Table 3.
Summary of TEAEs in patients who achieved CR or CRi
| n (%) | CPX-351 (n = 73) | 7+3 (n = 52) |
|---|---|---|
| Any TEAE* | 73 (100) | 52 (100) |
| Febrile neutropenia | 60 (82) | 40 (77) |
| Nausea | 38 (52) | 28 (54) |
| Constipation | 36 (49) | 24 (46) |
| Peripheral edema | 32 (44) | 29 (56) |
| Decreased appetite | 30 (41) | 23 (44) |
| Fatigue | 29 (40) | 26 (50) |
| Rash | 29 (40) | 15 (29) |
| Diarrhea | 28 (38) | 38 (73) |
| Dyspnea | 27 (37) | 13 (25) |
| Epistaxis | 25 (34) | 11 (21) |
| Chills | 23 (32) | 20 (38) |
| Cough | 23 (32) | 15 (29) |
| Headache | 22 (30) | 18 (35) |
| Hypotension | 20 (27) | 13 (25) |
| Dizziness | 19 (26) | 19 (37) |
| Mucosal inflammation | 19 (26) | 9 (17) |
| Pyrexia | 17 (23) | 14 (27) |
| Insomnia | 16 (22) | 13 (25) |
| Pleural effusion | 12 (16) | 15 (29) |
| Any serious TEAE† | 35 (48) | 24 (46) |
| Febrile neutropenia | 11 (15) | 6 (12) |
| Acute respiratory failure | 5 (7) | 1 (2) |
| Ejection fraction decreased | 4 (5) | 2 (4) |
| Sepsis | 4 (5) | 2 (4) |
| Pneumonia | 2 (3) | 3 (6) |
| Pulmonary edema | 1 (1) | 3 (6) |
| Grade 5 TEAE | 1 (1) | 3 (6) |
| Discontinuation due to TEAE | 1 (1) | 0 |
*
List of individual TEAEs includes all TEAEs occurring in ≥25% of patients in either treatment arm.
†
List of individual TEAEs includes all serious TEAEs occurring in ≥5% of patients in either treatment arm.