Overall survival
Survival . | Phase 2 and Exp (n = 60)∗ . | Phase 1b (n = 17)† . |
---|---|---|
Overall survival | ||
No. of events | 36 | 10 |
Median in mo (95% CI) | 17.1 (11.0-44.2) | 12.5 (4.5-NE) |
% alive at 7 d (95% CI) | 98 (89-100) | 100 |
% alive at 30 d (95% CI) | 95 (85-98) | 94 (65-99) |
% alive at 60 d (95% CI) | 90 (79-95) | 88 (61-97) |
% alive at 6 mo (95% CI) | 80 (67-88) | 65 (38-82) |
% alive at 24 mo (95% CI) | 47 (34-59) | 41 (19-63) |
Median follow-up in months (range) | 36.0 (6.2-55.4) | 41.1 (25.8-54.5) |
Death, n (%)‡ | ||
Within 7 d | 1 (2) | 0 (0) |
Within 30 d | 3 (5) | 1 (6) |
Within 60 d | 6 (10) | 2 (12) |
Survival . | Phase 2 and Exp (n = 60)∗ . | Phase 1b (n = 17)† . |
---|---|---|
Overall survival | ||
No. of events | 36 | 10 |
Median in mo (95% CI) | 17.1 (11.0-44.2) | 12.5 (4.5-NE) |
% alive at 7 d (95% CI) | 98 (89-100) | 100 |
% alive at 30 d (95% CI) | 95 (85-98) | 94 (65-99) |
% alive at 60 d (95% CI) | 90 (79-95) | 88 (61-97) |
% alive at 6 mo (95% CI) | 80 (67-88) | 65 (38-82) |
% alive at 24 mo (95% CI) | 47 (34-59) | 41 (19-63) |
Median follow-up in months (range) | 36.0 (6.2-55.4) | 41.1 (25.8-54.5) |
Death, n (%)‡ | ||
Within 7 d | 1 (2) | 0 (0) |
Within 30 d | 3 (5) | 1 (6) |
Within 60 d | 6 (10) | 2 (12) |
Overall survival in phase 2 and phase 2 expansion cohort was calculated from time of ENA start date to the date of death owing to any reason; patients who were alive were censored at the time of last follow-up.
Overall survival in phase 1b was calculated from time of combination therapy to the date of death owing to any reason; patients who were alive were censored at the time of last follow-up.
For phase 2 and expansion, deaths within 7, 30, or 60 days of the monotherapy are provided. For phase 1b, deaths within 7, 30, or 60 days of the combination therapy are provided. One death is included in both phase 2 and phase 1b, a patient who died 34 days after initiation of monotherapy and 13 days after the start of combination therapy.