Recording Adverse Events. All non-serious AEs (serious or non-serious) will be recorded from the time of implantation of BL-1040 on Day 1 until the end of the active study period (Day 180); all serious AEs will be recorded from the time of implantation of BL-1040 until the end of the long term follow-up (Month 60). AEs are to be recorded on the appropriate AE pages in the patient’s CRF: if the AE is serious, the appropriate box on the AE page of the CRF should also be ticked. Where possible, a diagnosis rather than a list of symptoms should be recorded. If a diagnosis has not been made then each symptom should be listed individually. The nature, time of onset and cessation, and any treatment provided shall be recorded.
Recording Adverse Events. All conditions present prior to the administration of the first dose of study drug (Day 1) should be documented as medical history. After the first dose, documentation of AEs shall continue until 30 days (+/- 3 days) following administration of the final dose of study medication, regardless of the relationship of the AE to study drug. Information to be collected includes type of event, date of onset, date of resolution, investigator-specified assessment of severity and relationship to study drug, seriousness, as well as any action taken. While an AE is ongoing, changes in the severity (e.g., worsening and improving) should be noted in the source documents, but when documenting the AE, only the total duration and greatest severity should be recorded in the eCRF. AEs characterized as intermittent require documentation of onset and duration. All drug-related (possibly, probably, or definitely related, see Section 11.4) AEs and abnormal laboratory test results reported or observed during the study must be followed to resolution (either return to baseline or within normal limits). All other AEs will be followed through the final visit indicated in Table 4, as appropriate. AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. Preexisting conditions (present before the start of the AE collection period) are considered concurrent medical conditions and should NOT be recorded as AEs. However, if the patient experiences a worsening or complication of such a concurrent condition, the worsening or complication should be recorded as an AE. Investigators should ensure that the AE term recorded captures the change in the condition (e.g., “worsening of…”). Any improvement in condition should be documented per Section 9.10.11. Each AE should be recorded to represent a single diagnosis. Accompanying signs (including abnormal laboratory test values or ECG findings) or symptoms should NOT be recorded as additional AEs. If a diagnosis is unknown, sign(s) or symptom(s) should be recorded as an AE(s). Changes in laboratory test values or ECG parameters are only considered AEs if they are judged to be clinically significant (i.e., if some action or intervention is required or if the investigator judges the change to be beyond the range of normal physiological fluctuation). If abnormal laboratory test values or ECG findings are the result of pathology for which there ...
Recording Adverse Events. Each subject must be carefully monitored for the development of any AEs. This information should be obtained in the form of non-leading questions (e.g., “How are you feeling?”) and from signs and symptoms detected during each examination, observations of study personnel, and spontaneous reports from subjects. All AEs (serious and non-serious) spontaneously reported by the subject and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures will be documented in the subject’s source documents and recorded in the eCRF. Any clinically relevant (as determined by the Investigator) deterioration in laboratory assessments or other clinical findings is considered an AE and must be recorded in the subject’s source documents and in the eCRF. Information about AEs will be collected from screening (i.e., after the ICF is signed) through 28 days after the last dose of study drug. The AE term should be reported in standard medical terminology when possible. Also when possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. For each AE, the investigator will evaluate and report the onset date, resolution date, intensity, causality, action taken, serious outcome (if applicable), and whether or not it caused the subject to discontinue the study.
