Summary of AEs in either treatment arm
| Event, n (%) [no. of reported AEs], unless otherwise stated . | SoC+ECP (n = 29) . | SoC (n = 31) . | Total (n = 60) . |
|---|---|---|---|
| Any AE | 28 (96.6) [223] | 28 (90.3) [316] | 56 (93.3) [539] |
| Any TEAE | 28 (96.6) [223] | 28 (90.3) [316] | 56 (93.3) [539] |
| TEAEs occurring in ≥10% of patients,*n (%) | |||
| Hypertension | 9 (31.0) | 4 (12.9) | 13 (21.7) |
| Cough | 6 (20.7) | 1 (3.2) | 7 (11.7) |
| Dyspnea | 5 (17.2) | 2 (6.5) | 7 (11.7) |
| Fatigue | 5 (17.2) | 1 (3.2) | 6 (10.0) |
| Hyperglycemia | 4 (13.8) | 4 (12.9) | 8 (13.3) |
| Increase of γ-glutamyltransferase | 4 (13.8) | 3 (9.7) | 7 (11.7) |
| Dizziness | 4 (13.8) | 2 (6.5) | 6 (10.0) |
| Decrease of platelet count | 3 (10.3) | 2 (6.5) | 5 (8.3) |
| Increase of blood cholesterol | 3 (10.3) | 1 (3.2) | 4 (6.7) |
| Hypertriglyceridemia | 3 (10.3) | 1 (3.2) | 4 (6.7) |
| Hypokalemia | 3 (10.3) | 1 (3.2) | 4 (6.7) |
| Dry mouth | 3 (10.3) | 0 | 3 (5.0) |
| Back pain | 2 (6.9) | 5 (16.1) | 7 (11.7) |
| Muscle spasms | 2 (6.9) | 4 (12.9) | 6 (10.0) |
| Peripheral edema | 2 (6.9) | 4 (12.9) | 6 (10.0) |
| Thrombocytopenia | 2 (6.9) | 4 (12.9) | 6 (10.0) |
| Diarrhea | 1 (3.4) | 4 (12.9) | 5 (8.3) |
| Pyrexia | 0 | 4 (12.9) | 4 (6.7) |
| Any treatment-related AE | 21 (72.4) [54] | 20 (64.5) [71] | 41 (68.3) [125] |
| Severe AE | 10 (34.5) [16] | 11 (35.5) [26] | 21 (35.0) [42] |
| Serious AE | 8 (27.6) [18] | 9 (29.0) [17] | 17 (28.3) [35] |
| Treatment-related SAE, n (%) | 6 (20.7) | 7 (22.6) | 13 (21.7) |
| Patients with any treatment-related SAEs leading to withdrawal,† n (%) | 6 (20.7) | 6 (19.4) | 12 (20.0) |
| Infections and infestations | 5 (17.2) | 2 (6.5) | 7 (11.7) |
| Respiratory, thoracic, and mediastinal disorders | 3 (10.3) | 0 | 3 (5.0) |
| Metabolism and nutrition disorders | 1 (3.4) | 1 (3.2) | 2 (3.3) |
| Musculoskeletal and connective tissue disorders | 0 | 2 (6.5) | 2 (3.3) |
| Psychiatric disorders | 0 | 1 (3.2) | 1 (1.7) |
| Life-threatening AE | 6 (20.7) [8] | 2 (6.5) [2] | 8 (13.3) [10] |
| Death | 4 (13.8) [4] | 0 | 4 (6.7) [4] |
| Event, n (%) [no. of reported AEs], unless otherwise stated . | SoC+ECP (n = 29) . | SoC (n = 31) . | Total (n = 60) . |
|---|---|---|---|
| Any AE | 28 (96.6) [223] | 28 (90.3) [316] | 56 (93.3) [539] |
| Any TEAE | 28 (96.6) [223] | 28 (90.3) [316] | 56 (93.3) [539] |
| TEAEs occurring in ≥10% of patients,*n (%) | |||
| Hypertension | 9 (31.0) | 4 (12.9) | 13 (21.7) |
| Cough | 6 (20.7) | 1 (3.2) | 7 (11.7) |
| Dyspnea | 5 (17.2) | 2 (6.5) | 7 (11.7) |
| Fatigue | 5 (17.2) | 1 (3.2) | 6 (10.0) |
| Hyperglycemia | 4 (13.8) | 4 (12.9) | 8 (13.3) |
| Increase of γ-glutamyltransferase | 4 (13.8) | 3 (9.7) | 7 (11.7) |
| Dizziness | 4 (13.8) | 2 (6.5) | 6 (10.0) |
| Decrease of platelet count | 3 (10.3) | 2 (6.5) | 5 (8.3) |
| Increase of blood cholesterol | 3 (10.3) | 1 (3.2) | 4 (6.7) |
| Hypertriglyceridemia | 3 (10.3) | 1 (3.2) | 4 (6.7) |
| Hypokalemia | 3 (10.3) | 1 (3.2) | 4 (6.7) |
| Dry mouth | 3 (10.3) | 0 | 3 (5.0) |
| Back pain | 2 (6.9) | 5 (16.1) | 7 (11.7) |
| Muscle spasms | 2 (6.9) | 4 (12.9) | 6 (10.0) |
| Peripheral edema | 2 (6.9) | 4 (12.9) | 6 (10.0) |
| Thrombocytopenia | 2 (6.9) | 4 (12.9) | 6 (10.0) |
| Diarrhea | 1 (3.4) | 4 (12.9) | 5 (8.3) |
| Pyrexia | 0 | 4 (12.9) | 4 (6.7) |
| Any treatment-related AE | 21 (72.4) [54] | 20 (64.5) [71] | 41 (68.3) [125] |
| Severe AE | 10 (34.5) [16] | 11 (35.5) [26] | 21 (35.0) [42] |
| Serious AE | 8 (27.6) [18] | 9 (29.0) [17] | 17 (28.3) [35] |
| Treatment-related SAE, n (%) | 6 (20.7) | 7 (22.6) | 13 (21.7) |
| Patients with any treatment-related SAEs leading to withdrawal,† n (%) | 6 (20.7) | 6 (19.4) | 12 (20.0) |
| Infections and infestations | 5 (17.2) | 2 (6.5) | 7 (11.7) |
| Respiratory, thoracic, and mediastinal disorders | 3 (10.3) | 0 | 3 (5.0) |
| Metabolism and nutrition disorders | 1 (3.4) | 1 (3.2) | 2 (3.3) |
| Musculoskeletal and connective tissue disorders | 0 | 2 (6.5) | 2 (3.3) |
| Psychiatric disorders | 0 | 1 (3.2) | 1 (1.7) |
| Life-threatening AE | 6 (20.7) [8] | 2 (6.5) [2] | 8 (13.3) [10] |
| Death | 4 (13.8) [4] | 0 | 4 (6.7) [4] |
Data are reported for the safety population. AEs and SAEs were categorized using MedDRA version 16.0. TEAEs were defined as AEs that started after study drug administration on day 1, or reemerged or worsened during treatment. SAEs were defined as any untoward medical occurrence that, at any dose, is life-threatening, requires or prolongs in-patient hospitalization, or results in a persistent or significant disability, congenital anomaly or birth defect, an important medical event, or death.
TEAEs reported by MedDRA Preferred Term, where ≥10% of patients in either the SoC+ECP or the SoC group reported the TEAE (indented values).
SAEs leading to withdrawal are reported by MedDRA System Organ Class (indented values).