|
|
253 |
104 |
|
Blood and Lymphatic System Disorders |
|
Anemia |
50 |
30 |
45 |
20 |
|
Neutropenia |
25 |
19 |
14 |
10 |
|
Gastrointestinal Disorders |
|
Nausea |
46 |
42 |
43 |
38 |
|
Dysgeusia |
35 |
16 |
44 |
11 |
|
Diarrhea |
25 |
22 |
24 |
16 |
|
Vomiting |
20 |
13 |
15 |
8 |
|
Dry Mouth |
11 |
10 |
15 |
9 |
|
General Disorders and Administration Site Conditions |
|
Fatigue |
58 |
59 |
55 |
50 |
|
Chills |
34 |
29 |
33 |
30 |
|
Asthenia |
15 |
18 |
21 |
16 |
|
Metabolism and Nutrition Disorders |
|
Decreased Appetite |
25 |
24 |
26 |
16 |
|
Musculoskeletal and Connective Tissue Disorders |
|
Arthralgia |
19 |
19 |
23 |
16 |
|
Nervous System Disorders |
|
Dizziness |
19 |
16 |
16 |
10 |
|
Psychiatric Disorders |
|
Insomnia |
34 |
34 |
30 |
24 |
|
Irritability |
22 |
23 |
21 |
13 |
|
Respiratory, Thoracic, and Mediastinal Disorders |
|
Dyspnea Exertional |
8 |
8 |
11 |
5 |
|
Skin and Subcutaneous Tissue Disorders |
|
Alopecia |
27 |
27 |
22 |
16 |
|
Dry Skin |
18 |
18 |
22 |
9 |
|
Rash |
17 |
19 |
16 |
6 |
Among subjects (previously untreated subjects or those who failed previous therapy) who received VICTRELIS in combination with peginterferon alfa and ribavirin, the following adverse drug reactions were reported. These events are notable because of their seriousness, severity, or increased frequency in subjects who received VICTRELIS in combination with peginterferon alfa and ribavirin compared with subjects who received only peginterferon alfa and ribavirin.
Dysgeusia (alteration of taste) was an adverse event reported at an increased frequency in subjects receiving VICTRELIS in combination with peginterferon alfa and ribavirin compared with subjects receiving peginterferon alfa and ribavirin alone (Table 3). Adverse events such as dry mouth, nausea, vomiting and diarrhea were also reported at an increased frequency in subjects receiving VICTRELIS in combination with peginterferon alfa and ribavirin.
