Hope-icu trial

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3.12 Pharmacovigilance

There will be timely, accurate and complete recording and analysis of safety information required for protection of patients and mandated by regulatory agencies.
3.12.1 Definition of adverse events: The EU Clinical Trials Directive 2001/20 provides the definitions in Table 1:

Table 1

Term

Definition

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical trial subject to whom a medicinal product has been administered including occurrences which are not necessarily caused by or related to that product.

Adverse Reaction (AR)

Any untoward and unintended response to an investigational medicinal product related to any dose administered.

Unexpected Adverse Reaction (UAR)

An adverse reaction, the nature or severity of which is not consistent with the information about the medicinal product in question set out in the summary of product characteristics (or Investigator brochure) for that product.

Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) or Suspected Unexpected Serious Adverse Reaction (SUSAR)

Respectively any adverse event, adverse reaction or unexpected adverse reaction that:

results in death

is life-threatening

requires hospitalisation or prolongation of existing hospitalisation

results in persistent or significant disability or incapacity

consists of a congenital anomaly or birth defect*

is any other important medical event(s) that carries a real, not hypothetical, risk of one of the outcomes above

*In the case of Hope-ICU it is anticipated that all women of child bearing age admitted will have a pregnancy test. If, however, a subsequent pregnancy is discovered the pregnancy will be followed in order to assess the outcome regarding any adverse event.

3.12.2 Assessment of causality

Each AE should be clinically assessed for causality based on the information available, i.e. the relationship of the AE to the study drug. For the purposes of this trial the causality will be assessed by the Chief Investigator then the DMEC.

For AEs not judged to be serious the causality will be assessed as present if the Chief Investigator judges it as probable or definite according to the following definitions:
Probable – clinical event with a reasonable time relationship to the study drug administration, and is unlikely to be attributed to concurrent disease or other drugs or chemicals.
Definite – clinical event with plausible time relationship to study drug administration, and that cannot be explained by concurrent disease or other drugs or chemicals.
For all SAEs the causality will be evaluated for causality using the following guide:

Unrelated – clinical event with an incompatible time relationship to study drug administration, and that could be explained by underlying disease, or other drugs or chemicals

Unlikely – clinical event whose time relationship to study drug administration makes a causal connection improbable, but that could plausibly be explained by underlying disease or other drugs or chemicals
Possible – clinical event with reasonable time relationship to study drug administration, but that could also be explained by concurrent disease or other drugs or chemicals
Probable – clinical event with a reasonable time relationship to study drug administration, and is unlikely to be attributed to concurrent disease or other drugs or chemicals
Definite – clinical event with plausible time relationship to study drug administration, and that cannot be explained by concurrent disease or other drugs or chemicals
3.12.3 Adverse Event reporting period

The AE reporting period for this trial begins on enrolment into the trial and ends 30 days following the administration of the study drug. All AEs assessed as possibly related to the study drug and all SAEs that occur during this time will be followed until they are resolved or are clearly determined to be due to a patient’s stable or chronic condition or intercurrent illness(es).

3.12.4 Adverse Event reporting requirements

AEs will be reported and documented on the relevant pages of the CRF, in accordance with the procedures outlined below.

3.12.5 Adverse Event reporting

Because Hope-ICU is recruiting a population that is already in a life-threatening population, it is expected that many of the participants will experience AEs. Events that are expected in this population (i.e. events that are in keeping with the patient’s underlying medical condition) will not be reported as AEs. An adverse reaction (AR) is an AE which is related to the administration of the study drug. If any AEs are related to the study drug (i.e. are ARs) they will be reported on the AE form within the CRF.

The following are expected ARs and will be recorded on the CRF:

Oversedation.
QTc > 500 msecs
Extrapyramidal symptoms that persist despite halving the drug.

An unexpected adverse reaction (UAR) is an AE which is related to administration of the study drug and that is unexpected, in that it has not been previously reported in the current Summary of Product Characteristics (SPC). All UARs will be reported on the AE form within the CRF.
These events will be included as part of the safety analysis for the trial and do not need to be reported separately.

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