-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/transparency-neuropathy_research.pdf
March 01, 2018 - event reporting (2 of 10
studies with posted results, 20%). … event and deaths. … ClinicalTrials.gov began to mandate reporting of adverse
events in September 2009 as serious adverse … Event Reporting
Rauck, 20129
NCT00643760
392 / 420 No difference Similar number withdrawn for adverse … event reporting (2 of 10 studies with posted results, 20%).
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/saturated-fat-replacement-protocol.pdf
January 01, 2024 - low density
lipoprotein cholesterol (LDL-c) concentration, and between LDL-c concentration and CV event … and evidence-based guidance to optimize plasma lipoprotein profiles, with
the goal of lowering CV event … Question 2
● Cardiovascular events
o Atherosclerotic cardiovascular
disease (total)
o Major adverse … We will aim for a minimum of about
10 observational studies for each
specific intervention - CV event … TC
– total cholesterol; Tg = Triglycerides/Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/peripheral-artery-disease-treatment_research-protocol.pdf
January 31, 2013 - What are the significant safety concerns associated with each treatment strategy
(e.g., adverse drug … What are the significant safety concerns associated with each treatment strategy
(e.g., adverse drug … What are the significant safety concerns associated with each treatment strategy
(e.g., adverse drug … The safety outcomes
will be framed to help identify adverse events, including adverse drug reactions … Synthesis
We will summarize the primary literature by abstracting relevant continuous (e.g.,
age, event
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-bone-fracture_research-protocol.pdf
May 14, 2010 - • Outcomes:
- Any reported harms/adverse events (AEs) that can be directly associated with use … , 6)
2º Outcome: Adverse
effects of treatment
Factors that affect
Adherence/persistence
with … KQ4 assesses the evidence for adverse effects of treatment. … Common Terminology Criteria for Adverse Events (CTCAE).
Version 4.0. … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/kidney-stones-protocol.pdf
September 24, 2024 - visits and hospitalizations, quality of life, missed school or work, preventive treatment-
related adverse … events, imaging-related adverse events, serious adverse events,
discontinuations due to adverse events … visits and
hospitalizations, quality of life, missed school or work,
preventive treatment-related adverse … events, imaging-
related adverse events, serious adverse events,
discontinuations due to adverse events … In the event of
inclusion/exclusion conflicts between reviewers, we will adjudicate through discussion
-
effectivehealthcare.ahrq.gov/sites/default/files/topic-refinement.ppt
March 01, 2010 - The adverse events include altered glucose, diabetes mellitus, lymphoid overgrowth, and malignancy. … Outcomes included adverse effects, intermediate outcomes, and final health outcomes. … KQ 4: In patients with cystic fibrosis, what is the frequency of nonmalignant serious adverse effects … KQ 7: In patients with CF, how do the efficacy, effectiveness, safety, or adverse events of treatment … Key question 7: In patients with CF, how do the efficacy, effectiveness, safety, or adverse events of
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/polyunsaturated-fatty-protocol.pdf
January 01, 2024 - and evidence-based guidance to optimize plasma lipoprotein profiles, with
the goal of lowering CV event … Question 2
● Cardiovascular events
o Atherosclerotic cardiovascular
disease (total)
o Major adverse … prospectively
We will aim for a minimum of about
10 observational studies for each
specific PUFA - CV event … acids and cardiovascular disease
(https://doi.org/10.23970/AHRQEPCERTA223), we included: for cardiac event … – total cholesterol; Tg = Triglycerides/Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/episodic-migraine-surveillance-report-3.pdf
August 01, 2022 - No significant adverse
events were reported. … No serious adverse events or withdrawal due to adverse
events were reported. … No serious adverse events
were observed. … No
serious adverse events, death, and withdrawal due to
adverse events were reported. … No
patients reported adverse events.
-
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/product/pdf/pbi-protocol.pdf
August 09, 2021 - The review will also provide rates of
adverse events of the various PBI modalities necessary for shared … In adult women with early stage breast cancer, what are the comparative effectiveness,
adverse events … How do the effectiveness, adverse events, and cosmetic outcomes of partial breast
irradiation vary by … In adult women with early stage breast cancer, what are the comparative effectiveness,
adverse events … events (KQ1-2)
Rate of adverse events
(noncomparative series of PBI) (KQ 2a)
Financial toxicity (KQ
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/tympanostomy-tubes-disposition.pdf
May 05, 2017 - Our descriptive survey of adverse events
associated with TT directly reflects KQ 3 "what
adverse events … and adverse events (“a
variety of adverse events” is not
very specific, the authors should
specify … adverse
events).
