Adverse events associated with aprepitant pediatric bone cancer patients

2018 ◽  
Vol 25 (3) ◽  
pp. 735-738 ◽  
Author(s):  
Lucas M Okumura ◽  
Sacha A da Silva Ries ◽  
Clarice F Meneses ◽  
Mariana B Michalowski ◽  
Maria Angelica P Ferreira ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Adverse Events ◽  
Cancer Patients ◽  
Drug Information ◽  
Case Series ◽  
Bone Cancer ◽  
European Medicines Agency ◽  
Safety Studies ◽  
Official Sources

An eight-year long case series follow-up study with pediatric bone cancer patients was conducted to compare the occurrence of adverse events associated with aprepitant with official sources of drug information (manufacturer’s leaflet, clinical trials, and European Medicines Agency leaflet). All patients admitted were analyzed, representing 192 aprepitant cycles. Anorexia, febrile neutropenia, and headache were observed in frequencies over 43.8 per 100 patients, which was higher than previous estimates. Adverse events were classified as probable or possible, by using Naranjo score. The increased rates of adverse events, especially on the risk febrile neutropenia, warrant further safety studies on this population.

scholarly journals Olaparib dose re‐escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series

2021 ◽  
Vol 17 (S3) ◽  
pp. 3-11
Author(s):  
Siew‐Fei Ngu ◽  
Ka‐Yu Tse ◽  
Mandy M. Y. Chu ◽  
Hextan Y. S. Ngan ◽  
Karen K. L. Chan
Keyword(s):  
Ovarian Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Case Series

scholarly journals Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

2021 ◽  
Author(s):  
Ilkka Rauma ◽  
Tiina Mustonen ◽  
Juha Matti Seppä ◽  
Maritta Ukkonen ◽  
Marianne Männikkö ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Case Series ◽  
Retrospective Case ◽  
Serious Adverse Events ◽  
Highly Active ◽  
Disease Modifying Therapy ◽  
Case Series Study ◽  
Multiple Sclerosis Patients

Abstract Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

scholarly journals Management of Advanced Medullary Thyroid Carcinoma with Vandetanib: Case Series

2021 ◽  
Vol 5 (1) ◽  
pp. 01-07
Author(s):  
Andrés Flórez R
Keyword(s):  
Partial Response ◽  
Adverse Events ◽  
Thyroid Carcinoma ◽  
Medullary Thyroid Carcinoma ◽  
Stable Disease ◽  
Case Series ◽  
Medullary Thyroid ◽  
The Mean ◽  
Grade 3

Objective: To describe the tumor response and adverse events in patients with advanced medullary thyroid carcinoma (MTC) treated with vandetanib at the National Cancer Institute in Bogotá, Colombia. Materials and Methods: Case series including five patients with advanced MTC treated with vandetanib from April 2011 to August 2018 and a minimum follow-up of 6 months. Results: 5 patients met the inclusion criteria, including 3 women. The mean age was 49 years. A total of 4 patients underwent total thyroidectomy prior to starting vandetanib. The main indication for vandetanib was progression of liver metastasis (4 patients). Regarding treatment response, 3 patients presented stable disease, 1 patient showed partial response, and 1 had disease progression. The mean treatment duration was 16.5 months. Grade 3 or 4 adverse events were observed in three patients, 1 with diarrhea, 1 with hypertension, and 1 with rash. All symptoms improved with dose reduction or temporary suspension of vandetanib. Conclusions: The management of advanced MTC with vandetanib allows for prolonged disease control (stable disease or partial response). Although adverse events are frequent, most are mild and severe cases are manageable.

scholarly journals Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 746
Author(s):  
Luca Tudor Giurgea ◽  
Matthew James Memoli
Keyword(s):  
Adverse Events ◽  
Protective Efficacy ◽  
Phase 1 ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Safety Studies ◽  
Antibody Titers ◽  
Public Health Strategies

Vaccines against Coronavirus Disease 2019 Originated-19) have been developed with unprecedented rapidity, many utilizing novel strategies. As of November 2020, a series of publications have outlined the results of phase 1/2 studies of nine different vaccines planned to move forward to phase 3 trials. The results are encouraging, demonstrating a paucity of severe or serious adverse events and robust induction of antibody titers. Determination of the vaccine candidates with the highest protective efficacy and best adverse event profiles will be essential in refining public health strategies. However, differences in study design and reporting of data make comparisons of existing phase 1/2 studies difficult. With respect to safety, studies have variable follow-up times and may use different definitions for adverse events. Immunogenicity outcomes are even more inconsistent, with variations in timepoints and critical differences in the types of antibodies studied as well as methodological differences in assays. Furthermore, the correlates of protection in COVID-19 are not known. Harmonization of phase 3 trial designs and use of objective and meaningful clinical outcomes will be crucial in streamlining future global responses to the pandemic.

