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Table 1 Schedule of assessments

From: BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301)

  Baseline Induction Maintenance Year 2 to Year 5
Blood tests a X   Week 13  
Urine culture X   Week 13  
Cystoscopy b TURBT After last instillation After 4th, 7th and last instillation 3 monthly (Year 2); 6 monthly (Years 3 and 4); at 5 years
Health-related quality of life X Weeks 3,6,9,13 Weeks 25,37,49 3 monthly (Year 2); 6 monthly (Years 3 and 4); at 5 years
Assessments c X Prior to each treatment Prior to each treatment 3 monthly (Year 2); 6 monthly (Years 3 and 4); at 5 years
  1. aFull blood count, urea and electrolytes, liver function tests
  2. bUnder local anaesthesia (LA) except at end of induction and maintenance when must be under general anaesthesia (GA) with biopsies
  3. cAssessments include those for treatment toxicity, symptoms of UTI, adverse events, resource use and patient status