|
Total adverse events
|
457.6 (414.1–505.7)
|
346.9 (325.4–369.8)
|
< 0.001
|
373.2 (353.6–393.8)
|
|
Serious adverse events
|
35.7 (24.9–51.0)
|
43.2 (36.1–51.8)
|
0.347
|
41.4 (35.2–48.7)
|
|
Fatal adverse events
|
1.2 (0.2–8.4)
|
–
|
0.999
|
0.3 (0.0–2.0)
|
|
By system/organ class
|
|
Infections and infestations
|
253.2 (221.4–289.6)
|
136.0 (122.8–150.6)
|
< 0.001
|
163.8 (151–177.6)
|
|
Gastrointestinal disorders
|
30.9 (21.0–45.4)
|
18.1 (13.7–24.0)
|
0.028
|
21.1 (16.9–26.5)
|
|
Skin and subcutaneous tissue disorders
|
17.8 (10.7–29.6)
|
21.1 (16.2–27.3)
|
0.797
|
20.3 (16.1–25.6)
|
|
General disorders and administration site conditions
|
21.4 (13.5–34.0)
|
20.0 (15.3–26.0)
|
0.566
|
20.3 (16.1–25.6)
|
|
Eye disorders
|
23.8 (15.3–36.8)
|
13.3 (9.6–18.4)
|
0.037
|
15.8 (12.1–20.5)
|
|
Musculoskeletal and connective tissue disorders
|
11.9 (6.4–22.1)
|
11.8 (8.4–16.7)
|
0.988
|
11.8 (8.7–16)
|
|
Surgical and medical procedures
|
3.6 (1.2–11.1)
|
13.7 (9.9–18.9)
|
0.025
|
11.3 (8.3–15.4)
|
|
Nervous system disorders
|
10.7 (5.6–20.6)
|
11.5 (8.1–16.3)
|
0.857
|
11.3 (8.3–15.4)
|
|
Blood and lymphatic system disorders
|
10.7 (5.6–20.6)
|
8.9 (5.9–13.2)
|
0.631
|
9.3 (6.6–13.1)
|
|
Renal and urinary disorders
|
3.6 (1.2–11.1)
|
11.1 (7.7–15.9)
|
0.061
|
9.3 (6.6–13.1)
|
|
Reproductive system and breast disorders
|
4.8 (1.8–12.7)
|
9.6 (6.5–14.1)
|
0.190
|
8.5 (5.9–12.1)
|
|
Injury, poisoning, and procedural complications
|
8.3 (4.0–17.5)
|
8.1 (5.4–12.3)
|
0.957
|
8.2 (5.7–11.8)
|
|
Respiratory, thoracic, and mediastinal disorders
|
11.9 (6.4–22.1)
|
5.9 (3.6–9.6)
|
0.083
|
7.3 (5–10.8)
|
|
Neoplasms: benign, malignant, and unspecified (including cysts and polyps)
|
3.6 (1.2–11.1)
|
5.9 (3.6–9.6)
|
0.422
|
5.4 (3.4–8.4)
|
|
Hepatobiliary disorders
|
2.4 (0.6–9.5)
|
5.9 (3.6–9.6)
|
0.225
|
5.1 (3.2–8.1)
|
|
Metabolism and nutrition disorders
|
1.2 (0.2–8.4)
|
5.9 (3.6–9.6)
|
0.120
|
4.8 (3–7.7)
|
|
Pregnancy, puerperium, and perinatal conditions
|
0.0
|
5.5 (3.3–9.2)
|
0.997
|
4.2 (2.5–7)
|
|
Vascular disorders
|
1.2 (0.2–8.4)
|
4.8 (2.8–8.3)
|
0.178
|
3.9 (2.3–6.7)
|
|
Psychiatric disorders
|
5.9 (2.5–14.3)
|
3.3 (1.7–6.4)
|
0.298
|
3.9 (2.3–6.7)
|
|
Ear and labyrinth disorders
|
2.4 (0.6–9.5)
|
3.0 (1.5–5.9)
|
0.783
|
2.8 (1.5–5.2)
|
|
Immune system disorders
|
2.4 (0.6–9.5)
|
2.6 (1.2–5.4)
|
0.916
|
2.5 (1.3–4.9)
|
|
Cardiac disorders
|
3.6 (1.2–11.1)
|
1.8 (0.8–4.4)
|
0.368
|
2.3 (1.1–4.5)
|
|
Endocrine disorders
|
2.4 (0.6–9.5)
|
1.5 (0.6–3.9)
|
0.583
|
1.7 (0.8–3.8)
|
|
Congenital, familial, and genetic disorders
|
0.0
|
1.8 (0.8–4.4)
|
0.403
|
1.4 (0.6–3.4)
|
