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21. Antipsychotics-Children Research-Protocol (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/antipsychotics-children_research-protocol.pdf
    June 04, 2010 - number of people having an adverse event. … If a study mentions an adverse event in the discussion but does not report data on that adverse event … We will not assume an adverse event occurred unless a specific number of events are reported. … The dose of each medication that is associated with an adverse event will be recorded to facilitate … a dose-adverse event analysis.

22. Research Protocol: Radiation Therapy for Brain Metastases (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/radiation-therapy-brain-metases-protocol.pdf
    October 10, 2019 - , number of adverse events, any specific adverse event most often assessed, radiation necrosis, fatigue … The broader inclusion criteria for adverse event data take into account that rare adverse events are … adverse event research, assessing the following:75, 76 • Data collection of adverse events • Reporting … What is a Serious Adverse Event? … https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event.

23. App-E-Surv-Rept-1-Acute-Pain (xls file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-e-surv-rept-1-acute-pain.xlsx
    May 29, 2025 - B Any adverse event: 13.6% (11/81) vs. 18.6% (16/86) NR NR Fair Abbreviations: CI = confidence interval … B Any adverse event: 10.0% (6/60) vs. 18.6% (11/59), RR 0.54 (95% CI 0.21 to 1.36) Nausea: 0.8% (1/60 … B Any adverse event: 34% (26/76) vs. 9% (7/74), RR 3.62 (95% CI 1.67 to 7.82) Dizziness: 7.9% (6/76) … B Any adverse event: 11.6% (8/69) vs. 13.2% (9/68), p=0.57 NR Institutional grant Fair Frants, 2021 … D Any adverse event: 30.2% (62/205) vs. 46.2% (96/208) vs. 51.0% (105/206) vs. 23.2% (48/207) Nausea:

24. Comparative Effectiveness Review No. 258_Diagnostic Errors in the Emergency Department: A Systematic Review (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/diagnostic-error-executive-summary.pdf
    August 01, 2023 - Some of these patients suffer an adverse event because of the incorrect diagnosis (~2.0%), and some … of these adverse events are serious (~0.3%). … event, and 1 in 350 suffering permanent disability or death. … event as a result, and about 370,000 (0.3%) suffer serious harms from diagnostic error. … The overall (not disease-specific), per ED visit, potentially preventable diagnostic adverse event rates

25. Layout 1 (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/ace-inhibitor-arb-update_executive.pdf
    June 01, 2011 - This may reflect low event rates among otherwise healthy patients and relatively few studies with extended … ARB); event rates were very low or zero for all studies; this limited Insufficient our ability to accurately … In the four studies that did report episodes of ARB) angioedema, this adverse event was observed only … large databases with sufficient sample sizes to obtain more precise estimates of this rare but serious event … event rates, overall adverse event rates, and withdrawals due to adverse events, withdrawal rates, and

26. App-D-Opioid-Chronic-Pain-Surveillance-Report-2 (xls file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-d-opioid-chronic-pain-surveillance-report-2.xlsx
    September 30, 2015 - Abbreviations: AE = adverse event; BMI = body mass index; CI = confidence interval; COWS = Clinical Opiate … event; SD = standard deviation; U.S. = United States; VAS = Visual Analog Scale Appendix Table D-1. … D Any opioid-related event: 5.3% vs. 6.1% vs. 3.4% vs. 3.6%, p<0.0001 Suicide (fatal or nonfatal): 1.0% … HR 1.67 (95% CI 1.51 to 1.84) Safety event hospitalizations A vs. B vs. … event B: Controls: (n=2,311), patients without an opioid-related adverse event, 1:1 matching based on

27. App-D-Opioid-Chronic-Pain-Surveill-Report-1 (xls file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-d-opioid-chronic-pain-surveill-report-1.xlsx
    September 30, 2015 - Abbreviations: AE = adverse event; BMI = body mass index; CI = confidence interval; COWS = Clinical Opiate … event; SD = standard deviation; U.S. = United States; VAS = Visual Analog Scale Appendix Table E-1. … D Any opioid-related event: 5.3% vs. 6.1% vs. 3.4% vs. 3.6%, p<0.0001 Suicide (fatal or nonfatal): 1.0% … HR 1.67 (95% CI 1.51 to 1.84) Safety event hospitalizations A vs. B vs. … event B) Controls: (n=2,311), patients without an opioid-related adverse event, 1:1 matching based on

28. Comments to Effective Heath Care Program Draft Documents (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/registries-guide-2nd-edition_disposition-comments.pdf
    March 03, 2010 - The pros and cons of using a registry for reporting adverse events are addressed in the "Adverse Event … events and the association (if any) between exposures and adverse event rates. … Do they mean adverse event? We changed this term to adverse event. … We changed this term to adverse event. … The time constraints of physicians and surgeons further inhibit adverse event reporting.

29. Evidence-based Practice Center Systematic Review Protocol (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/vaccine-safety_research-protocol.pdf
    September 18, 2012 - Event Reporting System (VAERS),11 the Vaccine Safety Datalink,12 and the Clinical Immunization Safety … Internet-based reporting to the vaccine adverse event reporting system: a more timely and complete way … event CTCAE = Common Terminology Criteria for Adverse Events Hib = Haemophilus influenzae type b … event Tdap = Tetanus, diphtheria, and acellular pertussis VAERS = Vaccine Adverse Event Reporting … Adverse events of interest, included in electronic search terms Adverse event Vaccine type Acute

30. Prioritization and Selection of Harms for Inclusion in Systematic Reviews (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/ehc-presentation-selection-harms-systematic-reviews.pdf
    February 01, 2018 - What is a Serious Adverse Event? … What is a Serious Adverse Event? … , not an adverse event. … is a failed treatment, not an adverse event. … What is a Serious Adverse Event? 2016.

