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Adverse event

MedGen UID:
209094
Concept ID:
C0877248
Pathologic Function
Synonyms: ADVERSE EVENT; Adverse Event; adverse event; Adverse Experience; AdverseEvent; AE
 

Definition

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. "[Modified from ICH E2A]" Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary) [from NCI]

Term Hierarchy

CClinical test,  RResearch test,  OOMIM,  GGeneReviews
  • CROGAdverse event

Recent clinical studies

Etiology

Li Q, Melton K, Lingren T, Kirkendall ES, Hall E, Zhai H, Ni Y, Kaiser M, Stoutenborough L, Solti I
J Am Med Inform Assoc 2014 Sep-Oct;21(5):776-84. Epub 2014 Jan 8 doi: 10.1136/amiajnl-2013-001914. [Epub ahead of print] PMID: 24401171Free PMC Article
Stockwell DC, Kirkendall E, Muething SE, Kloppenborg E, Vinodrao H, Jacobs BR
J Patient Saf 2013 Dec;9(4):203-10. doi: 10.1097/PTS.0000000000000055. PMID: 24257063
Nozawa M, Nonomura N, Ueda T, Nishimura K, Kanayama HO, Miki T, Nakatani T, Tomita Y, Azuma H, Yoshioka T, Tsujihata M, Uemura H
Jpn J Clin Oncol 2013 Nov;43(11):1132-8. Epub 2013 Sep 1 doi: 10.1093/jjco/hyt121. [Epub ahead of print] PMID: 23999768
Auerbach JD, McGowan KB, Halevi M, Gerling MC, Sharan AD, Whang PG, Maislin G
J Bone Joint Surg Am 2013 Aug 21;95(16):1450-6. doi: 10.2106/JBJS.L.00251. PMID: 23965694
Martin D, Menschik D, Bryant-Genevier M, Ball R
Drug Saf 2013 Jul;36(7):547-56. doi: 10.1007/s40264-013-0051-9. PMID: 23657824

Diagnosis

Li Q, Melton K, Lingren T, Kirkendall ES, Hall E, Zhai H, Ni Y, Kaiser M, Stoutenborough L, Solti I
J Am Med Inform Assoc 2014 Sep-Oct;21(5):776-84. Epub 2014 Jan 8 doi: 10.1136/amiajnl-2013-001914. [Epub ahead of print] PMID: 24401171Free PMC Article
Roberto G, Piccinni C, D'Alessandro R, Poluzzi E
Cephalalgia 2014 Jan;34(1):5-13. Epub 2013 Aug 6 doi: 10.1177/0333102413499649. [Epub ahead of print] PMID: 23921799
Moro PL, Harrington T, Shimabukuro T, Cano M, Museru OI, Menschik D, Broder K
Vaccine 2013 Oct 9;31(43):4984-7. Epub 2013 Aug 29 doi: 10.1016/j.vaccine.2013.08.001. [Epub ahead of print] PMID: 23994022
Okon E, Engell C, van Manen R, Brown J
Pharmacotherapy 2013 Jan;33(1):63-8. doi: 10.1002/phar.1159. PMID: 23307547
Forster AJ, Taljaard M, Bennett C, van Walraven C
PLoS One 2012;7(7):e41239. Epub 2012 Jul 26 doi: 10.1371/journal.pone.0041239. PMID: 22844445Free PMC Article

Therapy

Li Q, Melton K, Lingren T, Kirkendall ES, Hall E, Zhai H, Ni Y, Kaiser M, Stoutenborough L, Solti I
J Am Med Inform Assoc 2014 Sep-Oct;21(5):776-84. Epub 2014 Jan 8 doi: 10.1136/amiajnl-2013-001914. [Epub ahead of print] PMID: 24401171Free PMC Article
Eberth JM, Kline KN, Moskowitz DA, Montealegre JR, Scheurer ME
J Adolesc Health 2014 Mar;54(3):289-95. Epub 2013 Nov 17 doi: 10.1016/j.jadohealth.2013.09.005. [Epub ahead of print] PMID: 24257032Free PMC Article
Darssan D, Thompson MH, Pettitt AN
Stat Med 2014 Mar 30;33(7):1146-61. Epub 2013 Oct 7 doi: 10.1002/sim.6011. [Epub ahead of print] PMID: 24122859
Nozawa M, Nonomura N, Ueda T, Nishimura K, Kanayama HO, Miki T, Nakatani T, Tomita Y, Azuma H, Yoshioka T, Tsujihata M, Uemura H
Jpn J Clin Oncol 2013 Nov;43(11):1132-8. Epub 2013 Sep 1 doi: 10.1093/jjco/hyt121. [Epub ahead of print] PMID: 23999768
Gandhi PK, Gentry WM, Bottorff MB
Semin Arthritis Rheum 2013 Jun;42(6):562-6. Epub 2013 Jan 24 doi: 10.1016/j.semarthrit.2012.11.002. [Epub ahead of print] PMID: 23352248

