PMID- 35789689
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 1179-1349 (Print)
IS  - 1179-1349 (Electronic)
IS  - 1179-1349 (Linking)
VI  - 14
DP  - 2022
TI  - A Real-World Disproportionality Analysis of Olaparib: Data Mining of the Public 
      Version of FDA Adverse Event Reporting System.
PG  - 789-802
LID - 10.2147/CLEP.S365513 [doi]
AB  - BACKGROUND: Olaparib, the world's first poly ADP-ribose polymerase (PARP) 
      inhibitor (PARPi), has been approved for treatment of ovarian cancer, breast 
      cancer, pancreatic cancer and prostate cancer by FDA. The current study was to 
      assess olaparib-related adverse events (AEs) of real-world through data mining of 
      the US Food and Drug Administration Adverse Event Reporting System (FAERS). 
      METHODS: Disproportionality analyses, including the reporting odds ratio (ROR), 
      the proportional reporting ratio (PRR), the Bayesian confidence propagation 
      neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) 
      algorithms were employed to quantify the signals of olaparib-associated AEs. 
      RESULTS: Out of 8,450,009 reports collected from the FAERS database, 6402 reports 
      of olaparib-associated AEs were identified. A total of 118 significant 
      disproportionality preferred terms (PTs) conforming to the four algorithms 
      simultaneously were retained. The most common AEs included anemia, 
      thrombocytopenia, nausea, decreased appetite, blood creatinine increased and 
      dermatomyositis, which were corresponding to those reported in the specification 
      and clinical trials. Unexpected significant AEs as interstitial lung disease, 
      Pneumocystis jirovecii pneumonia, folate deficiency, renal impairment and 
      intestinal obstruction might also occur. The median onset time of 
      olaparib-related AEs was 61 days (interquartile range [IQR] 14-182 days), and 
      most of the cases occurred within the first 1 month after olaparib initiation. 
      CONCLUSION: Results of our study were consistent with clinical observations, and 
      we also found potential new and unexpected AEs signals for olaparib, suggesting 
      prospective clinical studies were needed to confirm these results and illustrate 
      their relationship. Our results could provide valuable evidence for further 
      safety studies of olaparib.
CI  - (c) 2022 Shu et al.
FAU - Shu, Yamin
AU  - Shu Y
AUID- ORCID: 0000-0002-1532-8135
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, People's Republic of China.
FAU - He, Xucheng
AU  - He X
AD  - Department of Pharmacy, Pengzhou Second People's Hospital, Pengzhou, People's 
      Republic of China.
FAU - Liu, Yanxin
AU  - Liu Y
AD  - Department of Pharmacy, Pengzhou People's Hospital, Pengzhou, People's Republic 
      of China.
FAU - Wu, Pan
AU  - Wu P
AD  - Department of Pharmacy, Qionglai Maternal & Child Health and Family Planning 
      Service Center, Qionglai, People's Republic of China.
FAU - Zhang, Qilin
AU  - Zhang Q
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20220628
PL  - New Zealand
TA  - Clin Epidemiol
JT  - Clinical epidemiology
JID - 101531700
PMC - PMC9250344
OTO - NOTNLM
OT  - FAERS
OT  - PARP inhibitor
OT  - data mining
OT  - olaparib
OT  - pharmacovigilance
COIS- The authors declare that they have no conflicts of interest.
EDAT- 2022/07/06 06:00
MHDA- 2022/07/06 06:01
PMCR- 2022/06/28
CRDT- 2022/07/05 19:52
PHST- 2022/03/30 00:00 [received]
PHST- 2022/06/14 00:00 [accepted]
PHST- 2022/07/05 19:52 [entrez]
PHST- 2022/07/06 06:00 [pubmed]
PHST- 2022/07/06 06:01 [medline]
PHST- 2022/06/28 00:00 [pmc-release]
AID - 365513 [pii]
AID - 10.2147/CLEP.S365513 [doi]
PST - epublish
SO  - Clin Epidemiol. 2022 Jun 28;14:789-802. doi: 10.2147/CLEP.S365513. eCollection 
      2022.