Table 3.
Adverse events for the full patient cohort and each treatment group
| Adverse Event | All Patients (N = 35) | Entinostat + Lapatinib + Trastuzumab (Patient: N = 21) | Entinostat + Lapatinib (Patient: N = 14) | |||
|---|---|---|---|---|---|---|
| All Grades N (%) | Grade 3-4 N (%) | All Grades N (%) | Grade 3-4 N (%) | All Grades N (%) | Grade 3-4 N (%) | |
| Any Adverse Event | 35 (100) | 28 (80) | 21 (100) | 18 (85.7) | 14 (100) | 10 (71.4) |
| Abdominal pain | 2 (5.7) | 2 (5.7) | 1 (4.8) | 1 (4.8) | 1 (7.1) | 1 (7.1) |
| Alkaline phosphatase increased | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Anaemia | 5 (14.3) | 5 (14.3) | 5 (23.8) | 5 (23.8) | 0 (0) | 0 (0) |
| Arthralgia | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Blood bilirubin increased | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Dehydration | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Diarrhoea | 31 (88.6) | 4 (11.4) | 18 (85.7) | 4 (19) | 13 (92.9) | 0 (0) |
| Dyspnoea | 3 (8.6) | 3 (8.6) | 0 (0) | 0 (0) | 3 (21.4) | 3 (21.4) |
| Fatigue | 8 (22.6) | 8 (22.6) | 3 (14.3) | 3 (14.3) | 5 (35.7) | 5 (35.7) |
| Hyperglycaemia | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Hypocalcaemia | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Hypokalaemia | 3 (8.6) | 3 (8.6) | 3 (14.3) | 3 (14.3) | 0 (0) | 0 (0) |
| Hyponatraemia | 2 (5.7) | 2 (5.7) | 1 (4.8) | 1 (4.8) | 1 (7.1) | 1 (7.1) |
| Lung infection | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Myalgia | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - (Other), specifya | 2 (5.7) | 2 (5.7) | 1 (4.8) | 1 (4.8) | 1 (7.1) | 1 (7.1) |
| Neutrophil count decreased | 11 (31.4) | 11 (31.4) | 8 (38.1) | 8 (38.1) | 3 (21.4) | 3 (21.4) |
| Pain of skin | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Platelet count decreased | 8 (22.6) | 8 (22.6) | 6 (28.6) | 6 (28.6) | 2 (14.3) | 2 (14.3) |
| Rash maculo-papular | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Sepsis | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Urinary tract infection | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| White blood cell decreased | 3 (8.6) | 3 (8.6) | 3 (14.3) | 3 (14.3) | 0 (0) | 0 (0) |
| Any Treatment-Related Adverse Event | 34 (97.1) | 28 (80) | 20 (95.2) | 18 (85.7) | 14 (100) | 10 (71.4) |
| Abdominal pain | 2 (5.7) | 2 (5.7) | 1 (4.8) | 1 (4.8) | 1 (7.1) | 1 (7.1) |
| Alkaline phosphatase increased | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Anaemia | 5 (14.3) | 5 (14.3) | 5 (23.8) | 5 (23.8) | 0 (0) | 0 (0) |
| Arthralgia | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Blood bilirubin increased | 1 (2.9) | 1 (2.9) | 1 (4.8) | 0 (0) | 0 (0) | 0 (0) |
| Dehydration | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Diarrhoea | 31 (88.6) | 4 (11.4) | 18 (85.7) | 4 (85.7) | 13 (92.9) | 0 (0) |
| Dyspnoea | 3 (8.6) | 3 (8.6) | 0 (0) | 0 (0) | 3 (21.4) | 3 (21.4) |
| Fatigue | 8 (22.6) | 8 (22.6) | 3 (14.3) | 3 (14.3) | 5 (35.7) | 5 (35.7) |
| Hyperglycaemia | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Hypocalcaemia | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Hypokalaemia | 3 (8.6) | 3 (8.6) | 3 (14.3) | 3 (14.3) | 0 (0) | 0 (0) |
| Hyponatraemia | 2 (5.7) | 2 (5.7) | 1 (4.8) | 1 (4.8) | 1 (7.1) | 1 (7.1) |
| Lung infection | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Myalgia | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Neutrophil count decreased | 11 (31.4) | 11 (31.4) | 8 (38.1) | 8 (38.1) | 3 (21.4) | 3 (21.4) |
| Pain of skin | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Platelet count decreased | 8 (22.6) | 8 (22.6) | 6 (28.6) | 6 (28.6) | 2 (14.3) | 2 (14.3) |
| Rash maculo-papular | 1 (2.9) | 1 (2.9) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) |
| Sepsis | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| Urinary tract infection | 1 (2.9) | 1 (2.9) | 1 (4.8) | 1 (4.8) | 0 (0) | 0 (0) |
| White blood cell decreased | 3 (8.6) | 3 (8.6) | 3 (14.3) | 3 (14.3) | 0 (0) | 0 (0) |
aNeoplasms benign, malignant and unspecified: one in each arm is the only grade 5 adverse event that is unrelated with treatment