Prognosis

Li Q, Melton K, Lingren T, Kirkendall ES, Hall E, Zhai H, Ni Y, Kaiser M, Stoutenborough L, Solti I
J Am Med Inform Assoc 2014 Sep-Oct;21(5):776-84. Epub 2014 Jan 8 doi: 10.1136/amiajnl-2013-001914. [Epub ahead of print] PMID: 24401171Free PMC Article
Eberth JM, Kline KN, Moskowitz DA, Montealegre JR, Scheurer ME
J Adolesc Health 2014 Mar;54(3):289-95. Epub 2013 Nov 17 doi: 10.1016/j.jadohealth.2013.09.005. [Epub ahead of print] PMID: 24257032Free PMC Article
Roberto G, Piccinni C, D'Alessandro R, Poluzzi E
Cephalalgia 2014 Jan;34(1):5-13. Epub 2013 Aug 6 doi: 10.1177/0333102413499649. [Epub ahead of print] PMID: 23921799
Stockwell DC, Kirkendall E, Muething SE, Kloppenborg E, Vinodrao H, Jacobs BR
J Patient Saf 2013 Dec;9(4):203-10. doi: 10.1097/PTS.0000000000000055. PMID: 24257063
Kip KE, Swoger JM, Grandinetti LM, Barrie AM 3rd, Greer JB, Regueiro MD
Inflamm Bowel Dis 2013 May;19(6):1164-72. doi: 10.1097/MIB.0b013e31828075bd. PMID: 23518804

Clinical prediction guides

Li Q, Melton K, Lingren T, Kirkendall ES, Hall E, Zhai H, Ni Y, Kaiser M, Stoutenborough L, Solti I
J Am Med Inform Assoc 2014 Sep-Oct;21(5):776-84. Epub 2014 Jan 8 doi: 10.1136/amiajnl-2013-001914. [Epub ahead of print] PMID: 24401171Free PMC Article
Eberth JM, Kline KN, Moskowitz DA, Montealegre JR, Scheurer ME
J Adolesc Health 2014 Mar;54(3):289-95. Epub 2013 Nov 17 doi: 10.1016/j.jadohealth.2013.09.005. [Epub ahead of print] PMID: 24257032Free PMC Article
Darssan D, Thompson MH, Pettitt AN
Stat Med 2014 Mar 30;33(7):1146-61. Epub 2013 Oct 7 doi: 10.1002/sim.6011. [Epub ahead of print] PMID: 24122859
Stockwell DC, Kirkendall E, Muething SE, Kloppenborg E, Vinodrao H, Jacobs BR
J Patient Saf 2013 Dec;9(4):203-10. doi: 10.1097/PTS.0000000000000055. PMID: 24257063
Martin D, Menschik D, Bryant-Genevier M, Ball R
Drug Saf 2013 Jul;36(7):547-56. doi: 10.1007/s40264-013-0051-9. PMID: 23657824

Recent systematic reviews

Sivendran S, Latif A, McBride RB, Stensland KD, Wisnivesky J, Haines L, Oh WK, Galsky MD
J Clin Oncol 2014 Jan 10;32(2):83-9. Epub 2013 Dec 9 doi: 10.1200/JCO.2013.52.2219. [Epub ahead of print] PMID: 24323037
Zhao S, Nishimura T, Chen Y, Azeloglu EU, Gottesman O, Giannarelli C, Zafar MU, Benard L, Badimon JJ, Hajjar RJ, Goldfarb J, Iyengar R
Sci Transl Med 2013 Oct 9;5(206):206ra140. doi: 10.1126/scitranslmed.3006548. PMID: 24107779Free PMC Article
Péron J, Maillet D, Gan HK, Chen EX, You B
J Clin Oncol 2013 Nov 1;31(31):3957-63. Epub 2013 Sep 23 doi: 10.1200/JCO.2013.49.3981. [Epub ahead of print] PMID: 24062406
Verrotti A, Loiacono G, Di Sabatino F, Zaccara G
Acta Neurol Scand 2013 Nov;128(5):297-304. Epub 2013 Jun 13 doi: 10.1111/ane.12147. [Epub ahead of print] PMID: 23763367
Cornelius VR, Sauzet O, Williams JE, Ayis S, Farquhar-Smith P, Ross JR, Branford RA, Peacock JL
Pain 2013 Feb;154(2):213-20. Epub 2012 Nov 3 doi: 10.1016/j.pain.2012.08.012. [Epub ahead of print] PMID: 23127360

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