CTCAE versión 5.0. Evaluación de la gravedad de los eventos adversos dermatológicos de las terapias antineoplásicas

Freites-Martínez, Azael; Santana, N.; Arias‐Santiago, Salvador; Viera, Anthony J.

doi:10.1016/j.ad.2019.05.009

Cited by 329 publications

(23 citation statements)

References 7 publications

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“…Exclusion criteria were pregnant or breastfeeding females and patients presenting with any of the following conditions prior to the diagnosis of COVID-19: Cancer, ischemic heart disease, chronic decompensated systemic disease, creatinine 1.25 times higher than the normal value or creatinine clearance <50 milliliters/min (Cockcroft-Gault method), blood hemoglobin <10 g/dl, drug addiction (illegal drugs) or known liver disease with a doubling of liver function test values [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) or bilirubin]. In addition, the following elimination criteria were applied: Patients who decided to drop out of the study, patients who at any point of the study, presented with severe toxicity (grade 3 or higher, according to the Common Terminology Criteria for Adverse Events v5.0, US Department of Health and Human Services) ( 32 ), that was attributable to the administration of the experimental drug.…”

Section: Methodsmentioning

confidence: 99%

Safety and efficacy of a COVID‑19 treatment with nebulized and/or intravenous neutral electrolyzed saline combined with usual medical care vs. usual medical care alone: A randomized, open‑label, controlled trial

Delgado‐Enciso

Paz-Garcia²,

Barajas-Saucedo

et al. 2021

Exp Ther Med

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Coronavirus disease 2019 (COVID-19) is currently the major public health problem worldwide. Neutral electrolyzed saline solution that contains reactive chlorine and oxygen species may be an effective therapeutic. In the present study, the treatment efficacy of intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care vs. usual medical care alone was evaluated in ambulatory patients with COVID-19. A prospective, 2-arm, parallel-group, randomized, open-label, multi-center, phase I-II clinical trial including 214 patients was performed. The following two outcomes were evaluated during the 20-day follow-up: i) The number of patients with disease progression; and ii) the patient acceptable symptom state. Serial severe acute respiratory syndrome coronavirus 2 naso/oro-pharyngeal detection by reverse transcription-quantitative (RT-q) PCR was performed in certain patients of the experimental group. Biochemical and hematologic parameters, as well as adverse effects, were also evaluated in the experimental group.

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Section: Methodsmentioning

confidence: 99%

Safety and efficacy of a COVID‑19 treatment with nebulized and/or intravenous neutral electrolyzed saline combined with usual medical care vs. usual medical care alone: A randomized, open‑label, controlled trial

Delgado‐Enciso

Paz-Garcia²,

Barajas-Saucedo

et al. 2021

Exp Ther Med

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“…Participants can withdraw from the clinical trial at any time for any reason without prejudice to the investigator’s right to treat their disease. After fully considering the benefit of the participants, the investigator has the right to request the participants to withdraw for any reason, such as the occurrence of concomitant disease, adverse events [ 13 ], or treatment failure. The ethics committee reserves the right to request withdrawal of the participants for program violation, administrative reasons, or other valid and ethical reasons.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and safety of polysaccharide iron complex capsules compared with iron sucrose in hemodialysis patients: study protocol for a randomized, open-label, positive control, multicenter trial (IHOPE)

