-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/transparency-neuropathy_research.pdf
March 01, 2018 - Comparison of the sample size, primary outcome, and withdrawals due to adverse
events reported in the … ClinicalTrials.gov began to mandate reporting of adverse
events in September 2009 as serious adverse … events and non-serious adverse events. … We
compared the total adverse events reported in ClinicalTrials.gov with the total reported in
the … CT.gov reported more adverse
events.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/disposition-of-comments-cer-192-anxiety-in-children.pdf
August 31, 2017 - This is particularly a problem for rare
adverse events. … Studies are
required to report any adverse events
that occur during study participation;
however, … For withdrawals, we reported overall
withdrawals and withdrawals due to
adverse events. … TEP 3
Results I believe there was a line that stated
there were no serious adverse events in
the … Nevertheless, we
present each specific adverse
events so that readers can make
these judgments on
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/migraine-treatments-research-amended-protocol.pdf
January 09, 2020 - In addition to effectiveness, decisionmakers need information on potential adverse risks, and
special … Pain, function, pain relief satisfaction and quality of life,
harms/adverse events (including withdrawal … events
KQ 3: Non-invasive non-pharm Therapy:
Pain, function, pain relief satisfaction, quality of … life and quality of
life, harms, adverse events
None
Timing At the following intervals: < 1 day … events in patients
with migraine.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/gout_executive.pdf
March 01, 2016 - KQ1, 2
KQ1, 2
Adverse
Events
Discon�nua�on of
An�-inflammatory
Therapy KQ5b
KQ5b
(including presence … Observational studies
were also included for rare adverse events. … The most commonly reported adverse
events in trials of febuxostat were abdominal pain,
diarrhea, and … • High-strength evidence supports a lack of difference in
overall adverse events between allopurinol … Adverse events associated
with colchicine drug interactions: Analysis of the public version
of the
-
effectivehealthcare.ahrq.gov/products/high-cholestorol-medicines-update/research-protocol
May 17, 2013 - events when compared with statin monotherapy. … events (SAEs) associated with coadministration of different lipid-modifying agents compared with higher … The CER will examine surrogate markers of CHD events including lipid levels and atherosclerosis, as well … Ridker PM, Rifai N, Pfeffer MA, et al; Cholesterol and Recurrent Events Investigators. … Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/high-cholestorol-medicines-update_research-protocol.pdf
December 31, 2013 - events when compared with statin monotherapy. … The CER will examine surrogate markers
of CHD events including lipid levels and atherosclerosis, as … Ridker PM, Rifai N, Pfeffer MA, et al; Cholesterol and Recurrent Events Investigators. … Primary prevention of acute coronary events with
lovastatin in men and women with average cholesterol … Rosuvastatin to
prevent vascular events in men and women with elevated C-‐reactive
protein.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-bone-fracture_research-protocol.pdf
May 14, 2010 - events will be analyzed for KQ4 … • Outcomes:
- Any reported harms/adverse events (AEs) that can be directly associated with use … KQ4 assesses the evidence for adverse effects of treatment. … Events.9 Then, a verbatim account of the AE will be recorded on the form. … Common Terminology Criteria for Adverse Events (CTCAE).
Version 4.0.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/prostate-cancer-surveillance_research-protocol.pdf
May 19, 2011 - However, both surgical and radiation treatments
result in significant short- and long-term adverse … events. … Thus, all men who undergo treatment
risk suffering the adverse events of the treatment, while only … events, and costs. … Randomized controlled trials, nonrandomized comparative studies, and cohort
studies; for adverse events
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/antibiotics-respiratory-infection_executive.pdf
January 01, 2016 - drug events, and
decreased health care costs. … events along with overall prescribing. … events and efficacy (N = 1 RCT). … events
(N = 1 RCT). … Since the absolute numbers
of events were low, the estimates are likely to be unstable
and could change
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/evidence-summary-cer-199-skin-cancer.pdf
December 01, 2017 - • Serious adverse events,
events leading to treatment
discontinuation, and treatment site
infections … Adverse Events, All BCC Lesions
In Table B drugs were most likely to have adverse events
leading to … Events
Leading to
Discontinuation
(95% CI)
Serious
Adverse
Events (95%
CI)
Adverse
Events: … Adverse Events, All SCCIS Lesions
In Table C the highest mean frequency of adverse events
leading to … Adverse events
were inconsistently reported.
