Analysis and reporting of adverse events in randomised controlled trials: a review.

Phillips R, Hazell L, Sauzet O, Cornelius V (2019)
BMJ open 9(2): e024537.

Zeitschriftenaufsatz | Veröffentlicht | Englisch
 
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Autor*in
Phillips, Rachel; Hazell, Lorna; Sauzet, OdileUniBi; Cornelius, Victoria
Abstract / Bemerkung
OBJECTIVE: To ascertain contemporary approaches to the collection, reporting and analysis of adverse events (AEs) in randomised controlled trials (RCTs) with a primary efficacy outcome.; DESIGN: A review of clinical trials of drug interventions from four high impact medical journals.; DATA SOURCES: Electronic contents table of the BMJ, the Journal of the American Medical Association (JAMA), the Lancet and the New England Journal of Medicine (NEJM) were searched for reports of original RCTs published between September 2015 and September 2016.; METHODS: A prepiloted checklist was used and single data extraction was performed by three reviewers with independent check of a randomly sampled subset to verify quality. We extracted data on collection methods, assessment of severity and causality, reporting criteria, analysis methods and presentation of AE data.; RESULTS: We identified 184 eligible reports (BMJ n=3; JAMA n=38, Lancet n=62 and NEJM n=81). Sixty-two per cent reported some form of spontaneous AE collection but only 29% included details of specific prompts used to ascertain AE data. Numbers that withdrew from the trial were well reported (80%), however only 35% of these reported whether withdrawals were due to AEs. Results presented and analysis performed was predominantly on 'patients with at least one event' with 84% of studies ignoring repeated events. Despite a lack of power to undertake formal hypothesis testing, 47% performed such tests for binary outcomes.; CONCLUSIONS: This review highlighted that the collection, reporting and analysis of AE data in clinical trials is inconsistent and RCTs as a source of safety data are underused. Areas to improve include reducing information loss when analysing at patient level and inappropriate practice of underpowered multiple hypothesis testing. Implementation of standard reporting practices could enable a more accurate synthesis of safety data and development of guidance for statistical methodology to assess causality of AEs could facilitate better statistical practice. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Erscheinungsjahr
2019
Zeitschriftentitel
BMJ open
Band
9
Ausgabe
2
Art.-Nr.
e024537
ISSN
2044-6055
Page URI
https://pub.uni-bielefeld.de/record/2934267

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Phillips R, Hazell L, Sauzet O, Cornelius V. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open. 2019;9(2): e024537.
Phillips, R., Hazell, L., Sauzet, O., & Cornelius, V. (2019). Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open, 9(2), e024537. doi:10.1136/bmjopen-2018-024537
Phillips, R., Hazell, L., Sauzet, O., and Cornelius, V. (2019). Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open 9:e024537.
Phillips, R., et al., 2019. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open, 9(2): e024537.
R. Phillips, et al., “Analysis and reporting of adverse events in randomised controlled trials: a review.”, BMJ open, vol. 9, 2019, : e024537.
Phillips, R., Hazell, L., Sauzet, O., Cornelius, V.: Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open. 9, : e024537 (2019).
Phillips, Rachel, Hazell, Lorna, Sauzet, Odile, and Cornelius, Victoria. “Analysis and reporting of adverse events in randomised controlled trials: a review.”. BMJ open 9.2 (2019): e024537.

56 References

Daten bereitgestellt von Europe PubMed Central.

Harmonisation in pharmacovigilance.
Edwards IR, Biriell C., Drug Saf 10(2), 1994
PMID: 8011183
ICH Harmonised Tripartite Guideline E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
AUTHOR UNKNOWN, 1994
Attachment B: clinical safety review of an NDA or BLA of the good review practice
AUTHOR UNKNOWN, 2010
Reporting of safety data from randomised trials.
Ioannidis JP, Contopoulos-Ioannidis DG., Lancet 352(9142), 1998
PMID: 9848355
Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain.
Edwards JE, McQuay HJ, Moore RA, Collins SL., J Pain Symptom Manage 18(6), 1999
PMID: 10641469
Reporting of safety results in published reports of randomized controlled trials.
