-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/hepatitis-c_executive.pdf
November 01, 2012 - serious adverse
events.16-19,38,52
Triple Therapy Regimens With Pegylated
Interferon, Ribavirin, … risk of serious adverse events
than dual therapy with pegylated interferon alfa-2a plus
ribavirin ( … However, serious adverse events were
only reported in two trials,18,19 and the rate of serious
adverse … adverse events with use of protease inhibitors, and the
adverse events appear to be self-limited following … There was no difference in risk of withdrawal due to
adverse events.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/procalcitonin-future_research.pdf
August 01, 2014 - Does the use of procalcitonin guidance reduce antibiotic resistance and antibiotic adverse
events? … events of
testing (pain, local
bleeding, or infection)
Adverse events of therapy
(persistent … Does the use of procalcitonin guidance reduce antibiotic resistance and antibiotic adverse
events? … events of
testing (pain, local
bleeding, or infection)
Adverse events of therapy
(persistent … These should include fewer antibiotic adverse events and emergence of
drug-resistant pathogens.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/dietary-supplements_research-protocol.pdf
December 15, 2010 - , withdrawal
due to adverse events)? … events
o Serious adverse events (composite outcome)c
o Neurologic adverse events (e.g., neuropathy … /intraventricular,
gastrointestinal, hematuria)
o Withdrawal due to adverse events
o Other reported … important clinical adverse events
• Organ toxicity
o Liver (aspartate aminotransferase [AST], … events (composite outcome—FDA definition of serious adverse events24),
withdrawal due to adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/assessing-applicability.ppt
January 01, 2009 - events. … events. … drug events, no response)
Events rates markedly different than in community Event rates in treatment … events) was chosen. … events.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/treatment-resistant-depression_surveillance.pdf
April 01, 2016 - For reviewing adverse events (KQ 4), per our
standard approach, we include observational studies. … (SOE: Insufficient)
Specific adverse events. … We looked at both withdrawals
that investigators attributed to adverse events
and overall numbers … There
was no difference in cognitive function
between groups.
1
Abbreviations: AE=Adverse Events … (SOE:
Insufficient)
Specific adverse events.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-224-depression-children-comments.pdf
April 10, 2020 - Therefore, it is not clear how serious adverse events are
defined or qualified for the purpose of the … If the serious adverse
events aren’t defined by industry standards, AACAP recommends that
the term … Public reviewer:
AACAP
Measure-
ment of
Adverse
Outcomes/
Events
The Review brings attention … Some terms are not well-defined
such as “mixed
depressive disorders” and “serious adverse events”. … We also added text to
methods section on “serious adverse
events.”
-
effectivehealthcare.ahrq.gov/sites/default/files/Evidence%20Summary_2.pdf
May 01, 2020 - Partogram use: Evidence summary for major outcomes and adverse events
Category Outcome
Study Design … Low
(non-U.S. setting, 1
study)
Adverse
Events
Maternal
Outcomes –
Hemorrhage
3 RCTs24,25,29 … Moderate
(Indirect,
consistent)
Existing SR
was consistent
with RCT
findings
Adverse
Events … High
Adverse
Events
Maternal Outcomes –
Infection
3 RCTs37
(1,933)
2 SRs44-46
(3,475 patients … Low
(Indirect, 1 study)
Adverse
Events
Maternal
Outcomes –
Trauma to the
Pelvic Floor
1 RCT76
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-d-opioid-chronic-pain-surveillance-report-3.xlsx
September 30, 2015 - Events and Withdrawals Due to Adverse Events Sponsor Quality
Hruschak, 2021 RCT
Duration: 6 weeks University … to study medications: 12.7% (7/55) vs. 29.1% (16/55), RR 0.44 (95% CI 0.20 to 0.98)
Serious AEs: No events … B (events/total person-years); adjusted Incidence Rate Ratio (aIRR):
Overdose: 3241/22097 vs. 11433/ … cardiovascular events (including ischemic heart disease, congestive heart failure, acute ischemic stroke … B
Major adverse cardiovascular events: 52 vs. 72
Incidence rate per 10,000 person months (95% CI): 30.12
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/transparency-tympanostomy_research.pdf
June 01, 2017 - Secondary
Adverse events, otoscopic exams, audiometry, and tympanometry
Microbiological response … In general, there were few serious adverse events and many other
adverse events. … showed more adverse events in the intervention group. … events, including serious adverse events (not defined), other
adverse events (not defined), and acute … Question 3: What adverse events, surgical complications, and sequelae are associated with
inserting
-
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/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/cer-250-cannabis-2024-surv-rep-update-table-e5.xlsx
January 01, 2024 - Events Other Reported Outcomes Funding Source Risk of Bias
21087411 Bestard, 2011 Prospective cohort … C
% (n/N)
Any adverse event
3 months: 35% (19/49) vs. 47% (30/52) vs. NR, RR for A vs. … B 0.72 (95% CI 0.49 to 1.07)
Serious adverse events: none in any group
Withdrawals due to adverse events … adverse events: 13% (28/215) vs. 19.4% (42/216), RR 0.67 (95% CI 0.43 to 1.04)
Withdrawals due to adverse … events: 4.65% (10/215) vs.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/depression-childhood-protocol.pdf
August 06, 2018 - events (AEs); that is, some interventions
Source: www.effectivehealthcare.ahrq.gov
Published … All guidelines suggest active monitoring for potential
adverse events and ensuring that the treatment … Adverse events may occur at any point after the treatment is received.
