SDC 3. Adverse Events and Grade 3 to 4 Laboratory Abnormalities According to Study
Group through Week 481
Tenofovir DF
Placebo Group
Group (N=45)
(N=42)
Adverse event – number (%)
45 (100.0)
40 (95.2)
Grade 2 to 4 adverse event – number (%)
32 (71.1)
21 (50.0)
Common Grade 2 to 4 adverse event2 –
number (%)
Diarrhea
2 (4.4)
0
Nausea
2 (4.4)
0
Vomiting
3 (6.7)
2 (4.8)
Gastritis
3 (6.7)
0
Jaundice
1 (2.2)
3 (7.1)
Oral herpes
2 (4.4)
1 (2.4)
Herpes zoster
0
2 (4.8)
Varicella
2 (4.4)
0
Pneumonia
2 (4.4)
2 (4.8)
Pneumocystis jiroveci pneumonia
2 (4.4)
0
Sinusitis
3 (6.7)
1 (2.4)
Acute sinusitis
1 (2.2)
2 (4.8)
Anorexia
2 (4.4)
0
3
Osteopenia
3 (6.7)
1 (2.4)
Dizziness
3 (6.7)
2 (4.8)
Adverse event related to study drug –
number (%)
Common adverse event related to study
drug2 – number (%)
Vomiting
Osteopenia3
12 (26.7)
6 (14.3)
4 (8.9)
3 (6.7)
0
1 (2.4)
Adverse event leading to permanent
discontinuation of study drug – number (%)
Vomiting
1 (2.2)
0
1 (2.2)
0
Serious adverse event – number (%)
Common serious adverse event2 – number
(%)
Pneumonia
Pneumocystis jiroveci pneumonia
Sinusitis
Serious adverse event related to study drug
10 (22.2)
3 (7.1)
3 (6.7)
2 (4.4)
2 (4.4)
0
1 (2.4)
0
0
0
Grade 3 or 4 laboratory abnormality –
number (%)
Absolute neutrophil count < 750 cells/mm3
Alanine aminotransferase > 5 x ULN
Calcium < 7.0 mg/dL
Creatine kinase > 10 x ULN
Total bilirubin > 2.5 x ULN
Fasting total cholesterol >300 mg/dL
1
7 (15.6)
0
1 (2.2)
0
4 (8.9)
0
2 (4.8)
1 (2.4)
0
1 (2.4)
4 (9.5)
1 (2.4)
Adverse event terms are from the Medical Dictionary for Regulatory Activities
(MedDRA), version 11.1. The laboratory-abnormality grade was assigned on the basis of
the 2004 Division of AIDS criteria (http://rsc.techres.com/Document/safetyandpharmacovigilance/Table_for_Grading_Severity_of_Adult_
Pediatric_Adverse_Events.pdf). ULN denotes upper limit of the normal range.
2
Common adverse events are defined as occurring in more than 3% in either group.
3
Osteopenia events include only those spontaneously reported by investigators. No
specific definition for osteopenia were used in the protocol or given to the investigators.