Table 3 Summary of AEs/SAEs
AE | ARPIs | ARPIs (physician’s choice control) | Taxanes | Taxanes (physician’s choice control) | ||||
|---|---|---|---|---|---|---|---|---|
(N = 51) | (N = 37) | (N = 75) | (N = 48) | |||||
Any AE | 37 | 72.5% | 28 | 75.7% | 64 | 85.3% | 45 | 93.8% |
Treatment-related AE | 26 | 51.0% | 19 | 51.4% | 50 | 66.7% | 38 | 79.2% |
Any SAE/AE resulting in IMP interruption | 4 | 7.8% | 6 | 16.2% | 18 | 24.0% | 8 | 16.7% |
An SAE/AE resulting in IMP (dose) adjustment | 2 | 3.9% | 2 | 5.4% | 12 | 16.0% | 8 | 16.7% |
Any SAE/AE resulting in permament discontinuation of IMP | 5 | 9.8% | 6 | 16.2% | 14 | 18.7% | 7 | 14.6% |
Most common AE (all grades, occurring in ≥5% of patients) | ||||||||
Fatigue | 7 | 13.7% | 9 | 24.3% | 25 | 33.3% | 17 | 35.4% |
Back pain | 9 | 17.6% | 3 | 8.1% | 19 | 25.3% | 9 | 18.8% |
Anemia | 6 | 11.8% | 2 | 5.4% | 9 | 12.0% | 9 | 18.8% |
Pain (hip) | 5 | 9.8% | 3 | 8.1% | 6 | 8.0% | 6 | 12.5% |
Nausea | 3 | 5.9% | 1 | 2.7% | 4 | 5.3% | 8 | 16.7% |
Diarrhea | 1 | 2.0% | 0 | 0.0% | 8 | 10.7% | 7 | 14.6% |
Dysgeusia | 0 | 0.0% | 1 | 2.7% | 9 | 12.0% | 5 | 10.4% |
Dyspnea | 3 | 5.9% | 2 | 5.4% | 8 | 10.7% | 2 | 4.2% |
Neuropathy/peripheral sensory neuropathy | 2 | 3.9% | 2 | 5.4% | 14 | 18.7% | 8 | 16.7% |
Constipation | 1 | 2.0% | 1 | 2.7% | 6 | 8.0% | 5 | 10.4% |
Fever | 2 | 3.9% | 3 | 8.1% | 5 | 6.7% | 4 | 8.3% |
Pain (leg/extremities) | 2 | 3.9% | 1 | 2.7% | 6 | 8.0% | 3 | 6.3% |
Thromboembolic event | 0 | 0.0% | 0 | 0.0% | 7 | 9.3% | 6 | 12.5% |
Neutropenia | 0 | 0.0% | 0 | 0.0% | 6 | 8.0% | 6 | 12.5% |
Weight loss | 1 | 2.0% | 3 | 8.1% | 4 | 5.3% | 5 | 10.4% |
SAEs | 16 | 31.4% | 13 | 35.1% | 26 | 34.7% | 21 | 43.8% |
Treatment-related SAEs | 5 | 9.8% | 6 | 16.2% | 17 | 22.7% | 18 | 37.5% |
Number of SAEs | ||||||||
1 | 10 | 19.6% | 9 | 24.3% | 14 | 18.7% | 10 | 20.8% |
2 | 4 | 7.8% | 2 | 5.4% | 10 | 13.3% | 6 | 12.5% |
≥3 | 2 | 3.9% | 2 | 5.4% | 2 | 2.7% | 5 | 10.4% |
SAE system organ class | ||||||||
Infections and infestations | 5 | 9.8% | 4 | 10.8% | 8 | 10.7% | 8 | 16.7% |
Gastrointestinal disorders | 4 | 7.8% | 2 | 5.4% | 1 | 1.3% | 4 | 8.3% |
Vascular disorders | 2 | 3.9% | 0 | 0.0% | 6 | 8.0% | 6 | 12.5% |
Cardiac disorders | 2 | 3.9% | 3 | 8.1% | 4 | 5.3% | 3 | 6.3% |
Musculoskeletal and connective tissue disorders | 1 | 2.0% | 0 | 0.0% | 2 | 2.7% | 4 | 8.3% |
General disorders and administrations site conditions | 2 | 3.9% | 1 | 2.7% | 3 | 4.0% | 1 | 2.1% |
Nervous system disorders | 1 | 2.0% | 3 | 8.1% | 2 | 2.7% | 1 | 2.1% |
Blood and lymphatic disorders | 1 | 2.0% | 0 | 0.0% | 4 | 5.3% | 1 | 2.1% |
Renal and urinary disorders | 0 | 0.0% | 3 | 8.1% | 0 | 0.0% | 0 | 0.0% |
Injury, poisoning and procedural complications | 2 | 3.9% | 1 | 2.7% | 1 | 1.3% | 1 | 2.1% |
Metabolism and nutrition disorders | 1 | 2.0% | 0 | 0.0% | 1 | 1.3% | 1 | 2.1% |
Respiratory, thoracic and mediastinal disorders | 0 | 0.0% | 1 | 2.7% | 1 | 1.3% | 2 | 4.2% |
Grade 5 AEs | 0 | 0.0% | 0 | 0.0% | 2a | 2.7% | 1a | 2.1% |
