March 31, (), Publish Date: August 9, Common documentation of AE names on Case Report Forms. The CTCAE v Available at Accessed March 20, Nexavar spackage insert]. West Haven, CT: Bayer Pharmaceuticals. (£mma Resources – Multinational Association of Supportive Care in Cancer: Therapy Evaluation Program: National .

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Stricter adherence to these toxicity criteria should be followed.

The standardized AE lexicon was required and was assigned five points in our scoring system, as it comprises the major part of CTCAE v3. Detailed rating information is described in the Methods section.

The use of and adherence to CTCAE v3.0 in cancer clinical trial publications

An AE is a term that is a ftep representation of a specific event used for medical documentation and scientific analyses. Adverse event reporting in publications compared with sponsor database for cancer clinical trials.

Angiogenesis and vascular targeting: Combining this drug with locoregional or systemic therapy may improve the outcome of advanced HCC patients. Sorafenib inhibits tumor cell proliferation and tumor angiogenesis, and increases the rate of apoptosis in a number of tumors 4.

A phase II study.

Use and misuse of common terminology criteria for adverse events in cancer clinical trials

Deep electro-hyperthermia EHY with or without thermo-active agents in patients with advanced hepatic cell carcinoma: Should be more specific; for example: This article is mentioned in: Patients with measurable, histologically confirmed and inoperable HCC who had not received prior systemic treatment for HCC were eligible fov enrollment. Sign up for eToc alerts. The baseline characteristics of the patients are shown in Table I.

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The evaluation of the AE descriptors and their grades was based canccer data provided by these tables. Adverse event reporting in cancer clinical trial publications. Treatment-related mortality with bevacizumab in cancer patients: The mean score for this section was 1.

Cfep and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy JCOG Any discrepancy was resolved by consensus among all authors of this study. Though the CTCAE was originally intended for the oncology field, this lexicon is frequently used by physicians making routine care decisions, such as the appropriate dosages of drugs or modes of supportive care.

Trotti A, Bentzen SM.

For example, 47 articles xancer Mucositis as a Supra-ordinate term, but hardly any of them used this term correctly. These results compare favorably with the sorafenib phase II study conducted by Abou-Alfa et al 17 in patients with advanced HCC; three 2.

Especially considering that most cancer therapies have limited therapeutic indexes, it should be easier to compare cancer studies with one another than non-cancer studies [ 1 — 3 ]. Univariate and multivariate linear regression analyses were used to identify factors associated with higher total scores.

The secondary endpoints were: The correct use of supra-ordinate terms was regarded as the second requirement, and was assigned two points in our scoring system.

Scharf O, Colevas AD. The mean score for AE terms was only cancfr. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. Effect of hyperthermia on liver cell lines: J Natl Cancer Inst.

The use of and adherence to CTCAE v in cancer clinical trial publications

Publications were limited to trials exploring pharmacologic interventions in patients with solid tumors. A total of publications were included in this analysis. Since there were only seven studies sponsored by the NCI in this analysis, this finding may need to be confirmed in future studies.


The safety assessment included documentation of the adverse events, clinical laboratory tests hematological and biochemical analysesphysical examination and measurement of vital signs. In the present study, the sorafenib plus EHY ccaev3 was feasible and well tolerated, and no major complications were observed. Our study provides evidence of poor reporting of toxicity in clinical trials. Three percent of articles showed the AE tables only in the online appendix.

Our results further extended these findings, specifically evaluating the quality of reporting toxicity in the context of CTCAE v3. Only four studies used this type of term, and none of them used it correctly. Single-step therapy – feasibility and safety of simultaneous transarterial. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma.

In addition, it is critical to develop more advanced methods of reporting adverse events AEs for the purpose of evaluating treatment toxicity in secondary analyses and meta-analyses [ 4 — 6 ]. Author information Article notes Copyright and License information Disclaimer.

Conversely, doxorubicin appears to have a defined temperature threshold, whilst the majority of antimetabolites such as 5-fluorouracilas well as vinca alkaloids and taxanes, show no dependency to hyperthermia 9.