Serious Adverse Event Sample Clauses

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. 19.1. 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. 19.2. The Principal Investigator shall report such Serious Adverse Event in the timetable and manner prescribed in the Trial Protocol and Guidelines. 19.3. In the occurrence of a Serious Adverse Event the Principal Investigator and the Medical Center Helsinki Committee shall be entitled to immediately cease the performance of the Trial, pending a prior notice of at least 24 hours to BioCancell regarding such decision and its execution. 19.4. In the occurrence of a Serious Adverse Event BioCancell will immediately take all measures at their disposal to evaluate the risk to the Subjects and/or other patients and will instruct the Principal Investigator which measures to take with regard to that risk. 19.5. BioCancell has an obligation, as the trial sponsor, to notify each investigator, including the Principal Investigator of any Serious Adverse Events that are reported by any site during the trial that are submitted to the FDA in a safety report. Each Principal Investigator is obligated to provide these reports to the appropriate Helsinki Committee.

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 Fund Helsinki Committee and/or the Fund management and/or the authorized national health authorities. 18.2. The Principal Investigator shall report such Serious Adverse Event in the timetable and manner prescribed in the Trial Protocol and Guidelines. 18.3. In the occurrence of a Serious Adverse Event the Principal Investigator and the Fund Helsinki Committee shall be entitled to immediately cease the performance of the Trial, pending a prior notice of at least 24 hours to BioCancell regarding such decision and its execution. 18.4. In the occurrence of a Serious Adverse Event BioCancell will immediately take all measures at their disposal to evaluate the risk to the other patients and will instruct the Principal Investigator which measures to take with regard to that risk. 18.5. BioCancell has an obligation, as the trial sponsor, to notify each investigator of any Serious Adverse Events that are reported by any site during the trial that are submitted to the FDA in a safety report. Each Principal Investigator is obligated to provide these reports to the appropriate Helsinki Committee.

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. 18.2. The Principal Investigator shall report such Serious Adverse Event in the timetable and manner prescribed in the Trial Protocol and Guidelines. 18.3. In the occurrence of a Serious Adverse Event the Principal Investigator and the Medical Center Helsinki Committee shall be entitled to immediately cease the performance of the Trial, pending a prior notice of at least 24 hours to BioCancell regarding such decision and its execution. Template – agreement with medical centers

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. 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 Clinical Trial Site’ IRB. 18.2. The Principal Investigator shall report such Serious Adverse Event in the timetable and manner prescribed in the Trial Protocol. 18.3. In the event of the occurrence of a Serious Adverse Event at another Clinical Trial Site that resulted in the submission of a Safety Report to the FDA, BioCancell will notify the Principal Investigator who in turn provide such notification to the Clinical Trial Site’ IRB.

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. 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. An 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 4, 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 4, as appropriate), including events resulting from protocol-associated procedures as defined in relevant legislation, and regardless of their relationship to study drug or their clinical significance. The Sponsor may request additional information from the investigator to ensure the timely completion of accurate safety reports. All SAEs reported or observed during the study must be followed to resolution or until the investigator deems the event to be chronic or the patient to be stable. Reata or designee may contact the investigator to obtain additional information on any SAE which has not resolved at the time the patient completes the study.

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