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Solicited Adverse Event

MedGen UID:
1790688
•Concept ID:
C5552829
•
Finding
Synonym: Solicited

Definition

An adverse event that is reported by a healthcare professional, consumer, or patient through an organized data collection system. [from NCI]

Term Hierarchy

CClinical test,  RResearch test,  OOMIM,  GGeneReviews,  VClinVar  
  • CROGVSolicited Adverse Event

Professional guidelines

PubMed

Patient preference and decision-making for initiating metastatic colorectal cancer medical treatment.
Fu AZ, Graves KD, Jensen RE, Marshall JL, Formoso M, Potosky AL
J Cancer Res Clin Oncol 2016 Mar;142(3):699-706. Epub 2015 Nov 18 doi: 10.1007/s00432-015-2073-4. PMID: 26577827Free PMC Article
Topical calcineurin inhibitors for atopic dermatitis: review and treatment recommendations.
Carr WW
Paediatr Drugs 2013 Aug;15(4):303-10. doi: 10.1007/s40272-013-0013-9. PMID: 23549982Free PMC Article
Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors.
Abshire T, Kenet G
Haemophilia 2008 Sep;14(5):898-902. Epub 2008 Aug 4 doi: 10.1111/j.1365-2516.2008.01829.x. PMID: 18684126

Recent clinical studies

Etiology

Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial.
Wassil J, Sisti M, Fairman J, Davis M, Fierro C, Bennett S, Johnson D, Migone TS, Nguyen K, Sauer P, Currie M, Iki S, Simon JK
Lancet Infect Dis 2024 Mar;24(3):308-318. Epub 2023 Dec 4 doi: 10.1016/S1473-3099(23)00572-8. PMID: 38061367
A single blinded, phase IV, adaptive randomised control trial to evaluate the safety of coadministration of seasonal influenza and COVID-19 vaccines (The FluVID study).
Ramsay JA, Jones M, Vande More AM, Hunt SL, Williams PCM, Messer M, Wood N, Macartney K, Lee FJ, Britton WJ, Snelling TL, Caterson ID
Vaccine 2023 Nov 22;41(48):7250-7258. Epub 2023 Oct 29 doi: 10.1016/j.vaccine.2023.10.050. PMID: 37903680
Harmonizing the collection of solicited adverse events in prophylactic vaccine clinical trials.
Cheuvart B, Spiessens B, van Heesbeen R, Hung D, Andrade C, Korejwo-Peyramond J, Tavares-Da-Silva F
Expert Rev Vaccines 2023 Jan-Dec;22(1):849-859. Epub 2023 Oct 9 doi: 10.1080/14760584.2023.2262571. PMID: 37750613
Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial.
Tschismarov R, Van Damme P, Germain C, De Coster I, Mateo M, Reynard S, Journeaux A, Tomberger Y, Withanage K, Haslwanter D, Terler K, Schrauf S, Müllner M, Tauber E, Ramsauer K, Baize S
Lancet 2023 Apr 15;401(10384):1267-1276. Epub 2023 Mar 16 doi: 10.1016/S0140-6736(23)00048-X. PMID: 36934733
Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trial.
Munro APS, Feng S, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Qureshi E, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kanji N, Libri V, Llewelyn MJ, McGregor AC, Maallah M, Minassian AM, Moore P, Mughal M, Mujadidi YF, Holliday K, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Bawa T, Saralaya D, Sharma S, Sheridan R, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Lambe T, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN; COV-BOOST study group
Lancet Infect Dis 2022 Aug;22(8):1131-1141. Epub 2022 May 9 doi: 10.1016/S1473-3099(22)00271-7. PMID: 35550261Free PMC Article

Therapy

Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial.
Wassil J, Sisti M, Fairman J, Davis M, Fierro C, Bennett S, Johnson D, Migone TS, Nguyen K, Sauer P, Currie M, Iki S, Simon JK
Lancet Infect Dis 2024 Mar;24(3):308-318. Epub 2023 Dec 4 doi: 10.1016/S1473-3099(23)00572-8. PMID: 38061367
A single blinded, phase IV, adaptive randomised control trial to evaluate the safety of coadministration of seasonal influenza and COVID-19 vaccines (The FluVID study).
Ramsay JA, Jones M, Vande More AM, Hunt SL, Williams PCM, Messer M, Wood N, Macartney K, Lee FJ, Britton WJ, Snelling TL, Caterson ID
Vaccine 2023 Nov 22;41(48):7250-7258. Epub 2023 Oct 29 doi: 10.1016/j.vaccine.2023.10.050. PMID: 37903680
Harmonizing the collection of solicited adverse events in prophylactic vaccine clinical trials.
Cheuvart B, Spiessens B, van Heesbeen R, Hung D, Andrade C, Korejwo-Peyramond J, Tavares-Da-Silva F
Expert Rev Vaccines 2023 Jan-Dec;22(1):849-859. Epub 2023 Oct 9 doi: 10.1080/14760584.2023.2262571. PMID: 37750613
Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial.
Tschismarov R, Van Damme P, Germain C, De Coster I, Mateo M, Reynard S, Journeaux A, Tomberger Y, Withanage K, Haslwanter D, Terler K, Schrauf S, Müllner M, Tauber E, Ramsauer K, Baize S
Lancet 2023 Apr 15;401(10384):1267-1276. Epub 2023 Mar 16 doi: 10.1016/S0140-6736(23)00048-X. PMID: 36934733
Detecting treatment emergent adverse events in clinical trials : a comparison of spontaneously reported and solicited collection methods.
Wernicke JF, Faries D, Milton D, Weyrauch K
Drug Saf 2005;28(11):1057-63. doi: 10.2165/00002018-200528110-00006. PMID: 16231957

