Trial Outcomes & Findings for A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma (NCT NCT00622336)

NCT ID: NCT00622336

Last Updated: 2019-11-20

Results Overview

An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 330 participants
• Primary outcome timeframe: Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.
• Results posted on: 2019-11-20

Participant Flow

This was an international, open-label single arm study of oral lenalidomide in participants with multiple myeloma who had previously received high dose dexamethasone alone or in combination with thalidomide in the study NCT 00057564, or previously received high dose dexamethasone alone in studies NCT 00056160 and NCT 00424047.

To be eligible participants must have developed disease progression or were unable to tolerate the lowest dosing regimen of thalidomide and/or high-dose dexamethasone without Grade 3 or 4 toxicity

Participant milestones

Measure	Lenalidomide 25mg Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Treatment Phase STARTED	330
Treatment Phase Safety Population	330
Treatment Phase COMPLETED	21
Treatment Phase NOT COMPLETED	309
Extension Phase STARTED	21
Extension Phase COMPLETED	0
Extension Phase NOT COMPLETED	21

Reasons for withdrawal

Measure	Lenalidomide 25mg Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Treatment Phase Progression of Disease	181
Treatment Phase Adverse Event	46
Treatment Phase Other	40
Treatment Phase Death	14
Treatment Phase Lack of therapeutic effect	13
Treatment Phase Withdrawal by Subject	13
Treatment Phase Lost to Follow-up	2
Extension Phase Adverse Event	2
Extension Phase Progressive Disease	6
Extension Phase Lack of therapeutic effect	2
Extension Phase Withdrawal by Subject	1
Extension Phase Lost to Follow-up	1
Extension Phase Other	9

Baseline Characteristics

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

Baseline characteristics by cohort

Measure	Lenalidomide 25mg (CC-5013) n=330 Participants Oral 25mg daily on Days 1-21 every 28 days
Age, Continuous	63.3 years STANDARD_DEVIATION 9.43 • n=5 Participants
Age, Customized > 65 years	136 participants n=5 Participants
Age, Customized ≤ 65 years	194 participants n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants
Sex: Female, Male Male	193 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants
Race/Ethnicity, Customized White	309 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = Fully Active	95 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 = Restricted Activity	178 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 = Ambulatory; not able to work	44 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 3 = Limited Self Care	1 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 4 = Completely Disabled	0 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Missing= Unspecified	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.

Population: The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.

An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

Outcome measures

Measure	Lenalidomide 25mg (CC-5013) n=330 Participants Oral 25mg daily on Days 1-21 every 28 days
Number of Participants With Adverse Events (AE) During the Treatment Phase Adverse Event (AE)	327 participants
Number of Participants With Adverse Events (AE) During the Treatment Phase Adverse Event related to study drug	268 participants
Number of Participants With Adverse Events (AE) During the Treatment Phase Adverse Event NCI CTC (Version2.0) Grade 3 or 4	256 participants
Number of Participants With Adverse Events (AE) During the Treatment Phase Serious Adverse Event (SAE)	177 participants
Number of Participants With Adverse Events (AE) During the Treatment Phase AE leading to discontinuation of study drug	52 participants
Number of Participants With Adverse Events (AE) During the Treatment Phase AE leading to dose reduction/interruption	210 participants

PRIMARY outcome

Timeframe: From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.

Population: Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.

An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

Outcome measures

Measure	Lenalidomide 25mg (CC-5013) n=21 Participants Oral 25mg daily on Days 1-21 every 28 days
Number of Participants With Adverse Events (AE) During the Extension Phase ≥ 1 Adverse Event (AE)	13 participants
Number of Participants With Adverse Events (AE) During the Extension Phase Adverse Event related to study drug	1 participants
Number of Participants With Adverse Events (AE) During the Extension Phase Adverse Event NCI CTC (Version2.0) Grade 3 or 4	5 participants
Number of Participants With Adverse Events (AE) During the Extension Phase ≥ 1 Serious Adverse Event (SAE)	5 participants
Number of Participants With Adverse Events (AE) During the Extension Phase ≥ 1 AE leading to discontinuation of study drug	1 participants
Number of Participants With Adverse Events (AE) During the Extension Phase ≥ 1 AE leading to dose reduction/interruption	3 participants

SECONDARY outcome

Timeframe: Up to 70 months

Population: Time to progression not analyzed per the sponsors decision.

Time to progression based on the myeloma response determination criteria developed by Bladé et al 1998 and is defined as the time from registration to the first documented progression. The progressive disease criteria included increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 70 months

Population: Myeloma Response Rate not analyzed per the sponsors decision.

Myeloma response determination criteria developed by Bladé et al 1998. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 70 months

Population: Duration of response not analyzed per the sponsors decision.

Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998 and defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on International Myeloma Working Group (IMWG) criteria.

