Trial Outcomes & Findings for A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma (NCT NCT00413036)

Last Updated: 2017-03-01

Results Overview

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article. * Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy. * Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow. * Partial Response(PR): \>50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson. * Stable Disease(SD): Less than PR, but not progressive disease. * Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

217 participants

Primary outcome timeframe

Up to 1459 days

Results posted on

2017-03-01

Participant Flow

217 participants were enrolled and received at least one dose of study medication.

Participant milestones

Participant milestones
Measure	Lenalidomide 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Study STARTED	217
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	217

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Study Adverse Event	44
Overall Study Lack of Efficacy	129
Overall Study Withdrawal by Subject	7
Overall Study Death	9
Overall Study Other	26
Overall Study Missing	2

Baseline Characteristics

A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide n=217 Participants 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Age, Continuous	65.0 years STANDARD_DEVIATION 11.54 • n=99 Participants
Age, Customized < 65 years	90 Participants n=99 Participants
Age, Customized > = 65 years	127 Participants n=99 Participants
Gender Female	77 Participants n=99 Participants
Gender Male	140 Participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participant n=99 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	0 Participant n=99 Participants
Race/Ethnicity, Customized Black	4 Participant n=99 Participants
Race/Ethnicity, Customized Hispanic	2 Participant n=99 Participants
Race/Ethnicity, Customized White	202 Participant n=99 Participants
Race/Ethnicity, Customized Unspecified	9 Participant n=99 Participants
Non-Hodgkin's Lymphoma Diagnosis/Histopathology Diffuse Large Cell Lymphoma	108 Participants n=99 Participants
Non-Hodgkin's Lymphoma Diagnosis/Histopathology Follicular Lymphoma, Grade 3	19 Participants n=99 Participants
Non-Hodgkin's Lymphoma Diagnosis/Histopathology Mantle Cell Lymphoma	57 Participants n=99 Participants
Non-Hodgkin's Lymphoma Diagnosis/Histopathology Transformed Lymphoma	33 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 1459 days

Population: Intent-to-treat population

Outcome measures

Outcome measures
Measure	Lenalidomide n=217 Participants 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Participants Categorized by Best Response as Determined by Central Review Complete Response (CR)	7 Participants
Participants Categorized by Best Response as Determined by Central Review Complete Response Unconfirmed (CRu)	21 Participants
Participants Categorized by Best Response as Determined by Central Review Partial Response (PR)	40 Participants
Participants Categorized by Best Response as Determined by Central Review Stable Disease (SD)	71 Participants
Participants Categorized by Best Response as Determined by Central Review Progressive Disease	78 Participants

SECONDARY outcome

Timeframe: Up to 1459 days

Population: Intent-to-treat population

Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma. For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.

Outcome measures

Outcome measures
Measure	Lenalidomide n=217 Participants 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Duration of Response as Determined by Central Review	18.4 Months Interval 6.51 to 34.06

SECONDARY outcome

Timeframe: Up to 1459 days

Population: Intent-to-treat population

Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression. Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article. * Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.

Outcome measures

Outcome measures
Measure	Lenalidomide n=217 Participants 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Time to Progression as Determined by Central Review	4.5 Months Interval 3.68 to 6.28

SECONDARY outcome

Timeframe: Up to 1459 days

Population: Intent-to-treat population

Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first. Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article. * Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.

Outcome measures

Outcome measures
Measure	Lenalidomide n=217 Participants 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Progression-free Survival as Determined by Central Review	4.5 Months Interval 3.68 to 6.28

SECONDARY outcome

Timeframe: Up to 1459 days

Population: Tumor Control Rate or Proportion of Participants Who Experienced Stable Disease or Better (SD+PR+CRu+CR) was not analyzed. Overall Response Rate (PR+CRu+CR) is presented as the primary endpoint, and because it is a more widely accepted/used efficacy endpoint than tumor control rate, a decision was made not to analyze tumor control rate.

