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Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (ELOQUENT - 2)

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ClinicalTrials.gov Identifier: NCT01239797
Recruitment Status : Active, not recruiting
First Posted : November 11, 2010
Results First Posted : January 5, 2017
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma
Multiple Myeloma
Interventions Drug: Lenalidomide
Drug: Dexamethasone
Drug: Dexamethasone (Oral)
Drug: Dexamethasone (IV)
Biological: Elotuzumab (BMS-901608; HuLuc63)
Enrollment 761
Recruitment Details Study initiated: June 2011; Study Completion: Study on-going
Pre-assignment Details 761 participants were enrolled and 646 participants were randomized (321 Lenalidomide with Elotuzumab, E-Ld and 325 Lenalidomide, Ld). 635 were treated (318 Lenalidomide with Elotuzumab, E-Ld and 317 Lenalidomide, Ld). Reason for non-treatment include 11 non-specified reasons.
Arm/Group Title Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Hide Arm/Group Description

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (Oral):

On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (IV):

On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug

Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Period Title: Randomized Participants
Started 321 325
Completed 319 316
Not Completed 2 9
Period Title: Treated Participants
Started 318 [1] 317 [1]
Completed 83 [2] 43 [2]
Not Completed 235 274
Reason Not Completed
Disease Progression             153             161
Study Drug Toxicity             30             44
Adverse Event Unrelated to Study Drug             22             32
Withdrawal by Subject             27             23
Non-specified             1             11
Death             1             1
Subject No Longer Meets Study Criteria             1             1
Poor/Non-compliance             0             1
[1]
1 participant was randomized to treatment E-Ld but received treatment Ld
[2]
Completed = Still on Treatment
Arm/Group Title Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone Total
Hide Arm/Group Description

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (Oral):

On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (IV):

On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug

Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Total of all reporting groups
Overall Number of Baseline Participants 321 325 646
Hide Baseline Analysis Population Description
Randomized: all participants randomized to any treatment group
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 321 participants 325 participants 646 participants
66.2  (9.34) 65.3  (10.26) 65.7  (9.81)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 321 participants 325 participants 646 participants
< 65 years old 134 142 276
>= 65 and < 75 years old 119 122 241
>= 75 years old 68 61 129
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 321 participants 325 participants 646 participants
Female
129
  40.2%
132
  40.6%
261
  40.4%
Male
192
  59.8%
193
  59.4%
385
  59.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 321 participants 325 participants 646 participants
Hispanic or Latino
5
   1.6%
1
   0.3%
6
   0.9%
Not Hispanic or Latino
28
   8.7%
33
  10.2%
61
   9.4%
Unknown or Not Reported
288
  89.7%
291
  89.5%
579
  89.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 321 participants 325 participants 646 participants
White 264 280 544
Black or African American 13 10 23
American Indian or Alaska Native 0 0 0
Asian 33 31 64
Native Hawaiian or Other Pacific Islander 1 0 1
Other 9 4 13
Not Reported 1 0 1
1.Primary Outcome
Title Median Progression Free Survival (PFS)
Hide Description Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
Time Frame Randomization until 326 events (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to any treatment group
Arm/Group Title Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Hide Arm/Group Description:

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (Oral):

On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (IV):

On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug

Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Overall Number of Participants Analyzed 321 325
Median (95% Confidence Interval)
Unit of Measure: months
19.35
(16.62 to 22.18)
14.85
(12.09 to 17.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
Comments Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Log Rank
Comments 2-sided p-value for stratified log rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.60 to 0.89
Estimation Comments [Not Specified]
2.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
Time Frame Randomization to end of treatment (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to any treatment group
Arm/Group Title Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Hide Arm/Group Description:

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (Oral):

On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (IV):

On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug

Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Overall Number of Participants Analyzed 321 325
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.5
(73.6 to 82.9)
65.5
(60.1 to 70.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
Comments Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by B2 microglobulin (<3.5 mg/L vs >=3.5 mg/L), number of prior lines of therapy (1 vs >=2), and immunomodulatory drug use at randomization
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.95
Confidence Interval (2-Sided) 95%
1.36 to 2.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
Comments Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
6.2 to 19.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.
Time Frame Randomization to 427 deaths (approximately 7 years)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores
Hide Description Outcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Time Frame Baseline to Study Completion (up to 7 years)
Outcome Measure Data Not Reported
Time Frame Day 1 (date of first dose) up to 60 days post last dose of study therapy
Adverse Event Reporting Description Study initiated: Jun 2011; Study Completion: study on-going
 
Arm/Group Title Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Hide Arm/Group Description

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (Oral):

On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (IV):

