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<article xlink="http://www.w3.org/1999/xlink" dtd-version="1.0" article-type="healthcare" lang="en"><front><journal-meta><journal-id journal-id-type="publisher">IJCRR</journal-id><journal-id journal-id-type="nlm-ta">I Journ Cur Res Re</journal-id><journal-title-group><journal-title>International Journal of Current Research and Review</journal-title><abbrev-journal-title abbrev-type="pubmed">I Journ Cur Res Re</abbrev-journal-title></journal-title-group><issn pub-type="ppub">2231-2196</issn><issn pub-type="opub">0975-5241</issn><publisher><publisher-name>Open Science Publishers LLP</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">28</article-id><article-id pub-id-type="doi"/><article-id pub-id-type="doi-url"/><article-categories><subj-group subj-group-type="heading"><subject>Healthcare</subject></subj-group></article-categories><title-group><article-title>TRABECTEDIN-RELATED MUSCULAR AND OTHER ADVERSE EFFECTS; DATA FROM PUBLIC VERSION OF THE FDA ADVERSE EVENT REPORTING SYSTEM&#13;
</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Malla</surname><given-names>Swathi</given-names></name></contrib><contrib contrib-type="author"><name><surname>Banda</surname><given-names>Sahaja</given-names></name></contrib><contrib contrib-type="author"><name><surname>Bansal</surname><given-names>Dipika</given-names></name></contrib><contrib contrib-type="author"><name><surname>Gudala</surname><given-names>Kapil</given-names></name></contrib></contrib-group><pub-date pub-type="ppub"><day>31</day><month>03</month><year>2013</year></pub-date><volume>03</volume><issue>07</issue><fpage>11</fpage><lpage>17</lpage><permissions><copyright-statement>This article is copyright of Popeye Publishing, 2009</copyright-statement><copyright-year>2009</copyright-year><license license-type="open-access" href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence, and indicate if changes were made.</license-p></license></permissions><abstract><p>Objective: To describe the pattern and frequency of adverse events (AE) reported with use of trabectedin. Research Methodology: Retrospective review of adverse event reports (AERs) submitted in the USFDA Adverse Event Reporting System (AERS) database from 2007 to September 2011 was done. Any patient who reported an AE with the use of marine derived anticancer product trabectedin captured in the AERS was documented. After excluding arbitrary drug names and duplicated submissions, AERs were analyzed. Descriptive statistics were used. Results: Based on 1,888,123 AERs submitted to AERS during study period, 193 reports were related to trabectedin out of which 171 (88.6%) were expedited, 19 (9.8%) periodic and 3 (1.5%) were direct. 93% reports were submitted by health care providers and 69% were submitted in 2010-11. Two-third reports were from males with average all patients age being 58.4 years. Predominant indication of use was sarcoma (76.2%). 58 (30%) reports were detected for trabectedin related muscular adverse events and rhabdomyolysis contributed to 39 (20%) AERs. Conclusion: Data from FDA__ampersandsignrsquo;s AE reporting system, AERs, is useful for examining trabectedin-associated muscular adverse events. Trabectedin has only short history of use. The entire safety profile is yet to be explored. The data strongly suggests the necessity of well conducted clinical studies with respect to trabectedin associated muscular adverse events.&#13;
</p></abstract><kwd-group><kwd>Adverse events</kwd><kwd> Data mining</kwd><kwd> Trabectedin.</kwd></kwd-group></article-meta></front></article>
