This includes a review of safety data for signals that might warrant modification, suspension, or discontinuation of a particular study.
Rates of premature discontinuation of study drug or study withdrawal because of any adverse event were similar for both study drugs.
Figure 2 shows the primary reasons for discontinuation (of study or of study drug) over time.
A temporary discontinuation of the study with a consecutive safety analysis will be performed if ≥ 3 of 10 consecutive patients turn out to be not grossly resectable during surgery.
Based on the interims-analyses of the outcomes the DSMB can vote for a discontinuation of the study.
There was an increased rate of discontinuation of the study owing to an adverse event in the treatment group (4.2 %) compared with the placebo group (1.6 %).
Adherence in the VivaGel® group was higher than in the placebo group at the Kisumu site, contributed in part by the early closure of the study and the discontinuation of study product in a greater proportion of those randomized to the placebo arm.
Time-sensitive actions to optimally manage DILI include discontinuation of the study drug in a timely manner, avoiding re-challenge, modification of dosage, performance of time-sensitive diagnostic tests and institution of therapeutic interventions.
A steering committee oversees the conduct of the trial and an independent data monitoring committee receives unblinded data and has the power to recommend to the steering committee modifications to the study conduct, including early discontinuation of the study, based on a risk/benefit assessment of the study data.
After the discontinuation of study treatment, a follow-up examination, including clinical examination, blood samples (liver enzymes, CEA), CT or ultrasound of the abdomen, was performed every 3 months, until the progression of the disease or death.
