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 (%) |
||
Nervous system disorders
Paresthesia e
|
2 ( 0.9 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
39 ( 13.3 ) |
30 ( 10.7 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
Peripheral neuropathy * e |
34 ( 15.2 ) |
30 ( 13.6 ) |
8 ( 3.6 ) |
8 ( 3.6 ) |
29 ( 9.9 ) |
15 ( 5.4 ) |
4 ( 1.4 ) |
2 ( 0.7 ) |
|
Headache d |
11 ( 4.9 ) |
8 ( 3.6 ) |
5 ( 2.2 ) |
1 ( 0.5 ) |
25 ( 8.5 ) |
21 ( 7.5 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Investigations Alanine aminotransferase |
16 ( 7.1 ) |
3 ( 1.4 ) |
8 ( 3.6 ) |
0 ( 0.0 ) |
5 ( 1.7 ) |
5 ( 1.8 ) |
0 ( 0.0 ) |
1 ( 0.4 ) |
|
increased Aspartate aminotransferase |
13 ( 5.8 ) |
5 ( 2.3 ) |
6 ( 2.7 ) |
0 ( 0.0 ) |
2 ( 0.7 ) |
5 ( 1.8 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
increased d
Metabolism and nutrition disorders Hypokalemia
|
24 ( 10.7 ) |
13 ( 5.9 ) |
16 ( 7.1 ) |
12 ( 5.4 ) |
12 ( 4.1 ) |
1 ( 0.4 ) |
2 ( 0.7 ) |
0 ( 0.0 ) |
|
Dehydration |
9 ( 4.0 ) |
5 ( 2.3 ) |
7 ( 3.1 ) |
3 ( 1.4 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Hypophosphatemia d |
16 ( 7.1 ) |
15 ( 6.8 ) |
13 ( 5.8 ) |
14 ( 6.3 ) |
0 ( 0.0 ) |
1 ( 0.4 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Musculoskeletal and connective tissue disorders | |||||||||
Muscle spasms e |
0 ( 0.0 ) |
1 ( 0.5 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
98 ( 33.4 ) |
43 ( 15.4 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
Myalgia e |
7 ( 3.1 ) |
8 ( 3.6 ) |
3 ( 1.3 ) |
5 ( 2.3 ) |
19 ( 6.5 ) |
12 ( 4.3 ) |
2 ( 0.7 ) |
1 ( 0.4 ) |
|
Musculoskeletal pain e |
1 ( 0.4 ) |
1 ( 0.5 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
19 ( 6.5 ) |
11 ( 3.9 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Hepatobiliary disorders
Hyperbilirubinemia e
|
34 ( 15.2 ) |
19 ( 8.6 ) |
4 ( 1.8 ) |
2 ( 0.9 ) |
4 ( 1.4 ) |
1 ( 0.4 ) |
2 ( 0.7 ) |
0 ( 0.0 ) |
|
Respiratory , thoracic and mediastinal disorders | |||||||||
Cough e |
23 ( 10.3 ) |
12 ( 5.4 ) |
3 ( 1.3 ) |
1 ( 0.5 ) |
80 ( 27.3 ) |
56 ( 20.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Dyspnea c e |
15 ( 6.7 ) |
9 ( 4.1 ) |
8 ( 3.6 ) |
4 ( 1.8 ) |
17 ( 5.8 ) |
9 ( 3.2 ) |
2 ( 0.7 ) |
0 ( 0.0 ) |
|
Rhinorrhea e |
0 ( 0.0 ) |
3 ( 1.4 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
15 ( 5.1 ) |
6 ( 2.1 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
|
Pulmonary embolism c d e |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
0 ( 0.0 ) |
3 ( 1.0 ) |
0 ( 0.0 ) |
2 ( 0.7 ) |
0 ( 0.0 ) |
|
Vascular disorders Deep vein thrombosis * c d % |
8 ( 3.6 ) |
2 ( 0.9 ) |
5 ( 2.2 ) |
2 ( 0.9 ) |
7 ( 2.4 ) |
1 ( 0.4 ) |
4 ( 1.4 ) |
1 ( 0.4 ) |
|
Neoplasms benign , malignant and unspecified ( incl cysts and polyps ) | |||||||||
Myelodysplastic syndrome c d e |
5 ( 2.2 ) |
0 ( 0.0 ) |
2 ( 0.9 ) |
0 ( 0.0 ) |
3 ( 1.0 ) |
0 ( 0.0 ) |
1 ( 0.3 ) |
0 ( 0.0 ) |
|
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 |