-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/COVID-19-pharmaceutical-treatments-rapid-review.pdf
March 01, 2024 - Serious adverse events, convalescent plasma, 45 days or less
Serious
Adverse
Event
Study ID Days … Serious adverse events, convalescent plasma, more than 45 days
Serious
Adverse Event Study ID Days … Serious adverse events, nirmatrelvir and ritonavir
Serious Adverse
Event
Study
ID
Days n/N … Serious adverse events, molnupiravir
Serious
Adverse
Event
Study ID Days n/N
Intervention
n … Serious adverse events, bebtelovimab
Serious
Adverse
Event
Study ID Days n/N
Intervention
n
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/COVID-19-pharmaceutical-treatments.pdf
December 23, 2023 - events
Common Terminology Criteria for Adverse Events (CTCAE) severity
category3
CTCAE event … instrument4: whether reporting was passive (i.e., outpatients contacted researchers if they
experienced an event … pre-determined list of events); whether the authors report the proportion of patients
experiencing each event … event or death. … Adverse effects of vaccines: evidence
and causality. 2012
VI.
-
effectivehealthcare.ahrq.gov/sites/default/files/s108.pdf
October 01, 2007 - That is, once the adverse event was experienced, the adverse
event status variable was set to the value … an adverse
event. … status alone; (2)
adverse event status plus baseline severity; (3) adverse event
status plus lagged … adverse event, the probability of the observed
adverse event status was equal to 1 minus the probability … of
experiencing an adverse event.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/medicine-safety-call-center_research.pdf
September 01, 2007 - Keywords: Adverse event reporting, community pharmacy safety network, post-marketing
surveillance … In a 1996 article titled “The Clinical Impact of Adverse Event Reporting” the FDA
estimated that only … In Section 3,
we review previous literature discussing technological solutions to the adverse event … stored in the Adverse Event Reporting System (AERS) database. … still under-perform chart review based methods for adverse event
detection.
-
effectivehealthcare.ahrq.gov/sites/default/files/it-architecture-for-post-marketing-surveillance-arizona-cert.pdf
September 01, 2007 - Keywords: Adverse event reporting, community pharmacy safety network, post-marketing
surveillance … In a 1996 article titled “The Clinical Impact of Adverse Event Reporting” the FDA
estimated that only … In Section 3,
we review previous literature discussing technological solutions to the adverse event … stored in the Adverse Event Reporting System (AERS) database. … still under-perform chart review based methods for adverse event
detection.
-
effectivehealthcare.ahrq.gov/sites/default/files/mcda-ijzerman.pdf
January 01, 2011 - event related to
drug use), and additional costs to patients (out-of-pocket). … (4 criteria, 6
comparisons)
7
Adverse event 1/3 1 1/3 1/5
Treatment impact 5
Reciprocal … event
Treatment
impact
Co-
payment
Average
Clinical benefit 0.15
0.42
0.75 0.63 … 0.49
Adverse event 0.05
0.14
0.05 0.02 0.06
Treatment impact 0.77 0.42 0.15 0.27 … Other serious adverse events
• Adverse events, which points to:
o Sexual dysfunction
o Other adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/ijzerman_ahrq-webinar-mcda.pdf
January 01, 2011 - Events
high blood pressure
high blood pressure
No adverse events
Out-of-Pocket Costs
5 US$ … Events
high blood pressure
high blood pressure
No adverse events
Out-of-Pocket Costs
5 US$ … event Treatment impact Co-payment
Clinical benefit 1 3 5 7
Adverse event 1/3 1 1/3 1/5
Treatment … event Treatment impact Co-payment
Clinical benefit 0.15 0.42 0.75 0.63
Adverse event 0.05 0.14 0.05 … events
Disease
specific QoL
Adverse events
Serious adverse events
Adverse events
Prioritize
-
effectivehealthcare.ahrq.gov/sites/default/files/s96.pdf
October 01, 2007 - –S102)
An adverse drug event (ADE) occurs when a drug intended
for therapeutic use has an unintended … Event Surveil-
lance project (NEISS-CADES). … Adverse drug event data collection, National Elec-
tronic Injury Surveillance System-Cooperative Adverse … Assessing the national electronic injury surveillance system-cooperative
adverse drug event surveillance … The FDA safety information and adverse event reporting
program.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-266-cdd-executive-summary.pdf
November 01, 2023 - event was higher with posterior approaches than
ACDF in patients with 3 or more level disease (SOE: … event; BMP-2 = bone morphogenetic protein 2; CDD = cervical
degenerative disease; EMS = electromagnetic … event; SOE = strength of evidence; T2 = T2 weighted image
Strength of Evidence: low (+), moderate … However, there were some differences in the
frequency of adverse events for some comparisons. … Limited evidence also suggests a
lower likelihood of experiencing any serious adverse event with ACDF
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-harms_methods.pdf
November 01, 2008 - adverse event, which may be critical to any decisions. … event” should generally be the default term over “adverse effect” or “adverse
reaction/adverse drug … Serious adverse event Any adverse event with serious medical consequences, including death, hospital … Severe adverse event An adverse event whose intensity is considered severe (including “nonserious” adverse … event and adverse event appearing at an appropriate
time interval after exposure)
Lack of alternative
-
effectivehealthcare.ahrq.gov/sites/default/files/methodsguide_chou_assessing_harms_when_comparing.pdf
