Novel Adverse Events of Trastuzumab: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database
Author(s)
Spoorthi H J, MPH.
Student, M S Ramaiah University Of Applied Sciences, Bangalore, India.
Student, M S Ramaiah University Of Applied Sciences, Bangalore, India.
OBJECTIVES: The study aimed to determine the novel signals reported for Trastuzumab in the USFDA Adverse Event Reporting System (FAERS) database
METHODS: In the study, FAERS data was analysed to identify a novel signal for Trastuzumab. The Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) values are obtained from Open Vigil database. Positive signals were defined as values of PRR≥2 and ROR-1.96SE>2 and Chi Square >4.
RESULTS: In the database, a total of 30179725 was reported. Out of them, 8520 responses were linked to Trastuzumab since the drug was approved by USFDA on September 25, 1998. The Open Vigil data showed 10 events of osteosclerosis, 3 events of fingerprint loss and 3 events of glossopharyngeal nerve paralysis. The PRR was found to be 7.979 ( 4.272 ; 14.903 ),ROR was 7.982 ( 4.273 ; 14.911 ) and Chi-Square was 53.393 for osteosclerosis The PRR was found to be 16.257 ( 5.147 ; 51.345 ), ROR was 16.259 ( 5.147 ; 51.357 ) and Chi-Square was 28.102 for fingerprint loss, whereas for glossopharyngeal nerve paralysis, PRR was 59.176 ( 17.868 ; 195.983 ), ROR was found to be 59.182 17.867 ; 196.029 ) and Chi-Square was 105.568 which indicated positive signals.
CONCLUSIONS: The results revealed that Trastuzumab may cause osteosclerosis, fingerprint loss and glossopharyngeal nerve paralysis. These findings have to be confirmed, and further pharmacoepidemiologic research is required to increase the accuracy of the prevalence and/or risk factors of these events.
METHODS: In the study, FAERS data was analysed to identify a novel signal for Trastuzumab. The Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) values are obtained from Open Vigil database. Positive signals were defined as values of PRR≥2 and ROR-1.96SE>2 and Chi Square >4.
RESULTS: In the database, a total of 30179725 was reported. Out of them, 8520 responses were linked to Trastuzumab since the drug was approved by USFDA on September 25, 1998. The Open Vigil data showed 10 events of osteosclerosis, 3 events of fingerprint loss and 3 events of glossopharyngeal nerve paralysis. The PRR was found to be 7.979 ( 4.272 ; 14.903 ),ROR was 7.982 ( 4.273 ; 14.911 ) and Chi-Square was 53.393 for osteosclerosis The PRR was found to be 16.257 ( 5.147 ; 51.345 ), ROR was 16.259 ( 5.147 ; 51.357 ) and Chi-Square was 28.102 for fingerprint loss, whereas for glossopharyngeal nerve paralysis, PRR was 59.176 ( 17.868 ; 195.983 ), ROR was found to be 59.182 17.867 ; 196.029 ) and Chi-Square was 105.568 which indicated positive signals.
CONCLUSIONS: The results revealed that Trastuzumab may cause osteosclerosis, fingerprint loss and glossopharyngeal nerve paralysis. These findings have to be confirmed, and further pharmacoepidemiologic research is required to increase the accuracy of the prevalence and/or risk factors of these events.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH171
Topic
Epidemiology & Public Health, Methodological & Statistical Research, Real World Data & Information Systems
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Infectious Disease (non-vaccine), Oncology, Sensory System Disorders (Ear, Eye, Dental, Skin), Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)