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Facial Medical-Aesthetic Treatments in Oncology Patients
Published in Paloma Tejero, Hernán Pinto, Aesthetic Treatments for the Oncology Patient, 2020
Victoria Zamorano Triviño, Silvia Gabriela Ortiz Zamorano
Different dermal fillers have very different properties, associated risks, and injection requirements. All dermal fillers have the potential to cause complications, most related to volume and technique, but some associated with the material itself. The majority of adverse reactions are mild and transient, such as bruises and trauma-related edema. Serious adverse events are rare, and most are avoidable with proper planning and technique.
Regulation of Nutraceuticals and Functional Foods
Published in Robert E.C. Wildman, Richard S. Bruno, Handbook of Nutraceuticals and Functional Foods, 2019
Rick Collins, Jay Manfre, Robert E.C. Wildman
An adverse event is any health-related event associated with the use of a dietary supplement that is adverse. A serious adverse event is an adverse event which (A) results in (i) death, (ii) a life-threatening experience, (iii) inpatient hospitalization, (iv) a persistent or significant disability or incapacity, or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). Once it is determined that a serious adverse event has occurred, the manufacturer, packer, or distributor (responsible person) of a dietary supplement whose name appears on the label of the supplement shall submit to the Secretary of Health and Human Services any report received of the serious adverse event accompanied by a copy of the label on or within the retail packaging of the dietary supplement. The responsible person has 15 business days to submit the report to the FDA after being notified of the serious adverse event. Following the initial report, the responsible person must submit follow-up reports of new medical information that they receive for 1 year.
Selection of Endpoints
Published in Susan Halabi, Stefan Michiels, Textbook of Clinical Trials in Oncology, 2019
Katherine S. Panageas, Andrea Knezevic
A serious adverse event (SAE) is defined by the FDA as any AE that results in death, illness requiring hospitalization, events deemed life-threatening, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important condition [17,18].
An update on Alectinib: a first line treatment for ALK-positive advanced lung cancer
Published in Expert Opinion on Pharmacotherapy, 2023
Yourong Zhou, Yiming Yin, Jiangxin Xu, Zhifei Xu, Bo Yang, Qiaojun He, Peihua Luo, Hao Yan, Xiaochun Yang
The most common adverse events in patients with NSCLC treated with alectinib are mild to moderate, including skin and subcutaneous tissue disorders, gastrointestinal disorders, and respiratory disorders. These events can be resolved with symptomatic treatment. The occurrence of serious adverse events is rare. However, the above-mentioned events are the major reason for dose reduction or interruption of treatment. After remission, patients may gradually resume dosing. The adverse events from the four completed phase II and III trials that have been concluded are summarized in Table 2. It is important to note that the adverse events here are any untoward medical occurrence in a participant administered a pharmaceutical product. Serious adverse events are events that require hospitalization, prolong hospitalization, disability, affect work capacity, endanger life or death, or cause congenital malformations that occur during the course of the clinical trial.
Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review
Published in Topics in Stroke Rehabilitation, 2023
Clare Turnbull, Aafke Boomsma, Rachel Milte, Tasha R Stanton, Brenton Hordacre
The review process was carried out in three steps. First, one reviewer (CT or AB) screened the titles and abstracts to remove studies that were obviously irrelevant. Second, two reviewers (CT or AB and BH) independently screened full texts. Third, two reviewers (CT or AB and BH) independently performed a quality appraisal and data extraction. Any disputes were resolved through discussion between reviewers. The quality appraisal was performed with the Cochrane risk of bias assessment tool.15,16 Extracted data included: (1) study design, (2) adverse events (severity and description where possible), (3) participant characteristics (time since stroke onset, age, sex, type of stroke), and (4) ES parameters (electrode montage, electrode size and type, current intensity, current density at the active electrode, duration and frequency). Data were narratively synthesized and, where possible, studies were grouped according to chronicity of stroke.17 Frequency of an adverse event was defined as the number of studies (out of the total number of included studies) that reported at least one participant experiencing a specific type of adverse event. In a subset of studies, the prevalence of adverse events was also determined for studies that provided the total sample size, the number of participants that experienced adverse events and which intervention group they were allocated to (i.e. active ES or control). Finally, serious adverse events were defined as any event, experience or reaction that may require medical assistance, be life threatening, cause irreversible brain damage or cause death.
Danish national guideline for the treatment of Clostridioides difficile infection and use of faecal microbiota transplantation (FMT)
Published in Scandinavian Journal of Gastroenterology, 2021
Simon Mark Dahl Baunwall, Jens Frederik Dahlerup, Jørgen Harald Engberg, Christian Erikstrup, Morten Helms, Mie Agerbæk Juel, Jens Kjeldsen, Hans Linde Nielsen, Anna Christine Nilsson, Anne Abildtrup Rode, Lars Vinter-Jensen, Christian Lodberg Hvas
All patients offered FMT should be informed in person and in writing about any risks of the treatment. The patient’s consent to treatment is oral, but follow-up for quality monitoring purposes after the patient’s course has been completed and for dissemination of health information can take place only after prior written patient consent. Adverse events and serious adverse events are documented by the attending physician. The individual FMT service defines how serious adverse events are registered and evaluated. Immediate side effects to FMT are seen in approximately one-third of patients [19]or more, as systematic reviews have found that adverse events after FMT are underreported [120,121]. Adverse events include abdominal pain, diarrhoea and rumbling. The patient should be informed of this prior to treatment. Long-term side effects are consequences that extend beyond the first 1–3 days after treatment. Serious adverse events are recorded in the patient record. When describing serious adverse events, the severity of the events and the causality of FMT are described [122].