|
eactions of moderate to severe intensity (Grades 2 - 4) in at least 2% of treatment-experienced subjects in either treatment group are summarized in Table 2 below.
Table 2 Adverse Reactions Reported in Randomized, Controlled Clinical Trials (1182.12 and 1182.48) Based on Treatment-Emergent Clinical Adverse Reactions of Moderate to Severe Intensity (Grades 2 - 4) in at least 2% of Treatment-Experienced Subjects in either Treatment Groupa (48-week Analyses)
|
|
Percentage of patients (rate per 100 patient-exposure years) |
|
|
APTIVUS/ritonavir (500/200 mg
BID) + OBRc
(n=749; 757.4 patient-exposure years) |
Comparator PI/ritonavirb + OBR
(n=737; 503.9 patient-exposure years) |
|
a Excludes laboratory abnormalities that were Adverse Events |
|
b Comparator PI/ritonavir: lopinavir/ritonavir 400/100 mg BID, indinavir/ritonavir 800/100 mg BID, saquinavir/ritonavir 1000/100 mg BID, amprenavir/ritonavir 600/100 mg BID |
|
c Optimized Background Regimen |
|
Blood and Lymphatic Disorders |
|
Anemia |
3.3% (3.4) |
2.3% (3.4) |
|
Neutropenia |
2.0% (2.0) |
1.0% (1.4) |
|
Gastrointestinal Disorders |
|
Diarrhea |
15.0% (16.5) |
13.4% (21.6) |
|
Nausea |
8.5% (9.0) |
6.4% (9.7) |
|
Vomiting |
5.9% (6.0) |
4.1% (6.1) |
|
Abdominal pain |
4.4% (4.5) |
3.4% (5.1) |
|
Abdominal pain upper |
1.5% (1.5) |
2.3% (3.4) |
|
General Disorders |
|
Pyrexia |
7.5% (7.7) |
5.4% (8.2) |
|
Fatigue |
5.7% (5.9) |
5.6% (8.4) |
|
Investigations |
|
Weight decreased |
3.1% (3.1) |
2.2% (3.2) |
|
ALT increased |
2.0% (2.0) |
0.5% (0.8) |
|
GGT increased |
2.0% (2.0) |
0.4% (0.6) |
|
Metabolism and Nutrition Disorders |
|
Hypertriglyceridemia |
3.9% (4.0) |
2.0% (3.0) |
|
Hyperlipidemia |
2.5% (2.6) |
0.8% (1.2) |
|
Dehydration |
2.1% (2.1) |
1.1% (1.6) |
|
Musculoskeletal and Connective Tissue Disorders |
|
Myalgia |
2.3% (2.3) |
1.8% (2.6) |
|
Nervous System Disorders |
|
Headache |
5.2% (5.3) |
4.2% (6.3) |
|
Peripheral neuropathy |
1.5% (1.5) |
2.0% (3.0) |
|
Psychiatric Disorders |
|
Inso |
|
