Evidence map›Paper›PMID 35024073›Full record

ArticleCurrent therapeutic research, clinical and experimental2022

Post-Marketing Surveillance of a generic Oxaliplatin (Alvoxal

Farhad Shahi, Mojtaba Gorji, Mehrdad Payandeh, Hamid Rezvani, Mohammad Vaezi, Sharareh Seifi, Alireza Baari, Reza Khalili-Dizaji, Seyed Mehdi Hashemi, Saeid Salimi and 7 more

Open access · goldAbstract read
In one paragraph

Article in Current therapeutic research, clinical and experimental, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 1 country.

Farhad ShahiDepartment of Medical Oncology, Cancer Research Center, Cancer Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Mojtaba GorjiDepartment of Internal Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.
Mehrdad PayandehDepartment of Hematology and Medical Oncology, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Hamid RezvaniDepartment of Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammad VaeziHematology, Oncology Research Center, Stem Cell Transplant, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.
Sharareh SeifiChronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Alireza BaariHematology and Oncology Section, Internal Medicine Department, Ghaem Hospital, Mashhad, Iran.
Reza Khalili-DizajiHematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Seyed Mehdi HashemiZahedan University of Medical Sciences, Clinical Immunology Research Center, Zahedan, Iran.
Saeid SalimiFirouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
Hosein KamranzadehHematology, Oncology Research Center, Stem Cell Transplant, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.
Babak ShazadDepartment of Hematology and Medical Oncology, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Sina SalariDepartment of Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Davoud Oulad DameshghiClinical Research Development, Qom Medical University, Qom, Iran.
Mehdi SarkheilQazvin University of Medicine, Qazvin, Iran.
Mehrzad MirzaniaDepartment of Medical Oncology, Cancer Research Center, Cancer Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Nassim AnjidaniMedical Department, Orchid Pharmed Company, Tehran, Iran.
Imam Khomeini Hospital · IRKermanshah University of Medical Sciences · IRShahid Beheshti University of Medical Sciences · IRFiroozgar General Hospital · IRGhaem Hospital · IRLorestan University of Medical Sciences · IRMasih Daneshvari Hospital · IRQazvin University of Medical Sciences · IRQom University of Medical Science and Health Services · IRShariati Hospital · IRTabriz University of Medical Sciences · IRUniversity of Tehran · IRZahedan University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic colon cancer. Oxaliplatin is also used in the off-label treatment of gastric cancer. FDA uses post-marketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. It is necessary to perform safety monitoring after marketing authorization is received; such monitoring can be done by means of characterizing the safety of drugs in patients being treated in real-world clinical practice settings.

objectivesThis Phase IV study aimed to evaluate the safety profile of a brand-name formulation of the generic drug oxaliplatin (Alvoxal

methodsPatients with colorectal cancer, gastric cancer, or other malignancies receiving oxaliplatin as a part of their treatment were included in this open-label, multicenter, observational Phase IV study. This study aimed to assess the safety profile of oxaliplatin in patients diagnosed with different cancers.

findingsA total of 483 patients from 16 cities in Iran were enrolled. The most common malignancy was colorectal cancer (55.49%), followed by gastric cancer (28.16%). Based on the results, 405 patients experienced at least 1 adverse event. Most of these adverse events were grade 1 or 2, and the most commonly reported adverse event was anemia (60.66%). During the study, 26 serious adverse events occurred in 15 (3.11%) patients, which were perhaps related to oxaliplatin. There were no remarkable differences in the incidences of adverse events in the system organ classes of blood and lymphatic system disorders, gastrointestinal disorders, or nervous system disorders among patients with different malignancies (ie, colorectal cancer, gastric cancer, and other malignancies) or between genders. The results of this open-label, multicenter, observational, postmarketing surveillance study demonstrated no unexpected safety findings from the use of this oxaliplatin product (Alvoxal

conclusionsThis Phase IV study provides data on the safety profile of a number of chemotherapy regimens containing an oxaliplatin product given to Iranian patients diagnosed with different types of cancer.

Indexed as

AlvoxalⓇcolorectal cancergastric cancerobservationalPhase IVsafety

Identifiers

PMID35024073
PMCPMC8732752
OpenAlexW3216719298

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.