Table 11 summarizes the most frequently observed adverse reactions regardless of relationship to treatment with REVLIMID. Across the 134 patients treated in this study, median duration of treatment was 95 days (1-1002 days). Seventy-eight patients (58%) received 3 or more cycles of therapy, 53 patients (40%) received 6 or more cycles, and 26 patients (19%) received 12 or more cycles. Seventy-six patients (57%) underwent at least one dose interruption due to adverse events, and 51 patients (38%) underwent at least one dose reduction due to adverse events. Twenty-six patients (19%) discontinued treatment due to adverse events.

Table 11: Incidence of Adverse Reactions (≥10%) or Grade 3 / 4 AE (in at least 2 patients) in Mantle Cell Lymphoma

1-MCL trial AEs – All treatment emergent AEs with ≥10% of subjects
2-MCL trial Grade 3/4 AEs – All treatment-emergent Grade 3/4 AEs in 2 or more subjects
$-MCL trial Serious AEs – All treatment-emergent SAEs in 2 or more subjects
@ - AEs where at least one resulted in a fatal outcome
% - AEs 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 except for rare infections of Public Health interest will be considered listed
+-All adverse reactions under HLT of Rash will be considered listed

Body System
Adverse Reaction All AEs1 (N=134) Grade 3/4 AEs2 (N=134)
 n (%) n (%)
General disorders and administration site conditions
Fatigue 45 (34) 9 (7)
Pyrexia$ 31 (23) 3 (2)
Edema peripheral  21 (16) 0
Asthenia$ 19 (14) 4 (3)
General physical health deterioration 3 (2) 2 (1)
Gastrointestinal disorders
Diarrhea$ 42 (31) 8 (6)
Nausea$ 40 (30) 1 (<1)
Constipation  21 (16) 1 (<1)
Vomiting$ 16 (12) 1 (<1)
Abdominal pain$ 13 (10) 5 (4)
Musculoskeletal and connective tissue disorders
Back pain  18 (13) 2 (1)
Muscle spasms  17 (13) 1 (<1)
Arthralgia  11 (8) 2 (1)
Muscular weakness$ 8 (6) 2 (1)
Respiratory, thoracic and mediastinal disorders
Cough  38 (28) 1 (<1)
Dyspnea$ 24 (18) 8 (6)
Pleural Effusion 10 (7) 2 (1)
Hypoxia 3 (2) 2 (1)
Pulmonary embolism  3 (2) 2 (1)
Respiratory distress$ 2 (1) 2 (1)
Oropharyngeal pain 13 (10) 0
Infections and infestations
Pneumonia@$ 19 (14) 12 (9)
Upper respiratory tract infection  17 (13) 0
Cellulitis$ 3 (2) 2 (1)
Bacteremia$ 2 (1) 2 (1)
Staphylococcal sepsis$ 2 (1) 2 (1)
Urinary tract infection$ 5 (4) 2 (1)
Skin and subcutaneous tissue disorders
Rash+ 30 (22) 2 (1)
Pruritus 23 (17) 1 (<1)
Blood and lymphatic system disorders
Neutropenia 65 (49) 58 (43)
Thrombocytopenia%$ 48 (36) 37 (28)
Anemia$ 41 (31) 15 (11)
Leukopenia$ 20 (15) 9 (7)
Lymphopenia 10 (7) 5 (4)
Febrile neutropenia$ 8 (6) 8 (6)
Metabolism and nutrition disorders
Decreased appetite  19 (14) 1 (<1)
Hypokalemia 17 (13) 3 (2)
Dehydration$ 10 (7) 4 (3)
Hypocalcemia 4 (3) 2 (1)
Hyponatremia 3 (2) 3 (2)
Renal and urinary disorders
Renal failure$ 5 (4) 2 (1)
Vascular disorders
Hypotension@$ 9 (7) 4 (3)
Deep vein thrombosis$ 5 (4) 5 (4)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Tumor flare 1