.7) 11 (2.1) 8 (1.5) 6 (1.1)
Injury, Poisoning, and Procedural Complications
Fall f 43 (8.1) 25 (4.6) 25 (4.6) <1% 6 (1.1) 6 (1.1)
Contusion f 33 (6.2) 24 (4.4) 15 (2.8) <1% <1% 0 (0.0)
Eye disorders
Cataract 73 (13.7) 31 (5.7) 5 (0.9) 31 (5.8) 14 (2.6) 3 (0.6)
Cataract subcapsular e <5% <5% <5% 7 (1.3) 0 (0.0) 0 (0.0)
Investigations
Weight decreased 72 (13.5) 78 (14.4) 48 (8.9) 11 (2.1) 4 (0.7) 4 (0.7)
Cardiac disorders
Atrial fibrillationc 37 (7.0) 25 (4.6) 25 (4.6) 13 (2.4) 9 (1.7) 6 (1.1)
Myocardial infarction (including acute) c,e <5% <5% <5% 10 (1.9) 3 (0.6) 5 (0.9)
Renal and Urinary disorders
Renal failure (including acute)c @, f 49 (9.2) 54 (10.0) 37 (6.8) 28 (5.3) 33 (6.1) 29 (5.4)
Neoplasms benign, malignant and unspecified (Incl cysts and polyps)
Squamous cell carcinoma c e <5% <5% <5% 8 (1.5) 4 (0.7) 0 (0.0)
Basal cell carcinomac e,f <5% <5% <5% <1% <1% 0 (0.0)
Newly Diagnosed MM - REVLIMID Maintenance Therapy Following Auto-HSCT:
Data were eva luated from 1018 patients in two randomized trials who received at least one dose of REVLIMID 10 mg daily as maintenance therapy after auto-HSCT until progressive disease or unacceptable toxicity, The mean treatment duration for REVLIMID treatment was 30.3 months for Maintenance Study 1 and 24.0 months for Maintenance Study 2 (overall range across both studies from 0.1 to 108 months). As of the cut-off date of 1 Mar 2015, 48 patients (21%) in the Maintenance Study 1 REVLIMID arm were still on treatment and none of the patients in the Maintenance Study 2 REVLIMID arm were still on treatment at the same cut-off date
The adverse reactions listed from Maintenance Study 1 included events reported post-transplant (completion of high-dose melphalan /auto-HSCT), and the maintenance treatment period. In Maintenance Study 2, the adverse reactions were from the maintenance treatment period only. In general, the most frequently reported adverse reactions (more than 20% in the REVLIMID arm) across both studies were neutropenia, thrombocytopenia, leukopenia, anemia, upper respiratory tract infection, bronchitis, nasopharyngitis, cough, gastroenteritis, diarrhea, rash, fatigue, asthenia, muscle spasm and pyrexia. The most frequently reported Grade 3 or 4 reactions (more than 20% in the REVLIMID arm) included neutropenia, thrombocytopenia, and leukopenia. The serious adverse reactions lung infection and neutropenia (more than 4.5%) occurred in the REVLIMID arm.
For REVLIMID, the most common adverse reactions leading to dose interruption were hematologic events (29.7%, data available in Maintenance Study 2 only). The most common adverse reaction leading to dose reduction of REVLIMID were hematologic events (17.7%, data available in Maintenance Study 2 only). The most common adverse reactions leading to discontinuation of REVLIMID were thrombocytopenia (2.7%) in Maintenance Study 1 and neutropenia (2.4%) in Maintenance Study 2.
The frequencies of onset of adverse reactions were generally highest in the first 6 months of treatment and then the frequencies decreased over time or remained stable throughout treatment.
Table 5 summarizes the adverse reactions reported for the REVLIMID and placebo maintenance treatment arms.
Table 5: All
