Alvopem® (Pemetrexed) Safety Assessment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non Small Cell Lung Cancer, Malignant Pleural Mesothelioma

Intervention / Treatment
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* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|Alvopem® was administered every 3 weeks with a dose of 500 mg/m2|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment | In this safety assessment study, the incidence and intensity of all reported adverse events (AEs) and serious adverse events (SAEs) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events version 5.0 and terminology for AEs was chosen according to the MedDRA system organ class and preferred term. Also, intensity, seriousness, onset of AEs, and interventions for management of the adverse events were documented in the booklet. For each AE, data was summarized using incidence according to system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done and its results was reported by frequency and percentage. | This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC; Mesothelioma; Pemetrexed; Safety assessment; PMS