Pitrou I, Boutron I, Ahmad N, Ravaud P., Arch. Intern. Med. 169(19), 2009
PMID: 19858432
Adverse event reporting in randomised controlled trials of neuropathic pain: considerations for future practice.
Cornelius VR, Sauzet O, Williams JE, Ayis S, Farquhar-Smith P, Ross JR, Branford RA, Peacock JL., Pain 154(2), 2012
PMID: 23127360
Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations.
Smith SM, Wang AT, Katz NP, McDermott MP, Burke LB, Coplan P, Gilron I, Hertz SH, Lin AH, Rappaport BA, Rowbotham MC, Sampaio C, Sweeney M, Turk DC, Dworkin RH., Pain 154(7), 2013
PMID: 23602344
Better reporting of harms in randomized trials: an extension of the CONSORT statement.
Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D; CONSORT Group., Ann. Intern. Med. 141(10), 2004
PMID: 15545678
Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective.
Lineberry N, Berlin JA, Mansi B, Glasser S, Berkwits M, Klem C, Bhattacharya A, Citrome L, Enck R, Fletcher J, Haller D, Chen TT, Laine C., BMJ 355(), 2016
PMID: 27697753

AUTHOR UNKNOWN, 2017
Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial.
Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, Sandel M, Iverson RE Jr, Lee-Paritz A, Strunk RC, Bacharier LB, Macones GA, Zeiger RS, Schatz M, Hollis BW, Hornsby E, Hawrylowicz C, Wu AC, Weiss ST., JAMA 315(4), 2016
PMID: 26813209
Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial.
Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators, Zanchetta JR, Albergaria BH, Borges JL, Kulak CA, Russo L, Zerbini CA, Lau E, Hala T, Machkova M, Alexandersen P, Krogsaa A, Nedergaard BS, Maasalu K, Valter I, Visockiene Z, Czajkowska-Kaczmarek E, Glogowska-Szelag J, Jendrych B, Supronik J, Racewicz A, Wojtecka-Grabka M, Mustatea S, Bolognese M, Marquez F, Miller PD, Woodson G., JAMA 316(7), 2016
PMID: 27533157
Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial.
Libman IM, Miller KM, DiMeglio LA, Bethin KE, Katz ML, Shah A, Simmons JH, Haller MJ, Raman S, Tamborlane WV, Coffey JK, Saenz AM, Beck RW, Nadeau KJ; T1D Exchange Clinic Network Metformin RCT Study Group, DiMeglio L, Woerner S, Jagielo B, Terrell J, Katz M, Hathway J, Milaszewski K, Bethin K, Ecker M, Shah A, Caswell K, Simmons J, Robertson A, Nadeau K, Klingensmith G, Manseau K, Willi S, Carchidi C, Libman I, Diaz A, Foster C, Slater H, Wheeler K, Wood J, Ichihara B, Haller M, Cintron M, Copeland K, Less J, Bacha F, Johnson E, Cemeroglu A, Kleis L, Goland R, Wolk A, Daniels M, Speer H, Cengiz E, Steffen A, Zgorski M, Gubitosi-Klug R, Campbell W, Zipf W, Dyer J, Sieple D, Nathan B, Street A, Leschyshyn J, Solorzano CB, Puskaric J, Gottschalk M, Hashiguchi M, Adi S, Torok C, Raman S, Hester L, Rodriguez H, Henson D, Calikoglu A, Duncan V, Brown H., JAMA 314(21), 2015
PMID: 26624824
Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.
Writing Committee for the Diabetic Retinopathy Clinical Research Network, Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW., JAMA 314(20), 2015
PMID: 26565927
Stopping vs. Continuing Aspirin before Coronary Artery Surgery.
Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network, Myles P, Wallace S, Galagher W, Farrington C, Ditoro A, Peyton P, Baulch S, Sidiropoulos S, Potgieter D, Baker R, Pesudovs B, O'Loughlin E, Wells J, Lynch K, Bolsin S, Osborne C, Ives K, Smith J, Hulley A, Christie-Taylor G, Painter T, Lang S, Cokis C, March S, Bannon P, Wong C, Turner L, Jackson A, Scott D, Silbert B, Said S, Bussieres J, Gagne N, Lamy A, Power P, Chan M, Underwood M, Mou A, Landoni G, Lembo R, McGuinness S, Parke R, Jayarajah M, Alderton J, Waugh D, Platt M, Alston P, Pai A, Sevillano A, Saravanan P, Vasudevan V., N. Engl. J. Med. 374(8), 2016
PMID: 26933848
High-Dose Perioperative Atorvastatin and Acute Kidney Injury Following Cardiac Surgery: A Randomized Clinical Trial.
