Definition of Adverse Events. 11.2.1. Adverse Event (AE) An AE is any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with the investigational drug. An AE can, therefore, be any unfavorable and unintended symptom, sign, disease, condition, or test abnormality that occurs during or after administration of an IP whether or not considered related to the IP. Adverse events include: • Symptoms described by the patient or signs observed by the Investigator or medical staff. • Test abnormalities (laboratory tests, ECG, X-rays, etc.) that result in an alteration in medical care (diagnostic or therapeutic). Abnormalities present at baseline are considered AEs only if they reoccur after resolution or worsen during the AE collection period.
Definition of Adverse Events. An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment. The investigator is responsible for ensuring that any AEs observed or reported by the participant are recorded in the medical record The definition of AEs includes worsening of a pre-existing medical condition. Worsening indicates the pre-existing medical condition (e.g., diabetes, migraine headaches, gout) has increased in severity, frequency, and/or duration, and/or has an association with a significantly worse outcome. An AE does not include: medical / surgical procedures (but the condition that leads to the procedure may be and AE; situation where an untoward medical occurrence has not occurred (e.g. hospitalization for cosmetic surgery); overdose of study drug(s) or concomitant medication that does not result in any signs or symptoms (if signs or symptoms are present, then will be recorded as an AE); or underlying disease progression (DME in the study eye). A treatment emergent adverse event (TEAE) is an AE that was not present prior to treatment with the study drug(s), or an event that was present prior to treatment, but worsens either in intensity or frequency following treatment.
Definition of Adverse Events. 11.2.1.1. Adverse Event (AE) An adverse event (AE) is defined as 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, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs include, but are not limited to: (1) a worsening or change in nature, severity, or frequency of condition(s) present at the start of the study; (2) subject deterioration due to primary illness;
Definition of Adverse Events. An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with RBM-007. An AE, therefore, can be an unintended sign (including an abnormal laboratory finding), symptom, or disease that has clinical significance and is temporally associated with the use of a medicinal (investigational) product, whether related or not related to the medicinal (investigational) product. In clinical studies, an undesirable medical condition occurring at any time, including- baseline or pre-treatment period, may be recorded as an AE even if no RBM-007 has been administered. Any significant adverse change in a subject's condition from baseline, regardless of causality, is to be considered an AE, unless the change is determined to be a continuation of a pre-existing condition that is documented in the subject's medical history. However, a clinically significant worsening in severity, intensity, or frequency of a pre-existing condition may indicate an AE. In addition, all conditions that lead to hospitalizations, defined as an overnight hospital stay, are considered as AEs. This includes planned elective surgeries. Lack of efficacy of the i.vt. RBM-007 for the condition being investigated is not considered an AE unless a clinically significant change is assessed by the Clinical Investigator. An elective surgical procedure scheduled or planned prior to study entry is not considered an AE if an overnight hospital stay is not required, and the underlying diagnosis for which surgery is to be performed should be captured in the medical history as a pre-existing condition. The surgical procedure should also include the term "elective" in all reports.
Definition of Adverse Events. An adverse event (AE) is any untoward medical occurrence in a subject that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. An adverse event can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. Accordingly, an adverse event could include any of the following: • intercurrent illnesses • physical injuries • events possibly related to concomitant medication • significant worsening (change in nature, severity, or frequency) of the disease under study or other preexisting conditions. • drug interactions • events occurring during diagnostic procedures or any washout phase of the study • laboratory or diagnostic test abnormalities occurring after the start of the study (i.e., after screening and once confirmed by repeat testing) that results in the withdrawal of the subject from the study, requires medical treatment or further diagnostic work up, or is considered by the study investigator to be clinically significant. The investigator must, for any target or non-target SK related AE, question the subject in detail to determine if there are any confounding factors (e.g., irritation by clothing or activity, sunburn) for any such AE. The investigator should, when certain, report a diagnosis rather than the signs, symptoms or clinically relevant abnormal laboratory values associated with the AE. Otherwise, signs, symptoms or abnormal laboratory values may be used to describe the AE. The investigator must start reporting non-serious AEs starting with the subject’s first study medication treatment continuing through Visit 11.
Definition of Adverse Events. According to the April 1996 (E6) International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP), an AE is 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 therefore can be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. If a previously reported AE or pre-existing illness increases in severity or frequency, it will be considered a new event. Any abnormal laboratory value that the Investigator considers clinically significant will be reported as an AE. All AEs determined not to be study drug related will be followed through week 48 and noted as “continuing” if not resolved at the week 48 visit. AEs considered to be study drug related will be followed until they have resolved or stabilized or, in the case of a pre-existing illness, returned to its baseline status recorded prior to the injection of study drug. Subjects that are withdrawn from the study due to an AE or experience an AE that is deemed related to the study drug, will be followed until the event has resolved or has stabilized.
Definition of Adverse Events
