|
|
5 (0.3%) |
|
Cardiac Failure |
9 (0.5%) |
4 (0.2%) |
|
Cardiac Disorder |
5 (0.3%) |
0 (0%) |
|
Ventricular Dysfunction |
4 (0.2%) |
0 (0%) |
Respiratory Thoracic Mediastinal Disorders |
|
Cough |
81 (5%) |
34 (2%) |
|
Influenza |
70 (4%) |
9 (0.5%) |
|
Dyspnea |
57 (3%) |
26 (2%) |
|
URI |
46 (3%) |
20 (1%) |
|
Rhinitis |
36 (2%) |
6 (0.4%) |
|
Pharyngolaryngeal Pain |
32 (2%) |
8 (0.5%) |
|
Sinusitis |
26 (2%) |
5 (0.3%) |
|
Epistaxis |
25 (2%) |
1 (0.06%) |
|
Pulmonary Hypertension |
4 (0.2%) |
0 (0%) |
|
Interstitial Pneumonitis |
4 (0.2%) |
0 (0%) |
Gastrointestinal Disorders |
|
Diarrhea |
123 (7%) |
16 (1%) |
|
Nausea |
108 (6%) |
19 (1%) |
|
Vomiting |
58 (3.5%) |
10 (0.6%) |
|
Constipation |
33 (2%) |
17 (1%) |
|
Dyspepsia |
30 (2%) |
9 (0.5%) |
|
Upper Abdominal Pain |
29 (2%) |
15 (1%) |
Musculoskeletal & Connective Tissue Disorders |
|
Arthralgia |
137 (8%) |
98 (6%) |
|
Back Pain |
91 (5%) |
58 (3%) |
|
Myalgia |
63 (4%) |
17 (1%) |
|
Bone Pain |
49 (3%) |
26 (2%) |
|
Muscle Spasm |
46 (3%) |
3 (0.2%) |
Nervous System Disorders |
|
Headache |
162 (10%) |
49 (3%) |
|
Paraesthesia |
29 (2%) |
11 (0.6%) |
Skin & Subcutaneous Tissue Disorders |
|
Rash |
70 (4%) |
10 (0.6%) |
|
Nail Disorders |
43 (2%) |
0 (0%) |
|
Pruritis |
40 (2%) |
10 (0.6%) |
General disorders |
|
Pyrexia |
100 (6%) |
6 (0.4%) |
|
Edema Peripheral |
79 (5%) |
37 (2%) |
|
Chills |
85 (5%) |
0 (0%) |
|
Aesthenia |
75 (4.5%) |
30 (2%) |
|
Influenza‑like Illness |
40 (2%) |
3 (0.2%) |
|
Sudden Death |
1 (0.06%) |
0 (0%) |
Infections |
|
Nasopharyngitis |
135 (8%) |
43 (3%) |
|
UTI |
39 (3%) |
13 (0.8%) |
Immune System Disorders |
|
Hypersensitivity |
10 (0.6%) |
1 (0.06%) |
|
Autoimmune Thyroiditis |
4 (0.3%) |
0 (0%) |
