Serious Adverse Event. 18.1. In the event one or more of the Subjects sustains any Serious Adverse Event related to the Trial, the Principal Investigator shall inform BioCancell and the Medical Center Helsinki Committee and/or the Medical Center management and/or the authorized national health authorities.
Serious Adverse Event. TSD shall immediately inform PPD in writing of the occurrence of any Serious Adverse Event with regard to a Product.
Serious Adverse Event. (SAE) A serious adverse event (SAE) is any adverse event that led to any of the following: a) death,
Serious Adverse Event. (SAE) A serious adverse event (experience or reaction) is an AE that results in one or more of the following: • Results in death - An adverse event that caused or contributed to a fatal outcome • Is life-threatening - Refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe. • Requires inpatient hospitalization or results in prolongation of existing hospitalization. • Results in persistent or significant disability/incapacity • Results in a congenital abnormality or birth defect • Important medical events when based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Serious Adverse Event. (SAE) A serious adverse event is any untoward medical occurrence that at any dose results in one or more of the following: • Results in death • It is immediately life-threatening • It requires in-patient hospitalization or prolongation of existing hospitalization • It results in persistent or significant disability or incapacity • Results in a congenital abnormality or birth defect • It is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
Serious Adverse Event. A Serious Adverse Event is an Adverse Event that fulfils one or more of the following criteria: o fatal o immediately life threatening o results in persistent or significant disability/incapacity o results in in-patient hospitalisation or prolongs an existing hospitalisation o congenital abnormality/birth defect o cancer o manifested signs and symptoms caused by overdose
Serious Adverse Event. A serious adverse event (SAE) is any AE occurring at any dose and regardless of causality that: • Results in death; • Is life-threatening; • Requires inpatient hospitalization or prolongation of existing hospitalization; • Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; • Is a congenital anomaly or birth defect in an offspring of a patient taking study drug; • Is an important medical event. The term "life-threatening" refers to an event in which the patient was at immediate risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe. Important medical events are those that may not meet any of the criteria defined above; however, they may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the SAE definition. Pregnancy is not considered an AE; however, information will be collected for any pregnancies that occur during the study (from the time of the first dose of study drug until the final visit indicated in Table 3, as appropriate). Certain pregnancy outcomes will require submission as an SAE (See Section 9.8). The investigator is responsible for reporting to Reata or designee all AEs and SAEs that are observed or reported by the patient during the study (from the time of administration of the first dose of study drug until the final visit indicated in Table 3, as appropriate), regardless of their relationship to study drug or their clinical significance. The Sponsor, or the Contract Research Organization (CRO) on the behalf of the Sponsor, must be notified immediately regarding the occurrence of any SAE that occurs after the patient is randomized and throughout the study, regardless of study drug administration, including SAEs resulting from protocol-associated procedures, as defined in relevant legislation. The procedures for reporting all SAEs, regardless of causal relationship, are as follows: • Record the SAE on the AE eCRF and complete the “Serious Adverse Event Report” form within the electronic database. • In the event the electronic database is not functional, a paper SAE form will be available for the reporting of SAEs. The Sponsor may request additional information from the investigator to ensure the timely completion of accurate safety reports. All SAE...
Serious Adverse Event. A serious adverse event is an adverse event occurring during any study phase and at any dose of the investigational product, comparator or placebo, that fulfills 1 or more of the following: • It results in death • It is immediately life-threatening • It requires inpatient hospitalization or prolongation of existing hospitalization • It results in persistent or significant disability or incapacity • It results in a congenital abnormality or birth defect • It is an important medical event that may jeopardize the subject or may require medical intervention to prevent 1 of the outcomes listed above. All serious adverse events that occur after any subject has been enrolled, whether or not they are related to the study, must be recorded for the duration of the study on the SAE form provided by Sage Therapeutics or designee.
Serious Adverse Event. An SAE is any AE occurring at any dose that results in any of the following outcomes: • Death • Is life-threatening • Requires inpatient hospitalization • Requires prolongation of existing hospitalization • A persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions • A congenital anomaly or birth defect • Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered an SAE when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization Note that hospitalization is defined as admission to treat a clinical AE. The following events would not be considered hospitalizations for SAE reporting purposes: 23-hour hold for observation, admission to a hospice facility or nursing home, respite care, outpatient surgery, social admission (eg, a homeless patient) or admission not associated with a precipitating clinical AE (eg, elective or pre-planned surgery, or in-patient administration of subsequent chemotherapy, etc).
Serious Adverse Event. Each adverse event should be assessed for its seriousness. The definition below should be used for this assessment. Please note that the term serious adverse event is not synonymous with a “severe” adverse event, which may be used to describe the intensity of an event experienced by the subject. (Please refer to Section 7.6 for severity definitions.) An adverse event should be classified as serious if it meets any of the following criteria: Death Death was an outcome of the adverse event. Life-threatening The subject was at substantial risk of dying at the time of the adverse event, or use or continued use of the device. Hospitalization (initial or prolonged) Admission to the hospital or prolongation of hospitalization was a result of the adverse event.
