the sample size of this study was 199 patients.

Conditions

• Non Small Cell Lung Cancer
• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Pemetrexed	Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2

Timeline

• Start date: 2016-03-15
• Primary completion: 2020-01-22
• Completion: 2020-01-22
• First posted: 2021-04-13
• Last updated: 2024-10-23
• Results posted: 2024-10-23