The tolerability of viscosupplementation: low incidence and clinical management of local adverse events

2003 ◽  
Vol 19 (7) ◽  
pp. 575-580 ◽  
Author(s):  
David D. Waddell
Keyword(s):  
Adverse Events ◽  
Clinical Management ◽  
Low Incidence

scholarly journals Clinical management of immune-related adverse events following immunotherapy treatment in patients with non-small cell lung cancer

2021 ◽  
pp. jim-2021-001806
Author(s):  
Hannah Elizabeth Green ◽  
Jorge Nieva
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Mechanism Of Action ◽  
Immune Checkpoint ◽  
Clinical Management ◽  
Immune Checkpoint Blockade ◽  
Small Cell ◽  
Checkpoint Blockade ◽  
Small Cell Lung ◽  
Autoimmune Conditions

The advent of checkpoint blockade-based immunotherapy is rapidly changing the management of lung cancer. Whereas past anticancer drugs’ primary toxicity was hematologic, the newer agents have primarily autoimmune toxicity. Thus, it is no longer enough for oncology practitioners to be skilled only in hematology. They must also understand management of autoimmune conditions, leveraging the skills of the rheumatologist, endocrinologist and gastroenterologist in the process. Herein we describe the mechanism of action and toxicities associated with immune checkpoint blockade in patients with lung cancer and provide a framework for management of adverse events.

Efficacy of an Oxycodone-Propofol Combination versus a Fentanyl-Propofol Combination in Conscious Sedation during Therapeutic Endoscopic Retrograde Cholangiopancreatography in Elderly Patients

Gerontology ◽  
2020 ◽  
pp. 1-8
Author(s):  
Peipei Guo ◽  
Huisheng Wu ◽  
Lan Liu ◽  
Qiu Zhao ◽  
Zhao Jin
Keyword(s):  
Adverse Events ◽  
Elderly Patients ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Postoperative Nausea ◽  
Recovery Time ◽  
Adverse Reactions ◽  
Conscious Sedation ◽  
Endoscopic Retrograde ◽  
Patients Satisfaction ◽  
Low Incidence

<b><i>Background:</i></b> With a rapidly aging population, the need for endoscopic retrograde cholangiopancreatography (ERCP) is increasing. The commonly used sedation anesthesia in ERCP is a combination of propofol and fentanyl, even though fentanyl may cause some adverse reactions such as respiratory depression. <b><i>Objectives:</i></b> This study aimed to evaluate the efficacy of oxycodone combined with propofol versus fentanyl combined with propofol for sedation anesthesia during ERCP. <b><i>Methods:</i></b> A total of 193 patients aged from 65 to 80 years undergoing ERCP were enrolled and randomized into two groups: an “oxycodone combined with propofol” group (group OP, <i>n</i> = 97) and a “fentanyl combined with propofol” group (group FP, <i>n</i> = 96). The rate of perioperative adverse events as well as the recovery time, patients’ satisfaction, and endoscopists’ satisfaction were noted. <b><i>Results:</i></b> There was no difference in the frequency of hypotension or bradycardia between the two groups, but there were more episodes of desaturation (SpO<sub>2</sub> &#x3c;90% for &#x3e;10 s in 8.3%), postoperative nausea (7.3%), and vomiting (5.2%) in group FP than in group OP. Patients’ satisfaction in group FP was lower than that in group OP. The recovery time was longer in group FP than in group OP. <b><i>Conclusions:</i></b> Oxycodone combined with propofol was effective in ERCP, with a low incidence of perioperative adverse events.

scholarly journals Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Small Sample Size ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Double Blind ◽  
Phase 2 Study ◽  
Clinically Significant ◽  
Low Incidence ◽  
To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

scholarly journals Clinical Management of Adverse Events Associated with Lorlatinib

2019 ◽  
Vol 24 (8) ◽  
pp. 1103-1110 ◽  
Author(s):  
Todd M. Bauer ◽  
Enriqueta Felip ◽  
Benjamin J. Solomon ◽  
Holger Thurm ◽  
Gerson Peltz ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Management

scholarly journals CLINICAL MANAGEMENT OF LOCALIZED BCG ADVERSE EVENTS IN CHILDREN

2016 ◽  
Vol 58 (0) ◽  
Author(s):  
Thais das Neves Fraga MOREIRA ◽  
Maria Isabel de MORAES-PINTO ◽  
Beatriz Tavares COSTA-CARVALHO ◽  
Anete Sevciovic GRUMACH ◽  
Lily Yin WECKX
Keyword(s):  
Adverse Events ◽  
Clinical Management

