Examples of potential side effects / adverse events include:
- Headache
- Nausea (feeling sick)
- Vomiting
When a patient experiences something unexpected, harmful or negative while taking a Roche medicine, this is called a side effect (also sometimes referred to as an Adverse Drug Reaction).
An adverse event (AE) is any untwoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Examples of potential side effects / adverse events include:
Even if you don't know what caused the potential side effect or if you suspect that it was not caused by the medicine, the potential side effect still needs to be reported.
Scenario: Potential Side Effect
Petro is attending a regional medical conference. One of the speakers at the conference is a patient who is receiving a Roche medicine for her condition. During the presentation, the patient tells the audience that when she first started taking the medicine she experienced frequent headaches. Because of this, her doctor reduced his dosage and after that, her headaches went away.
Petro must report this potential side effect because the new information may impact the safety profile of the medicine.
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