PMID- 32083419
OWN - NLM
STAT- MEDLINE
DCOM- 20210726
LR  - 20211201
IS  - 2724-6442 (Electronic)
IS  - 2724-6051 (Linking)
VI  - 73
IP  - 3
DP  - 2021 Jun
TI  - Adverse events related to radium-223 treatment: "real-life" data from the 
      Eudra-Vigilance database.
PG  - 342-348
LID - 10.23736/S2724-6051.20.03690-5 [doi]
AB  - BACKGROUND: The aim of our study was to analyze adverse events (AEs) associated 
      with radium-223 using real life data from Eudra-Vigilance (EV) database. METHODS: 
      EV database is the system for managing and analyzing information on suspected 
      adverse reactions to medicines which have been authorized or being studied in 
      clinical trials in the European economic area (EEA). We recorded number of AEs 
      for radium-223 per category and severity from 2013 to May 2019. We recorded AEs 
      per age group (<65 years old; between 65 and 85 years; >85 years old) pooled 
      relative risk (PRR) were used to compare groups. The number of individual cases 
      identified in EV database was 4339. RESULTS: According to the registry study the 
      most frequent AEs in patients treated with radium-223 were hematological, general 
      and gastrointestinal disorders and they were confirmed as the most frequent AEs 
      in the EV database. In the EV database over 90% of the reported AEs were defined 
      as serious and 8% were fatal. Older patients (>85 years) treated with radium-223 
      were at increased risk of cardiac, infectious, and metabolism disorders when 
      compared to younger patients (<65). However, we have no information on the number 
      of patients under treatment in the EV database. CONCLUSIONS: EV database 
      highlights several AEs which are not reported in registry studies as well as 
      different AEs profiles according to age. Clinicians should consider these data 
      when treating patients with radium-223.
FAU - Tema, Giorgia
AU  - Tema G
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy.
FAU - Lombardo, Riccardo
AU  - Lombardo R
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy.
FAU - Voglino, Olivia
AU  - Voglino O
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy.
FAU - Sica, Angela
AU  - Sica A
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy.
FAU - Baldassarri, Valeria
AU  - Baldassarri V
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy.
FAU - Nacchia, Antonio
AU  - Nacchia A
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy.
FAU - Iacovelli, Roberto
AU  - Iacovelli R
AD  - Division of Medical Oncology, IRCCS A. Gemelli University Polyclinic Foundation, 
      Rome, Italy.
FAU - Tubaro, Andrea
AU  - Tubaro A
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy.
FAU - DE Nunzio, Cosimo
AU  - DE Nunzio C
AD  - Department of Urology, Sant'Andrea Hospital, Rome, Italy - 
      cosimodenunzio@virgilio.it.
LA  - eng
PT  - Journal Article
DEP - 20200219
PL  - Italy
TA  - Minerva Urol Nephrol
JT  - Minerva urology and nephrology
JID - 101777299
RN  - 0 (Radiopharmaceuticals)
RN  - 8BR2SOL3L1 (Radium-223)
RN  - W90AYD6R3Q (Radium)
SB  - IM
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Databases, Factual
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pharmacovigilance
MH  - Radiopharmaceuticals/*adverse effects
MH  - Radium/*adverse effects
MH  - Retrospective Studies
MH  - Risk
EDAT- 2020/02/23 06:00
MHDA- 2021/07/27 06:00
CRDT- 2020/02/22 06:00
PHST- 2020/02/23 06:00 [pubmed]
PHST- 2021/07/27 06:00 [medline]
PHST- 2020/02/22 06:00 [entrez]
AID - S0393-2249.20.03690-5 [pii]
AID - 10.23736/S2724-6051.20.03690-5 [doi]
PST - ppublish
SO  - Minerva Urol Nephrol. 2021 Jun;73(3):342-348. doi: 
      10.23736/S2724-6051.20.03690-5. Epub 2020 Feb 19.