Summary of AEs and most common AEs (safety analysis set)
| . | MAGNOLIA study (N = 68) . |
|---|---|
| Any treatment-emergent AE | 68 (100.0) |
| Grade ≥3 AE | 33 (48.5) |
| Serious AE | 30 (44.1) |
| AE leading to dose reduction | 0 |
| AE leading to dose interruption | 25 (36.8) |
| AE leading to treatment discontinuation | 5 (7.4) |
| AE leading to death | 5 (7.4) |
| Any grade AE occurring in ≥10% of patients | |
| Contusion | 16 (23.5) |
| Diarrhea | 15 (22.1) |
| Constipation | 12 (17.6) |
| Arthralgia | 10 (14.7) |
| Pyrexia | 10 (14.7) |
| Upper respiratory tract infection | 9 (13.2) |
| Back pain | 8 (11.8) |
| Nausea | 7 (10.3) |
| Cough | 7 (10.3) |
| Grade ≥3 AEs occurring in at least 2 patients | |
| Neutropenia | 6 (8.8) |
| COVID-19 pneumonia | 4 (5.9) |
| Diarrhea | 3 (4.4) |
| Pneumonia | 3 (4.4) |
| Syncope | 3 (4.4) |
| Anemia | 2 (2.9) |
| Hypertension | 2 (2.9) |
| Neutrophil count decreased | 2 (2.9) |
| Pyrexia | 2 (2.9) |
| Thrombocytopenia | 2 (2.9) |
| . | MAGNOLIA study (N = 68) . |
|---|---|
| Any treatment-emergent AE | 68 (100.0) |
| Grade ≥3 AE | 33 (48.5) |
| Serious AE | 30 (44.1) |
| AE leading to dose reduction | 0 |
| AE leading to dose interruption | 25 (36.8) |
| AE leading to treatment discontinuation | 5 (7.4) |
| AE leading to death | 5 (7.4) |
| Any grade AE occurring in ≥10% of patients | |
| Contusion | 16 (23.5) |
| Diarrhea | 15 (22.1) |
| Constipation | 12 (17.6) |
| Arthralgia | 10 (14.7) |
| Pyrexia | 10 (14.7) |
| Upper respiratory tract infection | 9 (13.2) |
| Back pain | 8 (11.8) |
| Nausea | 7 (10.3) |
| Cough | 7 (10.3) |
| Grade ≥3 AEs occurring in at least 2 patients | |
| Neutropenia | 6 (8.8) |
| COVID-19 pneumonia | 4 (5.9) |
| Diarrhea | 3 (4.4) |
| Pneumonia | 3 (4.4) |
| Syncope | 3 (4.4) |
| Anemia | 2 (2.9) |
| Hypertension | 2 (2.9) |
| Neutrophil count decreased | 2 (2.9) |
| Pyrexia | 2 (2.9) |
| Thrombocytopenia | 2 (2.9) |
Most common AEs are any grade AEs occurring in >10% of patients and grade ≥3 AEs occurring in at least 2 patients.
Data are n (%).