Table 5 Placebo-controlled period summary of treatment-emergent adverse events (APTS)

Patients with TEAEs, n (%)

34 (34.0)

38 (40.9)

 Total number of TEAEs

59

74

TEAEs occurring in ≥ 2% of patients, n (%)

15 (15.0)

18 (19.4)

 Upper respiratory tract infection

2 (2.0)

3 (3.2)

 Dermatitis atopic

0 (0)

2 (2.2)

 Diarrhea

1 (1.0)

2 (2.2)

 Dizziness

2 (2.0)

2 (2.2)

 Glycosylated haemoglobin increased

1 (1.0)

2 (2.2)

 Muscle spasms

0 (0.0)

2 (2.2)

 Nasopharyngitis

0 (0.0)

2 (2.2)

 Nausea

2 (2.0)

2 (2.2)

 Proteinuria

0 (0.0)

2 (2.2)

 Urinary tract infection

1 (1.0)

2 (2.2)

 Influenza-like illness

2 (2.0)

1 (1.1)

 Fatigue

4 (4.0)

0 (0.0)

 Urinary tract infection, bacterial

4 (4.0)

0 (0.0)

Patients with SAEs, n (%)

0 (0.0)

2 (2.2)

 Total number of SAEs

0

2

Patients with TEAEs leading to infusion interruption/termination, n (%)

0 (0.0)

0 (0.0)

 Total number of TEAEs leading to study drug infusion interruption/termination

0

0

Patients with TEAEs leading to withdrawal, n (%)

1 (1.0%)

2 (2.2%)

 Total number of TEAEs leading to withdrawal

1

2

Deaths, n (%)

0 (0.0)

0 (0.0)