reporting leads to a x2 statistic of 20 which allows one to conclude that Drug 1 is more toxic than Drug 2 with a high confidence level (p < 10 ~4). This conclusion would be reversed if the underreporting affected Drug 1 predominantly, e.g. if U = 10 and U2 = 2. In this case, one would conclude that there was a significantly higher toxicity of Drug 2 (p = 0.006).

Moreover, for an equal but more marked underreporting, e.g. U = U2 = 10, a statistical comparison based on the numbers of reports would not allow one to conclude there was a significant difference (x2 statistic = 2; p = 0.16).

An elegant approach for "neutralizing" the effect of an unbalanced under-reporting has been proposed by Tubert-Bitter et al. (1996). It consists in expressing the CI for RR as a function of U = U1/U2:

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