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<p>The study was based on the FDA Adverse Event Reporting System (FAERS) database, with the objective of analysing the actual safety of Neulasta® (pegfilgrastim) in patients with solid tumours. This study also sought to provide a reference for the use of clinical drugs. For patients with solid tumors, data on adverse events (AEs) related to Neulasta® (pegfilgrastim) applications between the first quarter of 2004 and the fourth quarter of 2024 were collected and standardized. Subsequently, an analysis of the signal quantization technique was conducted. The following methods are included: Reporting Odds Ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian Confidence Propagation Neural Network (BCPNN) method, and Multi-Item Gamma Poisson Shrinker (MGPS) method. A total of 193,534 reports were retrieved, encompassing 6,380 Adverse Drug Event (ADE) reports in patients diagnosed with solid tumors, with Neulasta® (pegfilgrastim) identified as the primary suspected pharmaceutical agent. Following the incorporation of duplicate PRIMARYID, the study comprised a total of 2,428 patients. At the level of system organ classes (SOCs), four SOCs were positive in the four signal quantification techniques, including musculoskeletal and connective tissue disorders, general disorders and administration site conditions, blood and lymphatic system disorders, injury, poisoning, and procedural complications. At the preferred term (PTs) level, 251 PTs were found from 26 SOCs, including febrile neutropenia, leukocytosis, eye swelling, lip swelling, swollen tongue, influenza-like illness, application site hemorrhage, injection site pain, application site pain, swelling face, hypersensitivity, lower respiratory tract infection, wrong technique in product usage process, unintentional medical device removal, accidental exposure to product, device use error, drug dose omission by device, intercepted product preparation error, product preparation error, device placement issue, underdose, abnormal white blood cell count, abnormal neutrophil count, increased white blood cell count, bone pain, myalgia, decreased mobility, pelvic pain, urticaria, and hyperhidrosis. These findings, while hypothesis-generating, require validation through controlled epidemiological studies due to the inherent limitations of spontaneous reporting databases. Neulasta® (pegfilgrastim) is a promising treatment option for patients with solid tumors. This study focused on the population of solid tumors, providing more references and support for the FDA-approved labeling regarding the drug-related adverse reactions of Neulasta® (pegfilgrastim) in the population with solid tumors.</p>

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Safety assessment of Neulasta® (pegfilgrastim) in patients with solid tumors: a real-world adverse event analysis from the FAERS database

  • 期刊论文

  • 发表日期：

    2026年4月23日

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  • Keyun Lin,
  • Shuang Chen,
  • Shiying Huang,
  • Mei Jiang

摘要

The study was based on the FDA Adverse Event Reporting System (FAERS) database, with the objective of analysing the actual safety of Neulasta® (pegfilgrastim) in patients with solid tumours. This study also sought to provide a reference for the use of clinical drugs. For patients with solid tumors, data on adverse events (AEs) related to Neulasta® (pegfilgrastim) applications between the first quarter of 2004 and the fourth quarter of 2024 were collected and standardized. Subsequently, an analysis of the signal quantization technique was conducted. The following methods are included: Reporting Odds Ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian Confidence Propagation Neural Network (BCPNN) method, and Multi-Item Gamma Poisson Shrinker (MGPS) method. A total of 193,534 reports were retrieved, encompassing 6,380 Adverse Drug Event (ADE) reports in patients diagnosed with solid tumors, with Neulasta® (pegfilgrastim) identified as the primary suspected pharmaceutical agent. Following the incorporation of duplicate PRIMARYID, the study comprised a total of 2,428 patients. At the level of system organ classes (SOCs), four SOCs were positive in the four signal quantification techniques, including musculoskeletal and connective tissue disorders, general disorders and administration site conditions, blood and lymphatic system disorders, injury, poisoning, and procedural complications. At the preferred term (PTs) level, 251 PTs were found from 26 SOCs, including febrile neutropenia, leukocytosis, eye swelling, lip swelling, swollen tongue, influenza-like illness, application site hemorrhage, injection site pain, application site pain, swelling face, hypersensitivity, lower respiratory tract infection, wrong technique in product usage process, unintentional medical device removal, accidental exposure to product, device use error, drug dose omission by device, intercepted product preparation error, product preparation error, device placement issue, underdose, abnormal white blood cell count, abnormal neutrophil count, increased white blood cell count, bone pain, myalgia, decreased mobility, pelvic pain, urticaria, and hyperhidrosis. These findings, while hypothesis-generating, require validation through controlled epidemiological studies due to the inherent limitations of spontaneous reporting databases. Neulasta® (pegfilgrastim) is a promising treatment option for patients with solid tumors. This study focused on the population of solid tumors, providing more references and support for the FDA-approved labeling regarding the drug-related adverse reactions of Neulasta® (pegfilgrastim) in the population with solid tumors.