Billings FT 4th, Hendricks PA, Schildcrout JS, Shi Y, Petracek MR, Byrne JG, Brown NJ., JAMA 315(9), 2016
PMID: 26906014
Adjunctive Dexamethasone in HIV-Associated Cryptococcal Meningitis.
Beardsley J, Wolbers M, Kibengo FM, Ggayi AB, Kamali A, Cuc NT, Binh TQ, Chau NV, Farrar J, Merson L, Phuong L, Thwaites G, Van Kinh N, Thuy PT, Chierakul W, Siriboon S, Thiansukhon E, Onsanit S, Supphamongkholchaikul W, Chan AK, Heyderman R, Mwinjiwa E, van Oosterhout JJ, Imran D, Basri H, Mayxay M, Dance D, Phimmasone P, Rattanavong S, Lalloo DG, Day JN; CryptoDex Investigators, Ruzagira E, Anywaine Z, Kitonsa J, Nikweri Y, Masiira B, Hien TT, Chau TT, Loc TT, Duong VA, Thanh TL, Trieu PH, Lam PS, Le T, Thanh NT, Wertheim HF, Day N, Konpan P, Semram K, Teparrukkul P, Phanphang R, Dulsuk A, Kensila U, Nyondo E, Kaphale G, Mafuta H, Selemani G, Dip CK, Denis B, Ganiem AR, Tjahjani N, Wahyuningsih R, Dian S, Komari N, Bahri A, Lie S, Pratama GT, Adawyah R, Newton P., N. Engl. J. Med. 374(6), 2016
PMID: 26863355
Effect of Aspirin on Development of ARDS in At-Risk Patients Presenting to the Emergency Department: The LIPS-A Randomized Clinical Trial.
Kor DJ, Carter RE, Park PK, Festic E, Banner-Goodspeed VM, Hinds R, Talmor D, Gajic O, Ware LB, Gong MN; US Critical Illness and Injury Trials Group: Lung Injury Prevention with Aspirin Study Group (USCIITG: LIPS-A), Talmor D, Banner-Goodspeed VM, Henson TL, Mueller AL, Nielsen VA, Officer LV, Yuan H, Kaufman DA, Hou PC, Abdulnour RE, Aisiku IP, Dwyer RC, Frendl G, Gish RE, Goralnick E, Kuczmarski TM, Levy BD, Parmar S, Rempell JS, Seethala RR, Wilson MQ, Welsby IJ, Drake WG, Davies J, Bajwa E, Briat K, Cosgrove K, Holland C, Festic E, Gajic O, Kor DJ, Hinds R, Bansal V, Lingenini RK, Gunderson TM, Gong MN, Soto G, Hsieh SJ, Hope A, Martinez M, Salcedo J, Lora J, Levitt JE, Asuni A, Vojnik R, Marchetti N, Gentile NT, Dehnkamp K, Kalugdan V, Elie-Turenne MC, Alnuaiman H, Plourde M, Sadikot R, Akca O, Cavallazzi R, Platt M, Park P, Brierley KJ, Cherry-Bukowiec J, Napolitano LM, Raghavendran K, Younger J, Watkins TR, Hough CL, Gundel SA, Hogl L, Minhas A, Tran E, Hoth JJ, Wells C, Yoza BK, Talmor DS, Banner-Goodspeed VM, Gajic O, Kor DJ, Carter RE, Hinds R, Lingenini RK, Gunderson TM, Gong MN, Soto G, Martin G, Arabi Y, Carson S, Ferguson N, Mandrekar J, Clardy PF, Howell MD, Harabin A, Ghofrani P., JAMA 315(22), 2016
PMID: 27179988
Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial.
Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettila V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group, Bellomo R, Nichol A, French C, Cooper D, Huet O, Little L, Mak A, Pettila V, Presneill J, Vallance S, Varma D, Wills J, Duranteau J, Vicaut E, Gallula P, Raghavan V, Chamam A, Kambire S, Camelo S, Cook D, Crowther M, Brun-Buisson C, Lauzier F, Howe B, Paul E, Bailey M, Waddy H, Al Kishi M, Kambire S, Camelo S, Skrifvars M, Bendel S, Schilling C, Kerz T, Murray L, McArthur C, Chen Y, Simmonds C, Newby L, Kumar N, Walshe C, O'Rourke J, Schilling C, Given M, Mitchell I, Van Haren F, Rodgers H, Kot M, Henderson S, Mehrtens J, Noble S, De Ryke R, Bailey M, Hutchinson R, France D, Hill G, Richards B, Tallott M, Field J, Skrifvars M, Vartiala H, Eliasson M, Koivikko M, Lefrant JY, Muller L, Roger C, Bengler C, Barbaste P, Ayral A, Lloret S, Elotmani L, Veber B, Gilles-Baray M, Guitard PG, Braud H, Lamacz A, Duranteau J, Harrois A, Figueiredo S, Hamada S, Bussone J, Pasquier MC, Payen D, Lukaszewicz AC, Damoisel C, Kambire S, Bussone J, Pasquier MC, Payen JF, Manhes P, Franconey G, Boucheix P, Martinez L, Kerz T, Harrigan P, Hardie M, Tolfree A, Haddad S, Arabi Y, Al Kishi M, Deeb A, Al Harbi S, Al-Swaidan L, Al Moammar T, Lingling J, Caliwag S, Richi H, Al Jandan A, Bendel S, Rahikainen S, Myllymaki M, Saari P, Tam V, Micallef S, Robinson J, Cole L, Weisbrodt L, Strickland R, Rivett J, Kloeden S, O'Connor S, Cooper D, McAllister R, Stewart S, Harley N, Barge D, Moore E, Jordan A, King P, Finfer S, Yarad E, Bird S, O'Connor A, Thebridge L, Dobb G, Chamberlain J, Barr M, Jenkinson E, Zelesco M, Gattas D, Buhr H, Hutch D, Keir M, Burnett A, Nair P, Reynolds C, Knowles S, Tantau R, Cooper DJ, Board J, Vallance S, McCracken P, Young M, Wills J, Gordon G, Reeves S, Brennan S, Dinsdale R, Andrews L, Mackle D, Hurford S, McGregor S, Nayyar V, Whitehead C, Kong J, Bonovas G., Lancet 386(10012), 2015
PMID: 26452709
Effect of regional versus local anaesthesia on outcome after arteriovenous fistula creation: a randomised controlled trial.
Aitken E, Jackson A, Kearns R, Steven M, Kinsella J, Clancy M, Macfarlane A., Lancet 388(10049), 2016
PMID: 27492881
Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes.
Kaul U, Bangalore S, Seth A, Arambam P, Abhaichand RK, Abhaychand RK, Patel TM, Banker D, Abhyankar A, Mullasari AS, Shah S, Jain R, Kumar PR, Bahuleyan CG; TUXEDO–India Investigators, Kaul U, Gupta RK, Bali HK, Iqbal K, Wander GS, Kumar S, Chopra AK, Jain R, Chandra P, Saran RK, Goel PK, Sharma GL, Gupta R, Roy S, Alexander T, Mullasari A, Mathew R, Bahuleyan CG, C R, Kumar PR, Abhaychand RK, Shetty R, Rajashekar , Verghese K, Singh R, R K, Mohan M, Dani SI, Sathe S, Patel TM, Abhyankar A, Pinto B, Hiremath M, Duggal JS, Banker D, Jagtap P, Bhagwat A, Singh P, Parikh J, Joshi A, Arneja J, Khan AI, Shah S, Potdar A, Rane S, Bhattacharya D., N. Engl. J. Med. 373(18), 2015
PMID: 26466202
Antiretroviral Therapy for the Prevention of HIV-1 Transmission
Cohen MS, Chen YQ, McCauley M., 2016
Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children.