31. Evidence Report on the (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/antipsychotics-adults_research-protocol.pdf
    December 01, 2010 - ; this assumption may overestimate the number of people having an adverse event and lead to a unit-of … We will not assume that an adverse event occurred unless a specific number of events are reported. … By taking this approach, we may underestimate the number of patients for whom a particular adverse event … The dose of each medication that is associated with an adverse event will be recorded to facilitate … a dose- related adverse-event analysis.

32. CER 244 Evidence Summary: Safety of Vaccines Used for Routine Immunization in the United States: An Update (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/cer-244-safety-vaccines-update-evidence-summary.pdf
    May 01, 2021 - event following administration of that vaccine (either because the risk was not statistically significantly … event following administration of that vaccine (either because the risk was not statistically significantly … event following administration of that vaccine (either because the risk was not statistically significantly … event being studied and the challenges of conducting sufficiently powered studies when investigating … Adverse effects of vaccines: Evidence and causality.

33. Disposition of Comments_Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents: A Systematic Review (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/disruptive-behavior-disposition-comments.pdf
    April 10, 2025 - However, pharmacotherapy was associated with an increased risk of experiencing any adverse event. … Hoffman, American Academy of Pediatrics 4 Results Definition needed for "adverse event": The Results … and Discussion sections did not include a definition of “adverse event”? … If this is meant as medication side effects then I would recommend replacing “adverse event” with “ … Or, is this “adverse event” meant to reflect “worsening aggression,” or some other negative outcome

34. CER 215 Executive Summary: Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-215-depression-older-adults-executive-summary.pdf
    March 01, 2019 - event, withdrawal due to adverse events, mortality, hospitalization, serious adverse events, arrhythmias … event; ECG=electrocardiogram; OBS=observational; RCT=randomized controlled trial; SNRI=selective norepinephrine … Insufficient evidence: mortality, serious adverse events, withdrawals due to adverse events SSRI … duloxetine (RCT) Adverse events Fewer with vortioxetine (+++), NNT 6 (4 to 17)25 Serious adverse … event profiles, particularly when SOE ratings are low or for outcomes that do not have a SOE grade

35. Methods-Guide-Chapter-Prioritization-And-Selection-Of-Harms-For-Inclusion-In-Systematic-Reviews (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/prioritization-selection-of-harms.pdf
    February 01, 2018 - adverse event,” or “any serious adverse event”; rather, the reports generally focused on specific adverse … MedWatch: The FDA Safety Information and Adverse Event Reporting Program. … What is a Serious Adverse Event? 2016. … 4) Are there general (non-specific) harms (e.g., any adverse event, any serious adverse event, withdrawal … Are there general (non-specific) harms (e.g., any adverse event, any serious adverse event, withdrawal

36. Evidence Summary_Comparative Effectiveness Review No. 250_Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain: 2022 Update (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-250-cannabis-evidence-summary-2022-update_0.pdf
    January 01, 2022 - There was no increase in risk of serious adverse events or withdrawal due to adverse events. … • Other key adverse event outcomes (psychosis, cannabis use disorder, cognitive deficits) and outcomes … event; SOE = strength of evidence; THC = tetrahydrocannabinol; WAE = withdrawal due to adverse event … Understanding how the adverse event profiles of cannabis products compare with other available treatments … In order to better understand the small to moderate improvements in pain, and the complete adverse event

37. Adverse Effects of First-Line Pharmacologic Treatments of Major Depression in Older Adults (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/ehc-depression-research-protocol.pdf
    February 07, 2018 - event profiles, patient preferences, dosing schedules, costs, and drug interactions. … Outcomes: We are interested in the following adverse effects for KQ1 and KQ2: • Any adverse event … , as in those who experienced an adverse events • Withdrawal due to adverse events • Serious adverse … Effects • Adverse events • Withdrawal due to adverse events • Serious adverse events • Hospitalization … for rare event outcome: a simulation study.

38. Nonopioid Pharmacologic Treatments for Chronic Pain: Evidence Summary (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/nonopioid-chronic-pain-summary.pdf
    April 01, 2020 - Harms Across all classes, incidence of serious adverse event (SAEs) was low. … event not applicable to drug); SAE = serious adverse event; SNRI = serotonin-norepinephrine reuptake … event not applicable to drug); SAE = serious adverse event; SOE = strength of evidence; WAE = withdrawal … due to adverse event Effect size: none (i.e., no effect/no statistically significant effect), small, … event; SOE = strength of evidence; WAE = withdrawal due to adverse event Effect size: none (i.e., no

39. Protocol Amendment - Safety of Vaccines 030413 (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/vaccines-safety-protocol-130325.pdf
    September 18, 2012 - Event Reporting System (VAERS),11 the Vaccine Safety Datalink,12 and the Clinical Immunization Safety … Internet-based reporting to the vaccine adverse event reporting system: a more timely and complete way … event CTCAE = Common Terminology Criteria for Adverse Events Hib = Haemophilus influenzae type b … event Tdap = Tetanus, diphtheria, and acellular pertussis VAERS = Vaccine Adverse Event Reporting … Adverse events of interest, included in electronic search terms Adverse event Vaccine type Acute

40. Layout 1 (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/gerd-2005_executive.pdf
    January 01, 2005 - of adverse events and complications was inconsistent across studies. … Higher adverse event rates were described for PPIs than for H2RAs or placebo. … PPIs (1 RCT): no direct comparative adverse event data reported in this study; in surgical group, 3.7% … event data for PPIs not presented in this study. … There are no direct comparative adverse event data for endoscopic vs. laparoscopic procedures.