Table 5.
Incidence of adverse events (≥10% any grade incidence in any arm).
| Buparlisib + trastuzumab + paclitaxel N = 25 |
Placebo + trastuzumab + paclitaxel N = 25 |
|||
|---|---|---|---|---|
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| Non-haematological AEs, n (%) | ||||
| Increased ALT | 21 (84.0) | 12 (48.0) | 18 (72.0) | 2 (8.0) |
| Increased AST | 19 (76.0) | 7 (28.0) | 9 (36.0) | 0 (0.0) |
| Mucositis | 19 (76.0) | 2 (8.0) | 12 (48.0) | 0 (0.0) |
| Alopecia | 18 (72.0) | n.a. | 17 (68.0) | n.a. |
| Maculo-papular rash | 15 (60.0) | 5 (20.0) | 12 (48.0) | 0 (0.0) |
| Diarrhoea | 15 (60.0) | 1 (4.0) | 10 (40.0) | 1 (4.0) |
| Increased total cholesterol | 14 (58.3) (missing: n = 1) | 0 (0.0) | 14 (60.9) (missing: n = 2) | 0 (0.0) |
| Peripheral sensory neuropathy | 14 (56.0) | 0 (0.0) | 16 (64.0) | 1 (4.0) |
| Fatigue | 13 (52.0) | 0 (0.0) | 14 (56.0) | 1 (4.0) |
| Increased FPG | 13 (52.0) | 3 (12.0) | 8 (32.0) | 1 (4.0) |
| Infection | 12 (48.0) | 1 (4.0) | 19 (76.0) | 1 (4.0) |
| Increased aPTTa | 5 (45.5) (missing: n = 14) | 0 (0.0) | 6 (40.0) (missing: n = 10) | 0 (0.0) |
| Nausea | 11 (44.0) | 0 (0.0) | 8 (32.0) | 0 (0.0) |
| Pruritus | 10 (40.0) | 0 (0.0) | 5 (20.0) | 0 (0.0) |
| Decreased calcium | 9 (36.0) | 0 (0.0) | 11 (44.0) | 0 (0.0) |
| Decreased sodium | 9 (36.0) | 1 (4.0) | 7 (28.0) | 0 (0.0) |
| Increased GGT | 8 (32.0) | 2 (8.0) | 7 (28.0) | 0 (0.0) |
| Fever without neutropenia | 7 (28.0) | 0 (0.0) | 3 (12.0) | 0 (0.0) |
| Increased uric acid | 6 (24.0) | 0 (0.0) | 10 (40.0) | 0 (0.0) |
| Depression | 6 (24.0) | 1 (4.0) | 8 (32.0) | 0 (0.0) |
| Increased AP | 6 (24.0) | 0 (0.0) | 6 (24.0) | 0 (0.0) |
| Decreased potassium | 6 (24.0) | 0 (0.0) | 2 (8.0) | 0 (0.0) |
| Increased triglycerides | 5 (20.8) (missing: n = 1) | 0 (0.0) | 6 (26.1) (missing: n = 2) | 0 (0.0) |
| Decreased serum albumin | 5 (20.8) (missing: n = 1) | 0 (0.0) | 2 (8.3) (missing: n = 1) | 0 (0.0) |
| Anxiety | 5 (20.0) | 1 (4.0) | 3 (12.0) | 0 (0.0) |
| Anorexia | 5 (20.0) | 0 (0.0) | 1 (4.0) | 0 (0.0) |
| Constipation | 4 (16.0) | 0 (0.0) | 7 (28.0) | 0 (0.0) |
| Increased sodium | 4 (16.0) | 0 (0.0) | 2 (8.0) | 0 (0.0) |
| Increased potassium | 3 (12.0) | 0 (0.0) | 11 (44.0) | 1 (4.0) |
| Insomnia | 3 (12.0) | 0 (0.0) | 4 (16.0) | 1 (4.0) |
| Vomiting | 3 (12.0) | 0 (0.0) | 2 (8.0) | 0 (0.0) |
| Haematological AEs, n (%) | ||||
| Anaemia | 17 (68.0) | 0 (0.0) | 18 (72.0) | 1 (4.0) |
| Leukopenia | 11 (44.0) | 0 (0.0) | 15 (60.0) | 0 (0.0) |
| Lymphopenia | 11 (44.0) | 0 (0.0) | 8 (32.0) | 2 (8.0) |
| Neutropenia | 6 (24.0) | 1 (4.0) | 9 (36.0) | 0 (0.0) |
| Thrombopenia | 4 (16.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
AEs, adverse events; ALT, alanine aminotransferase; AP, alkaline phosphatase aPTT, activated partial thromboplastin time; AST, aspartate aminotransferase; FPG, fasting plasma glucose; GGT, gamma-glutamyl transferase; na, not available.
a
Assessed if clinically indicated.