Intralesional Methotrexate Treatment for Keratoacanthoma Tumors: A Retrospective Case Series

2012 ◽  
Vol 16 (3) ◽  
pp. 212-217 ◽  
Author(s):  
Nicolas Aubut ◽  
Jimmy Alain ◽  
Joël Claveau
Keyword(s):  
Adverse Events ◽  
Total Dose ◽  
Effective Treatment ◽  
Complete Resolution ◽  
Case Series ◽  
Response Rates ◽  
Initial Diagnosis ◽  
Retrospective Case ◽  
Methotrexate Treatment

Background: Intralesional methotrexate (IL-MTX) is an effective treatment for keratoacanthoma. Objective: We sought to determine the response rates and adverse events in KA treated with intralesional methotrexate. Methods: All cases of KA treated with intralesional methotrexate at our institutions from 2001 to 2009 were systematically reviewed. Results: Forty-six cases of KA treated with IL-MTX were identified. A complete resolution was achieved in 74% of patients, requiring an average of 1.8 injection sessions, for a mean total dose of 10 mg. Adverse events did not occur. Limitations: The follow-up period was short, and there was no histologic confirmation of the initial diagnosis. Conclusion: IL-MTX is an effective and well-tolerated alternative to surgery for the treatment of KA.

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design

2014 ◽  
Vol 56 (3) ◽  
pp. 513-525 ◽  
Author(s):  
Stanley Xu ◽  
Sophia Newcomer ◽  
Jennifer Nelson ◽  
Lei Qian ◽  
David McClure ◽  
...  
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design ◽  
Safety Studies

The impact of patient-related factors on the occurrence of febrile neutropenia in breast cancer patients receiving (neo-)adjuvant chemotherapy with 5-fluorouracil, epirubicin, and cyclofosfamide (FEC) x6 or FEC x3 followed by docetaxel (D) x3.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1078-1078
Author(s):  
Christof Vulsteke ◽  
Alena Pfeil ◽  
Barbara Brouwers ◽  
Matthias Schwenkglenks ◽  
Robert Paridaens ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Febrile Neutropenia ◽  
Serum Creatinine ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Related Factors ◽  
The Impact

1078 Background: Recently we described the impact of genetic variability on severe toxicity in breast cancer patients receiving (neo-) adjuvant FEC chemotherapy (Annals of Oncology 2013, In Press). We now further assessed the impact of a wide range of patient-related factors on FEC toxicity in routine clinical setting. Methods: Patients with early breast cancer receiving (neo-)adjuvant 6 cycles FEC or sequential 3 cycles of FEC and 3 cycles D were retrospectively evaluated through electronic chart review for febrile neutropenia (primary endpoint; CTC 3.0). Age at diagnosis, body mass index, body surface area, number of cycles received, germline genetic polymorphisms, and baseline biochemical variables (white blood cell count, absolute neutrophil count, platelets, aspartate aminotransferase, alanine aminotransferase, total bilirubin and creatinine) were available for most patients (missing data <10%). All patients had follow up for progression free survival (PFS) and overall survival (OS). Multivariate logistic regression analysis was performed including univariate associates of outcome with a p-value <0.25. Results: We identified 1,031 patients treated between 2000-2010 with 6x FEC (n=488) or 3x FEC followed by 3x D (n=543). 174 (16.9%) patients developed febrile neutropenia during FEC. After logistic regression analysis febrile neutropenia was found to be significantly associated with carriers of the rs45511401 variant T-allele in the MRP1 gene found in 12% of patients (p= 0.03, OR1.99, CI 1.07-3.71) and with increasing serum creatinine values (p=0.05 OR 4.58/CI 0.99-20.98); all other investigated patient-related parameters were not retained by the model. At a mean follow up of 5.2 years, the occurrence of febrile neutropenia was not correlated with PFS and OS. Conclusions: In this study, only the baseline level of serum creatinine and germline genetic polymorphisms in the MRP-1 gene were predictive for the occurrence of febrile neutropenia in patients receiving FEC chemotherapy. The occurrence of febrile neutropenia did not seem to impact on outcome.

