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Overview

From the first quarter of 2018 to the fourth quarter of 2023, this study obtained a total of 10,530,937 adverse event reports from the FAERS database. After removing duplicates of 2254, of the 9,060,312 cases reported, 1211 reports listed avatrombopag as primary suspected drug. An overview of AEs reported in association with avatrombopag is provided in Table 1. Women (54.3%) accounted for a larger proportion of AEs than men. Patients aged65years accounted for a larger proportion (22.2%) of participants. The largest number of AEs was reported in the United States (88.2%), followed by Spain (2.1%), Italy (1.8%), China (1.7%), and Australia (0.8%). Serious outcomes included hospitalization, death, life-threatening conditions, disability, and other serious outcomes. Excluding the other serious outcomes, hospitalization (34.6%) was the most frequently reported serious outcome, followed by death (15.4%). Consumers, physicians, and health professionals reported the most AEs (42.3%, 26.0%, and 24.6%, respectively). AEs were reported in 2018 (n=55, 4.5%), 2019 (n=110, 9.1%), 2020 (n=262, 21.6%), 2021 (n=257, 21.2%), 2022 (n=245, 20.2%), and 2023 (n=282, 23.3%).

In Table 2, potential signals for avatrombopag are described in accordance with the SOC. Statistics show that 26 organ systems were affected by reported AEs. No potential signals satisfied our signal criteria when AE reports were classified at the SOC level. Significant potential signals for the nervous system disorders, general disorders and administration site conditions, vascular disorders, investigations, and hepatobiliary disorders SOCs were identified for at least one of the four disproportionality indices.

In total, disproportionality signals were identified for 44 PTs involved 17 SOCs conforming to the four algorithms simultaneously are shown in Table 3. In our statistical results, the most common AEs were platelet count decreased (20.2%, n=165, PT: 10,035,528), headache (16.7%, n=136, PT: 10,019,211), platelet count increased (11.9%, n=97, PT: 10,051,608), platelet count abnormal (6.3%, n=51, PT: 10,035,526), contusion (2.7%, n=22, PT: 10,050,584), pulmonary embolism (2.3%, n=19, PT: 10,037,377), and deep vein thrombosis (2.1%, n=17, PT: 10,051,055). In this study, PTs that were reported at a high relative frequency were unlabeled in the avatrombopag product labeling7 were seasonal allergy (PT: 10,048,908), rhinorrhea (PT: 10,039,101), abnormal liver function (PT: 10,024,690), antiphospholipid syndrome (PT: 10,002,817), ear discomfort (PT: 10,052,137), and photopsia (PT: 10,034,962).

The onset times of AEs reported with avatrombopag were extracted from the database. Patients whose time-to-onset analysis report fields in FAERS were blank or contained inaccurate information were excluded, 499 AEs onset times (41.2%) were reported (median 60days). In approximately 55.7% of cases (n=278), AEs occurred within the first month after initiation of avatrombopag (Fig.2A). Additionally, the proportion of cases in which AEs occurred after 2months (n=62, 12.4%) and 3months (n=80, 16.0%) was significantly less than the number of AEs that occurred in the first month (P<0.01), and the proportion of occurrences gradually decreased after 3months. Furthermore, the highest number of AEs occurred on the first (n=57, 20.5%) and second (n=35, 12.6%) days after initiation of avatrombopag in the first month (Fig.2B).

Time to onset of reported AEs. (A) Time to onset of reported AEs grouped by month. (B) Time to onset of reported AEs grouped by days with avatrombopag in the first month. AE adverse event.

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Data mining and safety analysis of avatrombopag: a retrospective pharmacovigilance study based on the US food and ... - Nature.com