Table 4.
Most frequent on-treatment adverse events, regardless of study treatment relationship (all grade incidence ≥15% in any arm)
| Buparlisib+carboplatin arm | ||||||
| Preferred term, n (%) | Buparlisib (80 mg)+carboplatin (n=3) | Buparlisib (100 mg)+carboplatin (n=14) | All patients (buparlisib+carboplatin) (n=17) | |||
| All grades | Grades 3/4 | All grades | Grades 3/4 | All grades | Grades 3/4 | |
| Headache | 2 (66.7) | 0 | 7 (50.0) | 0 | 9 (52.9) | 0 |
| Fatigue | 3 (100) | 0 | 5 (35.7) | 1 (7.1) | 8 (47.1) | 1 (5.9) |
| Nausea | 2 (66.7) | 0 | 6 (42.9) | 0 | 8 (47.1) | 0 |
| Thrombocytopaenia | 0 | 0 | 6 (42.9) | 0 | 6 (35.3) | 0 |
| Constipation | 1 (33.3) | 0 | 4 (28.6) | 0 | 5 (29.4) | 0 |
| Depression | 1 (33.3) | 0 | 4 (28.6) | 1 (7.1) | 5 (29.4) | 1 (5.9) |
| Diarrhoea | 0 | 0 | 5 (35.7) | 0 | 5 (29.4) | 0 |
| Insomnia | 2 (66.7) | 0 | 3 (21.4) | 0 | 5 (29.4) | 0 |
| Neutropaenia | 0 | 0 | 5 (35.7) | 1 (7.1) | 5 (29.4) | 1 (5.9) |
| Decreased platelet count | 1 (33.3) | 0 | 4 (28.6) | 3 (21.4) | 5 (29.4) | 3 (17.6) |
| Decreased appetite | 0 | 0 | 4 (28.6) | 0 | 4 (23.5) | 0 |
| Hyperglycaemia | 1 (33.3) | 0 | 3 (21.4) | 0 | 4 (23.5) | 0 |
| Hypertension | 1 (33.3) | 0 | 3 (21.4) | 1 (7.1) | 4 (23.5) | 1 (5.9) |
| Decreased neutrophil count | 1 (33.3) | 1 (33.3) | 3 (21.4) | 2 (14.3) | 4 (23.5) | 3 (17.6) |
| Vomiting | 1 (33.3) | 0 | 3 (21.4) | 0 | 4 (23.5) | 0 |
| Decreased white cell count | 1 (33.3) | 0 | 3 (21.4) | 1 (7.1) | 4 (23.5) | 1 (5.9) |
| Anxiety | 1 (33.3) | 0 | 2 (14.3) | 0 | 3 (17.6) | 0 |
| Hiccups | 1 (33.3) | 0 | 2 (14.3) | 0 | 3 (17.6) | 0 |
| Pruritus | 2 (66.7) | 0 | 1 (7.1) | 0 | 3 (17.6) | 0 |
| Somnolence | 1 (33.3) | 0 | 2 (14.3) | 0 | 3 (17.6) | 0 |
| Dehydration | 1 (33.3) | 1 (33.3) | 1 (7.1) | 0 | 2 (11.8) | 1 (5.9) |
| Hypokalaemia | 0 | 0 | 2 (14.3) | 2 (14.3) | 2 (11.8) | 2 (11.8) |
| Lymphopaenia | 0 | 0 | 2 (14.3) | 2 (14.3) | 2 (11.8) | 2 (11.8) |
| Myalgia | 1 (33.3) | 0 | 1 (7.1) | 0 | 2 (11.8) | 0 |
| Seizure | 1 (33.3) | 0 | 1 (7.1) | 1 (7.1) | 2 (11.8) | 1 (5.9) |
| Urinary tract infection | 1 (33.3) | 0 | 1 (7.1) | 0 | 2 (11.8) | 0 |
| Buparlisib+lomustine arm | ||
| Preferred term, n (%) | Buparlisib (60 mg)+lomustine (n=18) | |
| All grades | Grades 3/4 | |
| Fatigue | 8 (44.4) | 1 (5.6) |
| Nausea | 8 (44.4) | 0 |
| Decreased platelet count | 8 (44.4) | 2 (11.1) |
| Anaemia | 6 (33.3) | 1 (5.6) |
| Confusional state | 5 (27.8) | 0 |
| Depression | 5 (27.8) | 1 (5.6) |
| Headache | 5 (27.8) | 0 |
| Anxiety | 4 (22.2) | 0 |
| Hypertension | 4 (22.2) | 1 (5.6) |
| Hypokalaemia | 4 (22.2) | 2 (11.1) |
| Insomnia | 4 (22.2) | 0 |
| Neutropaenia | 4 (22.2) | 2 (11.1) |
| Thrombocytopaenia | 4 (22.2) | 4 (22.2) |
| Decreased white cell count | 4 (22.2) | 2 (11.1) |
| Increased alanine aminotransferase | 3 (16.7) | 1 (5.6) |
| Asthenia | 3 (16.7) | 0 |
| Constipation | 3 (16.7) | 0 |
| Diarrhoea | 3 (16.7) | 0 |
| Gastro-oesophageal reflux disease | 3 (16.7) | 0 |
| Hyperglycaemia | 3 (16.7) | 1 (5.6) |
| Memory impairment | 3 (16.7) | 0 |
| Decreased neutrophil count | 3 (16.7) | 1 (5.6) |
| Seizure | 3 (16.7) | 1 (5.6) |
| Somnolence | 3 (16.7) | 0 |