IV. … Effects" OR TX
“adverse effect” or TX “adverse event” OR TX “adverse
events” OR TX "adverse outcome … Effects" OR
TX “adverse effect” or TX “adverse event” OR
TX “adverse events” OR TX "adverse
outcome
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/juvenile-arthritis-dmards_research-protocol.pdf
March 09, 2010 - KQ 3: In children with JIA, does the rate and type of adverse events differ
between the various DMARDs … • Adverse events: These are specific to the interventions being examined (see Table
2). … In addition, adverse events may occur at
any point after the treatment is received. … • Case control studies are acceptable to assess for adverse events of DMARD treatment
(KQ3, KQ4) … Event Reporting System (AERS) from July 2008 to June 2009 for
adverse events related to JIA treatment
-
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 … events
are mostly rare and evidence is insufficient to make conclusions. … These events are mostly
rare. … There was low to moderate SoE that serious
adverse events are uncommon with elective surgery, including
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/back-pain-treatment_clinician.pdf
November 01, 2016 - Pharmacological therapies are associated with increased risk
of adverse events when compared with placebo … �» Examples of reported adverse effects included mild bleeding at needling
sites with acupuncture, … events when compared with placebo (��� to ���) … Table 4: Adverse Effects of Interventions for Low Back Pain
Table 3: Nonradicular Chronic Low Back Pain … addiction, overdose, and death
Nonsteroidal
anti-inflammatory
drugs
��Cardiovascular thrombotic events
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/nppv-respiratory-failure_research-protocol.pdf
April 21, 2011 - events, or lower medical utilization:
a. … events outcomes). … The safety outcomes will be framed to help
identify adverse events, including aspiration, secondary … events; and
intermediate, final, and adverse events outcomes. … intervention-group
rates of events, or both.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/major-depressive-disorder_research-protocol.pdf
November 24, 2014 - events (safety and tolerability): overall adverse events, withdrawals
because of adverse events, serious … adverse events, specific adverse events
(including hyponatremia, seizures, suicidality, hepatotoxicity … events, or drug interactions (pharmacologic and alternative
treatments)
Timing
We will have no … events, results, and adverse events
reported. … events, if reported.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/head-neck-cancer_surveillance.pdf
August 01, 2012 - Events: The incidence of other adverse events i.e. dermatitis 7 and dysphagia 6
favored IMRT treatment … The original CER reported
inconsistent results for other adverse events. … events. … Similarly
inconsistent results
for adverse events
were found in the
original CER
1 signal (A1) … events.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/ptsd-6-protocol.pdf
December 07, 2024 - events, serious adverse events
• Timing:
o No limitation on study duration or length of follow up … Serious Adverse Event Percent
3. Serious Adverse Event Detail
4. … Serious Adverse Events Numerator
5. Serious Adverse Events Denominator
6. … Withdrawal Due to Adverse Events Percent
7. Withdrawal Due to Adverse Events Detail
8. … Withdrawal Due to Adverse Events Numerator
9. Withdrawal Due to Adverse Events Denominator
10.