Table 2:
SOC | SOC + S | ||
---|---|---|---|
Intent to treat population | 157 | 152 | |
Started SOC | 149 (95%) | 150 (99%) | |
Completed SOC | 114 (73%) | 112 (74%) | |
Started sirolimus treatment | N/A | 92 (61%) | |
Completed sirolimus treatment | N/A | 64 (42%) | |
Reason off-study | |||
Disease Progression on Study | 52 (33%) | 83 (55%) | |
Disease Progression during Follow-up Period | 69 (44%) | 34 (22%) | |
Complicating Disease / Intercurrent Illness | 13 (8%) | 8 (5%) | |
Follow-up period completed | 9 (6%) | 7 (5%) | |
Refused further treatment | 3 (2%) | 12 (8%) | |
Refused further follow up | 3 (2%) | 4 (3%) | |
Death on Study | 2 (1%) | 3 (2%) | |
Death during Follow-Up Period | 3 (2%) | 0 (0%) | |
Adverse Events / Side Effects | 3 (2%) | 1 (<1%) | |
Dogs dead during the study period | 146 (93%) | 143 (94%) | |
Dead with evidence of metastatic disease* | 118 (75%) | 124 (82%) | |
Dead without evidence of metastatic disease | 28 (18%) | 19 (13%) | |
Dogs alive at the end of the follow-up period | 6 (4%) | 9 (6%) | |
Alive with evidence of metastatic disease | 0 (0%) | 1 (<1%) | |
Alive without evidence of metastatic disease | 6 (4%) | 8 (5%) | |
Dogs lost to follow-up | 5 (3%) | 8 (5%) |
N/A: not applicable
clinical, imaging, or necropsy evidence