Table 5.
Adverse Events and Laboratory Abnormalities by Gender and Race, n (%)
| Male (n=109) | Female (n=97) | |||
|---|---|---|---|---|
| Black (N=70) | Nonblack (N=39) | Black (N=83) | Nonblack (N=14) | |
| Clinical adverse events (AEs) | 52 (74.3) | 30 (76.9) | 55 (66.3) | 12 (85.7) |
| Drug-relateda AE | 5 (7.1) | 4 (10.3) | 16 (19.3) | 1 (7.1) |
| Serious AE | 9 (12.9) | 3 (7.7) | 7 (8.4) | 2 (14.3) |
| Serious and drug-relateda AE | 1 (1.4) | 0 | 3 (3.6) | 0 |
| Discontinued due to AE | 1 (1.4) | 0 | 3 (3.6) | 1b (7.1) |
| Most common drug-relateda clinical AEs | ||||
| Abdominal discomfort | 0 | 0 | 2 (2.4) | 0 |
| Diarrhea | 1 (1.4) | 1 (2.6) | 2 (2.4) | 0 |
| Nausea | 2 (2.9) | 2 (5.1) | 4 (4.8) | 0 |
| Vomiting | 1 (1.4) | 1 (2.6) | 2 (2.4) | 0 |
| Myalgia | 0 | 0 | 2 (2.4) | 0 |
| Headache | 1 (1.4) | 0 | 2 (2.4) | 0 |
| Laboratory AEs | 5 (7.1) | 6 (15.4) | 11 (13.3) | 1 (7.1) |
| Drug-relateda AE | 2 (2.9) | 1 (2.6) | 1 (1.2) | 0 |
| Discontinued due to AE | 0 | 0 | 1 (1.2) | 0 |
| Laboratory abnormalities, grade 2 and higher | ||||
| Absolute neutrophil count | 8/70 (11.4) | 0 | 5/81 (6.2) | 1/13 (7.7) |
| Hemoglobin | 0 | 0 | 1/81 (1.2) | 1/13 (7.7) |
| Platelet count | 0 | 1/39 (2.6) | 0 | 0 |
| Fasting LDL cholesterol | 6/56 (10.7) | 1/27 (3.7) | 7/65 (10.8) | 0 |
| Fasting total cholesterol | 8/58 (13.8) | 5/29 (17.2) | 9/69 (13.0) | 1/11 (9.1) |
| Fasting triglycerides | 2/58 (3.4) | 2/29 (6.9) | 2/69 (2.9) | 0 |
| Fasting glucose | 6/59 (10.2) | 1/29 (3.4) | 6/67 (9.0) | 1/12 (8.3) |
| Total bilirubin | 6/70 (8.6) | 3/39 (7.7) | 4/81 (4.9) | 2/13 (15.4) |
| Serum creatinine | 1/70 (1.4) | 1/39 (2.6) | 3/81 (3.7) | 1/13 (7.7) |
| Aspartate aminotransferase | 2/70 (2.9) | 4/39 (10.3) | 2/81 (2.5) | 0 |
| Alanine aminotransferase | 1/70 (1.4) | 4/39 (10.3) | 3/81 (3.7) | 0 |
| Alkaline phosphatase | 0 | 0 | 2/81 (2.5) | 0 |
| Creatine kinase | 8/70 (11.4) | 3/39 (7.7) | 0 | 0 |
a
Determined by investigator to be possibly, probably, or definitely related to raltegravir alone or in combination with background ART.
b
This patient discontinued due to an adverse event in the poststudy period.