Safety profile in the Phase 3 trial consistent with 7+31,a,b
Common adverse reactions (≥20% incidence in the VYXEOS arm) during the induction phase1
Adverse reaction | All gradesc | Grades 3 to 5c | ||
---|---|---|---|---|
VYXEOS
(N=153) n (%) |
7+3
(N=151) n (%) |
VYXEOS
(N=153) n (%) |
7+3
(N=151) n (%) |
|
Hemorrhage | 107 (70) | 74 (49) | 15 (10) | 9 (6) |
Febrile neutropenia | 104 (68) | 103 (68) | 101 (66) | 102 (68) |
Rash | 82 (54) | 55 (36) | 8 (5) | 2 (1) |
Edema | 78 (51) | 90 (60) | 2 (2) | 5 (3) |
Nausea | 72 (47) | 79 (52) | 1 (1) | 1 (1) |
Diarrhea/colitis | 69 (45) | 100 (66) | 4 (3) | 10 (7) |
Mucositis | 67 (44) | 69 (46) | 2 (1) | 7 (5) |
Constipation | 61 (40) | 57 (38) | 0 | 0 |
Musculoskeletal pain | 58 (38) | 52 (34) | 5 (3) | 4 (3) |
Abdominal pain | 51 (33) | 45 (30) | 3 (2) | 3 (2) |
Cough | 51 (33) | 34 (23) | 0 | 1 (1) |
Headache | 51 (33) | 36 (24) | 2 (1) | 1 (1) |
Dyspnea | 49 (32) | 51 (34) | 17 (11) | 15 (10) |
Fatigue | 49 (32) | 58 (38) | 8 (5) | 8 (5) |
Arrhythmia | 46 (30) | 41 (27) | 10 (7) | 7 (5) |
Decreased appetite | 44 (29) | 57 (38) | 2 (1) | 5 (3) |
Pneumonia (excluding fungal) | 39 (26) | 35 (23) | 30 (20) | 26 (17) |
Sleep disorders | 38 (25) | 42 (28) | 2 (1) | 1 (1) |
Bacteremia (excluding sepsis) | 37 (24) | 37 (25) | 35 (23) | 31 (21) |
Vomiting | 37 (24) | 33 (22) | 0 | 0 |
Chills | 35 (23) | 38 (25) | 0 | 0 |
Hypotension | 30 (20) | 32 (21) | 7 (5) | 1 (1) |
Non-conduction cardiotoxicity | 31 (20) | 27 (18) | 13 (9) | 15 (10) |
Adverse reaction | All gradesc | |
---|---|---|
VYXEOS
(N=153) n (%) |
7+3
(N=151) n (%) |
|
Hemorrhage | 107 (70) | 74 (49) |
Febrile neutropenia | 104 (68) | 103 (68) |
Rash | 82 (54) | 55 (36) |
Edema | 78 (51) | 90 (60) |
Nausea | 72 (47) | 79 (52) |
Diarrhea/colitis | 69 (45) | 100 (66) |
Mucositis | 67 (44) | 69 (46) |
Constipation | 61 (40) | 57 (38) |
Musculoskeletal pain | 58 (38) | 52 (34) |
Abdominal pain | 51 (33) | 45 (30) |
Cough | 51 (33) | 34 (23) |
Headache | 51 (33) | 36 (24) |
Dyspnea | 49 (32) | 51 (34) |
Fatigue | 49 (32) | 58 (38) |
Arrhythmia | 46 (30) | 41 (27) |
Decreased appetite | 44 (29) | 57 (38) |
Pneumonia (excluding fungal) | 39 (26) | 35 (23) |
Sleep disorders | 38 (25) | 42 (28) |
Bacteremia (excluding sepsis) | 37 (24) | 37 (25) |
Vomiting | 37 (24) | 33 (22) |
Chills | 35 (23) | 38 (25) |
Hypotension | 30 (20) | 32 (21) |
Non-conduction cardiotoxicity | 31 (20) | 27 (18) |
Adverse reaction | Grades 3 to 5c | |
---|---|---|
VYXEOS
(N=153) n (%) |
7+3
(N=151) n (%) |
|
Hemorrhage | 15 (10) | 9 (6) |
Febrile neutropenia | 101 (66) | 102 (68) |
Rash | 8 (5) | 2 (1) |
Edema | 2 (2) | 5 (3) |
Nausea | 1 (1) | 1 (1) |
Diarrhea/colitis | 4 (3) | 10 (7) |
Mucositis | 2 (1) | 7 (5) |
Constipation | 0 | 0 |
Musculoskeletal pain | 5 (3) | 4 (3) |
Abdominal pain | 3 (2) | 3 (2) |
Cough | 0 | 1 (1) |
Headache | 2 (1) | 1 (1) |
Dyspnea | 17 (11) | 15 (10) |
Fatigue | 8 (5) | 8 (5) |
Arrhythmia | 10 (7) | 7 (5) |
Decreased appetite | 2 (1) | 5 (3) |
Pneumonia (excluding fungal) | 30 (20) | 26 (17) |
Sleep disorders | 2 (1) | 1 (1) |
Bacteremia (excluding sepsis) | 35 (23) | 31 (21) |
Vomiting | 0 | 0 |
Chills | 0 | 0 |
Hypotension | 7 (5) | 1 (1) |
Non-conduction cardiotoxicity | 13 (9) | 15 (10) |
Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and 0.7% in the control arm1
Other adverse reactions that occurred in ≥10% of patients in the VYXEOS arm included: dizziness, fungal infection, hypertension, hypoxia, upper respiratory infections (excluding fungal), chest pain, pyrexia, catheter/device/injection site reaction, delirium, pleural effusion, anxiety, pruritus, sepsis (excluding fungal), hemorrhoids, petechiae, renal insufficiency, transfusion reactions, and visual impairment (except bleeding)1
- Cytarabine 100 mg/m2 and daunorubicin 60 mg/m2.1
- The safety population included all patients in the VYXEOS cohort and 151 patients from the 7+3 cohort (5 patients withdrew consent before the receipt of treatment).2
- Adverse reactions were graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.