PMID- 27767430
OWN - NLM
STAT- MEDLINE
DCOM- 20170717
LR  - 20181202
IS  - 1943-569X (Electronic)
IS  - 0003-1488 (Linking)
VI  - 249
IP  - 9
DP  - 2016 Nov 1
TI  - A systematic review of adverse event reporting in companion animal clinical 
      trials evaluating cancer treatment.
PG  - 1079-1087
AB  - OBJECTIVE To evaluate methods used to ascertain, define, and report adverse 
      events (AEs) in companion animal clinical trials involving cancer treatment. 
      DESIGN Systematic review. SAMPLE English-language articles describing prospective 
      clinical trials involving dogs and cats with naturally occurring cancer published 
      in peer-reviewed journals between 2008 and 2014. PROCEDURES Reports were 
      identified via MEDLINE and CAB database searches combined with a hand-searching 
      strategy. General article characteristics were abstracted and summarized. Data 
      for AE reporting were collected with a 14-item checklist adapted from the 2004 
      CONSORT extension for reporting harms. Study characteristics associated with the 
      AE reporting checklist score were identified by means of linear regression 
      analysis. RESULTS 168 articles with data for 6,132 animals were included. 
      Standardized terminology was significantly more likely to be used to describe AEs 
      for trials that included chemotherapy (92/115 [80.0%]) than for trials that did 
      not (16/53 [30.2%]). Median AE reporting checklist score was 5 out of 14 (range, 
      0 to 12). Poorly reported items included methods and time frame of AE 
      ascertainment, AE data analysis, and reasons for treatment discontinuation and 
      death. Trials with industry funding, a single-arm design, and treatment with 
      chemotherapy were associated with a significantly higher quality of AE reporting. 
      CONCLUSIONS AND CLINICAL RELEVANCE Reporting of adverse events in veterinary 
      clinical trials evaluating cancer treatment was selective and heterogeneous. 
      Harms associated with cancer treatments could be underestimated because of 
      suboptimal collection and reporting of AE data. Findings supported the adoption 
      of a higher standard for AE surveillance and reporting in veterinary patients.
FAU - Giuffrida, Michelle A
AU  - Giuffrida MA
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
PL  - United States
TA  - J Am Vet Med Assoc
JT  - Journal of the American Veterinary Medical Association
JID - 7503067
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Animals
MH  - Antineoplastic Agents/*adverse effects
MH  - Clinical Trials as Topic/*veterinary
MH  - Drug-Related Side Effects and Adverse Reactions/*veterinary
MH  - Neoplasms/drug therapy/*veterinary
MH  - *Pets
EDAT- 2016/10/22 06:00
MHDA- 2017/07/18 06:00
CRDT- 2016/10/22 06:00
PHST- 2016/10/22 06:00 [pubmed]
PHST- 2017/07/18 06:00 [medline]
PHST- 2016/10/22 06:00 [entrez]
AID - 10.2460/javma.249.9.1079 [doi]
PST - ppublish
SO  - J Am Vet Med Assoc. 2016 Nov 1;249(9):1079-1087. doi: 10.2460/javma.249.9.1079.