November 01, 2008 - adverse event, which may be critical to any decisions. … event” should generally be the default term over “adverse effect” or “adverse
reaction/adverse drug … Serious adverse event Any adverse event with serious medical consequences, including death, hospital … Severe adverse event An adverse event whose intensity is considered severe (including “nonserious” adverse … event and adverse event appearing at an appropriate
time interval after exposure)
Lack of alternative
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-e-surv-report-3-acute-pain.xlsx
May 29, 2025 - B
Any adverse event: 13.6% (11/81) vs. 18.6% (16/86) NR NR Fair
Abbreviations: CI = confidence interval … B
Any adverse event: 10.0% (6/60) vs. 18.6% (11/59), RR 0.54 (95% CI 0.21 to 1.36)
Nausea: 0.8% (1/60 … B
Any adverse event: 34% (26/76) vs. 9% (7/74), RR 3.62 (95% CI 1.67 to 7.82)
Dizziness: 7.9% (6/76) … B
Any adverse event: 11.6% (8/69) vs. 13.2% (9/68), p=0.57 NR Institutional grant Fair
Frants, 2021 … B
Any adverse event: 52.7% (15/36) vs. 8.8% (3/34), p=0.002
Any severe adverse event: 16.7% (6/36) vs
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-e-surv-report-2-acute-pain.xlsx
May 29, 2025 - B
Any adverse event: 13.6% (11/81) vs. 18.6% (16/86) NR NR Fair
Abbreviations: CI = confidence interval … B
Any adverse event: 10.0% (6/60) vs. 18.6% (11/59), RR 0.54 (95% CI 0.21 to 1.36)
Nausea: 0.8% (1/60 … B
Any adverse event: 34% (26/76) vs. 9% (7/74), RR 3.62 (95% CI 1.67 to 7.82)
Dizziness: 7.9% (6/76) … B
Any adverse event: 11.6% (8/69) vs. 13.2% (9/68), p=0.57 NR Institutional grant Fair
Frants, 2021 … B
Any adverse event: 52.7% (15/46) vs. 8.8% (3/34), p=0.002
Any severe adverse event: 16.7% (6/36) vs
-
effectivehealthcare.ahrq.gov/sites/default/files/s89.pdf
October 01, 2007 - In addition, for a rare adverse event,
analysis using matched controls may not provide the earliest
possible … event. … Safety data on meningococcal poly-
saccharide vaccine from the Vaccine Adverse Event Reporting System … Poisson sequential sampling modified towards maximal safety in
adverse event monitoring. … A maximized sequential probability ratio test for drug and
vaccine adverse event surveillance.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/white-paper-lumbar-spondylolisthesis.pdf
March 01, 2021 - Of note, a directly asserted association
between adverse event and medical intervention may not be present … event). … events, defined as any treatment-related adverse event (see list above) that
occurs > 30 days post-treatment … event and is captured under Clinical
Response. … Events of Interest Adverse events associated
with disease progression
Adverse events associated with
-
effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/white-paper-lumbar-spondylolisthesis.pdf
March 01, 2021 - Of note, a directly asserted association
between adverse event and medical intervention may not be present … event). … events, defined as any treatment-related adverse event (see list above) that
occurs > 30 days post-treatment … event and is captured under Clinical
Response. … Events of Interest Adverse events associated
with disease progression
Adverse events associated with
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/safety-vaccines-protocol.pdf
January 30, 2020 - The current CTCAE system (version 5)
differentiates 837 adverse events within 26 adverse event domains … event
assessment (e.g., use of a scale or checklist) and whether adverse event data were … KQ3b, i.e., to determine whether a specific adverse event is associated with a
vaccine. … Common Terminology Criteria for Adverse Events
classification system (CTCAE) adverse event domains … Common Terminology Criteria for Adverse Events classification system (CTCAE) adverse event domains
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-220-analgesics-acute-pain-summary.pdf
September 01, 2019 - Analytic framework
Abbreviations: AE=adverse event; KQ=Key Question
Data Sources
We searched MEDLINE … event, hypotension, mental status changes, and
respiratory depression). … The IN route
was also common in studies reporting adverse
event outcomes for the comparison of opioids … event” where analgesics were primarily administered IN. … that at least 50 percent of treated patients
will experience some type of adverse event but
low-strength
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/evidence-summary-cer-200-post-acs-depression.pdf
November 01, 2017 - pharmacologic and
nonpharmacologic treatments for
depression in adult patients within 3
months of an ACS event … Clinical outcomes
Response or remission
Cardiac-related outcomes
– Cardiac mortality
Repeat ACS event … cardiovascular event (MACE) cardiac mortality, all-
cause mortality, repeat ACS, revascularization, … or
hospitalization in individuals following an ACS event
Table D. … cardiovascular event; MCS=mental component summary; MI=myocardial infarction; NR=not reported; RCT=
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-250-cannabis-other-plant-based-treatments-evidence-summary_0.pdf
October 01, 2021 - • Other key adverse event outcomes (psychosis, cannabis use disorder, cognitive
deficits) and outcomes … Some nonopioid treatments had frequent overall adverse events and some less frequent
yet serious adverse … event; SOE = strength of evidence; THC =
tetrahydrocannabinol; WAE = withdrawal due to adverse event … Understanding how the adverse
event profiles of cannabis products compare with other available treatments … In order to better understand the small to moderate improvements in pain, and
the complete adverse event