TriangleNCT04843007 · REGISTRY CONDITION SEARCH
Alvopem® (Pemetrexed) Safety Assessment
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- COMPLETED
- Registry last update
- 2024-10-23
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).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility 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.
- healthy Volunteers
- false
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
- study Population
- Patients with non-small cell lung cancer and malignant pleural mesothelioma were included in the study.
Treatment arms and interventions
- arm Groups
- description
- 500 mg/m\^2 pemetrexed, intravenous (IV) infusion
- intervention Names
- Drug: Pemetrexed
- label
- NanoAlvand Pemetrexed
- interventions
- arm Group Labels
- NanoAlvand Pemetrexed
- description
- Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
- name
- Pemetrexed
- other Names
- Alvopem®
- type
- DRUG
Study design
- observational Model
- CASE_ONLY
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 199
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- In this study, number of participants who experienced at least one adverse event (AE) or one serious adverse event (SAE) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and terminology for AEs was chosen according to the Medical Dictionary for Regulatory Activities (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 system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done based on the World health organization-Uppsala Monitoring Centre (WHO-UMC) system.
- measure
- Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE))
- time Frame
- 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
Full 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 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.
Source references
- references
- citation
- Seifi S, Salimi B, Monfared ZE, Sabahi C, Kafi H, Khosravi A. Alvopem(R) (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance. J Pharm Policy Pract. 2023 Jan 25;16(1):16. doi: 10.1186/s40545-023-00524-5.
- pmid
- 36698207
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- Malignant Mesothelioma
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Preserved source evidence · Not medical advice