Table 2.

Safety summary of the open-label period

Parameter	By initial treatment assignment		All (N = 585)
	TDF–TDF (n = 389)	ADV–TDF (n = 196)
Deaths [n (%)]	9a (2.3)	3b (1.5)	12 (2.1)
Study drug-related AE leading to drug discontinuation [n (%)]	2 (0.5)	1 (0.5)	3 (0.5)
Study drug-related serious AE [n (%)]	5 (1.3)	2 (1.0)	7 (1.2)
Study drug–related grade 3 or 4 AE [n (%)]	3 (0.8)	3 (1.5)	6 (1.0)
Renal impairmentc,d [n (%)]
Serum creatinine ≥ 0.5 mg/dL above baseline	6 (1.5)	4 (2.0)	10 (1.7)
Serum phosphate < 2 mg/dL	5 (1.3)	4 (2.0)	9 (1.5)
Creatinine clearance < 50 mL/min	3 (0.8)	3 (1.5)	6 (1.0)

ADV adefovir dipivoxil, AE adverse event, SD standard deviation, TDF tenofovir disoproxil fumarate

^aCauses of death included motor vehicle accident (n = 2), hepatocellular carcinoma (n = 2), liver cancer, lung cancer (n = 2), nasopharyngeal carcinoma, and unknown cause

^bCauses of death included cervical cancer with pulmonary metastases, hepatocellular carcinoma, and multifocal carcinoma

^cEach parameter was confirmed on retest

^dA given patient may have had more than one event of renal impairment; 21 patients had 25 confirmed renal events