Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

Established in 1927 by the American College of Physicians

Abstract/Editors' Note | Full Text | PDF

FIGURES/TABLES SUMMARY PAGE

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Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

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Table 1. Original CONSORT Checklist

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Table 2. Checklist of Items To Include When Reporting Harms in Randomized, Controlled Trials

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Table 3. Common Poor Reporting Practices for Harms-Related Data

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Appendix Table 1. Adverse Events among Human Immunodeficiency Virus-Infected Patients Whose Aphthous Ulcers Had Healed Previously When Treated with Thalidomide and Who Then Were Treated with Thalidomide or Placebo in a Maintenance-Phase Study

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Appendix Table 2. Adverse Events during the First 8 Weeks