ASSESSMENT OF SAFETY. Assessment of possible (serious) adverse events (AEs/SAEs) after surgery (e.g. intestinal bleeding, bowel perforation) from randomization until reaching the primary endpoint or 12 months post enterostomy closure. AEs and SAEs have to be reported in the eCRF. Serious adverse events will be reported to the Ethics Committee according to the Declaration of Helsinki.
ASSESSMENT OF SAFETY. 10.1. Definition and Grading Intensity of Adverse Events/Experiences An adverse event/experience (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 adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment emergent adverse event is an event that first appears during treatment, which was absent before or which worsens relative to the pre-treatment state. Adverse events/experiences comprise all disturbances of general health status, subjective and objective disease symptoms (including laboratory abnormalities), and accidents observed in the context of a clinical trial, irrespective of a possible causal relationship with the administration of the trial substance. Events occurring in the framework of a clinical trial during drug-free, and post-treatment periods, or in a reference group receiving drug therapy, are also to be designated as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: • Results in death; • Is life threatening (life threatening refers to an event in which the subject 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); • Requires inpatient hospitalization or prolongation of existing hospitalization; • Results in persistent or significant disability or incapacity; • Is a congenital anomaly or birth defect; or • Is medically significant, and though not included in the above list, is an important medical event that may jeopardize the subject or require medical intervention to prevent one of the outcomes listed above. Discontinuation of Study drug or conduct of additional diagnostic evaluations, will not, by themselves, satisfy the criterion for a medically significant event. All AEs, whether volunteered, elicited, or noted on physical examination, will be recorded throughout the study. Where possible, the severity of AEs will be categorized Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 [Cancer Therapy Evaluation Program, 2003] or otherwise as follows:
ASSESSMENT OF SAFETY. The events reported during the entire course of the study for patients will be evaluated. The data will be examined for the types of events reported and their frequency of occurrence. Re-operations, revisions, removals or supplemental fixation will be assessed at each post-surgical follow-up visit.
ASSESSMENT OF SAFETY. The study will be conducted on an outpatient basis. Subjects will be instructed to self-administer the study drug with food each evening. Adverse events will be collected throughout the subject’s participation. If safety concerns arise, the Investigator may hospitalize the patients as clinically indicated. Instructions to the subject must include warnings about avoiding activities for which sedative effects of the study drug may impair performance, such as interactions with the infant, driving a motor vehicle, and operating machinery. If daily monitoring calls reveal AEs, the PI will be notified and the subjects may be brought in for evaluation at the PI’s discretion. During these visits, if the PI determines that dose adjustment is needed, subjects will be dispensed the lower dose (20 mg) for the remaining dosing period.
ASSESSMENT OF SAFETY. Assessment of possible (serious) adverse events (AEs/SAEs) after surgery (e.g. intestinal bleeding, bowel perforation, sepsis, abscess) from randomization until reaching the primary endpoint or 12 months post enterostomy closure. AEs and SAEs have to be reported in the eCRF. Serious adverse events will be reported to the Ethics Committee according to the Declaration of Helsinki. AE´s and XXX´s will be classified at the end of the trial for achieving standardized grouping and minimizing intergroup differences. To classify postoperative complications the Clavien- Dindo system is used.
ASSESSMENT OF SAFETY. An adverse event(AE) is any untoward medical or psychological occurrence in a human research participant, including any abnormal laboratory finding, symptom or disease, and which does not necessarily have a causal relationship with the research or any risk associated with the research. It also includes any event that can affect research participants or data integrity negatively, or that has the potential to impact negatively on members of the research team, or on the project as a whole, and that is deemed significant by the investigator. A serious adverse event (SAE) is an adverse event that, in the view of either the investigator or sponsor, is life-threatening or results in death, hospitalisation, persistent or significant disability, a birth defect or requires intensive intervention to prevent permanent impairment or any of the previously mentioned outcomes. AEs/SAEs can be considered related or unrelated to study procedures. As this is not an interventional study, we do not expect clinical AEs or SAEs to be related to any study procedures. All SAEs will be reported in a standardized way. Additional reporting of adverse events to the EDCTP will be done according to their reporting requirements. All SAEs will be reported for the whole study period and even after the study has been completed, if the study team becomes aware of SAEs potentially related to study procedures. The principal investigator should be notified of the SAE immediately. XXXx should be captured on a SAE form, which will be filed in the study regulatory file. Additionally, SAEs will be reported to the Stellenbosch University Human Research Ethics Committee within 7 calendar days.
ASSESSMENT OF SAFETY. In this study, safety will be assessed by evaluating the following: reported adverse events clinical laboratory test results, xxxxx xxxxx measurements, 12-lead ECG findings, physical examination results (including physical examination symptom directed findings), concomitant medication usage, suicidality, and anaphylaxis. During the conduct of the study, an independent, external DSMB will oversee the safety of the patients enrolled in the study and monitor the occurrence of flare throughout the study to ensure the continuing safety of the study patients and study conduct issues.
ASSESSMENT OF SAFETY. In addition to reporting adverse events throughout the study the investigator, a designated and appropriately trained HCP will perform the safety assessments according to the schedules noted below.
ASSESSMENT OF SAFETY