Digitally captured step counts for evaluating performance status in advanced cancer patients: A single cohort, prospective trial (Digi-STEPS).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6651-TPS6651
Author(s):  
Gillian Gresham ◽  
Andrew Eugene Hendifar ◽  
Jun Gong ◽  
Arash Asher ◽  
Christine S. Walsh ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Performance Status ◽  
Advanced Cancer Patients ◽  
Step Counts ◽  
Wide Range ◽  
Ecog Ps ◽  
Single Cohort

TPS6651 Background: Advanced cancer patients undergo dynamic changes in their functionality and physical activity over the course of their treatment. Monitoring patient function is important because it can inform treatment decisions and allow for timely and appropriate intervention. Current scales that assess patient function, such as the ECOG Performance Status (PS), are limited in their ability to capture the wide range in activity that cancer patients can experience on a daily basis outside of the clinic setting. Given recent technological advances in wearable activity monitors, we can collect real-time, objective information about a patient’s daily activity including steps, stairs, heart rate, sleep, and activity intensity. Thus, the primary objective of this study is to determine whether longitudinal changes in objectively-assessed activity are associated with change in physician-rated ECOG PS. Methods: This is a prospective, single cohort trial being conducted at Cedars-Sinai Medical Center. Stage 3/4 cancer patients who are English or Spanish-speaking, ambulatory (assistive walking devices are allowed) and expected to be seen for treatment or follow-up with their oncologist at least every 8 weeks are eligible for study. Consenting patients will be asked to wear a Fitbit Charge HR continuously for 8 weeks during the study period and for one week prior to the 6 month and 1 year follow-up visits. Primary outcomes are change in average daily step counts and ECOG PS at 8 weeks from baseline. Secondary outcomes include: 1) Change in NIH PROMIS patient-reported outcomes (physical function, pain, sleep, emotional distress, and fatigue), 2) Change in frailty status at 8 weeks, 3) Occurrence of adverse events, and 4) 6-month and 1-year survival outcomes. Baseline assessments include a physical exam, medical history, and frailty assessment. The attending oncologist will rate the patient's ECOG PS at baseline and at the end-of-study visit. Weekly NIH PROMIS questionnaires will be administered online over the 8-week study and again at 6 months and 1 year follow-up. The occurrence of serious cancer-related adverse events, chemotherapy-associated toxicities, and hospitalizations will be documented up to 12 weeks from baseline. Survival will be assessed at 6 months and 1 year. Accrual is ongoing with 20 patients currently enrolled of a target sample size of 60 patients. Clinical trial information: NCT03757182.

scholarly journals Comparing the incidence of common adverse events of interest following influenza vaccination in the first season adjuvanted trivalent immunisation was introduced: English sentinel network annual report paper 2018/19 (Preprint)

2020 ◽  
Author(s):  
Simon de Lusignan ◽  
Ruby Tsang ◽  
Oluwafunmi Akinyemi ◽  
Jamie Lopez Bernal ◽  
Gayatri Amirthalingam ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Seasonal Influenza ◽  
Reference Group ◽  
Case Series ◽  
European Medicines Agency ◽  
Seasonal Effect ◽  
Sentinel Network ◽  
Relative Incidence

BACKGROUND Vaccination is the most effective form of prevention of seasonal influenza; the UK has a national influenza vaccination programme to cover targeted population groups. Influenza vaccines are known to be associated with some common minor adverse events of interest (AEIs), but it is not known if the adjuvanted trivalent influenza vaccine (aTIV, first offered in the 2018/19 season) would be associated with more AEIs than other types of vaccines. OBJECTIVE To determine the Relative Incidence (RI) of AEIs following seasonal influenza vaccination, and compare RIs between aTIV, quadrivalent influenza vaccine (QIV) and live attenuated influenza vaccine (LAIV). METHODS We carried out a retrospective cohort study using computerised medical record data from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network database. We extracted data on vaccine exposure and consultations for European Medicines Agency (EMA)-specified AEIs for the 2018/19 influenza season. We used a self-controlled case series design and computed relative incidence (RI) of AEIs following vaccination, and compared RI of AEIs associated with aTIV, QIV and LAIV. We also compared RI of AEIs for vaccinations that took place in a practice with those that took place elsewhere. RESULTS The majority of AEIs occurred within seven days following vaccination, with a seasonal effect observed. Using aTIV as the reference group, QIV was associated with a higher RI of AEIs (RI=1.46, 95% CI 1.41-1.52), whereas LAIV was associated with a lower RI of AEIs (RI=0.79, 95% CI 0.73-0.83). No effect of vaccination setting on RI of AEIs was observed. CONCLUSIONS Routine sentinel network data offer an opportunity to make comparisons between safety profiles of different vaccines. Evidence that supports the safety of newer types of vaccines may be reassuring for patients and could help improve uptake in the future.

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