Outcome measures

Outcome data not reported

Adverse Events

Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009

Serious events: 177 serious events

Other events: 0 other events

Deaths: 0 deaths

Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009 n=330 participants at risk Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle	Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013 n=21 participants at risk Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Infections and infestations Pneumonia NOS	11.5% 38/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	9.5% 2/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Respiratory tract infection NOS	1.8% 6/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Lobar pneumonia NOS	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Sepsis NOS	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Bacteraemia	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Bronchitis acute NOS	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Bronchopneumonia NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Cellulitis	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Lung infection NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Pyelonephritis NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Abscess NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Arthritis infective NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Bronchitis chronic NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Candida pneumonia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Catheter related infection	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Haemophilus sepsis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Lower respiratory tract infection NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Obstructive chronic bronchitis with acute exacerbation	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Osteomyelitis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Osteomyelitis chronic NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Pneumonia legionella	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Pyelonephritis chronic NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Septic shock	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Streptococcal bacteraemia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Streptococcal sepsis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Tracheobronchitis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Urinary tract infection NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Urosepsis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Varicella	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Infections and infestations Viral infection NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Anaemia NOS	3.3% 11/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Febrile neutropenia	2.7% 9/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Thrombocytopenia	2.7% 9/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Leukopenia NOS	1.5% 5/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Neutropenia	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Pancytopenia	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Hyperviscosity syndrome	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Pyrexia	4.2% 14/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Asthenia	2.1% 7/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Multi-organ failure	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Disease progression NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Fatigue	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders General physical health deterioration	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Injection site cellulitis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Lethargy	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Sudden death	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Gastroenteritis NOS	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Constipation	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Diarrhoea NOS	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Abdominal pain NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Oesophagitis NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Periproctitis	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Appendicitis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Diverticulitis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Enterocolitis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Gastritis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Gastrointestinal haemorrhage NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Gastrointestinal pain NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Hiatus hernia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Inguinal hernia NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Intestinal obstruction NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Gastrointestinal disorders Umbilical hernia NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Bone pain	2.4% 8/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Back pain	1.8% 6/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Pathological fracture	1.8% 6/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Arthralgia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Chondrocalcinosis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Jaw osteitis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Joint swelling	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Localised osteoarthritis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Neck pain	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Osteoarthritis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Pain in limb	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Synovitis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Musculoskeletal and connective tissue disorders Tendonitis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 5/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Bronchitis NOS	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Asthma NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Chronic obstructive airways disease	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Lung infiltration NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Atrial fibrillation	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Cardiac failure NOS	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema NOS	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Acute myocardial infarction	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Cardiac failure congestive	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Myocardial infarction	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Angina unstable	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Atrial flutter	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Atrial tachycardia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Cardio-respiratory arrest	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Coronary artery disease NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Myocardial ischaemia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Cardiac disorders Sick sinus syndrome	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Cerebrovascular accident	1.8% 6/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Subdural haematoma	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Brain oedema	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Carotid artery stenosis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Cerebral haemorrhage	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Cerebral infarction	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Cerebral ischaemia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Cerebrovascular disorder NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Dementia NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Encephalopathy	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Metabolic encephalopathy NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Phantom pain	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Radiculitis brachial	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Spinal cord compression NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Transient ischaemic attack	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Craniopharyngioma	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Light chain disease	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer stage unspecified	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Renal failure acute	1.8% 6/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Renal failure NOS	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Calculus urinary	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Nephropathy NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Renal failure acute or chronic	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Azotaemia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Nephropathy toxic	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Renal and urinary disorders Renal failure chronic	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Femur fracture	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Hip fracture	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Spinal compression fracture	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Accident NOS 1 ( 0.3)	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Femoral neck fracture	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Intracranial injury NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Perirenal haematoma	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Radius fracture	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Injury, poisoning and procedural complications Spinal fracture NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Metabolism and nutrition disorders Hypercalcaemia	1.2% 4/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Metabolism and nutrition disorders Dehydration	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Metabolism and nutrition disorders Diabetes mellitus NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Metabolism and nutrition disorders Hyperproteinaemia	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Metabolism and nutrition disorders Hypokalaemia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Vascular disorders Deep vein thrombosis	1.8% 6/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Vascular disorders Hypotension NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Vascular disorders Aortic thrombosis	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Vascular disorders Circulatory collapse	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Vascular disorders Thrombophlebitis superficial	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Psychiatric disorders Confusional state	0.91% 3/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Psychiatric disorders Agitation	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Psychiatric disorders Conversion disorder	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Psychiatric disorders Depression	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Psychiatric disorders Disorientation	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Psychiatric disorders Insomnia	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Hepatobiliary disorders Cholecystitis acute NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Hepatobiliary disorders Cholelithiasis	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Hepatobiliary disorders Hepatic failure	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Hepatobiliary disorders Hepatitis NOS	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Hepatobiliary disorders Hepatitis toxic	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Investigations Liver function tests NOS abnormal	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Investigations International normalised ratio increased	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Investigations Prostatic specific antigen increased	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Investigations Weight decreased	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Skin and subcutaneous tissue disorders Rash NOS	0.61% 2/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Skin and subcutaneous tissue disorders Dermatitis medicamentosa	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.30% 1/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	0.00% 0/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaemia of Malignant Disease	0.00% 0/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	4.8% 1/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.

Other adverse events

Measure	Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009 n=330 participants at risk Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle	Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013 n=21 participants at risk Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Blood and lymphatic system disorders Anaemia NOS	0.00% 0/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	9.5% 2/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
General disorders Asthenia	0.00% 0/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	14.3% 3/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Nervous system disorders Headache	0.00% 0/330 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.	14.3% 3/21 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.

Additional Information

Senior Manager, Clinical Trial Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: ClinicalTrialDisclosure@celgene.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator has the right to publish and/or present study data after multicentric publication or one year has elapsed until completion this multicentric study provided that he/she (i) furnishes the sponsor a copy of any proposed publication or presentation before its submission, (ii) deletes any sponsor's confidential data as pointed out by sponsor, and (iii) delays any submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications.
• Publication restrictions are in place

Restriction type: OTHER