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Table 1 severity grading for the QTcF interval on-treatment ECGs, adapted from [14]

From: A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

(1) Absolute QTcF >480 and ≤500 ms and QTcF change from baseline >0 ms and ≤30 ms; or

(1) Absolute QTcF >480 ms and ≤500 ms and QTcF change from baseline >30 ms and ≤ 60 ms; or

(1) Absolute QTcF >500 ms; or

Life-threatening consequence, e.g. torsades de pointes or other associated serious ventricular dysrhythmia.

-

(2) absolute QTcF ≤480 ms and QTcF change from baseline >30 and ≤60 ms

(2) absolute QTcF ≤480 and QTcF change from baseline >60 ms.

(2) absolute QTcF >480 and QTcF change from baseline >60 ms.

 

-

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Trials

ISSN: 1745-6215