Outcome measures

Outcome data not reported

Adverse Events

Lenalidomide

Serious events: 102 serious events

Other events: 188 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide n=217 participants at risk 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
General disorders Pyrexia	5.5% 12/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders General Physical Health Deterioration	3.7% 8/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Asthenia	3.2% 7/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Multi-Organ Failure	1.8% 4/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Fatigue	1.4% 3/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Non-Cardiac Chest Pain	1.4% 3/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Disease Progression	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Oedema Peripheral	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Pain	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Performance Status Decreased	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Sudden Death	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Urinary Tract Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations West Nile Viral Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Wound Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Pneumonia	4.1% 9/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Sepsis	2.3% 5/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Cellulitis	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Infection	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Respiratory Tract Infection	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Appendicitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Bacteraemia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Bronchitis Chronic	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Candidiasis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Central Line Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Clostridial Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Device Related Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Gastroeneteritis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Lobar Pneumonia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Lung Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Meningitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Neutropenic Sepsis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Pharyngitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Infections and infestations Staphylococcal Infection	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.7% 8/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.8% 6/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.3% 5/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Asthma	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pneumonthorax	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Neutropenia	5.1% 11/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Anaemia	2.8% 6/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Febrile Neutropenia	2.8% 6/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Thrombocytopenia	2.3% 5/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Pancytopenia	1.8% 4/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Leukopenia	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Lymphadenopathy	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Splenic Infarction	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Abdominal Pain	1.8% 4/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Diarrhoea	1.4% 3/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Vomiting	1.4% 3/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Abdominal Pain Upper	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Nausea	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Small Intestinal Obstruction	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Colitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Constipation	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Dysphagia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Gastritis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Intestinal Obstruction	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Pancreatitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Rectal Haemorrhage	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	2.8% 6/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm of Thyroid Gland	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central Nervous System Lymphoma	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Meninges	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Flare	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Lysis Syndrome	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Necrosis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Cardiac disorders Cardio-Respiratory Arrest	1.4% 3/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Cardiac disorders Cardiac Arrest	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Cardiac disorders Myocardial Infarction	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Cardiac disorders Atrial Fibrillation	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Cardiac disorders Cardiac Failure Congestive	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Cardiac disorders Sinus Tachycardia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Cardiac disorders Tachycardia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Renal and urinary disorders Renal Failure Acute	1.8% 4/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Renal and urinary disorders Renal Failure	1.4% 3/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Anuria	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Renal and urinary disorders Hydronephrosis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Renal and urinary disorders Urinary Retention	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Vascular disorders Hypotension	2.3% 5/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Vascular disorders Deep Vein Thrombosis	1.8% 4/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Vascular disorders Thrombosis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Anastomotic Stenosis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Contusion	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Fall	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Femur Fracture	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Fracture	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Haemothorax	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Intentional Overdose	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Joint Dislocation	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Limb Injury	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Postoperative Ileus	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Injury, poisoning and procedural complications Spinal Fracture	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Cerebrovascular Accident	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Syncope	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Convulsion	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Dementia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Epilepsy	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Hypoaesthesia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Neuropathy Peripheral	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Paraesthesia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Paresis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Speech Disorder	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Tremor	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Metabolism and nutrition disorders Dehydration	2.8% 6/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Metabolism and nutrition disorders Hypercalcaemia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Back Pain	2.3% 5/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Psychiatric disorders Confusional State	1.4% 3/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Psychiatric disorders Suicide Attempt	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Hepatobiliary disorders Cholangitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Hepatobiliary disorders Cholelithiasis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Hepatobiliary disorders Cytolytic Hepatitis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Hepatobiliary disorders Jaundice	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Investigations C-Reactive Protein Increased	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Investigations Liver Function Test Abnormal	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Investigations White Blood Cell Count Decreased	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Rash	0.92% 2/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Dermatitis Exfoliative	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Hypoaesthesia Facial	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Congenital, familial and genetic disorders Pyloric Stenosis	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Eye disorders Diplopia	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Immune system disorders Anaphylactic Shock	0.46% 1/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.

Other adverse events

Other adverse events
Measure	Lenalidomide n=217 participants at risk 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Gastrointestinal disorders Constipation	10.1% 22/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Nausea	8.3% 18/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Diarrhoea	6.5% 14/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Gastrointestinal disorders Abdominal pain	5.5% 12/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Fatigue	11.5% 25/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Oedema Peripheral	6.0% 13/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Pyrexia	6.0% 13/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
General disorders Asthenia	5.5% 12/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Muscle spasms	6.9% 15/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Back pain	6.0% 13/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Nervous system disorders Dizziness	6.0% 13/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Rash	9.2% 20/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Cough	7.4% 16/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Dsypnoea	5.1% 11/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.1% 11/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Investigations White Blood Cell Count Decreased	6.9% 15/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Neutropenia	10.1% 22/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Anaemia	8.3% 18/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
Blood and lymphatic system disorders Thrombocytopenia	7.8% 17/217 • Up to 1459 days Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.

Additional Information

Associate Director, Clinical Trial Disclosure

Celgene

Phone: 1-888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator can publish/present study data after multicenter publication is submitted or 1 yr after study completion. Investigator shall (i) furnish the sponsor a copy of any proposed publication/presentation at least 60 days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for up to 90 days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
Publication restrictions are in place

Restriction type: OTHER