Isanaka S, Langendorf C, Berthe F, Gnegne S, Li N, Ousmane N, Harouna S, Hassane H, Schaefer M, Adehossi E, Grais RF., N. Engl. J. Med. 374(5), 2016
PMID: 26840134
Effect of Early Prophylactic High-Dose Recombinant Human Erythropoietin in Very Preterm Infants on Neurodevelopmental Outcome at 2 Years: A Randomized Clinical Trial.
Natalucci G, Latal B, Koller B, Ruegger C, Sick B, Held L, Bucher HU, Fauchere JC; Swiss EPO Neuroprotection Trial Group, Zeilinger G, Pasquier S, Capone A, Buhrer C, Glanzmann R, Schulzke S, Weber P, Scharrer B, Bar W, Keller E, Killer C, Pfister R, Karin K, Huppi PS, Borradori-Tolsa C, Bucher HU, Fauchere JC, Koller B, Wellmann S, Hagmann C, Latal B, Natalucci G., JAMA 315(19), 2016
PMID: 27187300
Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.
Sheehan WJ, Mauger DT, Paul IM, Moy JN, Boehmer SJ, Szefler SJ, Fitzpatrick AM, Jackson DJ, Bacharier LB, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Pongracic JA, Beigelman A, Baxi SN, Benson M, Blake K, Chmiel JF, Daines CL, Daines MO, Gaffin JM, Gentile DA, Gower WA, Israel E, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Ly N, Marbin J, Morgan WJ, Myers RE, Olin JT, Peters SP, Raissy HH, Robison RG, Ross K, Sorkness CA, Thyne SM, Wechsler ME, Phipatanakul W; NIH/NHLBI AsthmaNet, Mauger DT, Israel E, Phipatanakul W, Smith L, Solway J, Krishnan J, Pongracic J, Wechsler M, Szefler S, Sorkness C, Lemanske R, Wenzel S, Holguin F, Lazarus S, Cabana M, Castro M, Bacharier L, Kraft M, Martinez F, Peters S, Fitzpatrick A, Busse WW, Butler E, Maiolo J, Misplay S, Skoner D, Smith G, Flexas I, Kumar R, Makhija M, Qamar N, Szychlinski C, Bloss V, Brown M, Chee K, David S, Ehrman CS, Ezmigna D, Goodwin J, Grad R, Hiranratta A, Lopez S, Paco A, Priefert J, Provencio NS, Ryan E, Varela M, Vasquez M, Weese R, Wences J, Decker J, Harrison K, Long D, Meade K, Mok R, Nelson-Purdy C, Ren D, Stessel H, Bartnikas L, Bouzaher A, Burke C, Cavanaugh M, Chen J, Cunningham E, Cunningham A, Friedlander J, Hindi E, Kantor D, Kopel L, Permaul P, Rao D, Rossi M, Schierembergg D, Schneider L, Troung J, Umetsu D, Zhou J, Aujla S, Broyles J, Chong H, Dubin P, Finder J, Green TD, Holt L, Kufen A, Kurland G, Lanzo R, Nash D, Parente J, Smith C, Spahr J, Weiner DJ, Beaty T, Brown SW, Bruce AC, Dodds JC, Douglas S, Freedle K, Simon DM, Whitlock DM, Gleason M, Spears G, Sundstrom DA, White M, Batalla J, Littlefield M, Rutledge B, Seymour D, Brown S, OquendoFlores O, Doty L, Gern B, Merchlinski A, Nelson J, Schmidt J, Texter L, Updegrave A, Zeller J, Zimmerman R Jr, Craven D, DiMarino A, Hart M, Kerns LA, Logan L, Veri L, Codispoti C, Fu J, Li G, Munoz-Mendoza D, Stevens S, Thompson B, Zitzer S, Bowman J, Bowyer V, Gonzales-Vargas J, McKean M, Tran N, Batson C, Davies L, Kelly F, Morales E, Redway A, Spicher M, Kaminski L, Knutson MR, Olson S, Turcsanyi S, Watson T, Wilmoth C, Caldwell W, Dula C, Ellis A, Horner C, Kertz L, Norris T, Rivera-Spoljaric K, Rodriguez O, Strunk R., N. Engl. J. Med. 375(7), 2016
PMID: 27532828
Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI Liraglutide trial).
