PMID- 36477747
OWN - NLM
STAT- MEDLINE
DCOM- 20221215
LR  - 20230111
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 17
IP  - 12
DP  - 2022
TI  - A real-world pharmacovigilance study of FDA Adverse Event Reporting System 
      (FAERS) events for venetoclax.
PG  - e0278725
LID - 10.1371/journal.pone.0278725 [doi]
LID - e0278725
AB  - BACKGROUND: Venetoclax (VEN) is the first selective small molecule Bcl-2 
      inhibitor approved by FDA and used in adult chronic lymphocytic leukemia (CLL), 
      small lymphocytic lymphoma (SLL) and some acute myeloid leukemia (AML). However, 
      the long-term safety of VEN in large sample population was unknown. This study 
      evaluated the adverse events (AEs) of VEN from FDA Adverse Event Reporting System 
      (FAERS) since its approval in 2016 by data mining. METHODS: The 
      disproportionality analyses, including four algorithms of reporting odd ratio 
      (ROR), proportional reporting ratio (PRR), bayesian configuration promotion 
      neural network (BCPNN), and multi item gamma poisson shrinker (MGPS), were 
      employed to quantify the signals of VEN-associated AEs. RESULTS: From the FAERS 
      database, a total of 8,379,682 reports were collected during the study period. 
      After removing the duplication, the number of reports with VEN as the primary 
      suspect (PS) was 19,107. The 19,107 cases of AEs involved 27 organ systems, 256 
      significant PTs which conforming to the four algorithms. Unexpected serious AEs, 
      such as pleural effusion, splenic infarction, atrial fibrillation, skin squamous 
      cell carcinoma, etc., have signals. The median time of occurrence of AEs related 
      to VEN was 31 days (inter quartile range [IQR] 7-131 days), and half of the 
      reported AEs occurred within 1 month after administration. CONCLUSION: Our 
      research has found new significant AEs signals of VEN, which improved its safety 
      information in real-world after marketing approval, and contributed to its risk 
      control of use in clinic.
CI  - Copyright: (c) 2022 Yang et al. This is an open access article distributed under 
      the terms of the Creative Commons Attribution License, which permits unrestricted 
      use, distribution, and reproduction in any medium, provided the original author 
      and source are credited.
FAU - Yang, Yang
AU  - Yang Y
AUID- ORCID: 0000-0003-4571-1327
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, 430030, China.
FAU - Shu, Yamin
AU  - Shu Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, 430030, China.
FAU - Chen, Guosong
AU  - Chen G
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, 430030, China.
FAU - Yin, Yanchao
AU  - Yin Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, 430030, China.
FAU - Li, Feie
AU  - Li F
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, 430030, China.
FAU - Li, Juan
AU  - Li J
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, 430030, China.
LA  - eng
PT  - Journal Article
DEP - 20221207
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - *Bayes Theorem
PMC - PMC9728853
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/12/09 06:00
MHDA- 2022/12/15 06:00
PMCR- 2022/12/07
CRDT- 2022/12/08 12:14
PHST- 2022/08/10 00:00 [received]
PHST- 2022/11/21 00:00 [accepted]
PHST- 2022/12/08 12:14 [entrez]
PHST- 2022/12/09 06:00 [pubmed]
PHST- 2022/12/15 06:00 [medline]
PHST- 2022/12/07 00:00 [pmc-release]
AID - PONE-D-22-22403 [pii]
AID - 10.1371/journal.pone.0278725 [doi]
PST - epublish
SO  - PLoS One. 2022 Dec 7;17(12):e0278725. doi: 10.1371/journal.pone.0278725. 
      eCollection 2022.