Table 5.
Verbatim outcome name and definition heterogeneity
| a) RECURRENCE | b) PROGRESSION | c) OVERALL SURVIVAL | d) CANCER-SPECIFIC SURVIVAL | e) ADVERSE EVENTS | f) TREATMENT RESPONSE (for cis) | g) DEFINITIONS FOR INSTILLATION TREATMENT COMPLETION |
| Time to recurrencemedian time to first recurrencetime to initial recurrenceearly recurrence (0– 2 years) late recurrence (> 2 years) recurrence-free survivalrelapse-free survival recurrence-free period disease-free time disease-free survival first bladder recurrence first TCC recurrence Recurrence-free interval disease-free interval Recurrence rate (%) recurrence rate and recurrence free rate at different time points: 1,2,3,5,10 yrs incident of recurrence probability of recurrence at 5,10 and 15 yrs Recurrence risk (at 3 year and 5 year) NMIBC recurrence (pTa, pT1) Recurrence per year recurrence rate per year tumor per year rate Recurrence index/100 patients per month Number of recurrences 50 % recurrence time (days) Recurrence-rate reduction absolute recurrence risk reduction Recurrence-free ratenon-recurrence rate relapse-free patients 1-year recurrence free survival 5-year recurrence free survival Tumor size of first recurrence | Time to progression Time to first progression Time to progression in stage Time to progression to MIBC Time to progression in grade Time to progression to distant metastasis Time to distant metastasis Progression-free survival 5-year progression-free survival Progression-free at 5 years Worsening free survival Progression-free time Duration of progression-free interval Progression rate Disease progression rate Free of progression Progression-free survival rate Rate of progression to T2 or grater Progression rate at the first recurrence | Survival rate Overall survival Overall mortality Survival Cancer deaths Death Survival time5-year overall survival Time to death by any cause Duration of survival Causes of deaths | Cancer-specific survival rate Cancer deaths Cancer-specific death rate Disease-specific mortality Death from bladder cancer Cancer specific survival timeTime to death due to bladder cancer Cancer-specific survival Cause-specific survival Disease-specific survival Disease-free survival Cancer-specific survival time | Standardised outcome term Local toxicity Systematic toxicity Allergic reactions (dermatological) Constitutional symptoms Laboratory abnormality Treatment interruption Death due to toxicity Definitions/Instruments used CTCAE v3.0 (Common Terminology Criteria of Adverse) NCI-CTC v2.0 (National Cancer Institute-Common Toxicity) WHO toxicity grading scale WHO-ART (1979 WHO Adverse Reaction Terminology) | complete response rate complete response at 3 months and 1 year response to treatment efficacy of induction therapy number of instillations need to achieve a complete response complete response rate in patients with CIS or concomitant carcinoma in situ (pTa or pT1) treatment efficacy in patients with CIS overall complete response rate | completion rate (all planned instillations in the cycle were administered) performance rate (at least one of the three planned instillations in the cycle was administered) completion and performance rate at 3, 6, 12 and 18 months% of patients that received all 8 scheduled courses during 3 years% of patients completed the planned 2-year programmed treatment% of patients that received maintenance therapy for 6 months and 18 monthsthe number of institutions number of patients receiving 6-11 instillations number of patients receiving < 6 instillations number of patients received induction treatment maintenance (long-term arm): number of patients complete six instillations and also 1 yr, 2 and 3 yr of maintenance therapy median number of instillations probability of non-cessation of instillations (%) at 6, 12 and 15 months number of patients received at least 4 instillations as induction course number of patients that received fewer than the planned 28 instillatons of the protocol |