Medically Attended Events

Phase II, open-label study to assess the safety and …

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-10-20-21/02-influenza-izikson-508.pdf

Medically Attended AE (MAAE):A new onset or a worsening of a condition that prompts to seek unplanned medical advice at a physician’s office or Emergency Department Safetysummary(Solicited Reactions) Injection site reactions QIV-HD: …

A Reader’s Guide to Safety & Adverse Event Data From …

https://absolutelymaybe.plos.org/2021/02/21/a-readers-guide-to-safety-adverse-event-data-from-vaccine-trials/

These are events that either pose immediate or potentially ongoing health concerns, either themselves, or because they could be indicators of …

Submitting Study Datasets for Vaccines to the Office …

https://www.fda.gov/media/112581/download

To differentiate an efficacy clinical event (i.e., case of the disease of interest) from other clinical events, the variable CECAT should be utilized, and “efficacy” should be stated. …

What is a Serious Adverse Event? | FDA

https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event

Medically attended | definition of medically attended by …

https://medical-dictionary.thefreedictionary.com/medically+attended

Among the studies examining medically attended adverse events, no association was seen between vaccination and such events or reactions, including neurologic …

Medically Attended Adverse Events Sample Clauses

https://www.lawinsider.com/clause/medically-attended-adverse-events

Medically Attended Adverse Events. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32

Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate …

Study to Evaluate Immunogenicity and Safety of …

https://clinicaltrials.gov/ct2/show/NCT01711736

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for …

Medically Attended Illness due to Respiratory Syncytial …

https://pubmed.ncbi.nlm.nih.gov/35968869/

Medically Attended Illness due to Respiratory Syncytial Virus Infection Among Infants Born in the United States Between 2016 and 2020 Medically Attended …

"medically attended" - ニューイングランド師匠

https://masternejm.blog.fc2.com/blog-entry-774.html

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for …