Alvopem® (Pemetrexed) Safety Assessment

NanoAlvand

Status

Completed

Conditions

Malignant Pleural Mesothelioma

Non Small Cell Lung Cancer

Treatments

Drug: Pemetrexed

Study type

Observational

Funder types

Industry

Identifiers

NCT04843007

ALVOPEM.NA.AK.95 (IV)

Details and patient eligibility

About

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).

Full 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.

Enrollment

199 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients diagnosed with non-small cell lung cancer and malignant pleural mesothelioma under chemotherapy regimens with Alvopem® were enrolled in the study.

Exclusion Criteria: There were no exclusion criteria for this study.