Edited to provide specific time frames for KQ 1. … event, overall. … adverse
events rather than
providing a Table only.
-
effectivehealthcare.ahrq.gov/sites/default/files/tympanostomy-tubes-disposition.pdf
May 05, 2017 - Our descriptive survey of adverse events
associated with TT directly reflects KQ 3 "what
adverse events … and adverse events (“a
variety of adverse events” is not
very specific, the authors should
specify … adverse
events).
Edited to provide specific time frames for KQ 1. … event, overall. … adverse
events rather than
providing a Table only.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/hepatitis-c_research-protocol.pdf
November 30, 2011 - dosages and durations of treatment according to
various factors.
10
A common (50 to 60 percent) adverse … In addition, psychiatric,
gastrointestinal, dermatological, and hematologic adverse effects underlie … effects of intervention(s)
Harms from antiviral treatment, including withdrawals due to adverse … events, serious
adverse events such as severe neutropenia, psychological adverse events, flu-like … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/nephropathy-contrast-induced_executive-2016.pdf
January 01, 2016 - such as need for renal
replacement therapy (including dialysis or hemofiltration),
cardiac outcomes, adverse … Food and Drug
Administration Adverse Event Reporting System (AERS). … data on
cardiac outcomes, need for renal replacement therapy,
mortality, length of hospital stay, adverse … For less frequent adverse outcomes, we used
an optimum information size of 10,000, based on an
expected … renal replacement therapy (5 studies),
cardiovascular outcomes (7 studies), mortality (8 studies),
adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/bereaved-persons-research-executive-summ.pdf
March 01, 2025 - regarding participant
experience, validity and diagnostic accuracy of the screening tool or approach, or
adverse … 1.51; CI 0.86,
2.66)
Insufficient
Pharmacotherapy Loneliness N/A Insufficient
Pharmacotherapy Adverse … systematic effect (RR 0.41; CI 0.01,
13.72)
Low for benefit
Expert-facilitated
Support Group
Adverse … Support Loneliness N/A Insufficient
Peer Support Suicide outcomes N/A Insufficient
Peer Support Adverse … more evidence is needed to quantify the presence and
absence of unintended consequences, harms, and adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/cer-241-physical-activity-wheelchair-evidence-summary-updated.pdf
October 01, 2021 - • Adverse effects of the interventions were inadequately reported in many studies. … All studies focused
on benefits of physical activity, with inadequate reporting of adverse events in … activities, and intensity of physical activity; incomplete data
analysis; inadequate reporting of adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/ace-inhibitor-arb-future_research.pdf
March 01, 2012 - renal insufficiency or development of dialysis
dependence.
3
Impact of changing trends in outcome event … This may reflect low event rates among
otherwise healthy patients and relatively few studies with extended … Although several studies collected data on angioedema, the event
rates were very low or zero for all … In the four
studies that did report episodes of angioedema, this adverse event
was observed only in … Impact of changing trends in outcome event rates over time on the
comparative effectiveness of ACEI,
-
effectivehealthcare.ahrq.gov/sites/default/files/prostatic-hyperplasia-medications_disposition-comments.pdf
May 26, 2016 - To state that
adverse event rates increase in cohort studies of an intervention implies that
patients … cardiovascular
adverse effects.. … Seventy-six
percent of those patients were bothered by the adverse effect. … Key
points refer only to adverse effects identified
from RCT data; erections were not
considered adverse … Peer Reviewer
#3
Results -p. 23, lines 38-48 (long-term adverse effects).
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/hemorrhage-postpartum_executive.pdf
April 01, 2015 - Also, adverse
events may occur at any point after the intervention is
received.
Figure A. … A fourth review noted more adverse effects related to
misoprostol than placebo. … No serious adverse reactions were attributed to
the study drugs in either RCT but reporting in 1 RCT … within a
specific population with particular characteristics,
there is an irreducible level of risk, and event … Therefore, it is sometimes
hard to know whether to classify transfusion as an adverse
outcome.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/vitamin-d-calcium_research-protocol.pdf
September 13, 2013 - stratify the findings of the previous
review, as well as any newly included studies on efficacy and adverse … strength
Source: www.effectivehealthcare.ahrq.gov
Published online: June 10, 2013
4
o Adverse … mortality
Cancer and cancer-specific mortality
Renal outcomes
Soft tissue calcification
(Other) adverse … For upper limit
(adverse event [AE]) outcomes, we will include any adverse effects of high intake in … Summary of Protocol Amendments
In
the
event
of
protocol
amendments,
the
date