-
effectivehealthcare.ahrq.gov/products/major-depressive-disorder/research-protocol
June 19, 2014 - events are uncommon for most CAM treatments, but concern exists for potential drug interactions between … events (safety and tolerability): overall adverse events, withdrawals because of adverse events, serious … adverse events, specific adverse events (including hyponatremia, seizures, suicidality, hepatotoxicity … events, results, and adverse events reported. … events, if reported.
-
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 … symptoms, and hematological adverse events
Timing and Setting:
No minimum timing and all settings
-
effectivehealthcare.ahrq.gov/products/head-neck-cancer-update/research-protocol
February 04, 2014 - Evidence was insufficient to draw relative conclusions on survival or tumor control; adverse events other … Other tools used to assess adverse events include the Subjective, Objective, Management, Analytic (SOMA … Treatment-associated adverse events assume greater importance in patients identified with HPV as the … Outcomes
KQ 1, 3 & 4:
Final outcomes : QoL and adverse events including; radiation induced toxicities … Also, adverse events such as radiation-associated xerostomia and salivary dysfunction, dysphagia, mucositis
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/tympanostomy-tubes-disposition.pdf
May 05, 2017 - events of tubes without
stating adverse events of
comparative strategies),
which I would urge the … 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. … adverse
events rather than
providing a Table only.
-
effectivehealthcare.ahrq.gov/sites/default/files/tympanostomy-tubes-disposition.pdf
May 05, 2017 - events of tubes without
stating adverse events of
comparative strategies),
which I would urge the … 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. … adverse
events rather than
providing a Table only.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/migraine-prevention_executive.pdf
June 01, 2013 - For
categorical variables we abstracted the number of events
among treatment groups to calculate rates … The number
of avoided or excess events per population of 1,000 was
the difference between the two event … effects,
(2) strength of evidence, and (3) number of events
attributable to drug administration per … Few clinical trials
followed the recommendations from the Task Force on
Adverse Events in Migraine … Evaluation and
registration of adverse events in clinical drug trials in migraine.
-
effectivehealthcare.ahrq.gov/products/preterm-birth-terbutaline-pump/research
September 29, 2011 - for bronchopulmonary dysplasia, incidence of delivery <28 weeks and <34 weeks, and withdrawals due to adverse … events. … Until 2009, several cases of maternal deaths and maternal cardiovascular events in association with terbutaline
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/rheumatoid-arthritis-medicine_research-protocol.pdf
December 06, 2010 - Many questions remain about the
risks of these agents across a spectrum of adverse events—from relatively … 3: For patients with RA, do drug therapies differ in harms, tolerability, patient
adherence, or adverse … Morbidity, mortality, and other serious adverse events
ii. Tolerability
iii. Adherence
iv. … Other adverse effects
• Timing:
Minimum of 3 months of follow-up
• Settings:
Primary care … Also, adverse events may occur at any point after the treatment is received.
IV. Methods
A.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/acs-depression-research-protocol-amended.pdf
February 15, 2017 - events associated
with pharmacologic and/or nonpharmacologic treatments (KQ 2). … events outcomes). … The safety outcomes will be framed to help identify adverse events, including those
from drug therapies … interest;
that is, important characteristics are those that affect baseline (control group) rates of
events … , intervention group rates of events, or both.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/nephropathy-contrast-induced_executive-2016.pdf
January 01, 2016 - events, mortality, imaging
quality, and diagnostic accuracy. … Food and Drug
Administration Adverse Event Reporting System (AERS). … events, imaging
quality, and diagnostic accuracy. … events (12 studies), or image and diagnostic
quality (2 studies). … , mortality, need for renal replacement
therapy, or other adverse events.