PMID- 23525070
OWN - NLM
STAT- MEDLINE
DCOM- 20131119
LR  - 20220331
IS  - 1473-5741 (Electronic)
IS  - 0959-4973 (Linking)
VI  - 24
IP  - 6
DP  - 2013 Jul
TI  - Adverse events in patients with liver cancer.
PG  - 630-5
LID - 10.1097/CAD.0b013e3283607f4f [doi]
AB  - This study aimed to further the understanding of the incidence of adverse events 
      (AEs) in a population-based representative liver cancer population where there is 
      currently a lack of knowledge. We carried out a retrospective cohort study using 
      data from an administrative claims database between 1 January 2004 and 31 
      December 2010. Patients were included in the study if they had at least one 
      primary liver cancer diagnosis [International Classification of Diseases, Ninth 
      Revision, Clinical Modification (ICD-9-CM): 155.0] and a metastatic diagnosis 
      [ICD-9-CM: 196.x, 197.x (except 197.7), 198.x or 199.0]. We estimated the 
      incidence rate (IR) and 95% confidence interval (CI) for each AE under study. Of 
      the patients identified, 1292 fulfilled the inclusion and exclusion criteria. The 
      most common AEs were nausea and vomiting (IR=878.5/1000 person-years; 95% 
      CI=799.5-963.1). Other common AEs were hypertension (IR=648.7/1000 person-years; 
      95% CI=569.2-736.1) and hemorrhage (IR=580.0/1000 person-years; 95% 
      CI=518.6-646.6). The least common AEs were rare dermatologic diseases such as 
      Stevens-Johnson syndrome and toxic epidermal necrolysis where no cases were 
      observed. The rates detailed in this analysis are helpful in understanding the 
      benefit risk of treating patients with liver cancer in the real world. Although 
      no formal comparisons were performed, the increased risk of certain events 
      observed in sorafenib-treated patients from this analysis mirrors the risks 
      reported on the label for sorafenib. Therefore, this analysis provided a 
      reasonable assessment of the AEs that patients with liver cancer experience in 
      the real world.
FAU - Dreyfus, Brian
AU  - Dreyfus B
AD  - Department of Epidemiology, Bristol-Myers Squibb, Wallingford, Connecticut 06492, 
      USA. brian.dreyfus@bms.com
FAU - Kawabata, Hugh M
AU  - Kawabata HM
FAU - Gomez-Caminero, Andres
AU  - Gomez-Caminero A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Anticancer Drugs
JT  - Anti-cancer drugs
JID - 9100823
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Comorbidity
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Insurance Claim Review
MH  - Liver Neoplasms/*drug therapy/*pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Retrospective Studies
EDAT- 2013/03/26 06:00
MHDA- 2013/11/20 06:00
CRDT- 2013/03/26 06:00
PHST- 2013/03/26 06:00 [entrez]
PHST- 2013/03/26 06:00 [pubmed]
PHST- 2013/11/20 06:00 [medline]
AID - 10.1097/CAD.0b013e3283607f4f [doi]
PST - ppublish
SO  - Anticancer Drugs. 2013 Jul;24(6):630-5. doi: 10.1097/CAD.0b013e3283607f4f.