Evidence map›Paper›PMID 35205206›Full record

ArticleBiology2022

Comparative Study of Adverse Drug Reactions Associated with Filgrastim and Pegfilgrastim Using the EudraVigilance Database.

Shruti Rastogi, Vivekanandan Kalaiselvan, Yousef A Bin Jardan, Saima Zameer, Maryam Sarwat

Open access · goldAbstract read
In one paragraph

Article in Biology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

7 citing papers in PubMed, 10 citations in OpenAlex.

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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

5 authors at 4 institutions in 3 countries.

Shruti RastogiAmity Institute of Pharmacy, Amity University, Noida 201313, India.ORCID 0000-0003-3308-1655
Vivekanandan KalaiselvanIndian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Ghaziabad 201002, India.
Yousef A Bin JardanDepartment of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia.
Saima ZameerDepartment of Neurodegenerative Science, Van Andel Institute, Grand Rapids, MI 49503, USA.
Maryam SarwatAmity Institute of Pharmacy, Amity University, Noida 201313, India.ORCID 0000-0003-3972-3321
Amity University · INGovernment of India · INKing Saud University · SAVan Andel Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary prophylaxis with filgrastim (FIL) and pegfilgrastim (PEG-F) is recommended to decrease the severity of chemotherapy-induced neutropenia (CIN). The commonly reported adverse drug reactions (ADRs) with FIL and PEG-F is bone pain. ADRs pertaining to FIL and PEG-F were extracted from the European EudraVigilance (EV) database. The Individual Case Safety Reports (ICSRs) obtained from EV database that reported FIL and PEG-F as the suspected drug were analyzed. Registered ADRs (from the groups "General disorders and administration site conditions", "Blood and lymphatic system disorders", "Musculoskeletal and connective tissue disorders" and "Investigations") for FIL and PEG-F were collected from EV database from 2007 to 5 June 2021. The reporting odds ratio (ROR) was used to calculate ICSRs with most common ADRs related to FIL and PEG-F. A total of 17,403 ICSRs described the incidence of most common ADRs of FIL and PEG-F. The commonly reported ADRs for both drugs were pyrexia, bone pain, back pain, neutropenia and febrile neutropenia. The odds ratio of ICSRs belonging to the System Organ Class (SOC) "Investigations" (ROR 1.01 (CI 0.93-1.10)) revealed no significant difference in FIL and PEG-F. However, for the SOCs (General disorders and administration site conditions" and "Musculoskeletal and connective tissue disorders" ((ROR 1.14 (CI 1.06-1.21); ROR 1.21 (CI 1.18-1.32), respectively), an increased reporting probability with PEG-F was found. The authors reported a lower reporting probability for the SOC "Blood and lymphatic system disorders" for FIL versus PEG-F (ROR 0.75 (CI 0.70-0.80)). Our results have demonstrated that the occurrence of bone pain was similar with FIL and PEG-F. For the incidence of pyrexia and back pain, PEG-F was associated with a higher reporting probability as compared to FIL. However, the incidence of neutropenia and febrile neutropenia was higher in FIL compared to PEG-F. Further evaluation of data from real life is needed.

Indexed as

adverse drug reactionEudraVigilancefilgrastimneupogenpegfilgrastimsafety

Identifiers

PMID35205206
PMCPMC8869538
OpenAlexW4213154982

What OpenQuestion holds

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LicenceCC BY
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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.