. Author manuscript; available in PMC: 2019 Mar 11.

Published in final edited form as: J Clin Oncol. 2016 Sep 30;35(1):124–125. doi: 10.1200/JCO.2016.69.7748

Table 1.

Overall Survival: 2016 Revised Analysis and 2010 Publication—Stratified for the ITT Population

Variable	Revised OS Analysis		Original OS Analysis
Variable	PROSTVAC-VF (n = 84)	Control (n = 41)	PROSTVAC-VF (n = 84)	Control (n = 41)
No. (%) of patients
Died (event)	57 (67.9)	33 (80.5)	67 (79.8)	38 (92.7)
Censored	27 (32.1)	8 (19.5)	17 (20.2)	3 (7.3)
OS, months^*
Median (95% CI)	26.2 (20.4 to 32.1)	16.3 (13.7 to 19.8)	25.1 (NR)	17.7 (NR)
Hazard ratio (95% CI)^†	0.4997 (0.3201 to 0.7801)		0.581 (0.384 to 0.880)
P^‡	.0019		.0095

NOTE. Patient 046–0030 (assigned to the PROSTVAC-VF group), who died as a result of a completed suicide before receiving any study treatment, was treated as an event, with OS of 0 months.

Abbreviations: ITT, intent-to-treat; NR, not reported; OS, overall survival.

Overall survival in months was calculated as (the date of death/censored − date of randomization + 1)/30.4375.

^†

Hazard ratio was from a Cox proportional hazards model stratified by bisphosphonate use (yes or no).

^‡

P value was from a stratified log-rank test stratified by bisphosphonate use (yes or no).