Table 3 Summary of adverse events during week 0–24 (early TEAEs)

At least one below

11

4 (50.0%)

40

15 (88.2%)

41

14 (82.4%)

25

11 (73.3%)

117

44 (77.2%)

Cardiac disorders

1

1 (12.5%)

0

0 (0.0%)

1

1 (5.9%)

0

0 (0.0%)

2

2 (3.5%)

Eye disorders

1

1 (12.5%)

2

2 (11.8%)

0

0 (0.0%)

0

0 (0.0%)

3

3 (5.3%)

Gastrointestinal disorders

1

1 (12.5%)

3

2 (11.8%)

4

3 (17.6%)

1

1 (6.7%)

9

7 (12.3%)

General disorders and administration site conditions

1

1 (12.5%)

4

3 (17.6%)

7

7 (41.2%)

7

6 (40.0%)

19

17 (29.8%)

Hepatobiliary disorders

0

0 (0.0%)

0

0 (0.0%)

1

1 (5.9%)

0

0 (0.0%)

1

1 (1.8%)

Infections and infestations

1

1 (12.5%)

6

6 (35.3%)

3

2 (11.8%)

4

3 (20.0%)

14

12 (21.1%)

Injury, poisoning, and procedural complications

0

0 (0.0%)

2

1 (5.9%)

1

1 (5.9%)

0

0 (0.0%)

3

2 (3.5%)

Investigations

0

0 (0.0%)

0

0 (0.0%)

1

1 (5.9%)

0

0 (0.0%)

1

1 (1.8%)

Metabolism and nutrition disorders

0

0 (0.0%)

2

1 (5.9%)

0

0 (0.0%)

0

0 (0.0%)

2

1 (1.8%)

Musculoskeletal and connective tissue disorders

5

2 (25.0%)

15

6 (35.3%)

13

10 (58.8%)

11

5 (33.3%)

44

23 (40.4%)

Neoplasms benign, malignant, and unspecified (including cysts and polyps)

0

0 (0.0%)

2

2 (11.8%)

1

1 (5.9%)

0

0 (0.0%)

3

3 (5.3%)

Nervous system disorders

1

1 (12.5%)

1

1 (5.9%)

2

2 (11.8%)

1

1 (6.7%)

5

5 (8.8%)

Psychiatric disorders

0

0 (0.0%)

0

0 (0.0%)

1

1 (5.9%)

0

0 (0.0%)

1

1 (1.8%)

Renal and urinary disorders

0

0 (0.0%)

0

0 (0.0%)

1

1 (5.9%)

0

0 (0.0%)

1

1 (1.8%)

Respiratory, thoracic, and mediastinal disorders

0

0 (0.0%)

1

1 (5.9%)

2

2 (11.8%)

1

1 (6.7%)

4

4 (7.0%)

Skin and subcutaneous tissue disorders

0

0 (0.0%)

1

1 (5.9%)

1

1 (5.9%)

0

0 (0.0%)

2

2 (3.5%)

Surgical and medical procedures

0

0 (0.0%)

1

1 (5.9%)

2

1 (5.9%)

0

0 (0.0%)

3

2 (3.5%)