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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 adverse events (AEs).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoAlvand Pemetrexed | 500 mg/m^2 pemetrexed, intravenous (IV) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | Alvopem® was administered every 3 weeks with a dose of 500 mg/m^2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) | 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. | 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 |
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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.
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Patients with non-small cell lung cancer and malignant pleural mesothelioma were included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Adnan Khosravi, Assoc. Prof. | National Research Institute of Tuberculosis and Lung Disease (NRITLD) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36698207 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NanoAlvand Pemetrexed | 500 mg/m^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m^2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NanoAlvand Pemetrexed | 500 mg/m^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m^2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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)) | 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. | The safety population is defined as all patients who received at least one dose of the study drug. In this study, a total of 199 patients with non-squamous non-Small cell lung cancer (NSCLC) or malignant pleural mesothelioma (MPM) were enrolled. However, one patient was excluded from the safety analysis due to the absence of a recorded diagnosis, resulting in a safety population of 198 individuals. | Posted | Count of Participants | Participants | 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 |
Three years and half
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NanoAlvand Pemetrexed | 500 mg/m^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m^2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 4.0 Beta | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 4.0 Beta | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hamidreza kafi | NanoAlvand | 9129232594 | +98 | Kafi.h@orchidpharmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2019 | May 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2020 | May 14, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Surface Area (BSA) | Mean | Standard Deviation | m^2 |
|
| Smokers | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Serum Creatinine (SCr) | Mean | Standard Deviation | mg/dL |
|
| Bilirubin | Mean | Standard Deviation | mg/dL |
|
| Blood Urea Nitrogen (BUN) | Mean | Standard Deviation | mg/dL |
|
| Aspartate Aminotransferase (AST) | Mean | Standard Deviation | units/L |
|
| Alanine Aminotransferase (ALT) | Mean | Standard Deviation | units/L |
|
| Platelet (PLT) | Mean | Standard Deviation | cells/μL |
|
| White Blood Cell (WBC) | Mean | Standard Deviation | cells/μL |
|
| Neutrophil | Mean | Standard Deviation | cells/μL |
|
| Hemoglobin (Hb) | Mean | Standard Deviation | g/dL |
|
|
|
|
| 28 |
| 198 |
| 50 |
| 198 |
| 190 |
| 198 |
| leukopenia | Blood and lymphatic system disorders | MedDRA 4.0 Beta | Non-systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | MedDRA 4.0 Beta | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 4.0 Beta | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 4.0 Beta | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 4.0 Beta | Non-systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 4.0 Beta | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 4.0 Beta | Non-systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA 4.0 Beta | Non-systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |