Table 5 Adverse events of grade ≥3 with an incidence of ≥3% and serious adverse events in >1 patient, safety population

Any grade ≥3 adverse event

64 (60.4%)

 Neutropenia

33 (31.1%)

 Leukopenia

14 (13 · 2%)

 Diarrhea

7 (6.6%)

 Anemia

6 (5.7%)

 Febrile neutropenia

6 (5.7%)

 Asthenia

5 (4.7%)

 Constipation

4 (3.8%)

 Fatigue

4 (3.8%)

Total number of serious adverse events

44

Number of patients with ≥1 serious adverse event

32 (30.2%)

 Febrile neutropenia

6 (5.7%)

 Hypersensitivity

5 (4.7%)

 Abdominal pain

2 (1.9%)

 Drug hypersensitivity

2 (1.9%)

 Pneumonia

2 (1.9%)

 Pyrexia

2 (1.9%)

 Septic shock

2 (1.9%)^a

Adverse events leading to death (grade 5)

2 (1.9%)^a–c