Rituximab and/or Lenalidomide in Treating Patients With F... | NCT00238238

ID	Type	Description	Link
CALGB-50401
U10CA031946	U.S. NIH Grant/Contract		View source
CDR0000442872	Registry Identifier	NCI Physician Data Query

Name	Class
National Cancer Institute (NCI)	NIH

Label	Type	Description	Intervention Names
Arm I - rituximab	Active Comparator	Patients receive rituximab IV on days 1, 8, 15, and 22.	Biological: rituximab
Arm II - lenalidomide	Experimental	Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Drug: lenalidomide
Arm III - lenalidomide and rituximab	Experimental	Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.	Biological: rituximab Drug: lenalidomide

Name	Type	Description	Arm Group Labels	Other Names
rituximab	Biological	Given IV	Arm I - rituximab Arm III - lenalidomide and rituximab

Measure	Description	Time Frame
Overall Response Rate	Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.	Duration of treatment (12 cycles)
Time to Progression	Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.	Up to 10 years

Name	Affiliation	Role
John P. Leonard, MD	Weill Medical College of Cornell University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Rebecca and John Moores UCSD Cancer Center		La Jolla	California	92093-0658	United States
Kaiser Permanente Medical Office -Vandever Medical Office

PubMed Identifier	Type	Citation	Retractions
26304886	Result	Leonard JP, Jung SH, Johnson J, Pitcher BN, Bartlett NL, Blum KA, Czuczman M, Giguere JK, Cheson BD. Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance). J Clin Oncol. 2015 Nov 1;33(31):3635-40. doi: 10.1200/JCO.2014.59.9258. Epub 2015 Aug 24.

