Patients are at the heart of everything we do. We collect HSI to help us evaluate the safe use of our medicines. It’s the right thing to do and it’s required of us to protect the patients we serve. HSI from human subject research is reported as described in the study protocol.
Human safety information (HSI) is defined as information relating to human health and/or well-being following exposure to GSK products, such as Adverse Event (AE) information, including:
- Any unintended sign (including an abnormal laboratory finding) symptom or disease (new or exacerbated)
- Failure to produce expected benefits (i.e. lack of efficacy)
- Off-label use
- Medication errors or misuse, including drug overdose, whether accidental or intentional
- Drug abuse or effects of drug withdrawal
- Occupational exposure
- Patients taking GSK products whilst pregnant or breastfeeding
- Paternal exposure to a GSK product before and during pregnancy
- Transmission of an infectious agent via a medicinal product
- Safety information received as part of a product quality complaint
- Drug interaction
- Unexpected therapeutic benefits (i.e. an unexpected improvement in a concurrent condition other than the one being treated)
- Suspected adverse reactions associated with a suspected or confirmed falsified medicinal product or with a quality defect of a medicinal product
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient of clinical investigation subject or a consumer, temporally associated with the use of a GSK Product, whether or not considered related to the product.