On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
All-Cause Mortality
Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   208/318 (65.41%)   179/317 (56.47%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  5/318 (1.57%)  4/317 (1.26%) 
Neutropenia  1  1/318 (0.31%)  3/317 (0.95%) 
Pancytopenia  1  1/318 (0.31%)  0/317 (0.00%) 
Splenic infarction  1  0/318 (0.00%)  1/317 (0.32%) 
Eosinophilia  1  1/318 (0.31%)  0/317 (0.00%) 
Anaemia  1  9/318 (2.83%)  6/317 (1.89%) 
Bone marrow failure  1  1/318 (0.31%)  0/317 (0.00%) 
Thrombocytopenia  1  5/318 (1.57%)  2/317 (0.63%) 
Microangiopathic haemolytic anaemia  1  1/318 (0.31%)  0/317 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/318 (0.31%)  2/317 (0.63%) 
Arrhythmia  1  0/318 (0.00%)  1/317 (0.32%) 
Cardio-respiratory arrest  1  1/318 (0.31%)  0/317 (0.00%) 
Myocardial infarction  1  0/318 (0.00%)  3/317 (0.95%) 
Sick sinus syndrome  1  0/318 (0.00%)  1/317 (0.32%) 
Left ventricular failure  1  0/318 (0.00%)  1/317 (0.32%) 
Ventricular failure  1  1/318 (0.31%)  0/317 (0.00%) 
Cardiac failure congestive  1  2/318 (0.63%)  1/317 (0.32%) 
Acute myocardial infarction  1  0/318 (0.00%)  2/317 (0.63%) 
Angina pectoris  1  1/318 (0.31%)  0/317 (0.00%) 
Atrial fibrillation  1  6/318 (1.89%)  8/317 (2.52%) 
Cardiac failure  1  1/318 (0.31%)  2/317 (0.63%) 
Atrioventricular block complete  1  1/318 (0.31%)  0/317 (0.00%) 
Cardiac arrest  1  1/318 (0.31%)  1/317 (0.32%) 
Myocardial ischaemia  1  0/318 (0.00%)  2/317 (0.63%) 
Supraventricular tachycardia  1  1/318 (0.31%)  0/317 (0.00%) 
Eye disorders     
Visual impairment  1  1/318 (0.31%)  0/317 (0.00%) 
Cataract nuclear  1  1/318 (0.31%)  0/317 (0.00%) 
Cataract  1  5/318 (1.57%)  4/317 (1.26%) 
Gastrointestinal disorders     
Ileus  1  0/318 (0.00%)  1/317 (0.32%) 
Ileus paralytic  1  0/318 (0.00%)  1/317 (0.32%) 
Large intestinal ulcer  1  0/318 (0.00%)  1/317 (0.32%) 
Abdominal pain  1  2/318 (0.63%)  0/317 (0.00%) 
Constipation  1  1/318 (0.31%)  1/317 (0.32%) 
Gastrointestinal haemorrhage  1  2/318 (0.63%)  1/317 (0.32%) 
Intestinal obstruction  1  1/318 (0.31%)  0/317 (0.00%) 
Large intestine perforation  1  1/318 (0.31%)  0/317 (0.00%) 
Pancreatitis acute  1  2/318 (0.63%)  0/317 (0.00%) 
Colitis  1  1/318 (0.31%)  2/317 (0.63%) 
Enteritis  1  1/318 (0.31%)  0/317 (0.00%) 
Gastric ulcer  1  0/318 (0.00%)  1/317 (0.32%) 
Haemorrhoids  1  0/318 (0.00%)  1/317 (0.32%) 
Intestinal haemorrhage  1  0/318 (0.00%)  1/317 (0.32%) 
Mouth haemorrhage  1  1/318 (0.31%)  0/317 (0.00%) 
Pancreatitis  1  0/318 (0.00%)  1/317 (0.32%) 
Upper gastrointestinal haemorrhage  1  0/318 (0.00%)  1/317 (0.32%) 
Vomiting  1  1/318 (0.31%)  3/317 (0.95%) 
Nausea  1  1/318 (0.31%)  1/317 (0.32%) 
Inguinal hernia, obstructive  1  0/318 (0.00%)  1/317 (0.32%) 
Lower gastrointestinal haemorrhage  1  0/318 (0.00%)  1/317 (0.32%) 
Subileus  1  0/318 (0.00%)  1/317 (0.32%) 
Abdominal pain upper  1  1/318 (0.31%)  0/317 (0.00%) 
Diarrhoea  1  5/318 (1.57%)  8/317 (2.52%) 
General disorders     