Lind M, Hirsch IB, Tuomilehto J, Dahlqvist S, Ahren B, Torffvit O, Attvall S, Ekelund M, Filipsson K, Tengmark BO, Sjoberg S, Pehrsson NG., BMJ 351(), 2015
PMID: 26512041
Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial.
Lincoff AM, Mehran R, Povsic TJ, Zelenkofske SL, Huang Z, Armstrong PW, Steg PG, Bode C, Cohen MG, Buller C, Laanmets P, Valgimigli M, Marandi T, Fridrich V, Cantor WJ, Merkely B, Lopez-Sendon J, Cornel JH, Kasprzak JD, Aschermann M, Guetta V, Morais J, Sinnaeve PR, Huber K, Stables R, Sellers MA, Borgman M, Glenn L, Levinson AI, Lopes RD, Hasselblad V, Becker RC, Alexander JH; REGULATE-PCI Investigators., Lancet 387(10016), 2015
PMID: 26547100
Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial.
Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clement C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G., Lancet 387(10036), 2016
PMID: 27080498
Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial.
Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, Schlaen A, Pavesio C, Cimino L, Van Calster J, Camez AA, Kwatra NV, Song AP, Kron M, Tari S, Brezin AP., Lancet 388(10050), 2016
PMID: 27542302
Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: The CANOA Randomized Clinical Trial.
Rodes-Cabau J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Cote M, Marsal JR, Rivest D, Marrero A, Houde C., JAMA 314(20), 2015
PMID: 26551304
Prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis: a randomised trial.
Ruperto N, Pistorio A, Oliveira S, Zulian F, Cuttica R, Ravelli A, Fischbach M, Magnusson B, Sterba G, Avcin T, Brochard K, Corona F, Dressler F, Gerloni V, Apaz MT, Bracaglia C, Cespedes-Cruz A, Cimaz R, Couillault G, Joos R, Quartier P, Russo R, Tardieu M, Wulffraat N, Bica B, Dolezalova P, Ferriani V, Flato B, Bernard-Medina AG, Herlin T, Trachana M, Meini A, Allain-Launay E, Pilkington C, Vargova V, Wouters C, Angioloni S, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO), Apaz MT, Cuttica R, Espada G, Garay Stella M, Russo R, Hoyoux C, Joos R, Wouters C, Bica B, Ferriani Virginia PL, K Oliveira S, Marini R, Dolezalova P, Herlin T, Brochard K, Couillault G, Desjonqueres M, Fischbach M, Job Deslandre C, Pagnier A, Picherot G, Quartier P, Rodiere M, Soler C, Tardieu M, Dressler F, Trachana M, Uziel Y, Barone P, Bracaglia C, Cimaz R, Gerloni V, Corona F, Lepore L, Martino S, Meini A, Ravelli A, Zulian F, Herbigneaux RM, Stanevicha V, Burgos-Vargas R, Cespedes-Cruz A, Guilaisne BA, Ten Cate R, Wulffraat N, Flato B, Vojinovic J, Vargova V, Avcin T, Fasth A, Magnusson B, Pilkington C, Candell Chalom E, Sterba G., Lancet 387(10019), 2015
PMID: 26645190
Effect of Topical Intranasal Therapy on Epistaxis Frequency in Patients With Hereditary Hemorrhagic Telangiectasia: A Randomized Clinical Trial.
Whitehead KJ, Sautter NB, McWilliams JP, Chakinala MM, Merlo CA, Johnson MH, James M, Everett EM, Clancy MS, Faughnan ME, Oh SP, Olitsky SE, Pyeritz RE, Gossage JR., JAMA 316(9), 2016
PMID: 27599329
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
Schulz KF, Altman DG, Moher D; CONSORT Group, Altman DG, Barbour V, Berlin JA, Boutron I, Devereaux PJ, Dickersin K, Elbourne D, Ellenberg S, Gebski V, Goodman S, Gotzsche PC, Groves T, Grunberg S, Haynes B, Hopewell S, James A, Juhn P, Middleton P, Minckler D, Moher D, Montori VM, Mulrow C, Pocock S, Rennie D, Schriger DL, Schulz KF, Simera I, Wager E, Clarke M, Guyatt G., Ann. Intern. Med. 152(11), 2010
PMID: 20335313
Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial.
