Safety assessments were measured using adverse-event (AE) monitoring, clinical laboratory parameters, fundoscopy, physical and neurological examination, and vital-sign measurements.
The hygienist and nurse rated treatment acceptability will be measured using the Adverse Outcomes (A-O) scale.
Trial data were included if patients received only sorafenib monotherapy, and adverse events (AEs) were measured using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Adverse events (including description, severity and duration of symptom, probability of symptom being related to study intervention, and action taken) were measured using a standardised adverse event record, which was self-administered by participants throughout the intervention phase of the study.
The first primary objective is to determine if the IRE ablation procedure is safe as measured by the total number of (1) device related and (2) periprocedural and postprocedural adverse events as measured using the NCI Common Terminology Criteria for Adverse Events (CTCAE).
The device related, periprocedural and postprocedural adverse events will be measured using the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Childhood adversity was measured using a modified version of the Adverse Childhood Exposure (ACE) questionnaire used by Bruffaert and colleagues [ 27].
Data will be collected from notes and will include adverse events, measured using validated pre-defined criteria[ 30], falls, length of stay, whether antipsychotic or pain medication was prescribed on discharge, and whether there was a change of residence after discharge.
When adverse effects are measured using a psychometrically tested questionnaire both OXC and CBZ demonstrate that as dosages increase significant cognitive side effects are noted.
Maternal morbidity was measured using a validated composite indicator of adverse outcomes [ 12].
These adverse outcomes were measured using an electronic registration form which was integrated with the digital medical record.
