REVLIMID ® [ lenalidomide ] capsules , for oral use | |||||||||
Table 5 : All Adverse Reactions in ≥5.0 % and Grade 3 / 4 Adverse Reactions in ≥ 1.0 % of Patients in the REVLIMID Vs Placebo Arms * | |||||||||
Maintenance Study 1 |
Maintenance Study 2 |
||||||||
Body System |
All Adverse Reactions [ a ] |
Grade 3 / 4 Adverse
Reactions [ b ]
|
All Adverse Reactions [ a ] |
Grade 3 / 4 Adverse
Reactions [ b ]
|
|||||
Adverse Reaction |
REVLIMID |
Placebo |
REVLIMID |
Placebo |
REVLIMID |
Placebo |
REVLIMID |
Placebo |
|
( N = 224 ) |
( N = 221 ) |
( N = 224 ) |
( N = 221 ) |
( N = 293 ) |
( N = 280 ) |
( N = 293 ) |
( N = 280 ) |
||
n (%) |
n (%) |
n (%) |
n (%) |
n (%) |
n (%) |
n (%) |
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 |
60 ( 26.8 ) |
35 ( 15.8 ) |
7 ( 3.1 ) |
9 ( 4.1 ) |
32 ( 10.9 ) |
18 ( 6.4 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
infection e
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 ( |
2.2 ) |
2 ( 0.9 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
102 ( 34.8 ) |
84 ( 30.0 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
Gastroenteritis c |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
66 ( 22.5 ) |
55 ( 19.6 ) |
6 ( 2.0 ) |
0 ( 0.0 ) |
|
Rhinitis e |
2 ( 0.9 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
44 ( 15.0 ) |
19 ( 6.8 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Sinusitis e |
8 ( 3.6 ) |
3 ( 1.4 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
41 ( 14.0 ) |
26 ( 9.3 ) |
0 ( 0.0 ) |
1 ( 0.4 ) |
|
Influenza c |
8 ( 3.6 ) |
5 ( 2.3 ) |
2 ( 0.9 ) |
1 ( 0.5 ) |
39 ( 13.3 ) |
19 ( 6.8 ) |
3 ( 1.0 ) |
0 ( 0.0 ) |
|
Lung infection c |
21 ( 9.4 ) |
2 ( 0.9 ) |
19 ( 8.5 ) |
2 ( 0.9 ) |
9 ( 3.1 ) |
4 ( 1.4 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
Lower respiratory tract |
13 ( 5.8 ) |
5 ( 2.3 ) |
6 ( 2.7 ) |
4 ( 1.8 ) |
4 ( 1.4 ) |
4 ( 1.4 ) |
0 ( 0.0 ) |
2 ( 0.7 ) |
|
infection e
Infection c
|
12 ( 5.4 ) |
6 ( 2.7 ) |
9 ( 4.0 ) |
5 ( 2.3 ) |
17 ( 5.8 ) |
5 ( 1.8 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Urinary tract infection c d e |
9 ( 4.0 ) |
5 ( 2.3 ) |
4 ( 1.8 ) |
4 ( 1.8 ) |
22 ( 7.5 ) |
17 ( 6.1 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
Lower respiratory tract |
6 ( 2.7 ) |
1 ( 0.5 ) |
4 ( 1.8 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
infection bacterial d
Bacteremia d
|
5 ( 2.2 ) |
0 ( 0.0 ) |
4 ( 1.8 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Herpes zoster c d |
11 ( 4.9 ) |
10 ( 4.5 ) |
3 ( 1.3 ) |
2 ( 0.9 ) |
29 ( 9.9 ) |
25 ( 8.9 ) |
6 ( 2.0 ) |
2 ( 0.7 ) |
|
Sepsis * c d @ |
2 ( 0.9 ) |
1 ( 0.5 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
6 ( 2.0 ) |
1 ( 0.4 ) |
4 ( 1.4 ) |
1 ( 0.4 ) |
|
Gastrointestinal disorders Diarrhea |
122 ( 54.5 ) |
83 ( 37.6 ) |
22 ( 9.8 ) |
17 ( 7.7 ) |
114 ( 38.9 ) |
34 ( 12.1 ) |
7 ( 2.4 ) |
0 ( 0.0 ) |
|
Nausea e |
33 ( 14.7 ) |
22 ( 10.0 ) |
16 ( 7.1 ) |
10 ( 4.5 ) |
31 ( 10.6 ) |
28 ( 10.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Vomiting |
17 ( 7.6 ) |
12 ( 5.4 ) |
8 ( 3.6 ) |
5 ( 2.3 ) |
16 ( 5.5 ) |
15 ( 5.4 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
Constipation e |
12 ( 5.4 ) |
8 ( 3.6 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
37 ( 12.6 ) |
25 ( 8.9 ) |
2 ( 0.7 ) |
0 ( 0.0 ) |
|
Abdominal pain e |
8 ( 3.6 ) |
7 ( 3.2 ) |
1 ( 0.4 ) |
4 ( 1.8 ) |
31 ( 10.6 ) |
15 ( 5.4 ) |
1 ( 0.3 ) |
1 ( 0.4 ) |
|
Abdominal pain upper e |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
20 ( 6.8 ) |
12 ( 4.3 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
General disorders and administration site conditions | |||||||||
Asthenia |
0 ( 0.0 ) |
1 ( 0.5 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
87 ( 29.7 ) |
53 ( 18.9 ) |
10 ( 3.4 ) |
2 ( 0.7 ) |
|
Fatigue |
51 ( 22.8 ) |
30 ( 13.6 ) |
21 ( 9.4 ) |
9 ( 4.1 ) |
31 ( 10.6 ) |
15 ( 5.4 ) |
3 ( 1.0 ) |
0 ( 0.0 ) |
|
Pyrexia e |
17 ( 7.6 ) |
10 ( 4.5 ) |
2 ( 0.9 ) |
2 ( 0.9 ) |
60 ( 20.5 ) |
26 ( 9.3 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
Skin and subcutaneous tissue disorders | |||||||||
Dry skin e |
9 ( 4.0 ) |
4 ( 1.8 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
31 ( 10.6 ) |
21 ( 7.5 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Rash |
71 ( 31.7 ) |
48 ( 21.7 ) |
11 ( 4.9 ) |
5 ( 2.3 ) |
22 ( 7.5 ) |
17 ( 6.1 ) |
3 ( 1.0 ) |
0 ( 0.0 ) |
|
Pruritus |
9 ( 4.0 ) |
4 ( 1.8 ) |
3 ( 1.3 ) |
0 ( 0.0 ) |
21 ( 7.2 ) |
25 ( 8.9 ) |
2 ( 0.7 ) |
0 ( 0.0 ) ( continued ) |