. Author manuscript; available in PMC: 2022 Jul 1.

Published in final edited form as: Lancet Infect Dis. 2021 Feb 12;21(7):975–983. doi: 10.1016/S1473-3099(20)30770-2

Table 3:

QTc adverse events, by grade.

Arm	Total	Number (%) of Participants with QTc Prolongation...
Arm	Total	Grade 1		Grade 2		Grade 3		Grade 4
Bedaquiline	28	9	(32.1%)	1	(3.6%)	0	(0.0%)	0	(0.0%)
Delamanid	27	11	(40.7%)	0	(0.0%)	0	(0.0%)	0	(0.0%)
Bedaquiline plus delamanid	27	10	(37.0%)	2	(7.4%)	0	(0.0%)	0	(0.0%)
Total	82	30	(36.6%)	3	(3.7%)	0	(0.0%)	0	(0.0%)

Grade 1= 1) Absolute QTc >480 and ≤500 ms and QTc change from baseline >0 ms and ≤30 ms; or (2) absolute QTc ≤480 ms and QTc change from baseline >30 and ≤60 ms; Grade 2 = (1) Absolute QTc >480 ms and ≤500 ms and QTc change from baseline >30 ms and ≤ 60 ms; or (2) absolute QTc ≤480 and QTc change from baseline >60 ms. Grade 3 = (1) Absolute QTc >500 ms; or (2) absolute QTc >480 and QTc change from baseline >60 ms; Grade 4 = Life-threatening consequence, e.g., torsades de pointes or other associated serious ventricular dysrhythmia.