Report of fatal and life-threatening adverse events during endTB post-marketing safety surveillance of new and repurposed TB drugs

As part of the endTB project and observational study (2015-2019), rigorous post-marketing safety surveillance for all patients (referred to as "endTB patients") who began MDR/RR-TB regimens containing bedaquiline or delamanid was performed. This safety surveillance conformed to the "advanced" active TB Drug Safety Monitoring and Management (aDSM) package as defined by WHO (WHO/HTM/TB/2015.28).

The endTB Study Group is the group that is responsible for the endTB Observational Study (NCT02754765), which includes more than 2700 patients started on bedaquiline and delamanid containing regimens in 17 countries. Organized by country, this is a list of doctors, nurses, data managers, pharmacists, social workers, administrators and others who have spent many hours collecting and cleaning data, working closely with patients, and ensuring that the endTB Observational Study works smoothly in every aspect of its complex existence.

endTB Observational Study had sites in 17 countries. In each country, sites enrolled patients on treatment with bedaquiline and delamanid according to National TB Program guidelines, while collecting clinical and bacteriological data on efficacy and safety. Because many of the endTB Observational Study tools were found to be useful for clinicians and programs that were starting to use the new TB drugs and regimens, we made them freely available at the endTB website.