N/A
N=199
Alvopem® (Pemetrexed) Safety Assessment
Non Small Cell Lung Cancer · Malignant Pleural Mesothelioma
Bottom Line
View on ClinicalTrials.gov: NCT04843007 ↗Enrolled (actual)
199
Serious AEs
25.3%
Results posted
Oct 2024
Primary outcome: Primary: Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) — 190 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pemetrexed (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- NanoAlvand
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) |
190 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT04843007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.