Evidence map›Paper›PMID 35792924›Full record

ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2022

Evaluating the safety and effectiveness of PegaGen

Arash Jenabian, Ali Ehsanpour, Seyed Mohammad Reza Mortazavizadeh, Jahangir Raafat, Mohsen Razavi, Adnan Khosravi, Sharareh Seifi, Babak Salimi, Nassim Anjidani, Hamidreza Kafi

Registry-linked trialAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04460079 (Safety and Effectiveness Assessment of PeGagen®), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 54% 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.

NCT04460079 completednot on this map

Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients

TypeobservationalSponsorCinnagenRan2016 to 2019Enrolled654ConditionsChemotherapy-induced NeutropeniaArmsPeg-filgrastim
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Effectiveness and safety of pegylated filgrastim (Pelgraz®) for the prevention of febrile neutropenia during cancer chemotherapy in all-day practice in Germany.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Observational
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

10 authors at 6 institutions in 1 country.

Arash JenabianDepartment of Medical Oncology and Hematology, Booali Hospital, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran. dr.jenabian.a@gmail.com.
Ali EhsanpourThalassemia and Hemoglobinopathy Research Center, Research Institute of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Seyed Mohammad Reza MortazavizadehDepartment of Internal, Faculty of Medicine, Islamic Azad University, Yazd, Iran.
Jahangir RaafatMehrad Hospital, Tehran, Iran.
Mohsen RazaviDepartment of Oncology and Hematology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Adnan KhosraviChronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, 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.
Babak SalimiChronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Nassim AnjidaniMedical Department, Orchid Pharmed Company, Tehran, Iran.
Hamidreza KafiMedical Department, Orchid Pharmed Company, Tehran, Iran.
Shahid Beheshti University of Medical Sciences · IRAhvaz Jundishapur University of Medical Sciences · IRIran University of Medical Sciences · IRIslamic Azad University Medical Branch of Tehran · IRIslamic Azad University, Yazd · IRMasih Daneshvari Hospital · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePhase IV clinical trials are required to evaluate the real-world safety and effectiveness of drugs. This study aimed to evaluate the safety and effectiveness of once-per-cycle administration of PegaGen

methodsIn this open-label, multicenter, prospective, real-world, post-marketing surveillance study, patients with any type of cancer receiving chemotherapy regimens with a high risk of febrile neutropenia (FN) were included if they were prescribed pegfilgrastim for FN prophylaxis. The primary objective of this study was to assess the safety and the secondary objective was to assess the effectiveness of pegfilgrastim in the prevention of FN in cancer patients.

resultsA total of 654 patients (51.73 ± 15.12 years of age) were enrolled and 3615 cycles of pegfilgrastim injections were recorded. The most common malignancies among the study patients were breast cancer (n = 192, 29.36%), lymphoma (n = 131, 20.03%), and gastric cancer (n = 65, 9.94%). The median (Q1, Q3) number of pegfilgrastim cycles per patient was 6 (4, 7). A single 6 mg dose was injected in 99.17% of the cycles. A total number of 816 adverse events (AEs) were reported in 246 patients (37.62%). Bone pain was recorded in 141 patients (21.56%) and in 440 cycles (12.17%). Among all patients, 45 patients (6.88%) experienced FN 51 times, and FN frequency was 1.4% among cycles. Moreover, 14 (2.14%) patients were hospitalized following FN. Antibiotics were administered to 24 patients (3.67%) for FN treatment.

conclusionThe results from this post-marketing surveillance study support the safety and effectiveness of PegaGen

trial registrationClinicaltrials.gov identifier: NCT04460079.

Indexed as

Antineoplastic AgentsBreast NeoplasmsChemotherapy-Induced Febrile NeutropeniaFebrile NeutropeniaAnti-Bacterial AgentsAntineoplastic Combined Chemotherapy ProtocolsFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansPolyethylene GlycolsProduct Surveillance, PostmarketingProspective StudiesRecombinant ProteinsAnti-Bacterial AgentsAntineoplastic AgentsFilgrastimGranulocyte Colony-Stimulating FactorpegfilgrastimPolyethylene GlycolsRecombinant ProteinsFebrile neutropeniaPegfilgrastimPhase IVPMSPost-market surveillance

Identifiers

PMID35792924
OpenAlexW4283828498

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.