B. Number of Low-Grade AEs reported
|
System-Organ Class
|
Grade 1
|
Grade 2
|
Sum
|
|
Gastrointestinal disorders |
109 |
37 |
146 |
Investigations |
74 |
44 |
118 |
Blood and lymphatic system disorders |
38 |
27 |
65 |
General disorders and administration site conditions |
65 |
23 |
88 |
Skin and subcutaneous tissue disorders |
47 |
33 |
80 |
Metabolism and nutrition disorders |
54 |
16 |
70 |
Musculoskeletal and connective tissue disorders |
54 |
21 |
75 |
Nervous system disorders |
59 |
8 |
67 |
Respiratory, thoracic and mediastinal disorders |
33 |
10 |
43 |
Vascular disorders |
10 |
8 |
18 |
Infections and infestations |
12 |
11 |
23 |
Renal and urinary disorders |
14 |
11 |
25 |
Psychiatric disorders |
21 |
1 |
22 |
Reproductive system and breast disorders |
7 |
4 |
11 |
Eye disorders |
5 |
2 |
7 |
Ear and labyrinth disorders |
5 |
0 |
5 |
Injury, poisoning and procedural complications |
4 |
0 |
4 |
Immune system disorders |
1 |
3 |
4 |
Cardiac disorders |
4 |
0 |
4 |
|
ALL System-Organ Hasses |
616 |
259 |
875 |