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TABLE 3-4 Spectrum of Relative Concerns with Clinical Studies Data

Increasing Concern

Describes a serious adverse event, but with less information than would justify moderate or strong concern, and/or the interpretation of the clinical study is hampered by the presence of prominent confounding factors (e.g., multiple concomitant substances and/or conditions) that could not be controlled by balancing

AND/OR

Prominent methodological concerns (e.g., unexplained high level of dropouts, lack of control groups)

Nonsignificant, but clinically important, trend of a higher rate of a serious adverse event

OR

Abnormalities in clinical laboratory values

OR

Other abnormalities, such as electrocardiographic findings in the dietary supplement ingredient group

A significantly higher incidence of a serious adverse event

OR

Other potentially dangerous abnormalities, such as in clinical laboratory values that are associated with risk of serious adverse events

OR

Other abnormalities, such as electrocardiographic findings in the dietary supplement ingredient group

TABLE 3-5 Spectrum of Relative Concerns with Epidemiological Data

Increasing Concern

Case-control or cohort study (including registries), with small,a but statistically significant, relative risk or odds ratio of a serious adverse event

OR

Large relative risk or odds ratio of a serious adverse event that is not statistically significant

OR

Poorly conducted studies with large or significant effects

Case-control or cohort study (including registries), with moderate, statistically significant relative risk or odds ratio of a serious adverse event

OR

Moderate relative risk or odds ratio of a serious adverse event that is not statistically significant but that implies a trend

Well-conducted case-control or cohort study (including registries), with large, statistically significant relative risk or odds ratio of a serious adverse event

a In short, 2 or less is generally considered weak association, and 3 or more is considered strong, but this is only a very general “rule of thumb” guidance, which is somewhat debatable.



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