Prognosis

Harmonizing the collection of solicited adverse events in prophylactic vaccine clinical trials.
Cheuvart B, Spiessens B, van Heesbeen R, Hung D, Andrade C, Korejwo-Peyramond J, Tavares-Da-Silva F
Expert Rev Vaccines 2023 Jan-Dec;22(1):849-859. Epub 2023 Oct 9 doi: 10.1080/14760584.2023.2262571. PMID: 37750613
Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial.
López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, Díazgranados JA, Oñate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendaño AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I
JAMA 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071. PMID: 33662102Free PMC Article
Safety, reactogenicity, and immunogenicity of live attenuated varicella vaccine in children between 1 and 9 years of age with atopic dermatitis.
Kreth HW, Hoeger PH; Members of the VZV-AD study group
Eur J Pediatr 2006 Oct;165(10):677-83. Epub 2006 Jul 12 doi: 10.1007/s00431-006-0103-6. PMID: 16835758

Clinical prediction guides

Safety and durable immunogenicity of the TV005 tetravalent dengue vaccine, across serotypes and age groups, in dengue-endemic Bangladesh: a randomised, controlled trial.
Walsh MR, Alam MS, Pierce KK, Carmolli M, Alam M, Dickson DM, Bak DM, Afreen S, Nazib F, Golam K, Qadri F, Diehl SA, Durbin AP, Whitehead SS, Haque R, Kirkpatrick BD
Lancet Infect Dis 2024 Feb;24(2):150-160. Epub 2023 Sep 27 doi: 10.1016/S1473-3099(23)00520-0. PMID: 37776876Free PMC Article
Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial.
Tschismarov R, Van Damme P, Germain C, De Coster I, Mateo M, Reynard S, Journeaux A, Tomberger Y, Withanage K, Haslwanter D, Terler K, Schrauf S, Müllner M, Tauber E, Ramsauer K, Baize S
Lancet 2023 Apr 15;401(10384):1267-1276. Epub 2023 Mar 16 doi: 10.1016/S0140-6736(23)00048-X. PMID: 36934733
Prevention of influenza during mismatched seasons in older adults with an MF59-adjuvanted quadrivalent influenza vaccine: a randomised, controlled, multicentre, phase 3 efficacy study.
Beran J, Reynales H, Poder A, Yu CY, Pitisuttithum P, Yuan LL, Vermeulen W, Verhoeven C, Leav B, Zhang B, Sawlwin D, Hamers-Heijnen E, Edelman J, Smolenov I
Lancet Infect Dis 2021 Jul;21(7):1027-1037. Epub 2021 Feb 9 doi: 10.1016/S1473-3099(20)30694-0. PMID: 33577767
Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet.
Nolte H, Bernstein DI, Sussman GL, Svanholm Fogh B, Lu S, Husøy B, Nelson HS
J Allergy Clin Immunol Pract 2018 Nov-Dec;6(6):2081-2086.e1. Epub 2018 Feb 10 doi: 10.1016/j.jaip.2018.01.037. PMID: 29432959
Safety, tolerability and efficacy of intradermal rabies immunization with DebioJect™.
Vescovo P, Rettby N, Ramaniraka N, Liberman J, Hart K, Cachemaille A, Piveteau LD, Zanoni R, Bart PA, Pantaleo G
Vaccine 2017 Mar 27;35(14):1782-1788. doi: 10.1016/j.vaccine.2016.09.069. PMID: 28317660

Recent systematic reviews

Protective efficacy and safety of radiation-attenuated and chemo-attenuated Plasmodium Falciparum sporozoite vaccines against controlled and natural malaria infection: a systematic review and meta-analysis of randomized controlled trials.
Abuelazm MT, Elzeftawy MA, Kamal MA, Badr H, Gamal M, Aboulgheit M, Abdelazeem B, Abd-Elsalam S, Abouzid M
Infection 2024 Jun;52(3):707-722. Epub 2024 Feb 6 doi: 10.1007/s15010-024-02174-4. PMID: 38319556
Systematic review of the clinical development of group B streptococcus serotype-specific capsular polysaccharide-based vaccines.
Dzanibe S, Madhi SA
Expert Rev Vaccines 2018 Jul;17(7):635-651. Epub 2018 Jul 13 doi: 10.1080/14760584.2018.1496021. PMID: 29961350

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