Association between PD-L1 inhibitor, tumor site and adverse events of potential immune etiology within the US FDA adverse event reporting system

Immunotherapy ◽  
2021 ◽  
Author(s):  
Omar Abdel-Rahman
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Special Interest ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Multivariable Logistic Regression Analysis ◽  
Tumor Type ◽  
Related Factors ◽  
Event Reporting

Objective: To analyze tumor- and treatment-related factors that might impact the development of certain adverse events (AEs) of potential immune etiology among patients receiving PD-(L)1 inhibitors. Methods: The FDA Adverse Event Reporting System (FAERS) was accessed, and AE reports related to the use of PD-L1 inhibitors were reviewed. Associations between treatment, tumor type and occurrence of AEs of special interest were analyzed through multivariable logistic regression analysis. Results: A total of 80,304 AE reports were included in the current analysis. Diagnosis with lung cancer was associated with a higher probability of pneumonitis; diagnosis with melanoma was associated with a higher probability of hepatitis, hypophysitis/hypopituitarism and uveitis; and diagnosis with genitourinary cancers was associated with a higher probability of nephritis, adrenal insufficiency and myocarditis. Conclusion:  Within this cohort limited to AEs reported to the FAERS, there is an association between different AEs of special interest, agent(s) used and tumor(s) treated.

Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

Vaccine ◽  
2019 ◽  
Vol 37 (44) ◽  
pp. 6760-6767 ◽  
Author(s):  
Michael M. McNeil ◽  
Iwona Paradowska-Stankiewicz ◽  
Elaine R. Miller ◽  
Paige L. Marquez ◽  
Srihari Seshadri ◽  
...  
Keyword(s):  
United States ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adenovirus Type ◽  
Adverse Event Reporting ◽  
Event Reporting

Antidepressants-related cardiovascular adverse events using the adverse event reporting system

2018 ◽  
Vol 268 ◽  
pp. 441-446 ◽  
Author(s):  
Yoon Kyong Lee ◽  
Jung Su Shin ◽  
Youngwon Kim ◽  
Jae Hyun Kim ◽  
Yun-Kyoung Song ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting

Filing Sources after Oral P2Y12 Platelet Inhibitors to the Food and Drug Administration Adverse Event Reporting System (FAERS)

Cardiology ◽  
2017 ◽  
Vol 138 (4) ◽  
pp. 249-253 ◽  
Author(s):  
Victor L. Serebruany ◽  
Vasily Cherepanov ◽  
Moo Hyun Kim ◽  
Oleg Litvinov ◽  
Hector A. Cabrera-Fuentes ◽  
...  
Keyword(s):  
Health Care ◽  
Adverse Event ◽  
Adverse Events ◽  
Drug Administration ◽  
Health Care Professionals ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Platelet Inhibitors ◽  
Event Reporting

Background: The US Food and Drug Administration Adverse Event Reporting System (FAERS) is a global passive surveillance database that relies on voluntary reporting by health care professionals and consumers as well as required mandatory reporting by pharmaceutical manufacturers. However, the initial filers and comparative patterns for oral P2Y12 platelet inhibitor reporting are unknown. We assessed who generated original FAERS reports for clopidogrel, prasugrel, and ticagrelor in 2015. Methods: From the FAERS database we extracted and examined adverse event cases coreported with oral P2Y12 platelet inhibitors. All adverse event filing originating sources were dichotomized into consumers, lawyers, pharmacists, physicians, other health care professionals, and unknown. Results: Overall, 2015 annual adverse events were more commonly coreported with clopidogrel (n = 13,234) with known source filers (n = 12,818, or 96.9%) than with prasugrel (2,896; 98.9% out of 2,927 cases) or ticagrelor (2,163, or 82.3%, out of 2,627 cases, respectively). Overall, most adverse events were filed by consumers (8,336, or 44.4%), followed by physicians (5,290, or 28.2%), other health care professionals (2,997, or 16.0%), pharmacists (1,125, or 6.0%), and finally by lawyers (129, or 0.7%). The origin of 811 (4.7%) initial reports remains unknown. The adverse event filing sources differ among drugs. While adverse events coreported with clopidogrel and prasugrel were commonly originated by patients (40.4 and 84.3%, respectively), most frequently ticagrelor reports (42.5%) were filed by physicians. Conclusion: The reporting quality and initial sources differ among oral P2Y12 platelet inhibitors in FAERS. The ticagrelor surveillance in 2015 was inadequate when compared to clopidogrel and prasugrel. Patients filed most adverse events for clopidogrel and prasugrel, while physicians originated most ticagrelor complaints. These differences justify stricter compliance control for ticagrelor manufacturers and may be attributed to the confusion of treating physicians with unexpected fatal, cardiac, and thrombotic adverse events linked to ticagrelor.

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