TABLE 3.
Number and type of adverse events (AEs) reported per country and by regimen
| Country | Regimen type | Reporting period | Patients started on active PV monitoring n | AEs (includes SAE) n | SAEs# (includes death) n | Deaths¶ n |
| Ethiopia | Individualised+Bdq | Mar–Dec 2017+ | 16 | 15 | 4 | 2 |
| Individualised+Dlm | Mar–Dec 2017+ | 7 | 12 | 2 | 0 | |
| Shorter treatment regimen | Mar–Dec 2017+ | 0 | NA | NA | NA | |
| Kyrgyzstan | Individualised+Bdq | Jan–Dec 2017 | 133 | 23 | 8 | 5 |
| Individualised+Dlm | Jan–Dec 2017 | 79 | 6 | 0 | 0 | |
| Shorter treatment regimen | Jan–Dec 2017 | 129 | 4 | 0 | 0 | |
| Standard DS- and DR-TB regimens | Jan–Dec 2017 | Exact number unknown | 81 | 0 | 0 | |
| Tajikistan | Individualised+Bdq | Dec 2016–Dec 2017 | 64 | 13 | 5 | 3 |
| Shorter treatment regimen | Dec 2016–Dec 2017 | 75 | 8 | 0 | 0 | |
| Indonesia | Individualised+Bdq | Sept 2015–Apr 2018 | 120 | 285 | 77 | 13 |
| Myanmar | Individualised+Bdq | Jul 2017–Mar 2018 | 45 | 5 | 5 | 2 |
| Individualised+Dlm | Jul 2017–Mar 2018 | 14 | 5 | 5 | 1 | |
| Individualised+Bdq and Dlm | Jul 2017–Mar 2018 | 8 | 2 | 2 | 0 | |
| Shorter treatment regimen | Nov 2017–Mar 2018 | 59 | 9 | 9 | 0 | |
| Vietnam | Individualised+Bdq§ | Nov 2015– Dec 2017 | 99 | 758## | 65##,¶¶ | 7 |
| Standard DR-TB regimensƒ | Oct 2017–Oct 2018 | 265 | 40 | 21 | 1 |
PV: pharmacovigilance; SAE: serious adverse event; Bdq: bedaquiline; Dlm: delamanid; NA: not applicable; DS: drug-sensitive; DR: drug-resistant (rifampicin or multidrug-resistant); TB: tuberculosis. #: SAE following the definition provided in the World Health Organization (WHO) Handbook [37]; ¶: deaths occurring during the treatment; +: only includes numbers for sites directly supported by the Challenge TB Project; §: for regimens containing Bdq, this concerned cohort event monitoring; ƒ: this concerned monitoring of SAEs plus a list of pre-specified other AEs, which was more elaborate than the WHO recommended active drug safety management and monitoring intermediate package; ##: underestimated because only the first episode per patient of recurrent AEs was counted; ¶¶: 65 SAEs according to the WHO definition [37], whereas 143 SAEs were reported using a different definition of any event with severity grade 3 or 4 according to a grading scale specifically developed for this project.