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. Author manuscript; available in PMC: 2015 Feb 14.
Published in final edited form as: J Urol. 2010 Sep 17;184(5):1907–1913. doi: 10.1016/j.juro.2010.06.148

Table 1.

Analysis populations

Hexvix group White light group
Population number of patients number of patients
Safety Set All patients receiving HAL, and with safety data, includes training patients in the fluorescence cystoscopy group re-randomized out of the study. 421 381
All patients randomized Excludes patients re-randomized out of the fluorescence cystoscopy group. 395 384
ITT Set for detection primary endpoint analysis Patients receiving HAL, inspected with white and blue light, with histologically-confirmed results by central pathology consensus diagnosis. 3652 n/a1
PPS for detection primary endpoint Same as ITT set but excluding protocol violations such as HAL retention time or equipment failure. 352 n/a1
ITT Subset for recurrence primary endpoint analysis Patients receiving HAL, inspected with white and blue light, with histologically-confirmed Ta or T1 tumors (local pathology read) at baseline. 271 280
PPS Subset for recurrence primary endpoint Same as ITT set but excluding patients who did not complete the study according to the protocol. 200 202
1

Not applicable, False positive analysis only

2
Exclusion from ITT for detection:
  • 13 patients re- randomization out of fluorescence group
  • 4 withdrawn before treatment
  • 2 no cystoscopy
  • 2 no blue light inspection
  • 9 no consensus pathology data available at baseline