Safety Reporting
Safety Reporting
Safety Reporting
Safety Reporting
Definitions
What is an AE ? (1/3)
Adverse Event / Experience (AE):
Any unfavorable or unintended sign (including abnormal laboratory finding for example), symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to it
What is an AE ? (2/3)
This includes any undesirable signs experienced by the patient from signing of the informed consent until completion of the study [Week 78 (Day 545)]
Pre-existent disease signs, symptoms, and/ or laboratory abnormalities are not considered AE(s) unless
...these symptoms (AE) re-occur after the patient recovered or represent an exacerbation in intensity or frequency
A causal relationship between the medicinal product and the Adverse Event is at least a reasonable possibility, i.e. the relationship cannot be ruled out
Classification
Important medical events that based on appropriate medical judgment may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above
Life threatening The patient was at immediate risk of death from the adverse event as it occurred. (e.g. Anaphylaxis) Life threatening does not include that if an adverse event occurred in a more severe form, it might have caused death. Persistent or significant disability/incapacity Any adverse event that results in a substantial disruption of a persons ability to conduct normal life functions.
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Event that may not be immediately life threatening, or result in death or hospitalization, but which may jeopardize the patient or may require intervention to prevent one of the other serious criteria
Expectedness
Unexpected - Is any adverse event of which the specificity or severity is not consistent with the applicable product information. In clinical trials this generally refers to the current Investigator Brochure - Expectedness has nothing to do with expected complications of underlying disease
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Severity
Mild: symptom(s) barely noticeable to the patient; do not influence performance or functioning. Prescription RX usually not needed Moderate: symptom(s) of sufficient severity to make the patient uncomfortable; performance of daily activities is influenced; patient is able to continue in study; treatment may be needed Severe: symptom(s) causes severe discomfort the patient severe discomfort; severity may cause cessation of treatment with study drug; treatment of symptoms(s) may be given and/or patient hospitalized Life threatening: symptom(s) requires immediate treatment to prevent loss of life. Requires hospitalization & in-patient follow up
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Causality
Related (ADR) Definite Probable Possible
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AE follows reasonable temporal sequence from time of drug administration The AE follows a known response pattern of the study drug The AE cannot be reasonably explained by other factors such as the patients clinical state, therapeutic interventions or concomitant medications administered to the patient
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Not related
Those AE that are clearly and incontrovertibly due to extraneous causes (disease, environment, etc) as determined by the investigator
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Not a SAE !
The following cases do not constitute a hospitalization (unless they meet other SAE definitions): Emergency Room visits with patient treated and released < 24 hrs Patient in for observation < 24 hrs, but not admitted Out patient treatment, <24 hrs
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Pregnancy
Pregnancies occurring between the signing of the informed consent form till the end of study (week 78, day 545) the last dose of ADXS11-001 must be reported by the site staff within 24 hours of their knowledge of the event using the SAE Form Any patient who becomes pregnant during participation in this study must be promptly withdrawn from the study Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the infant will be required
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Safety Monitoring
Investigator
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event(s)
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Thank You
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