-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/ace-inhibitor-arb-update_disposition-comments.pdf
October 07, 2011 - We would like to suggest that the researchers
consider consulting other data sources such as adverse … Conceivably, information from adverse event databases
would support the clinical impression that the … The purpose of this section is to describe the
potential adverse events that may be
encountered in … Aside from the risk itself, the emergence of a new
adverse event from an outside meta-analysis raises … adverse event rates but no more
benefit than a single drug.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/fatty-acids-cardiovascular-disease_executive.pdf
August 01, 2016 - Adverse events:
• What adverse effects are related to n-3 FA intake
(in studies of CVD outcomes and … study arms, and no serious or
severe adverse event was attributed to n-3 FA. … Six of the
marine oil trials explicit stated that most or all adverse
events were mild. … • No serious or severe adverse events were related
to n-3 FA intake (supplementation). … differences in serious or nonserious adverse events
between marine oil and placebo.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/gout_executive.pdf
March 01, 2016 - Observational studies
were also included for rare adverse events. … The most commonly reported adverse
events in trials of febuxostat were abdominal pain,
diarrhea, and … Adverse events associated
with colchicine drug interactions: Analysis of the public version
of the … FDA adverse event reporting system. … Systematic review and meta-
analysis of the clinical efficacy and adverse effects of Chinese
herbal
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-224-depression-children-comments.pdf
April 10, 2020 - If the serious adverse
events aren’t defined by industry standards, AACAP recommends that
the term … “adverse event” be used instead. … Public reviewer:
AACAP
Measure-
ment of
Adverse
Outcomes/
Events
The Review brings attention … to adverse outcomes due to the side effects
of medicine. … We also added text to
methods section on “serious adverse
events.”
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/opioid-chronic-pain-surveillance-report-3.pdf
June 01, 2022 - Opioids were associated with increased risk of various adverse events,
including withdrawal due to adverse … There were no serious
adverse events with either TENS or opioids. … Harms and Adverse Events:
a. … Morphine Equivalent Total Dosage as
Predictor of Adverse Outcomes in Opioid
Prescribing. … Harms and Adverse Events:
Key Question 3. Dosing Strategies:
Key Question 4.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/back-pain-imaging_clinician.pdf
April 01, 2016 - population in clinical studies of back pain.1
Early imaging for back pain may be associated with adverse … information that is
needed to guide early treatment and management of back pain.
»» There are potential adverse … effects of radiation associated with
radiography and CT; however, some of these adverse effects
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cancer-anemia-update_disposition-comments.pdf
April 25, 2013 - Still, we point out that those trials reporting no adverse
mortality effect severely underpowered to … While any and all
mortality and adverse progression-free survival signals related to
ESA use are very … Trials reporting no adverse mortality effect were
severely underpowered to detect the magnitude of … On-
study mortality was typically determined based on adverse event data (e.g., an
adverse event with … Therefore, this was not a specified
endpoint and should be considered an adverse event endpoint.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/disruptive-behavior-disorder_clinician.pdf
August 01, 2016 - This is a summary of a systematic review evaluating the evidence regarding the potential benefits and adverse … Adverse effects
of medications reported in included studies were mild or
moderate, but the ability … harms reported in the studies were generally
mild or moderate and fairly immediate in nature:
�– Adverse … events frequently reported with risperidone
included weight gain, sedation, and somnolence.
�– Adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-233-diverticulitis-evidence-summary.pdf
October 01, 2020 - Adverse outcomes, such as mortality and
emergency surgery are uncommon (3% of patients or fewer), regardless … Evidence regarding dDeath,
treatment failure, diverticulitis-related morbidities, rehospitalization, and adverse … There was low to moderate SoE that serious
adverse events are uncommon with elective surgery, including
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-d-surv-report-3-noninvasive-nonpharma_0.xlsx
January 01, 2022 - Exercise) Adverse Events Including Withdrawals Funding Source Quality
Alqualo-Costa 2021
[Surveillance … NR, adj MD -0.1 (95% CI -0.4 to 0.6), p=0.7 NR NR No serious adverse events were observed This study … C
Adverse events that the external safety officer approved the designation of possibly or definitely … Five participants reported experiencing adverse symptoms after the MBSR intervention but at a very … C
Withdrawals due to AE: NR
Any possibly or definitely related adverse event: 7.1% (9/127) vs. 10.9%
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-222-evidence-summary-health-equity.pdf
January 01, 2020 - Additional research
on unstudied populations experiencing adverse
effects of healthcare disparities
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/antidepressants-2007_executive.pdf
January 01, 2007 - Differences in Harms (Adverse Events) (KQ 4)
We analyzed adverse events data from 72 head-to-head
efficacy … Methods of adverse events assessment in efficacy trials
differed greatly. … Adverse events profiles. … Severe adverse events.