ID	Title	Description
FG000	Arm I - Rituximab	Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
FG001	Arm II - Lenalidomide	Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events4 affected45 at risk EG0024 events4 affected45 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events1 affected45 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Hypothyroidism	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Dry eye syndrome	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0024 events1 affected45 at risk
Vision blurred	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Colitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Constipation	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0028 events4 affected45 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Ear, nose and throat examination abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Esophageal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Nausea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0023 events3 affected45 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Oral pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Vomiting	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0022 events2 affected45 at risk
Chest pain	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Chills	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Death NOS	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Disease progression	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Edema limbs	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0022 events2 affected45 at risk
Fatigue	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0016 events5 affected45 at risk EG00211 events7 affected45 at risk
Fever	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Gait abnormal	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Pain	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0020 events0 affected45 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Bronchitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Opportunistic infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Pneumonia	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0022 events2 affected45 at risk
Sepsis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Skin infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Vaginal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Intraoperative musculoskeletal injury	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Alanine aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events1 affected45 at risk
Alkaline phosphatase increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0023 events2 affected45 at risk
Blood bilirubin increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0024 events3 affected45 at risk
Creatinine increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0024 events3 affected45 at risk
Electrocardiogram QTc interval prolonged	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
INR increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Leukocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events4 affected45 at risk EG0026 events5 affected45 at risk
Lymphocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0023 events3 affected45 at risk
Neutrophil count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0026 events4 affected45 at risk
Platelet count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0017 events6 affected45 at risk EG0026 events5 affected45 at risk
Weight loss	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0020 events0 affected45 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0020 events0 affected45 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events4 affected45 at risk EG0027 events6 affected45 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0025 events5 affected45 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0024 events4 affected45 at risk
Serum glucose decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Serum magnesium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0025 events5 affected45 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0021 events1 affected45 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0022 events2 affected45 at risk
Tumor flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Dysgeusia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Ischemia cerebrovascular	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Mini mental status examination abnormal	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Neuralgia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Seizure	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Speech disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Depression	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Insomnia	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Kidney pain	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Proteinuria	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Renal failure	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events2 affected45 at risk EG0024 events4 affected45 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events3 affected45 at risk EG0024 events4 affected45 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0020 events0 affected45 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0025 events1 affected45 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Sweating	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Flushing	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Hot flashes	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Hypotension	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0021 events1 affected45 at risk
Thrombosis	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events3 affected45 at risk EG0022 events2 affected45 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00189 events19 affected45 at risk EG00286 events17 affected45 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0020 events0 affected45 at risk
Cardiac disorder	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Cardiac pain	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0023 events2 affected45 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
External ear pain	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events1 affected45 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Hypothyroidism	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG00224 events6 affected45 at risk
Dry eye syndrome	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events3 affected45 at risk EG0023 events2 affected45 at risk
Eye disorder	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Glaucoma	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events1 affected45 at risk EG0020 events0 affected45 at risk
Watering eyes	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0023 events1 affected45 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0027 events2 affected45 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0016 events3 affected45 at risk EG0029 events4 affected45 at risk
Anal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Constipation	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00140 events21 affected45 at risk EG00245 events16 affected45 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00146 events14 affected45 at risk EG00234 events14 affected45 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00112 events3 affected45 at risk EG0026 events4 affected45 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0017 events6 affected45 at risk EG0024 events2 affected45 at risk
Ear, nose and throat examination abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0023 events1 affected45 at risk
Esophageal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events2 affected45 at risk EG0020 events0 affected45 at risk
Gastroscopy abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Nausea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00140 events16 affected45 at risk EG00232 events12 affected45 at risk
Oral pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0020 events0 affected45 at risk
Stomach pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events1 affected45 at risk EG0020 events0 affected45 at risk
Toothache	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0023 events2 affected45 at risk
Vomiting	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0019 events4 affected45 at risk EG0027 events6 affected45 at risk
Chest pain	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0027 events1 affected45 at risk
Chills	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0027 events7 affected45 at risk
Edema limbs	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00128 events9 affected45 at risk EG00211 events6 affected45 at risk
Fatigue	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG001138 events35 affected45 at risk EG002166 events33 affected45 at risk
Fever	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0027 events7 affected45 at risk
Flu-like symptoms	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
General symptom	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Localized edema	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events2 affected45 at risk EG0020 events0 affected45 at risk
Pain	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events4 affected45 at risk EG00216 events4 affected45 at risk
Gallbladder pain	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG00212 events12 affected45 at risk
Hypersensitivity	Immune system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events3 affected45 at risk EG0023 events3 affected45 at risk
Immune system disorder	Immune system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Bronchitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Catheter related infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Gastric infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Gingival infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0023 events2 affected45 at risk
Infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0022 events2 affected45 at risk
Otitis media	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Pharyngitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events2 affected45 at risk
Rhinitis infective	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Sinusitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events3 affected45 at risk EG00215 events8 affected45 at risk
