Table 6.
Global Response Assessment (GRA) by Treatment Group. Frequencies represent number of patients (n) or n (%) as appropriate. For the GRA portion of the response assessment, responders are defined as those reporting “Markedly Improved” or “Moderately Improved” on the GRA. Patients for whom the GRA value is missing are considered non-responders, and are included in the denominator for the assessment of response rates. Subjects who withdrew are also included in the denominator.
| Therapy | |||
|---|---|---|---|
| GTM | MPT | Total | |
| Number of Subjects Randomized | 24 | 23 | 47 |
| Response Rate Based on GRA (p=0.03) | |||
| Responders | 5 (21%) | 13 (57%) | 18 (38%) |
| Non-responders | 19 (79%) | 10 (43%) | 29 (62%) |
| Response Rate for IC/PBS Subgroup (n=26; p= 0.03) | |||
| Responders | 1 (7%) | 6 (50%) | 7 (27%) |
| Non-responders | 13 (93%) | 6 (50%) | 19 (73%) |
| Response Rate for CP/CPPS Subgroup (n=21; p= 0.39) | |||
| Responders | 4 (40%) | 7 (64%) | 11 (52%) |
| Non-responders | 6 (60%) | 4 (36%) | 10 (48%) |
| Global Assessment of Response: | |||
| Markedly Improved | 3 | 8 | 11 |
| Moderately Improved | 2 | 5 | 7 |
| Slightly Improved | 10 | 6 | 16 |
| No Change | 5 | 2 | 7 |
| Slightly Worsened | 1 | 0 | 1 |
| Moderately Worsened | 1 | 1 | 2 |
| Markedly Worsened | 0 | 0 | 0 |
| Missing or Withdrawn | 2 | 1 | 3 |