The primary endpoint of unfavorable outcome was the incidence of bacteriologic failure, relapse or clinical failure or death through follow-up until 6 months after the end of treatment. Participants were considered to have a favourable outcome if their clinical TB disease resolved and they had a negative culture status at 6 months from end of therapy, and had not already been classified as having an unfavorable outcome. Secondary endpoints included: time to unfavorable outcome and time to sputum culture conversion through the treatment period. Culture conversion required at least 2 consecutive culture negative samples collected at least 7 days apart.
Safety and tolerability endpoints include all-cause mortality, incidence of treatment-emergent adverse events (TEAEs) occurring from the start of treatment. Here, we are reporting the TEAEs through 14 days after the end of treatment, categorised by grade according to the division of microbiology and infectious diseases (DMID) severity,[17 ] and drug relatedness and seriousness.
Safety and tolerability endpoints include all-cause mortality, incidence of treatment-emergent adverse events (TEAEs) occurring from the start of treatment. Here, we are reporting the TEAEs through 14 days after the end of treatment, categorised by grade according to the division of microbiology and infectious diseases (DMID) severity,[17 ] and drug relatedness and seriousness.
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