Zhang

Cai³

et al. 2021

Trials

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Background Anemia is one of the main complications of chronic kidney disease especially kidney failure, which includes treatment with erythropoiesis-stimulating agents and iron supplementation, including intravenous and oral iron. However, intravenous iron may pose limitations, such as potential infusion reactions. Oral iron is mainly composed of divalent iron, which can excessively stimulate the gastrointestinal tract. Iron polysaccharide complex capsules are a novel oral iron trivalent supplement with higher iron content and lower gastrointestinal irritation. However, since high-quality evidence-based medicinal support is lacking, it is necessary to conduct clinical studies to further evaluate the effectiveness and safety of oral iron polysaccharide complex in chronic kidney disease patients. Methods This randomized controlled trial uses an open-label, parallel group design, where the efficacy and safety of maintenance hemodialysis (MHD) participants is evaluated. The experimental group is assigned erythropoietins and iron polysaccharide complex (two capsules each time, bid), and the control group is assigned erythropoietin and sucrose iron (100mg, 2w) injection. Participants (aged 18–75 years) undergoing maintenance hemodialysis were considered for screening. Inclusion criteria included hemoglobin (Hb) ≥110g/L and < 130g/L, transferrin saturation (TSAT) > 20% and < 50%, and serum ferritin (SF) > 200μg/L and < 500μg/L. Exclusion criteria included acute or chronic bleeding, serum albumin < 35g/L, hypersensitive C-reactive protein (HsCRP) > 10 mg/L, and severe secondary hyperparathyroidism (iPTH ≥ 800 pg/mL). Full inclusion and exclusion criteria are described in the “Methods” section. The primary endpoint is TSAT of the participants at week 12. Secondary endpoints include Hb, SF, hematocrit (Hct), HsCRP, pharmacoeconomic evaluation, drug costs, quality of life, and indicators of oxidative stress. The treatment will last for 24 weeks with a follow-up visit at baseline (within 7 days prior to initial treatment) and weeks 4, 8, 12, 16, 20, and 24 after initial treatment. This clinical research includes 9 hemodialysis centers in mainland China and plans to enroll 186 participants. Discussion It is expected that it will provide strong evidence to reveal the clinical efficacy and safety of oral iron in the treatment of chronic CKD-related anemia in MHD patients through this clinical trial. Trial registration Chinese Clinical Trial Registry ChiCTR2000031166. Registered on March 23, 2020

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“…Thirty-eight percent of HCC patients receiving combined nivolumab plus ipilimumab (anti-CTLA-4 antibody) therapy developed Grade 3/4 treatment-related adverse events. However, only 5% of patients required treatment discontinuation [56] . ICI therapy is now also used in combination with vascular endothelial growth factor A.…”

Section: Adverse Eventsmentioning

confidence: 99%

Immune checkpoint inhibitors in liver transplant recipients - a review of current literature

Yin¹,

Baba²,

He³

et al. 2021

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Immuno-oncology, particularly with the development of immune checkpoint inhibitors (ICIs), has become a frontline category of cancer-directed therapy, including in the treatment of hepatocellular carcinoma (HCC). While liver transplant (LT) offers a potential cure for HCC, the use of ICIs is a topic of safety concern both pre-and posttransplant due to the risk of donor graft rejection. Nonetheless, some scenarios for which the therapeutic effects of ICI may be highly beneficial include the downstaging of unresectable HCC pre-transplant, or the treatment of recurrent HCC and secondary malignancies post-transplant. In this review, we explored the evidence surrounding the use of ICI in the peri-transplant setting, including safety and efficacy. In a comprehensive review of 28 cases of ICI use post-transplant, we found graft rejection in 9 of 28 cases (32%). Some factors that may increase the risk of rejection include younger age, less time between LT and ICI therapy, and PD-1/PD-L1 expression in the donor graft (particularly when using anti-PD-1/anti-PD-L1 ICIs). Despite these concerns, we relay a case of successful HCC downstaging with nivolumab and subsequent LT. We also describe several cases of response to ICIs post-LT (7 of 28 cases) among a group that is often heavily pre-treated. We conclude that ICIs are valuable options in the peritransplant setting that have demonstrated promising efficacy based on case reports. Controlled clinical trials are needed to further investigate the conditions that may allow safe delivery of these therapies.

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CTCAE versión 5.0. Evaluación de la gravedad de los eventos adversos dermatológicos de las terapias antineoplásicas

Cited by 329 publications

References 7 publications

Safety and efficacy of a COVID‑19 treatment with nebulized and/or intravenous neutral electrolyzed saline combined with usual medical care vs. usual medical care alone: A randomized, open‑label, controlled trial

Safety and efficacy of a COVID‑19 treatment with nebulized and/or intravenous neutral electrolyzed saline combined with usual medical care vs. usual medical care alone: A randomized, open‑label, controlled trial

Efficacy and safety of polysaccharide iron complex capsules compared with iron sucrose in hemodialysis patients: study protocol for a randomized, open-label, positive control, multicenter trial (IHOPE)

Immune checkpoint inhibitors in liver transplant recipients - a review of current literature

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