Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial

Table 5 Safety definitions

Term	Definition
Adverse event (AE)	Any untoward medical occurrence in a patient or clinical trial subject to whom an IMP has been administered including occurrences that are not necessarily caused by or related to that product.
Adverse reaction (AR)	Any untoward and unintended response to an IMP related to any dose administered. Response to an IMP means that there is a reasonable possibility that there is a causal relationship between the AE and the medication, i.e., that relationship cannot be excluded.
Unexpected adverse reaction (UAR)	An AR in which nature or severity is not consistent with the information about the IMP in question set out in the SmPC or Investigator Brochure (IB) for that product.
Serious adverse event (SAE) or serious adverse reaction (SAR) or suspected unexpected serious adverse reaction (SUSAR)	Respectively any AE, AR or UAR that: •Results in death •Is life-threatening^a •Requires hospitalization or prolongation of existing hospitalization^b •Results in persistent or significant disability or incapacity •Consists of a congenital anomaly or birth defect •Is another important medical condition^c

^aThe term life-threatening in the definition of a serious event refers to an event in which the patient is at risk of death at the time of the event; it does not refer to an event that hypothetically might cause death if it were more severe, for example, a silent myocardial infarction
^bHospitalization is defined as an inpatient admission, regardless of the length of stay, even if the hospitalization is a precautionary measure for continued observation. Hospitalizations for a pre-existing condition that has not worsened or for an elective procedure do not constitute an SAE.
^cMedical judgment should be exercised in deciding whether an AE or AR is serious in other situations. The following should also be considered serious: important AEs or ARs that are not immediately life-threatening or do not result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above; for example, a secondary malignancy, an allergic bronchospasm requiring intensive emergency treatment, seizures or blood dyscrasias that do not result in hospitalization or development of drug dependency

ISSN: 1745-6215