Table 2 Overview of TEAEs (safety population)

Any TEAE

86 (67.2)

41 (70.7)

Any treatment-emergent SAE

8 (6.3)

3 (5.2)

Any TEAE leading to death

0

0

Any TEAE leading to permanent treatment discontinuation

4 (3.1)

2 (3.4)

TEAEs occurring in ≥ 2% of individuals (preferred level term)^b

 Anemia

3 (2.3)

0

 Arthralgia

2 (1.6)

4 (6.9)

 Back pain

1 (0.8)

2 (3.4)

 Bronchitis

1 (0.8)

5 (8.6)

 Cellulitis

3 (2.3)

0

 Cough

1 (0.8)

3 (5.2)

 Diarrhea

6 (4.7)

4 (6.9)

 Dizziness

2 (1.6)

2 (3.4)

 Dyspnea

1 (0.8)

2 (3.4)

 Fall

3 (2.3)

2 (3.4)

 Fatigue

5 (3.9)

1 (1.7)

 Headache

2 (1.6)

3 (5.2)

 Hyperinsulinemic hypoglycemia

3 (2.3)

0

 Hypoglycemia

2 (1.6)

2 (3.4)

 Hypotension

1 (0.8)

2 (3.4)

 Influenza

6 (4.7)

2 (3.4)

 Injection-site bruising

3 (2.3)

0

 Injection-site pruritus

4 (3.1)

0

 Injection-site reaction

5 (3.9)

0

 Muscle spasms

3 (2.3)

1 (1.7)

 Musculoskeletal pain

4 (3.1)

2 (3.4)

 Myalgia

3 (2.3)

1 (1.7)

 Nausea

4 (3.1)

2 (3.4)

 Osteoarthritis

0

2 (3.4)

 Pain in extremity

1 (0.8)

2 (3.4)

 Sinusitis

1 (0.8)

2 (3.4)

 Type 2 diabetes mellitus

1 (0.8)

2 (3.4)

 Upper respiratory tract infection

5 (3.9)

2 (3.4)

 Urinary tract infection

11 (8.6)

2 (3.4)

 Viral upper respiratory tract infection

7 (5.5)

1 (1.7)

 Vitamin D deficiency

0

2 (3.4)