Skin infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Tooth infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0020 events0 affected45 at risk
Tracheitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Upper respiratory infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0017 events5 affected45 at risk EG0023 events2 affected45 at risk
Urinary tract infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG00211 events3 affected45 at risk
Vaginal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0022 events1 affected45 at risk
Bruising	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events1 affected45 at risk EG0021 events1 affected45 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Alanine aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00127 events8 affected45 at risk EG00235 events9 affected45 at risk
Alkaline phosphatase increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00114 events5 affected45 at risk EG0024 events2 affected45 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00121 events8 affected45 at risk EG00233 events10 affected45 at risk
Blood bilirubin increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0016 events2 affected45 at risk EG00231 events8 affected45 at risk
Creatinine increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00110 events6 affected45 at risk EG00214 events4 affected45 at risk
INR increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0020 events0 affected45 at risk
Laboratory test abnormal	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events1 affected45 at risk EG00215 events2 affected45 at risk
Leukocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00186 events21 affected45 at risk EG002131 events16 affected45 at risk
Lymphocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00121 events9 affected45 at risk EG00280 events13 affected45 at risk
Neutrophil count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00194 events19 affected45 at risk EG002123 events25 affected45 at risk
Platelet count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00196 events25 affected45 at risk EG002114 events23 affected45 at risk
Serum cholesterol increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Weight gain	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Weight loss	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0024 events3 affected45 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00112 events6 affected45 at risk EG0028 events5 affected45 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00150 events15 affected45 at risk EG00255 events14 affected45 at risk
Blood uric acid increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events3 affected45 at risk EG0022 events2 affected45 at risk
Glucose intolerance	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events1 affected45 at risk EG0020 events0 affected45 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00112 events7 affected45 at risk EG00218 events6 affected45 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00124 events8 affected45 at risk EG00238 events10 affected45 at risk
Serum calcium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG00211 events1 affected45 at risk
Serum glucose decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0016 events4 affected45 at risk EG00214 events7 affected45 at risk
Serum magnesium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00110 events6 affected45 at risk EG00223 events6 affected45 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00113 events7 affected45 at risk EG00227 events6 affected45 at risk
Serum potassium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events2 affected45 at risk EG0024 events2 affected45 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00120 events6 affected45 at risk EG00216 events6 affected45 at risk
Serum sodium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events1 affected45 at risk
Serum triglycerides increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG00213 events7 affected45 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0028 events3 affected45 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0019 events6 affected45 at risk EG00214 events6 affected45 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events1 affected45 at risk EG0024 events3 affected45 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events1 affected45 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events3 affected45 at risk EG00215 events4 affected45 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00116 events7 affected45 at risk EG00220 events6 affected45 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events3 affected45 at risk EG0020 events0 affected45 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0016 events4 affected45 at risk EG0029 events4 affected45 at risk
Tumor flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0022 events2 affected45 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Ataxia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events1 affected45 at risk EG0020 events0 affected45 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events1 affected45 at risk
Dizziness	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00111 events8 affected45 at risk EG00216 events10 affected45 at risk
Dysgeusia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00118 events5 affected45 at risk EG0027 events3 affected45 at risk
Headache	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00116 events5 affected45 at risk EG00210 events5 affected45 at risk
Memory impairment	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Neuralgia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events1 affected45 at risk EG0020 events0 affected45 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0021 events1 affected45 at risk
Olfactory nerve disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events1 affected45 at risk EG0020 events0 affected45 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0022 events1 affected45 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00132 events15 affected45 at risk EG00251 events17 affected45 at risk
Syncope	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Tremor	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0024 events1 affected45 at risk
Trigeminal nerve disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Anxiety	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0022 events2 affected45 at risk
Depression	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00115 events4 affected45 at risk EG0022 events1 affected45 at risk
Insomnia	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0016 events4 affected45 at risk EG00210 events4 affected45 at risk
Libido decreased	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Proteinuria	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0021 events1 affected45 at risk
Urinary frequency	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0024 events3 affected45 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Urinary retention	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0027 events2 affected45 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0025 events1 affected45 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00120 events9 affected45 at risk EG00212 events6 affected45 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00115 events8 affected45 at risk EG00230 events11 affected45 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00113 events6 affected45 at risk EG00214 events8 affected45 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0021 events1 affected45 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events2 affected45 at risk EG0026 events4 affected45 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0020 events0 affected45 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0010 events0 affected45 at risk EG0027 events1 affected45 at risk
Pulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0014 events4 affected45 at risk EG0028 events6 affected45 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0013 events1 affected45 at risk EG0020 events0 affected45 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00112 events7 affected45 at risk EG0022 events2 affected45 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00115 events10 affected45 at risk EG00222 events8 affected45 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events2 affected45 at risk EG0020 events0 affected45 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00117 events9 affected45 at risk EG00216 events6 affected45 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0021 events1 affected45 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG00116 events11 affected45 at risk EG00213 events10 affected45 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0019 events6 affected45 at risk EG00211 events8 affected45 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events1 affected45 at risk EG0020 events0 affected45 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0011 events1 affected45 at risk EG0020 events0 affected45 at risk
Sweating	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0018 events6 affected45 at risk EG0024 events3 affected45 at risk
Hot flashes	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0018 events1 affected45 at risk EG0020 events0 affected45 at risk
Hypotension	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0015 events3 affected45 at risk EG0020 events0 affected45 at risk
Peripheral ischemia	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0012 events1 affected45 at risk EG0020 events0 affected45 at risk
Thrombosis	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected0 at risk EG0017 events4 affected45 at risk EG0021 events1 affected45 at risk

ID	Title	Description
BG000	Arm I - Rituximab	Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
BG001	Arm II - Lenalidomide	Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
BG002	Arm III - Lenalidomide and Rituximab	Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
BG003	Total	Total of all reporting groups

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D008228	Lymphoma, Non-Hodgkin

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm I - Rituximab	Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.	0	0	0	0
EG001	Arm II - Lenalidomide	Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.	8	45	44	45
EG002	Arm III - Lenalidomide and Rituximab	Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.	12	45	41	45