Descriptive analysis of OS data with a cutoff date of 1 February 2016 are provided in Table 14. Median follow-up time was 81.6 and 96.7 months for Maintenance Study 1 and Maintenance Study 2, respectively. Median OS was 111.0 and 84.2 months for REVLIMID and placebo, respectively, for Maintenance Study 1, and 105.9 and 88.1 months, for REVLIMID and placebo, respectively, for Maintenance Study 2.

Table 14: Progression-free Survival and Overall Survival from Randomization in Maintenance Studies 1 and 2 (ITT Post-Auto-HSCT Population)

Date of Unblinding in Maintenance Study 1 and 2 = 17 December 2009 and 7 July 2010, respectively
Auto-HSCT = autologous hematopoietic stem cell transplantation; CI = confidence interval;
ITT = intent to treat; NE = not estimable; PFS = progression-free survival
PFS at time of unblinding for Maintenance Study 2 was based on assessment by an Independent Review Committee. All other PFS analyses were based on assessment by investigator.
Note: The median is based on Kaplan-Meier estimate, with 95% CIs about the median overall PFS time. Hazard ratio is based on a proportional hazards model stratified by stratification factors comparing the hazard functions associated with treatment arms (lenalidomide:placebo). 

Maintenance Study 1 Maintenance Study 2
REVLIMID
N = 231 Placebo
N = 229 REVLIMID
N = 307 Placebo
N = 307
PFS at Unblinding        
PFS Events n (%)     
 46 (20) 98 (43) 103 (34)  160 (52) 
Median in months [95% CI] 33.9
[NE, NE]  19.0
[16.2, 25.6]  41.2
[38.3, NE]  23.0
[21.2, 28.0] 
Hazard Ratio
[95% CI]  0.38
[0.27, 0.54]  0.50
[0.39, 0.64] 
Log-rank Test p-value <0.001  <0.001 
PFS at Updated Analysis
1 March 2015 (Studies 1 and 2)      
PFS Events n (%)  97 (42)  116 (51)  191 (62)  248 (81) 
Median in months [95% CI]  68.6
 [52.8, NE]  22.5
 [18.8, 30.0]  46.3
[40.1, 56.6]  23.8
[21.0, 27.3] 
Hazard Ratio
[95% CI]  0.38
[0.28, 0.50]  0.53
 [0.44, 0.64] 
OS at Updated Analysis
1 Feb 2016 (Studies 1 and 2)   
OS Events n (%)  82 (35)  114 (50)  143 (47)  160 (52) 
Median in months [95% CI]  111.0
[101.8, NE]  84.2
[71.0, 102.7]  105.9
[88.8, NE]  88.1
[80.7, 108.4] 
Hazard Ratio
[95% CI]  0.59
[0.44, 0.78]  0.90
 [0.72, 1.13] 

Kaplan-Meier Curves of Progression-free Survival From Randomization (ITT Post-Auto-HSCT Population)
in Maintenance Study 1 Between REVLIMID and Placebo Arms (Updated Cutoff Date 1 March 2015)

Kaplan-Meier Curves of Progression-free Survival From Randomization (ITT Post-ASCT Population) in Maintenance Study 1

Auto-HSCT = autologous hematopoietic stem cell transplantation; CI = confidence interval; HR = hazard ratio; ITT = intent to treat; KM = Kaplan-Meier; PFS = progression-free survival; vs = versus

Kaplan-Meier Curves of Progression-free Survival From Randomization (ITT Post-Auto-HSCT Population)
in Maintenance Study 2 Between REVLIMID and Placebo Arms (Upda