Management tips for the low incidence, of adverse events and well efficacy of regorafenib for metastatic colorectal cancer in Juntendo University Medical Hospital.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 778-778 ◽  
Author(s):  
Yoshie Higashihara ◽  
Nobuko Serizawa ◽  
Junko Kato ◽  
Tomohiro Kodani ◽  
Taro Osada ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Kinase Inhibitor ◽  
Japanese Patients ◽  
Similar Efficacy ◽  
Treatment Discontinuation ◽  
Common Grade ◽  
Low Incidence ◽  
Grade 3

778 Background: Regorafenib is an oral multi-kinase inhibitor that has demonstrated significant overall survival for metastatic colorectal cancer in CORRECT study. In the Japanese subset of CORRECT study, adverse events (AEs) such as hand-foot skin reaction (HFSR), anorexia, and liver dysfunction occurred at high frequency. Therefore, those AEs were one of the causes for treatment discontinuation. Methods: We retrospectively analyzed the safety and efficacy in 14 patients who received regorafenib monotherapy in our hospital between June 2013 and August 2014. Results: Among the 14 patients, median age was 64.5 years old (range 53-76). Median follows up time was 209 days (range 72-340), median PFS was 64 days (range 19-272), and median TTF was 66.5 days (range 18-280). There was no patient who had complete or partial response. The disease control rate was 36%. Nine patients initiated with 160 mg of regorafenib once daily, 4 patients with 120 mg, and one patient with 80 mg. The most common grade 3 or more AEs were HFSR, AST and ALT elevations and hypertension (2 patients, 14.2%, respectively). The frequency of HFSR was lower in our cohort the Japanese patients of CORRECT study. Treatment discontinuation due to drug related AEs occurred to 5 patients (35.7%). Dose reduction and interruption of regorafenib were required in 10 patients (71.4%) and 8 patients (57.1%), respectively. For prevention of HFSR, more than 90% of the patients were received proactive treatment including heparinoid and strong steroid from the start of the therapy. We carefully monitored their toxicities every week during the first cycle, and chose interruption if patients were had more grade 2 AEs. It is very important, we think to give the patients instructions on possible AEs and how to manage them using an illustrated book. Conclusions: Our cohort had lower HFSR in frequency than and similar efficacy to the Japanese subpopulation in CORRECT study. Enough explanation and instruction to patients might be important to decrease an incidence of AEs and treatment discontinuation due to drug- related AEs. We will increase the number of cases and examine in future.

scholarly journals Treatment-emergent adverse events occurring early in the treatment course of cladribine tablets in two phase 3 trials in multiple sclerosis

2021 ◽  
Vol 7 (3) ◽  
pp. 205521732110242
Author(s):  
Jiwon Oh ◽  
Bryan Walker ◽  
Gavin Giovannoni ◽  
Dominic Jack ◽  
Fernando Dangond ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Initiation ◽  
Treatment Discontinuation ◽  
Clear Understanding ◽  
Phase 3 ◽  
Two Phase ◽  
Post Hoc Analysis ◽  
Low Incidence ◽  
Post Hoc ◽  
Common Teaes

Background Treatment-emergent adverse events (TEAEs) that occur close to treatment initiation may negatively affect overall tolerability and adherence. It is important to develop a clear understanding of potential early TEAEs after initiating treatment with cladribine tablets. Objective To identify TEAEs that begin early in the course of treatment in patients enrolled in CLARITY and ORACLE-MS studies. Methods This post hoc analysis of CLARITY and ORACLE-MS safety populations assessed the incidence of TEAEs, serious TEAEs, drug-related TEAEs, and TEAEs leading to discontinuation in patients receiving cladribine tablets or placebo within 2, 6, and 12 weeks after treatment initiation. Results By Week 12, 61.3% of patients treated with cladribine tablets 3.5 mg/kg and 55.2% treated with placebo experienced a TEAE. More patients receiving cladribine tablets versus placebo experienced a drug-related TEAE by Week 12 (34.7% vs. 23.2%). The most common TEAEs reported with cladribine tablets were: headache (7.2%), lymphopenia (6.8%), and nausea (6.0%). Patients receiving cladribine tablets and placebo reported similar proportions of serious TEAEs (2.2% vs. 1.7%) and TEAEs leading to treatment discontinuation (1.6% vs. 1.4%). Conclusion Cladribine tablets were well tolerated during the first 12 weeks as evidenced by a low incidence of TEAEs leading to treatment discontinuation.

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