information content entity seriousness information An event is serious when the patient outcome is: Death, Life-threatening Hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly/birth Defect, required intervention to prevent permanent impairment or damage, in involved other important medical events. Source: U.S. Food and Drug Administration. “What is a Serious Adverse Event?” https://urldefense.proofpoint.com/v2/url?u=http-3A__www.fda.gov_Safety_MedWatch_HowToReport_ucm053087.htm&d=DwIGaQ&c=27AKQ-AFTMvLXtgZ7shZqsfSXu-Fwzpqk4BoASshREk&r=_AhKSLG63uT9j7OK4dL0o2DAco1lYASNsYomMJX92ng&m=akNLTN3AxpBiAQmCa5kBvV98eEf8Pl2M-D5MBaU5ANI&s=i_7V5GfnXHZV_wJ4fPZCRVM66e0ZhKlG86F0WWSbxSY&e= (accessed August 19, 2016) An information content entity that reports the degree to which a clinical consequence of a drug-drug interaction results in harm determining the type and speed of clinician intervention needed. Atorvastatin is subject to drug-drug interactions with cytochrome P450 3A4 (CYP3A4) inhibitors. Increased exposure due to CYP3A4 inhibition may lead to serious adverse events (AEs), including rhabdomyolysis Khalilieh, Sauzanne, et al. "Results of a doravirine-atorvastatin drug-drug interaction study." Antimicrobial Agents and Chemotherapy (2016): AAC-01364. Drug-drug interactions with insulin secretagogues are associated with increased risk of serious hypoglycemia in patients with type 2 diabetes Han, Xu, et al. "Biomedical Informatics Approaches to Identifying Drug-Drug Interactions: Application to Insulin Secretagogues." Epidemiology (2017). Nevertheless, long-term combination therapy with immunomodulators and anti-TNFα agents may be associated with increased risks of serious infections and malignancies. Xu, Zhenhua, Hugh M. Davis, and Honghui Zhou. "Clinical impact of concomitant immunomodulators on biologic therapy: pharmacokinetics, immunogenicity, efficacy and safety." The Journal of Clinical Pharmacology 55.S3 (2015): S60-S74. The degree to which a drug-drug interaction clinical consequence may result in harm and that will determine the type and speed of clinician intervention. Twenty-four healthy volunteers (11 males) were enrolled. All but 1 subject completed the trial, and no serious adverse events were reported Blonk, Maren, et al. "Pharmacokinetic Drug–Drug Interaction Study Between Raltegravir and Atorvastatin 20 mg in Healthy Volunteers." JAIDS Journal of Acquired Immune Deficiency Syndromes 69.1 (2015): 44-51.