Overall safety profile, and most common any-grade and grade 3 or above TEAEs occurring in at least 10% (any grade) or at least 10% (grade 3 or above) of pts in the safety population
| . | Tamibarotene + azacitidine . | Placebo + azacitidine . |
|---|---|---|
| Median duration of study treatment, mo | 5.1 (0.03-30.55) | 5 (0.03-29.98) |
| Participants with interrupted doses | 91 (56.88) | 39 (45.88) |
| Participants with missed doses | 99 (61.88) | 53 (62.35) |
| Participants with decreased doses | 16 (10) | 2 (2.35) |
| Incidence of TEAEs, n (%) | ||
| Any TEAE | 153 (95.63) | 81 (95.29) |
| Any drug-related TEAE | 94 (58.75) | 35 (41.18) |
| Any grade ≥3 TEAE | 37 (23.13) | 17 (20.00) |
| Any drug-related grade ≥3 TEAE | 84 (52.50) | 29 (34.12) |
| TEAE leading to discontinuation of tami/placebo, n (%) | 31 (19.38) | 6 (7.06) |
| TEAE leading to discontinuation of AZA, n (%) | 28 (17.50) | 8 (9.41) |
| On-study deaths, n (%) | 20 (12.50) | 8 (9.41) |
| Cause of death | ||
| Progressive disease | 3 (1.88) | 1 (1.18) |
| AE | 17 (10.63) | 7 (8.24) |
| Most common any-grade TEAEs (≥10% of pts) | ||
| Constipation | 65 (41) | 36 (42.3) |
| Nausea | 43 (26.9) | 18 (21.2) |
| Diarrhea | 31 (19.4) | 16 (18.9) |
| Vomiting | 21 (13.1) | 13 (15.3) |
| Anemia | 51 (31.9) | 31 (36.5) |
| Neutropenia | 51 (31.9) | 26 (30.6) |
| Thrombocytopenia | 43 (26.9) | 18 (21.2) |
| Febrile neutropenia | 29 (13.1) | 12 (14) |
| Asthenia | 20 (31.2) | 13 (15.3) |
| Pyrexia | 43 (26.9) | 13 (15.3) |
| Fatigue | 16 (10) | 8 (9.4) |
| Pneumonia | 27 (16.9) | 8 (9.4) |
| Hypertriglyceridemia | 55 (34.4) | 2 (2.4) |
| Decreased appetite | 28 (17.5) | 14 (16.5) |
| Rash | 34 (21.3) | 2 (2.4) |
| Pruritis | 25 (15.63) | 7 (8.24) |
| Alopecia | 23 (14.4) | 1 (1.2) |
| Arthralgia | 24 (15) | 6 (7.1) |
| Most common grade 3/4 TEAEs (≥10% of pts) | ||
| Anemia | 99 (61.9) | 24 (28.2) |
| Neutropenia | 40 (25) | 24 (28.2) |
| Thrombocytopenia | 37 (23.1) | 16 (18.8) |
| Febrile neutropenia | 29 (18.1) | 12 (14.1) |
| Pneumonia | 18 (11.3) | 7 (8.2) |
| Hypertriglyceridemia | 22 (13.75) | 0 |
| . | Tamibarotene + azacitidine . | Placebo + azacitidine . |
|---|---|---|
| Median duration of study treatment, mo | 5.1 (0.03-30.55) | 5 (0.03-29.98) |
| Participants with interrupted doses | 91 (56.88) | 39 (45.88) |
| Participants with missed doses | 99 (61.88) | 53 (62.35) |
| Participants with decreased doses | 16 (10) | 2 (2.35) |
| Incidence of TEAEs, n (%) | ||
| Any TEAE | 153 (95.63) | 81 (95.29) |
| Any drug-related TEAE | 94 (58.75) | 35 (41.18) |
| Any grade ≥3 TEAE | 37 (23.13) | 17 (20.00) |
| Any drug-related grade ≥3 TEAE | 84 (52.50) | 29 (34.12) |
| TEAE leading to discontinuation of tami/placebo, n (%) | 31 (19.38) | 6 (7.06) |
| TEAE leading to discontinuation of AZA, n (%) | 28 (17.50) | 8 (9.41) |
| On-study deaths, n (%) | 20 (12.50) | 8 (9.41) |
| Cause of death | ||
| Progressive disease | 3 (1.88) | 1 (1.18) |
| AE | 17 (10.63) | 7 (8.24) |
| Most common any-grade TEAEs (≥10% of pts) | ||
| Constipation | 65 (41) | 36 (42.3) |
| Nausea | 43 (26.9) | 18 (21.2) |
| Diarrhea | 31 (19.4) | 16 (18.9) |
| Vomiting | 21 (13.1) | 13 (15.3) |
| Anemia | 51 (31.9) | 31 (36.5) |
| Neutropenia | 51 (31.9) | 26 (30.6) |
| Thrombocytopenia | 43 (26.9) | 18 (21.2) |
| Febrile neutropenia | 29 (13.1) | 12 (14) |
| Asthenia | 20 (31.2) | 13 (15.3) |
| Pyrexia | 43 (26.9) | 13 (15.3) |
| Fatigue | 16 (10) | 8 (9.4) |
| Pneumonia | 27 (16.9) | 8 (9.4) |
| Hypertriglyceridemia | 55 (34.4) | 2 (2.4) |
| Decreased appetite | 28 (17.5) | 14 (16.5) |
| Rash | 34 (21.3) | 2 (2.4) |
| Pruritis | 25 (15.63) | 7 (8.24) |
| Alopecia | 23 (14.4) | 1 (1.2) |
| Arthralgia | 24 (15) | 6 (7.1) |
| Most common grade 3/4 TEAEs (≥10% of pts) | ||
| Anemia | 99 (61.9) | 24 (28.2) |
| Neutropenia | 40 (25) | 24 (28.2) |
| Thrombocytopenia | 37 (23.1) | 16 (18.8) |
| Febrile neutropenia | 29 (18.1) | 12 (14.1) |
| Pneumonia | 18 (11.3) | 7 (8.2) |
| Hypertriglyceridemia | 22 (13.75) | 0 |
AZA, azacitidine; tami, tamibarotene; TEAE, treatment-emergent AE.