Patients were treated with oral VPA at a starting dose of 15 mg/kg per day orally in divided doses, with the goal of reaching a serum level of >1 m M through weekly therapeutic drug monitoring and dose escalation.
An inpatient NTS challenge model could reduce the risk to participants by allowing close clinical monitoring, cautious dose escalation, and prompt antibiotic treatment as well as minimizing the risk of transmission to close household contacts [ 47].
An independent scientific committee that approved each dose escalation monitored all recorded data.
The known toxicities of gemcitabine, pulmonary toxicity, influenza-like symptoms and peripheral oedema, were closely monitored with dose –escalation; however, there did not appear to be an excess of events at the higher dose levels.
In the majority of patients, in which monitoring was extended, this escalation resulted in changes in treatment.
With so much at risk, it's none too soon to go on a permanent escalation watch, monitoring the major global hotspots for any sign of imminent flare-ups, hoping that early warnings (and the outcry that goes with them) might help avert catastrophe.
Finally, we analyzed whether an escalation of cardiovascular monitoring within the last 24 h influenced treatment strategies in the included patients.
Although our study was a phase I/II trial primarily focusing on toxicity, dose escalation and immuno-monitoring, the clinical outcome was a secondary objective.
The investigator/designee will contact the participant by phone between the randomisation and the clinical control in week 3 to monitor the study drug dose escalation and to investigate the participant's tolerance to the drug/placebo.
105, 106 However, owing to the enhanced risk of liver toxicity during the first 18 weeks of treatment in women with CD4+ T-cell counts of more than 250/μL, patients must be monitored closely, especially during dose escalation.
