-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/epilepsy-medicine_surveillance.pdf
August 01, 2012 - event
warnings have been communicated by the FDA
- The conclusions for KQ4 (subgroups) do not address … As such, it is difficult to assure that
the case population had the same baseline risk of
an acute event … , bone density, and cosmetic adverse effects? … event hyperesthesia was
added; the use in specific
populations was updated
(pregnancy: topamax can … As such, it is
difficult to assure that the case population had the same
baseline risk of an acute event
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/epilepsy-medicine_surveillance.pdf
August 01, 2012 - event
warnings have been communicated by the FDA
- The conclusions for KQ4 (subgroups) do not address … As such, it is difficult to assure that
the case population had the same baseline risk of
an acute event … , bone density, and cosmetic adverse effects? … event hyperesthesia was
added; the use in specific
populations was updated
(pregnancy: topamax can … As such, it is
difficult to assure that the case population had the same
baseline risk of an acute event
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/hip-fracture-pain.ppt
May 01, 2011 - Events:
Stroke
Myocardial infarction
Renal failure
Other Clinically Significant Outcomes and Adverse … adverse events influenced by pain interventions was examined for the effectiveness review. … event rates were similar in both treated and control groups, but studies were not powered to identify … Adverse Events Influenced by Pain Management Interventions
Overall, adverse event rates were similar … Conclusions About Benefits and Adverse Events
Abou-Setta AM, Beaupre LA, Jones CA, et al.
-
effectivehealthcare.ahrq.gov/sites/default/files/hip-fracture-pain.ppt
May 01, 2011 - Events:
Stroke
Myocardial infarction
Renal failure
Other Clinically Significant Outcomes and Adverse … adverse events influenced by pain interventions was examined for the effectiveness review. … event rates were similar in both treated and control groups, but studies were not powered to identify … Adverse Events Influenced by Pain Management Interventions
Overall, adverse event rates were similar … Conclusions About Benefits and Adverse Events
Abou-Setta AM, Beaupre LA, Jones CA, et al.
-
effectivehealthcare.ahrq.gov/sites/default/files/cer-242-radiation-therapy-brain-metastases-evidence-summary.pdf
June 01, 2021 - Outcomes including efficacy, impact on quality of life and neurocognition, and
adverse effects are important … • We did not detect consistent differences in serious adverse events, number of
reported adverse … events, adverse events, radiation
necrosis, headaches, fatigue, seizure, vomiting. … Risk of bias varied, 25 trials were terminated
early and the quality of adverse assessment and reporting … Adverse Events
We found no difference in serious adverse events when comparing WBRT plus SRS
with
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/gastric-cancers-supplementary-app-i.xlsx
January 01, 2019 - Definitely yes Age only effect modifier considered for adverse events. … ) of adverse events are evaluated for potential modification. … Many adverse events analyzed for potential modification.
40905 CRITICS Age Yes Grade 3 to 5 adverse … ) of adverse events are evaluated for potential modification. … Many adverse events analyzed for potential modification.
-
effectivehealthcare.ahrq.gov/sites/default/files/cer-229-opioid-treatments-chronic-pain-evidence-summary.pdf
April 01, 2020 - Harms and Adverse Events
a. … adverse events, with no difference in risk of serious adverse events
(SOE: low) … morphine; effects on pain, SF-36 physical and mental health; adverse events were
inconsistent, with … Rates
of adverse events of long-acting opioids in a state
medicaid program. … Opioid medication discontinuation
and risk of adverse opioid-related health care events.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/tethered-spinal-cord-protocol.pdf
July 19, 2023 - event
associated with an
intervention (not patients
being treated for tethered
spinal cord)
Interventions … events of interest (eligible adverse events will be
determined with the help of the TEP)
KQ 1: no … comparator
For KQ 2-4, Studies
without comparator except
for studies for an adverse
event of interest … We
will also abstract adverse events associated with the diagnostic procedure. … event reporting)
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/antipsychotics-children-surveillance-150120.pdf
October 01, 2014 - However, we included studies that aggregated adverse event data across patients with various
conditions … event profiles of
various SGAs. … event
(moderate strength of evidence)
Adverse events were reported in five new studies
compared … Patients tapering off the
drug had significantly longer time to “mood event”
than those on placebo. … events for
molindone
hydrochloride.
