scholarly journals Post-Marketing Surveillance of the Safety Profile of Iodixanol in the Outpatient CT Setting: A Prospective, Multicenter, Observational Study of Patient Risk Factors, Adverse Reactions and Preventive Measures in 9953 Patients

2014 ◽  
Vol 186 (11) ◽  
pp. 1028-1034 ◽  
Author(s):  
F. Müller
Keyword(s):  
Risk Factors ◽  
Observational Study ◽  
Safety Profile ◽  
Adverse Reactions ◽  
Preventive Measures ◽  
Patient Risk ◽  
Multicenter Observational Study ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Prospective Multicenter Observational Study

scholarly journals Safety Profile of Oxaliplatin in 3,687 Patients With Cancer in China: A Post-Marketing Surveillance Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Zaoqin Yu ◽  
Rui Huang ◽  
Li Zhao ◽  
Ximin Wang ◽  
Xiaofang Shangguan ◽  
...  
Keyword(s):  
Real World ◽  
Safety Profile ◽  
Adverse Reactions ◽  
Hepatic Function ◽  
Hypersensitivity Reactions ◽  
Registration Method ◽  
Patients With Cancer ◽  
Real World Setting ◽  
Post Marketing Surveillance ◽  
Post Marketing

BackgroundOxaliplatin (OXA), a third-generation platinum derivative, has become one of the main chemotherapeutic drugs for colorectal cancer and other cancers, but reports of adverse reactions are also increasing with the extensive application of OXA. In this study, post-marketing surveillance was carried out to investigate the safety profile of OXA in a real-world setting in Chinese cancer patients to provide a reference for the rational application of OXA.MethodsAll patients with cancer who received OXA-based chemotherapy in 10 tertiary hospitals in Hubei Province, China, between May 2016 and November 2016 were enrolled. A central registration method was used to document patients’ demographics, clinical use, and any incidence of adverse reactions to OXA. All adverse drug reactions (ADRs) were collected and analyzed to assess causality, severity, treatment, and outcome.ResultsIn total, 3687 patients were enrolled in this study. Approximately 64.6% of the patients were male, and 68.8% were aged 50-70 years, with a mean age of 55.3 years. The proportions of patients diagnosed with colorectal and gastric cancers were 59.3% and 31.6%, respectively. In this study, the overall incidence of ADRs and serious ADRs was 42.7% and 1.3%, respectively. The most common ADRs were gastrointestinal disorders (25.7%), blood disorders (21.1%), and peripheral nervous system disorders (8.0%). The serious ADRs identified were hypersensitivity reactions, thrombocytopenia, abnormal hepatic function, and leukopenia/neutropenia. The median onset of gastrointestinal toxicity, myelosuppression, peripheral neurotoxicity, and abnormal hepatic function was 1 d, 5 d, 1 d, and 14 d, respectively. The majority (84.7%) of hypersensitivity reactions were mild to moderate, and the median time to onset of these reactions was within the first 20 min of OXA infusion. Almost 88.0% of patients who experienced ADRs recovered or improved with treatment.ConclusionOur data suggest that OXA-induced ADRs are very common in Chinese patients with cancer; however, more attention should be paid to hypersensitivity reactions caused by OXA. This study provides a valuable reference regarding the safe application of OXA in a real-world setting.

scholarly journals A Prospective Multicenter Observational Study of Venous Thromboembolism after Gastric Cancer Surgery (SHISA-1601)

2021 ◽  
pp. 1-10
Author(s):  
Sachiko Kaida ◽  
Toru Miyake ◽  
Satoshi Murata ◽  
Tsuyoshi Yamaguchi ◽  
Takeshi Tatsuta ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Venous Thromboembolism ◽  
Blood Transfusion ◽  
Observational Study ◽  
Characteristic Curve ◽  
Cancer Surgery ◽  
Gastric Cancer Surgery ◽  
Multicenter Observational Study ◽  
Prospective Multicenter Observational Study ◽  
D Dimer

Introduction: This study aimed to clarify the frequency and risk factors of intercurrent venous thromboembolism (VTE) in patients undergoing major curative gastric cancer surgery. Methods: This prospective, multicenter, observational study included patients with gastric cancer who underwent radical gastrectomy at 5 hospitals between June 2016 and May 2018. Patients who were preoperatively administered anticoagulants were excluded. Results: A total of 126 patients were eligible to participate. VTE occurred within 9 days postoperatively in 5 cases (4.0%; 2 symptomatic and 3 asymptomatic). Postoperative day (POD) 1 plasma D-dimer and soluble fibrin (SF) levels were significantly higher in the VTE group than in the non-VTE group. Receiver-operating characteristic curve (ROC) analysis indicated a statistically significant ability of POD 1 D-dimer and SF levels to predict postoperative VTE development after gastrectomy; this finding was reflected by an area under the curve (AUC) of 0.97 (95% CI 0.92–1.0) and 0.87 (95% CI 0.74–1.0), respectively. Cutoff values of D-dimer (24.6 µg/mL) and SF (64.1 µg/mL) were determined. Intraoperative blood transfusion (odds ratio [OR] 7.86), POD 1 D-dimer ≥24.6 µg/mL (OR 17.35), and POD 1 SF ≥64.1 µg/mL (OR 19.5) were independent predictive factors for postoperative VTE (p < 0.05). Conclusion: VTE occurred in 4.0% patients (1.6% symptomatic and 2.4% asymptomatic) after gastric cancer surgery; however, with an early diagnosis and anticoagulant therapy, no patients experienced progression. Careful observation of patients with a high risk for VTE, including intraoperative blood transfusion and high POD 1 D-dimer or SF levels, would contribute to the early detection of VTE.

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