Lingvay I, Perez Manghi F, Garcia-Hernandez P, Norwood P, Lehmann L, Tarp-Johansen MJ, Buse JB; DUAL V Investigators, Perez Manghi F, Visco V, Saavedra S, Vico M, Lapertosa S, D'Emden M, Moses R, Chen R, Forbes M, Gerstman M, Nathow T, Bargiota A, Ioannidis I, Karatzidou K, Pagkalos E, Sambanis C, Tentolouris N, Tigas S, Dudas M, Harcsa E, Ory I, Bako B, Hidvegi T, Sauque Reyna L, Olvera Alvarez I, Morales de Teresa MA, Morales Franco G, Garcia Hernandez PA, Petunina N, Zalevskaya A, Galstyan G, Potin V, Sobolev A, Samoilova Y, Kharakhulakh M, Klimontov V, Nedogoda S, Zyangirova S, Alpenidze D, Khetagurova F, Ipatko I, Martinka E, Lacka J, Rummer K, Truban J, Gajdosikova L, Philippiova A, Behuncik M, Vargova A, Pastrnakova E, Kosikova M, Dzuponova J, Pastrnakova E, Mezquita Raya P, Rivas Fernandez M, Tofe S, de la Cuesta C, Merino Torres JF, Munoz M, Kok JA, Jacovides A, Snyman HH, Pillay D, Farris N, Cannon K, Lynn L, Bedel G, Chaykin L, Corder C, Gaona R, Kirstein J, McKenzie W, Morawski E, Ndukwu I, Risser J, Thurman J, Winslow D, Blaze K, Boden G, Jardula M, Klaff L, Norwood P, Stamps H, Tandron I, Tarshis G, Levinson L, Agaiby J, Ayele E, Hurley S, Inzerello A, Lane J, Uusinarkaus K, Lingvay I., JAMA 315(9), 2016
PMID: 26934259

Stephens MD, Talbot JC, Routledge PA., 1998
Best practices for reporting safety data to data monitoring committees. Trials Conference: 4th International Clinical Trials Methodology Conference, ICTMC and the 38th Annual Meeting of the Society for Clinical Trials United Kingdom
Davis S, Sun H, Jung K., 2017
Effective graphical analyses of adverse events in DMC reports. Trials Conference: 4th International Clinical Trials Methodology Conference, ICTMC and the 38th Annual Meeting of the Society for Clinical Trials United Kingdom
Furey A, Bechhofer R., 2017
Reports to Independent Data Monitoring Committees: An Appeal for Clarity, Completeness, and Comprehensibility.
Buhr KA, Downs M, Rhorer J, Bechhofer R, Wittes J., Ther Innov Regul Sci 52(4), 2017
PMID: 29714543
Graphical approaches to the analysis of safety data from clinical trials.
Amit O, Heiberger RM, Lane PW., Pharm Stat 7(1), 2008
PMID: 17323410
Summarizing the incidence of adverse events using volcano plots and time intervals.
Zink RC, Wolfinger RD, Mann G., Clin Trials 10(3), 2013
PMID: 23690094
Sample closed session DMC report
AUTHOR UNKNOWN, 2016
Absence of evidence is not evidence of absence.
Altman DG, Bland JM., BMJ 311(7003), 1995
PMID: 7647644
Reporting of drug tolerance in randomized clinical trials: when data conflict with authors' conclusions.
Jonville-Bera AP, Giraudeau B, Autret-Leca E., Ann. Intern. Med. 144(4), 2006
PMID: 16490923
Efavirenz-Based Antiretroviral Therapy Among Nevirapine-Exposed HIV-Infected Children in South Africa: A Randomized Clinical Trial.
Coovadia A, Abrams EJ, Strehlau R, Shiau S, Pinillos F, Martens L, Patel F, Hunt G, Tsai WY, Kuhn L., JAMA 314(17), 2015
PMID: 26529159

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