Sexual dysfunction. … Other severe adverse events.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/ptsd-repository-expanded-protocol.pdf
October 24, 2019 - functioning, quality of life, sleep,
substance use, suicide- and self-directed violence, withdrawal due to adverse … events, serious adverse events
• Timing:
o No limitation on study duration or length of followup … Quality of life
• Sleep
• Substance use
• Suicide and self-
directed violence
• Withdrawal due to
adverse … events
• Serious adverse events
(KQ 1)
(KQ 2)
4
IV. … Harms outcomes (withdrawals due to adverse events, serious adverse events)
14
APPENDIX
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/celiac-disease_clinician.pdf
July 01, 2016 - evidence regarding the comparative accuracy (the balance of sensitivity and
specificity) and possible adverse … Endoscopy with multiple
duodenal biopsies has a very low risk of adverse events.
1. … Overview of Clinical Research Evidence
Table 3: Summary of Findings and Strength of Evidence for Adverse … Events Associated With Invasive Diagnostic Tests
Adverse
Events Test Type and No. of Studies (Na) Systematic … testing because of symptoms.
�� Evidence was also insufficient to determine the impact of
indirect adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/management-adhd-adults-protocol-amendment.pdf
January 08, 2025 - We will create a comprehensive list of pertinent adverse
events using the Common Terminology Criteria … for Adverse Events (CTCAE) to ease in
their abstraction. … The McHarm tool is designed to directly assess the rigor of the adverse event assessment
(e.g., use … of a scale or checklist) and whether adverse event data were collected actively
(e.g., all participants … Common Terminology Criteria for
Adverse Events (CTCAE). Version 5.0. November 27, 2017.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/management-adhd-adults-protocol.pdf
June 10, 2024 - We will create a comprehensive list of pertinent adverse
events using the Common Terminology Criteria … for Adverse Events (CTCAE) to ease in
their abstraction. … The McHarm tool is designed to directly assess the rigor of the adverse event assessment
(e.g., use … of a scale or checklist) and whether adverse event data were collected actively
(e.g., all participants … Common Terminology Criteria for
Adverse Events (CTCAE). Version 5.0. November 27, 2017.
-
effectivehealthcare.ahrq.gov/sites/default/files/product/pdf/improved-cancer-outcomes-protocol_0.pdf
December 01, 2021 - preventing negative treatment outcomes such as effects on dose tolerance, hospital
utilizations, adverse … preventing negative treatment outcomes such as effects on dose tolerance, hospital
utilizations, adverse … treatment in preventing
negative treatment outcomes such as effects on dose, hospital utilizations, adverse … outcomes associated w ith cancer treatment such as effects on dose tolerance, hospital
utilizations, adverse … outcomes associated w ith cancer treatment such as effects on dose tolerance, hospital
utilizations, adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-262-pharmacotherapy-alcohol-summary.pdf
November 01, 2023 - Collection of adverse events data was notably inconsistent
across studies. … In particular, although some studies reported all adverse events, others
only reported them in the situation … Trials of topiramate
reported increased risks of many adverse events, including paresthesias, taste … For most serious harms, there was insufficient data to
determine comparative rates of adverse events
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/sleep-apnea_research-protocol.pdf
March 15, 2010 - central and obstructive etiology comprise the other
forms.2 OSA has been associated with a variety of adverse … Preoperative testing
People with sleep apnea are at increased risk of surgical and anesthesia-related adverse … Harms, Adverse events
a. Any adverse events
KQ 2, 5
7. … Harms, Adverse events
a. Any adverse events
KQ 6-7
• Adherence / Compliance
a. … events: No minimum duration
o Post-surgery: minimum 6 weeks (except adverse events)
• Prospective
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/asthma-treatment_research-protocol.pdf
February 10, 2010 - billion.5
The aim of asthma management is to achieve and maintain control of the disease with as few
adverse … Question 3
What is the nature and frequency of serious adverse effects of treatment with breathing … Do the safety or adverse effects of treatment with breathing techniques differ between
different subgroups … Events:
• Increased asthma symptoms or acute asthma exacerbations
• Adverse reactions to therapies … The
figure also depicts the possibility of adverse events occurring at any time after treatment
begins