25 studies compared the adverse
event profiles of various SGAs
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/atypical-antipsychotics-off-label-update_research-protocol.pdf
May 19, 2010 - It also found strong evidence
that atypical antipsychotics can increase chances of adverse events such … between the increased risk of death
and antipsychotics drugs, and comparison of the development of adverse … disorder; it is not clear if they have been
prescribed for other conditions;
• New or increased adverse … Outcome
measures for harms, or adverse events, are the same as in KQ4 below. … • “Adverse Events” section: adverse events will be analyzed for all controlled trials
as well as
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/weight-loss-surgery_research-protocol.pdf
December 14, 2010 - In the event that data are
lacking, an assessment should be made of what are the key variables influencing … (i.e. staple-line disruption or ulcer), nutritional deficiencies
- LAGB-specific adverse events: … Outcome
measures for harms, or adverse events, are the same as in KQ3, and KQ5 below. … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will … adverse
events
Adverse reactions to
medications
Figure 1.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/gerd_executive.pdf
September 01, 2011 - event profiles. … Does the incidence of adverse events vary with duration
of followup, specific surgical intervention, … To evaluate adverse events
and complications (Key Question 3), we assessed the
rate of each adverse event … Both could help ferret out any
possible association between treatment and
adverse events. … Adverse events Low • None of the quantitative estimates of adverse events are
reliable because of a
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/omega-3-maternity_executive.pdf
October 01, 2016 - Adverse Events
The original report identified 21 RCTs that reported on
adverse events with n-3 FA supplementation … Pregnant and
breastfeeding women reported no serious adverse events,
and adverse events in these groups … Few studies reported adverse events, but among the 20
studies that did report adverse events, 60 percent … Only 35 percent reported an
active mode of collection of adverse event information,
and of the studies … that reported serious adverse events
(or lack thereof), most did not define “serious adverse
event
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/headaches-pregnancy.pdf
March 23, 2019 - events
o Maternal
Serious maternal adverse events*
• “Serious” adverse events (including those … events*
o Fetal/infant
Serious fetal/infant adverse events*
• “Serious” adverse events (including … events
o Maternal
Serious maternal adverse events*
• “Serious” adverse events (including those … harm or harms or harmful or toxic or injurious or serious or fatal) AND (effect* or reaction* or
event … or harm or harms or
harmful or toxic or injurious or serious or fatal) AND (effect* or reaction* or event
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/colorectal-surgery-preparation_research-protocol.pdf
March 26, 2013 - potential adverse events? … This cutoff is chosen to ensure that studies can estimate low event
rates with adequate precision.b … event rate among patients receiving
the interventions of interest. … Study-level or summary estimates of event rates will also be used to
contextualize the relative effects … In the event of protocol amendments, the date of each
amendment will be accompanied by a description
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/ehc-presentation-quantitative-synthesis-chapter-3.pdf
February 01, 2018 - 11252006. http://dx.doi.org/10.1002/sim.650
Rare binary outcomes
• For rare binary events (e.g., adverse … Low-event-rate meta-analyses of clinical trials: implementing good practices. Stat Med. 2016. … dx.doi.org/10.1002/sim.6844
http://dx.doi.org/10.1002/sim.2528
• The Peto method performs best when event … few studies and/or high between-study heterogeneity
► Performs poorly for rare binary events (e.g., adverse … Low-event-rate meta-analyses of clinical trials: implementing good practices.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/autism-update_clinician.pdf
September 01, 2014 - .
� The evidence is insufficient to understand the adverse events from
all other medical interventions … Other Interventions
� The evidence is insufficient to understand the effectiveness, benefits,
or adverse … educational intervention.
� The evidence is insufficient to understand the effectiveness, benefits,
or adverse … and aripiprazole, there was not
enough evidence to estimate the severity and frequency
of potential adverse … which no research
has been conducted and on atypical antipsychotics that
may be less associated with adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/high-cholestorol-medicines-update_disposition-comments.pdf
September 01, 2014 - The only exception would be
studies in those with acute coronary syndrome
where event rates are high … PG37: Again, “Serious Adverse Events”
is undefined. … The
combination arm reported 8 patients out of 256
experienced a serious adverse event, while the … events or in the number of discontinuations due
to adverse events.” … These outcomes were abstracted individually across studies, however, the
event rates reported were typically
-
effectivehealthcare.ahrq.gov/sites/default/files/breast-reconstruction-mastectomy-protocol-appendix-a.pdf
May 29, 2025 - Tissue Transplantation”[Mesh] OR ((flap OR
flaps) AND (surgical OR surgery)))
AND
(safe* or adverse … or risk or risks or reaction* or
complication* or poison* OR side effect* or safety or unsafe OR ((adverse … Page 2 of 3
harm or harms or toxic or injurious or serious or fatal) AND (effect* or reaction* or event
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/osteoarthritis-pain-2006_executive.pdf
January 01, 2006 - The overall rate of
serious adverse events was higher with
rofecoxib than with naproxen. … similar average blood pressure changes may not
necessarily correspond with similar likelihoods of
an event … to
adverse events were similar … events and withdrawals
due to adverse events. … generally
consistent with our conclusions:
• A fair-quality meta-analysis of arrhythmia and
renal event