So like the attached image. There should be a purpose behind mentioning rare adverse reactions, otherwise why they would mention it.
The frequency (whether rare or very rare) speaks to how likely the adverse effect is to be a problem. If an adverse event is rare/very rare, then the benefits of the drug is likely going to outweigh the risk. This is especially when the disease condition is serious.
Any drug-related AES, which also defined By GCP E2A as Adverse Drug Reactions should be collected and documented. Even if they are not Serious (as per GCP definition) they could be or are indicative for adversity related to the medicatio and thus could influence risk-benefit ratio.
The frequency is only one parameter of the assessment. But for each particular patient each significant complication is problem. We must know what could happen and even what to do if this rare complication happens.
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