Definition of Adverse Event. Adverse event means any untoward medical occurrence associated with the use of an investigational product in humans, whether or not considered product-related. An adverse event (also referred to as an adverse experience) can be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product and does not imply any judgment about causality. An adverse event can arise with any use of the investigational product (e.g. off-label use, use in combination with another product) and with any route of administration, formulation, or dose, including an overdose. Medical conditions that exist prior to administration of the study vaccine (pre-existing conditions) will be recorded in the participant’s medical history to establish baseline. Day-to-day fluctuations in pre-existing conditions that do not represent a clinically significant change in the participant’s status will not necessarily be reported as adverse events. Any adverse change from the participant’s baseline condition (determined from screening evaluations conducted to confirm study eligibility) that occurs following the administration of the study vaccine will be considered an adverse event. This includes the occurrence of a new adverse event or the worsening of a baseline condition, whether or not considered related to the study vaccine. Intermittent conditions such as headaches in adults or irritability in infants may be present on study Day 0 but may represent an adverse event if the intensity or duration of the event is worse than usual following receipt of study vaccine. Adverse events include but are not limited to: adverse changes from baseline that represent increases in severity, adverse changes in the general condition of the participant, signs and symptoms noted by the participant, concomitant disease with onset or increased severity after study vaccine administration, and clinically significant changes in laboratory safety parameters occurring after study vaccine administration.
3.1. Solicited adverse events will be reported using pre-defined terms. Unsolicited adverse events will be reported using a recognised medical term or diagnosis that accurately reflects the event. Adverse event evaluations will be reviewed by the Principal Investigator or by a designated medically qualified practitioner. Adverse event information is to be completed by members of the study team designated in writing by the Pri...
Definition of Adverse Event. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom (including an AE occurring from drug abuse, an AE occurring from drug withdrawal and any failure of expected pharmacological action), or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. An elective surgery/procedure scheduled to occur during a study will not be considered an adverse event if the surgery/procedure is being performed for a pre-existing condition and the surgery/procedure has been pre-planned prior to study entry. However, if the pre-existing condition deteriorates unexpectedly during the study (e.g., surgery performed earlier than planned), then the deterioration of the condition for which the elective surgery/procedure is being done will be considered an adverse event.
Definition of Adverse Event. Adverse events must be assessed for the investigational product(s) in this study. An investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in the study, whether blinded or unblinded. The term “adverse event” is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE can arise with any use of the drug (eg, off-label use, use in combination with another drug) and with any route of administration, formulation, or dose, including an overdose. Medical occurrences that begin before the start of study medication but after obtaining informed consent will be recorded as pretreatment AEs. This includes pre- or posttreatment complications that occur as a result of protocol-mandated procedures (eg, invasive procedures, such as venipuncture or biopsy).While pregnancy itself is not considered an AE, for the purposes of safety, a pregnancy occurring after the start of study medication should be reported on the pregnancy forms. A TEAE is defined as an AE that emerges during treatment, having been absent prior to treatment, or worsens relative to the pretreatment state. In this study, any AE first assessed after receipt of the first dose of investigational product until 30 days after the last dose of study medication will be considered treatment-emergent, as defined in Section 10.3.5. All TEAEs will be recorded and reported. An AE (including a TEAE) can be one or more of the following: • Any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug and does not imply any judgment about causality. • Any new disease or exacerbation of an existing disease. • Recurrence of an intermittent medical condition (eg, headache) not present at baseline. • Any case of abuse of alcohol, illicit drugs, or prescription drugs; abuse of study medication(s) or protocol-specified drug(s); addiction. • Laboratory test or other clinical test (eg, ECG or X-ray) with a clinically significant abnormality (as defined below). • An effect of the study medication, including comparator. • Any dose of medication (study medication or other concomitant medication) that is taken at a dose higher than the prescribed dose (ie, an overdose). Overdose should be reported as an AE, only if it is associated with any symptoms or signs. The following are not considered to be ...
Definition of Adverse Event. A "Serious Adverse Event" for the Product shall have the meaning set forth in 21 C.F.R. Section 314.80(a), as amended from time to time and a "Non-Serious Adverse Event" is defined as an untoward medical occurrence at any dose for the Product that is not a Serious Adverse Event.
Definition of Adverse Event. An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, whether or not the event has a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. This definition includes intercurrent illnesses, accidents or injuries, exacerbations or preexisting conditions, changes on physical examination or physiological testing, abuse of drugs, or withdrawal reactions. [***] [***] Confidential Information Protocol version 1.1, 21 Aug 2012 Protocol XX-000-000 XX-000 [***]
