Note: AEs are coded to body system /adverse reaction using MedDRA v15.1. A subject with multiple occurrences of an AE is counted only once in each AE category.
a All treatment-emergent AEs in at least 5% of patients in the Lenalidomide Maintenance group and at least 2% higher frequency (%) than the Placebo Maintenance group.
b All grade 3 or 4 treatment-emergent AEs in at least 1% of patients in the Lenalidomide Maintenance group and at least 1% higher frequency (%) than the Placebo Maintenance group.
c All serious treatment-emergent AEs in at least 1% of patients in the Lenalidomide Maintenance group and at least 1% higher frequency (%) than the Placebo Maintenance group.
d Footnote “a” not applicable for either study
e Footnote “b” not applicable for either study
@ -ADRs where at least one resulted in a fatal outcome
% - ADRs where at least one was considered to be Life Threatening (if the outcome of the event was death, it is included with death cases)
# - All adverse reactions under Body System of Infections and Infestation except for rare infections of Public Health interest will be considered listed
* Adverse Reactions for combined ADR terms (based on relevant TEAE PTs included in Maintenance Studies 1 and 2 [per MedDRA v 15.1]):
Pneumonias Bronchopneumonia,. Lobar pneumonia, Pneumocystis jiroveci pneumonia, Pneumonia, Pneumonia klebsiella, Pneumonia legionella, Pneumonia
mycoplasmal, Pneumonia pneumococcal, Pneumonia streptococcal, Pneumonia viral, Lung disorder, Pneumonitis
Sepsis: Bacterial sepsis, Pneumococcal sepsis, Sepsis, Septic shock, Staphylococcal sepsis
Peripheral neuropathy: Neuropathy peripheral, Peripheral motor neuropathy, Peripheral sensory neuropathy, Polyneuropathy
Deep vein thrombosis: Deep vein thrombosis, Thrombosis, Venous thrombosis 

Body System
Adverse Reaction Maintenance Study 1 Maintenance Study 2
All Adverse Reactions [a] Grade 3/4 Adverse Reactions [b] All Adverse Reactions [a] Grade 3/4 Adverse Reactions [b]
REVLIMID
(N=224)
n (%) Placebo
(N=221)
n (%) REVLIMID
(N=224)
n (%) Placebo
(N=221)
n (%) REVLIMID
(N=293)
n (%) Placebo
(N=280)
n (%) REVLIMID
(N=293)
n (%) Placebo
(N=280)
n (%)
Blood and lymphatic system disorders
Neutropenia c % 177 ( 79.0) 94 ( 42.5) 133 ( 59.4) 73 ( 33.0) 178 ( 60.8) 33 ( 11.8) 158 ( 53.9) 21 ( 7.5)
Thrombocytopenia c % 162 ( 72.3) 101 ( 45.7) 84 ( 37.5) 67 ( 30.3) 69 ( 23.5) 29 ( 10.4) 38 ( 13.0) 8 ( 2.9)
Leukopenia c 51 ( 22.8) 25 ( 11.3) 45 ( 20.1) 22 ( 10.0) 93 ( 31.7) 21 ( 7.5) 71 ( 24.2) 5 ( 1.8)
Anemia 47 ( 21.0) 27 ( 12.2) 23 ( 10.3) 18 ( 8.1) 26 ( 8.9) 15 ( 5.4) 11 ( 3.8) 3 ( 1.1)
Lymphopenia 40 ( 17.9) 29 ( 13.1) 37 ( 16.5) 26 ( 11.8) 13 ( 4.4) 3 ( 1.1) 11 ( 3.8) 2 ( 0.7)
Pancytopenia c d % 1 ( 0.4) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 12 ( 4.1) 1 ( 0.4) 7 ( 2.4) 1 ( 0.4)
Febrile neutropenia c 39 ( 17.4) 34 ( 15.4) 39 ( 17.4) 34 ( 15.4) 7 ( 2.4) 1 ( 0.4) 5 ( 1.7) 1 ( 0.4)
Infections and infestations#
Upper respiratory
tract infection e 60 ( 26.8) 35 ( 15.8) 7 ( 3.1) 9 ( 4.1) 32 ( 10.9) 18 ( 6.4) 1 ( 0.3) 0 ( 0.0)
Neutropenic infection 40 ( 17.9) 19 ( 8.6) 27 ( 12.1) 14 ( 6.3) 0 ( 0.0) 0 ( 0.0)  0 ( 0.0) 0 ( 0.0)
Pneumonias* c % 31 ( 13.8) 15 ( 6.8) 23 ( 10.3) 7 ( 3.2) 50 ( 17.1) 13 ( 4.6) 27 ( 9.2) 5 ( 1.8)
Bronchitis c 10 ( 4.5) 9 ( 4.1) 1 ( 0.4) 5 ( 2.3) 139 ( 47.4) 104 ( 37.1) 4 ( 1.4) 1 ( 0.4)
Nasopharyngitis e 5 ( 2.