Serious Adverse Event Reporting Requirements. If an SAE occurs, VIVUS or designee is to be notified within 1 business day of awareness of the event. In particular, if the SAE is fatal or life-threatening, notification to VIVUS or designee must be made immediately, irrespective of the extent of available adverse event information. This timeframe also applies to additional new information (follow-up) on previously reported SAE. In the event that the investigator does not become aware of the occurrence of an SAE immediately (e.g., if an outpatient study subject initially seeks treatment elsewhere), the investigator is to report the event within 1 business day after learning of it and document the time of his/her first awareness of the adverse event. For all SAEs, the investigator is obligated to pursue and provide information to VIVUS or designee in accordance with the timeframes for reporting specified above. In addition, an investigator may be requested by VIVUS or designee to obtain specific additional follow-up information in an expedited fashion. This information may be more detailed than that captured on the adverse event CRF. In general, this will include a description of the SAE in sufficient detail to allow for a complete medical assessment of the case and independent determination of possible causality. Information on other possible causes of the event, such as concomitant medications and illnesses, must be provided. In the case of a subject death, a summary of available autopsy findings must be submitted as soon as possible to VIVUS or its designee.
Serious Adverse Event Reporting Requirements. If a serious adverse event occurs, VIVUS is to be notified within 1 business day of awareness of the event by the investigator. In particular, if the serious adverse event is fatal or life-threatening, notification to VIVUS must be made immediately, irrespective of the extent of available adverse event information. This timeframe also applies to additional new information (follow-up) on previously forwarded serious adverse event reports. *** For all serious adverse events, the investigator is obligated to pursue and provide information to VIVUS in accordance with the timeframes for reporting specified above. In addition, an investigator may be requested by VIVUS to obtain specific additional follow-up information in an expedited fashion. This information may be more detailed than that captured on the adverse event case report form. In general, this will include a description of the adverse event in sufficient detail to allow for a complete medical assessment of the case and independent determination of possible causality. Information on other possible causes of the event, such as concomitant medications and illnesses must be provided. In the case of a subject death, a summary of available autopsy findings must be submitted as soon as possible to VIVUS or its designated representative.
Serious Adverse Event Reporting Requirements. If a serious adverse event occurs, VIVUS, Inc., or designee, is to be notified within 1 business day of awareness of the event by the investigator. In particular, if the serious adverse event is fatal or life-threatening, notification to VIVUS, Inc., or designee, must be made immediately, irrespective of the extent of available adverse event information. This timeframe also applies to additional new information (follow-up) on previously forwarded serious adverse event reports. *** For all serious adverse events, the investigator is obligated to pursue and provide information to VIVUS, Inc. in accordance with the timeframes for reporting specified above. In addition, an investigator may be requested by VIVUS, Inc. or designee to obtain specific additional follow-up information in an expedited fashion. This information may be more detailed than that captured on the AE or SAE CRFs. In general, this will include a description of the adverse event in sufficient detail to allow for a complete medical assessment of the case and independent determination of possible causality. Information on other possible causes of the event, such as *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. concomitant medications and illnesses, must be provided. In the case of a subject death, a summary of available autopsy findings must be submitted as soon as possible to VIVUS, Inc. or its designated representative.
Serious Adverse Event Reporting Requirements. If a serious adverse event occurs, VIVUS, Inc. or designee is to be notified within 1 business day of awareness of the event by the investigator. In particular, if the serious adverse event is fatal or life-threatening, notification to VIVUS, Inc. or designee must be made immediately, irrespective of the extent of available adverse event information. This timeframe also applies to additional new information (follow-up) on previously forwarded serious adverse event reports. *** For all serious adverse events, the investigator is obligated to pursue and provide information to VIVUS, Inc. or designee in accordance with the timeframes for reporting specified above. In addition, an investigator may be requested by VIVUS, Inc. or designee to obtain specific additional follow-up information in an expedited fashion. This information may be more detailed than that captured on the adverse event case report form. In general, this will include a description of the adverse event in sufficient detail to allow for a complete medical assessment of the case and independent determination of possible causality. Information on other possible causes of the event, such as concomitant medications and illnesses, must be provided. In the case of a subject death, a summary of available autopsy findings must be submitted as soon as possible to VIVUS, Inc. or its designated representative.
Serious Adverse Event Reporting Requirements. All SAEs occurring during the study or within 30 days of the last administration of study drug must be reported to both TGA and Novartis Australia Ltd. within 24 hours learning of its occurrence. The principal investigator is responsible for submitting follow-up reports for all SAEs regarding the patient’s subsequent course until the SAE has resolved or until the patient’s condition stabilizes (in the case of persistent impairment), or the patient dies.
