Number and type of adverse events (AEs) reported per country and by regimen

CountryRegimen typeReporting periodPatients started on active PV monitoring nAEs (includes SAE) nSAEs# (includes death) nDeaths n
EthiopiaIndividualised+BdqMar–Dec 2017+161542
Individualised+DlmMar–Dec 2017+71220
Shorter treatment regimenMar–Dec 2017+0NANANA
KyrgyzstanIndividualised+BdqJan–Dec 20171332385
Individualised+DlmJan–Dec 201779600
Shorter treatment regimenJan–Dec 2017129400
Standard DS- and DR-TB regimensJan–Dec 2017Exact number unknown8100
TajikistanIndividualised+BdqDec 2016–Dec 2017641353
Shorter treatment regimenDec 2016–Dec 201775800
IndonesiaIndividualised+BdqSept 2015–Apr 20181202857713
MyanmarIndividualised+BdqJul 2017–Mar 201845552
Individualised+DlmJul 2017–Mar 201814551
Individualised+Bdq and DlmJul 2017–Mar 20188220
Shorter treatment regimenNov 2017–Mar 201859990
VietnamIndividualised+Bdq§Nov 2015– Dec 201799758##65##,¶¶7
Standard DR-TB regimensƒOct 2017–Oct 201826540211

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.