PMID- 32456497
OWN - NLM
STAT- MEDLINE
DCOM- 20210812
LR  - 20210812
IS  - 1750-7448 (Electronic)
IS  - 1750-743X (Linking)
VI  - 12
IP  - 7
DP  - 2020 May
TI  - Ear and labyrinth toxicities induced by immune checkpoint inhibitors: a 
      disproportionality analysis from 2014 to 2019.
PG  - 531-540
LID - 10.2217/imt-2019-0120 [doi]
AB  - Aim: We aimed to systematically characterize ear and labyrinth toxicities after 
      immune checkpoint inhibitors (ICIs) initiation. Materials & methods: Data were 
      extracted from the US FDA Adverse Event Reporting System database. 
      Disproportionality analysis including information component and reporting odds 
      ratio (ROR) was performed to access potential signals. Results: In FDA Adverse 
      Event Reporting System database, 284 records for ICIs-associated ear/labyrinth 
      adverse events (AEs) were involved. In general, there was no significant 
      association between total ICIs use and total ear and labyrinth AEs (ROR(025): 
      0.576). However, in ICIs monotherapy and polytherapy groups, signals were 
      detected in several specific ear and labyrinth AEs. Conclusion: Total ear and 
      labyrinth toxicities were not significantly reported with ICI immunotherapy, 
      while class-specific ear toxicities were detected in some strategies.
FAU - Hu, Fangyuan
AU  - Hu F
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Ye, Xiaofei
AU  - Ye X
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Zhai, Yinghong
AU  - Zhai Y
AD  - Tongji University School of Medicine, Shanghai, China.
FAU - Xu, Jinfang
AU  - Xu J
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Guo, Xiaojing
AU  - Guo X
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Guo, Zhijian
AU  - Guo Z
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Zhou, Xiang
AU  - Zhou X
AD  - Tongji University School of Medicine, Shanghai, China.
FAU - Ruan, Yiming
AU  - Ruan Y
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Zhuang, YongLong
AU  - Zhuang Y
AD  - Beijing Bioknow Information Technology Co. Ltd, Beijing, China.
FAU - He, Jia
AU  - He J
AUID- ORCID: 0000-0002-2338-9501
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
AD  - Tongji University School of Medicine, Shanghai, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200527
PL  - England
TA  - Immunotherapy
JT  - Immunotherapy
JID - 101485158
RN  - 0 (Immune Checkpoint Inhibitors)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/statistics & numerical data
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology
MH  - Female
MH  - Humans
MH  - Immune Checkpoint Inhibitors/*adverse effects
MH  - Immunotherapy/adverse effects
MH  - Male
MH  - Ototoxicity/epidemiology/*etiology
MH  - United States/epidemiology
MH  - United States Food and Drug Administration/statistics & numerical data
OTO - NOTNLM
OT  - FAERS database
OT  - disproportionality analysis
OT  - ear and labyrinth toxicities
OT  - immune checkpoint inhibitors
EDAT- 2020/05/28 06:00
MHDA- 2021/08/13 06:00
CRDT- 2020/05/28 06:00
PHST- 2020/05/28 06:00 [pubmed]
PHST- 2021/08/13 06:00 [medline]
PHST- 2020/05/28 06:00 [entrez]
AID - 10.2217/imt-2019-0120 [doi]
PST - ppublish
SO  - Immunotherapy. 2020 May;12(7):531-540. doi: 10.2217/imt-2019-0120. Epub 2020 May 
      27.