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Relationship to FMT |
Description |
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Definitely | Previously known toxicity of product; or an event that follows a reasonable temporal sequence from administration of the study product; that follows a known or expected response pattern to the suspected study product; that is confirmed by stopping or reducing the volume of the study product; and that is not explained by any other reasonable hypothesis. |
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Probably | An event that follows a reasonable temporal sequence from administration of study product; that follows a known or expected response pattern to the suspected study product; that is confirmed by stopping or reducing the dosage of the study product; and that is unlikely to be explained by the known characteristics of the subject's clinical state or by other interventions. |
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Possibly | An event that follows a reasonable temporal sequence from administration of study product; that follows a known or expected response pattern to the suspected study product; but that could readily have been produced by a number of other factors. |
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Unrelated | An event that can be determined with certainty to have no relationship to the study drug. |
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