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TABLE 3-1 Relative Spectrum of Concern for Individual Spontaneous Adverse Event Reports

Increasing Concern

Describes a serious adverse event with less information than would justify moderate or strong concern, and/or with prominent confounding factors (e.g., multiple concomitant substances and/or conditions)

Describes a serious adverse event with some, but not all, characteristics associated with strong concern

Describes a well-documented serious adverse event with plasma levels (if available) at a relevant range and demonstrates dechallenge and rechallenge (if possible), temporality, and strong attribution

TABLE 3-2 Relative Spectrum of Concern for Case Series of Spontaneous Adverse Event Reports

Increasing Concern

Describes a series of serious adverse events, with less information than would justify moderate or strong concern, and/or prominent confounding factors (e.g., multiple concomitant substances and/or conditions)

Describes a series of serious adverse events, with some, but not all, characteristics associated with strong concern

Describes a series of well-documented cases demonstrating consistent serious adverse events and clinical findings, and dechallenge (if possible), temporality, and strong attribution

TABLE 3-3 Relative Spectrum of Concern Raised by Historical Evidence of Toxicity

Increasing Concern

Traditional cautions (contraindications) exist regarding use in certain populations or circumstances

Traditional cautions (contraindications) exist regarding use in certain populations or circumstances that, if ignored, might be associated with a serious adverse effect (e.g., do not use during pregnancy)

There is clear evidence that traditional use causes conditions considered to be serious adverse events (e.g., hallucination, lethal poisoning)



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