Table 2.
Adverse events
|
Fulvestrant plus capivasertib group (n=69) |
Fulvestrant plus placebo group (n=71) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Diarrhoea | 28 (41%) | 18 (26%) | 10 (14%) | 0 | 21 (30%) | 1 (1%) | 2 (3%) | 1 (1%) |
| Rash* | 15 (22%) | 7 (10%) | 14 (20%) | 0 | 11 (15%) | 2 (3%) | 0 | 0 |
| Hyperglycaemia | 17 (25%) | 9 (13%) | 3 (4%) | 0 | 10 (14%) | 0 | 0 | 0 |
| Proteinuria | 18 (26%) | 8 (12%) | 0 | 0 | 8 (11%) | 0 | 0 | 0 |
| Hypertriglyceridaemia | 32 (46%) | 4 (6%) | 1 (1%) | 0 | 18 (25%) | 2 (3%) | 0 | 0 |
| Infection (including urinary tract infection) | 8 (12%) | 14 (20%) | 3 (4%) | 1 (1%) | 5 (7%) | 6 (8%) | 2 (3%) | 0 |
| Vomiting | 17 (25%) | 8 (12%) | 2 (3%) | 0 | 13 (18%) | 2 (3%) | 0 | 0 |
| Urea (high) | 12 (17%) | 1 (1%) | 0 | 0 | 6 (8%) | 0 | 0 | 0 |
| Creatinine increased | 9 (13%) | 2 (3%) | 0 | 0 | 4 (6%) | 0 | 0 | 0 |
| Back pain | 12 (17%) | 5 (7%) | 0 | 0 | 7 (10%) | 3 (4%) | 1 (1%) | 0 |
| Urinary tract infection | 4 (6%) | 6 (9%) | 1 (1%) | 0 | 2 (3%) | 3 (4%) | 0 | 0 |
| ECG QTc prolonged | 22 (32%) | 2 (3%) | 0 | 0 | 15 (21%) | 4 (6%) | 0 | 0 |
| Cholesterol high | 19 (28%) | 4 (6%) | 0 | 0 | 16 (23%) | 2 (3%) | 0 | 0 |
| Haemoglobin (low) | 14 (20%) | 4 (6%) | 0 | 0 | 7 (10%) | 5 (7%) | 1 (1%) | 0 |
| Hypercalcaemia | 16 (23%) | 1 (1%) | 0 | 0 | 12 (17%) | 0 | 0 | 0 |
| Hypoalbuminaemia | 7 (10%) | 4 (6%) | 0 | 0 | 5 (7%) | 1 (1%) | 0 | 0 |
| Mucositis oral | 7 (10%) | 3 (4%) | 0 | 0 | 5 (7%) | 0 | 0 | 0 |
| LDL (high) | 14 (20%) | 0 | 0 | 0 | 10 (14%) | 0 | 0 | 0 |
| Elevated alanine transaminase | 16 (23%) | 2 (3%) | 0 | 0 | 12 (17%) | 1 (1%) | 2 (3%) | 0 |
| Abdominal pain | 8 (12%) | 2 (3%) | 0 | 0 | 5 (7%) | 1 (1%) | 1 (1%) | 0 |
| Hypocalcemia | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Nausea | 30 (43%) | 8 (12%) | 0 | 0 | 31 (44%) | 5 (7%) | 0 | 0 |
| HDL (low) | 14 (20%) | 0 | 0 | 0 | 12 (17%) | 0 | 0 | 0 |
| Hyponatraemia | 1 (1%) | 0 | 2 (3%) | 0 | 0 | 0 | 1 (1%) | 0 |
| Hypertension | 20 (29%) | 21 (30%) | 22 (32%) | 0 | 23 (32%) | 22 (31%) | 17 (24%) | 0 |
| Pain (other) | 5 (7%) | 1 (1%) | 2 (3%) | 0 | 5 (7%) | 2 (3%) | 0 | 0 |
| Anaemia | 2 (3%) | 1 (1%) | 0 | 0 | 0 | 0 | 2 (3%) | 0 |
| Haemorrhage† | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cough | 5 (7%) | 2 (3%) | 0 | 0 | 5 (7%) | 2 (3%) | 0 | 0 |
| Fatigue | 24 (35%) | 15 (22%) | 1 (1%) | 0 | 26 (37%) | 12 (17%) | 3 (4%) | 0 |
| Elevated alkaline phosphatase | 15 (22%) | 5 (7%) | 1 (1%) | 0 | 16 (23%) | 4 (6%) | 2 (3%) | 0 |
| White blood cell count (high) | 7 (10%) | 3 (4%) | 0 | 0 | 7 (10%) | 4 (6%) | 0 | 0 |
| Pain in extremity | 6 (9%) | 3 (4%) | 0 | 0 | 6 (8%) | 2 (3%) | 2 (3%) | 0 |
| Influenza-like symptoms | 6 (9%) | 2 (3%) | 0 | 0 | 7 (10%) | 2 (3%) | 0 | 0 |
| Neutrophil count decreased | 7 (10%) | 1 (1%) | 0 | 0 | 8 (11%) | 1 (1%) | 0 | 0 |
| Platelet count decreased | 2 (3%) | 0 | 0 | 1 (1%) | 4 (6%) | 0 | 0 | 0 |
| Hot flashes | 8 (12%) | 2 (3%) | 0 | 0 | 12 (17%) | 0 | 0 | 0 |
| Constipation | 6 (9%) | 0 | 0 | 0 | 9 (13%) | 0 | 0 | 0 |
| Injection site reactions | 16 (23%) | 2 (3%) | 1 (1%) | 0 | 21 (30%) | 2 (3%) | 0 | 0 |
| Arthralgia | 12 (17%) | 5 (7%) | 2 (3%) | 0 | 17 (24%) | 6 (8%) | 0 | 0 |
| Elevated aspartate transaminase | 7 (10%) | 2 (3%) | 0 | 0 | 9 (13%) | 2 (3%) | 2 (3%) | 0 |
| Pulse (high) | 5 (7%) | 0 | 0 | 0 | 9 (13%) | 0 | 0 | 0 |
| Headache | 16 (23%) | 1 (1%) | 0 | 0 | 19 (27%) | 4 (6%) | 0 | 0 |
| Dyspnoea | 1 (1%) | 4 (6%) | 0 | 0 | 9 (13%) | 3 (4%) | 1 (1%) | 1 (1%) |
The table presents toxicities reported in at least 10% of patients in either group or any toxicity reported at grade 3 or worse, irrespective of cause. This table includes laboratory value changes that were confirmed as toxicities by research centres. ECG=electrocardiogram.
*
All preferred terms of rash have been combined.
†
One patient in the treatment group had a grade 5 haemorrhage.