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. 2020 Feb 12;13(3):599–607. doi: 10.1111/cts.12746

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© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

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(a) Comparison between switch‐corrected, and user‐corrected quarterly reported adverse drug reactions (ADRs), with a plot (a) of the absolute number of quarterly reported ADRs per active substance on the x‐axis and number of switch‐corrected quarterly reported ADRs per 100,000 switches on the y‐axis; and a plot of (b) of absolute number of quarterly reported ADRs per active substance on the x‐axis and number of user‐corrected quarterly reported ADRs per 100,000 users on the y‐axis; gray lines connect values for quarters of a single active substance in chronological order, and dashed lines are the threshold values, defined as the mean number of the absolute, switch‐corrected, or user‐corrected reported ADRs + 1 SD. The total number of quarterly data points per active substance is 30.