Recording Adverse Events. Adverse events spontaneously reported by the participant and/or in response to an open question from the study personnel or revealed by observation will be recorded during the study at the investigational site. The AE term should be reported in standard medical terminology when possible. For each AE, the investigator will evaluate and report the onset (date and time), resolution (date and time), intensity, causality, action taken, outcome, and seriousness (if applicable), and whether or not it caused the participant to discontinue the IP or withdraw early from the study. Intensity will be assessed according to the following scale: • Mild: symptom(s) barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) • Moderate: symptom(s) of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed
Recording Adverse Events. Adverse events spontaneously reported by the subject and/or in response to an open question from the study personnel or revealed by observation will be recorded during the study at the investigational site. Clinically significant changes in laboratory values, blood pressure, and pulse need not be reported as adverse events unless they prompt corrective medical action by the Investigator, constitute a serious adverse event, or lead to discontinuation of administration of study drug. Information about adverse events will be collected from the signing of the ICF until the final visit of the study for that subject. Adverse events that occur after the first administration of study drug will be denoted as treatment-emergent adverse events (TEAEs). All adverse events regardless of Investigator-determined causality, should be followed until the event is resolved or the Investigator determines the event is stable or no longer clinically significant. The adverse event term should be reported in standard medical terminology when possible. For each adverse event, the Investigator will evaluate and report the onset (date and time), resolution or clinical plateau (date and time), severity, causality, action taken, outcome, and whether or not it caused the subject to discontinue the study. Severity will be assessed according to the following scale: • Mild (awareness of sign or symptom, but easily tolerated) • Moderate (discomfort sufficient to cause interference with normal activities) • Severe (incapacitating, with inability to perform normal activities)
Recording Adverse Events. Adverse events spontaneously reported by the subject and/or in response to an open question from the study personnel or revealed by observation will be recorded during the study at the investigational site. Clinically significant changes in laboratory values, blood pressure, and pulse requiring an intervention should be reported as AEs. The AE term should be reported in standard medical terminology when possible. For each AE, the investigator will evaluate and report the onset (date and time), resolution (date and time), severity, causality, action taken, serious outcome (if applicable), and whether or not it caused the subject to discontinue the study. Adverse events should be collected and recorded in the source documents and on the eCRF beginning at the time of signing the informed consent. Adverse events and SAEs should be reported through End of Study Visit or Early Termination Visit. Both AEs and SAEs should be followed until resolution/stabilization or until a time that is mutually agreed upon between the medical monitor and investigator. Subjects who experience any AE or SAE should receive appropriate treatment and medical supervision as clinically indicated. All AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events table v5.0 (CTCAE, 2017). It is important to distinguish between serious and severe AEs. Severity is a measure of intensity whereas seriousness is defined by the criteria under Section 11.2.2. An AE of severe intensity may not be considered serious. Should a pregnancy occur, it must be reported and recorded on Xxxxxx’s pregnancy form. Pregnancy, in itself, is not regarded as an AE unless there is a suspicion that an investigational product may have interfered with the effectiveness of a contraceptive medication. The outcome of all pregnancies (spontaneous miscarriage, elective termination, normal birth or congenital abnormality) must be followed up and documented even if the subject was discontinued from the study. All reports of congenital abnormalities/birth defects are SAEs. Spontaneous miscarriages should also be reported and handled as SAEs. Elective abortions without complications should not be handled as AEs.
Recording Adverse Events. All AEs, both serious and non serious, regardless of relationship to the study intervention, should be recorded on the AE case report form (CRF). AE data should be collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology should be used when recording AEs. Furthermore, it is recommended that studies that plan to submit data to regulatory authorities should code their AE data using the Medical Dictionary for Regulatory Activities (MedDRA). The form may be modified so that a separate CRF is filled out at each study visit, rather than maintaining a running log.
Recording Adverse Events. All AEs/SAEs experienced from the time of informed consent/assent to the last follow-up will be recorded within each patient’s CRF. Information should include: a concise description of the event; date and time of event onset and resolution; determination of seriousness, severity, corrective treatment, outcome, and relationship to IP or study procedure or underlying disease; and any action taken will be recorded. Resolution occurs when the patient has returned to his baseline state of health or further improvement or worsening of the event is not expected. Whenever possible, a diagnosis will be recorded as an AE, rather than symptoms or isolated laboratory abnormalities related to that diagnosis. Several symptoms or laboratory results that are related to the same diagnosis can thus be part of the same AE. A medical or surgical procedure is not an AE; rather the condition leading to the procedure should be recorded as the AE. Similarly, death is not an AE, but is rather the outcome of the AE(s) that resulted in death. If the AE(s) leading to death are not known, then death must be reported as an AE. All AEs will be followed until the resolution of AE, completion of the patient’s study participation, or study termination, whichever occurs first. SAEs will be followed until resolution or until the condition stabilizes or returns to baseline status.
