{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"EORTC QLQ-BLM30 is a 30-item questionnaire for patients with muscle invasive bladder cancer (T2, T3, T4a and T4b). The muscle-invasive bladder cancer module contains additional items assessing urostomy problems, problems associated with the use of a catheter, and body image.\n\nChanges from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \\<0.20 = trivial; 0.20-\\<0.50 = small; 0.50-\\<0.80 = moderate; and \\>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.","groups":[{"description":"Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Avelumab and Cisplatin IV"}],"populationDescription":"All patients who were registered, treated, and completed the EORTC QLQ assessment at baseline and post-therapy were included in this analysis.","reportingStatus":"POSTED","timeFrame":"Baseline to 12 months","title":"Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] EORTCQOL-Muscle-Invasive Bladder Cancer Module [BLM]30","type":"SECONDARY"}