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The main outcomes of this cohort are treatment completion rates, side-effects of treatment, disease outcomes and quality of life.
Secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.
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The measure of effectiveness was treatment completion rate, since not all patients completing treatment have a bacteriological confirmation of cure.
The primary outcome is treatment completion, defined as the proportion of participants who complete ≥80% of the prescribed INH doses within 12 months of initiating treatment.
The primary endpoint is treatment completion rate.
The primary outcome of interest was treatment completion rate (TCR).
The primary study endpoint is treatment completion rate.
The primary endpoint of this study is treatment completion rate, which is expected to be higher than the treatment completion rate in the ACTS-CC [ 4] due to alternate-day S-1 administration.
The reasons for treatment discontinuation were: treatment completion (per-protocol duration of treatment: 9 months) in 8 cases (29.6%), non-manageable toxicity in 7 cases (25.9%), documented tumor progression in 7 cases (25.9%), clinical tumor progression without radiological documentation in 2 cases (7.4%) and patient or investigator decision in 3 cases (11.1%).
Drug resistance was extensive, care was complex, treatment completion rates were high, and treatment was expensive.
In reported new smear positive cases, the cure rate (those who had a smear negative result at the end of treatment) was 15%, treatment completion rate was 60% and the defaulter rate was 12% in the Western Zone of Uganda, which includes our study area, as reported by the National TB/Leprosy programme Uganda in 2009 (unpublished report).
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