Chest pain  1  1/318 (0.31%)  0/317 (0.00%) 
Pain  1  1/318 (0.31%)  0/317 (0.00%) 
Device dislocation  1  0/318 (0.00%)  1/317 (0.32%) 
Mucosal haemorrhage  1  1/318 (0.31%)  0/317 (0.00%) 
Multi-organ failure  1  1/318 (0.31%)  0/317 (0.00%) 
Pyrexia  1  22/318 (6.92%)  15/317 (4.73%) 
Asthenia  1  2/318 (0.63%)  0/317 (0.00%) 
Chills  1  0/318 (0.00%)  1/317 (0.32%) 
Fatigue  1  1/318 (0.31%)  0/317 (0.00%) 
Death  1  1/318 (0.31%)  1/317 (0.32%) 
Disease progression  1  13/318 (4.09%)  10/317 (3.15%) 
Malaise  1  1/318 (0.31%)  0/317 (0.00%) 
General physical health deterioration  1  6/318 (1.89%)  4/317 (1.26%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/318 (0.31%)  0/317 (0.00%) 
Hepatitis  1  1/318 (0.31%)  0/317 (0.00%) 
Cholangitis  1  1/318 (0.31%)  0/317 (0.00%) 
Hepatic failure  1  1/318 (0.31%)  0/317 (0.00%) 
Hepatic function abnormal  1  0/318 (0.00%)  1/317 (0.32%) 
Hyperbilirubinaemia  1  2/318 (0.63%)  0/317 (0.00%) 
Cholecystitis  1  1/318 (0.31%)  0/317 (0.00%) 
Cholecystitis acute  1  1/318 (0.31%)  0/317 (0.00%) 
Cholecystitis chronic  1  1/318 (0.31%)  0/317 (0.00%) 
Infections and infestations     
Diverticulitis  1  1/318 (0.31%)  0/317 (0.00%) 
Pyelonephritis  1  1/318 (0.31%)  0/317 (0.00%) 
Respiratory syncytial virus infection  1  1/318 (0.31%)  1/317 (0.32%) 
Skin infection  1  0/318 (0.00%)  1/317 (0.32%) 
Streptococcal bacteraemia  1  0/318 (0.00%)  1/317 (0.32%) 
Bronchitis  1  7/318 (2.20%)  7/317 (2.21%) 
Clostridium difficile infection  1  0/318 (0.00%)  1/317 (0.32%) 
Cytomegalovirus infection  1  1/318 (0.31%)  0/317 (0.00%) 
Endocarditis  1  1/318 (0.31%)  2/317 (0.63%) 
Enteritis infectious  1  1/318 (0.31%)  0/317 (0.00%) 
Lung infection  1  2/318 (0.63%)  1/317 (0.32%) 
Meningitis staphylococcal  1  1/318 (0.31%)  0/317 (0.00%) 
Neutropenic sepsis  1  1/318 (0.31%)  1/317 (0.32%) 
Pyelonephritis acute  1  0/318 (0.00%)  1/317 (0.32%) 
Staphylococcal sepsis  1  0/318 (0.00%)  1/317 (0.32%) 
Urinary tract infection  1  3/318 (0.94%)  5/317 (1.58%) 
Urosepsis  1  1/318 (0.31%)  0/317 (0.00%) 
Abscess oral  1  0/318 (0.00%)  1/317 (0.32%) 
Cerebral aspergillosis  1  1/318 (0.31%)  0/317 (0.00%) 
Osteomyelitis  1  1/318 (0.31%)  1/317 (0.32%) 
Pneumonia pneumococcal  1  3/318 (0.94%)  1/317 (0.32%) 
Staphylococcal bacteraemia  1  0/318 (0.00%)  1/317 (0.32%) 
Tooth abscess  1  0/318 (0.00%)  1/317 (0.32%) 
Bacterial sepsis  1  1/318 (0.31%)  0/317 (0.00%) 
Cellulitis  1  5/318 (1.57%)  0/317 (0.00%) 
Enterocolitis viral  1  1/318 (0.31%)  0/317 (0.00%) 
Gastroenteritis  1  1/318 (0.31%)  2/317 (0.63%) 
Pneumonia fungal  1  1/318 (0.31%)  0/317 (0.00%) 
Viral diarrhoea  1  1/318 (0.31%)  0/317 (0.00%) 
Viral infection  1  1/318 (0.31%)  0/317 (0.00%) 
Wound infection  1  1/318 (0.31%)  0/317 (0.00%) 
Atypical pneumonia  1  2/318 (0.63%)  0/317 (0.00%) 
Bacteraemia  1  0/318 (0.00%)  1/317 (0.32%) 
Bronchopneumonia  1  6/318 (1.89%)  3/317 (0.95%) 
Device related sepsis  1  0/318 (0.00%)  1/317 (0.32%) 
Endophthalmitis  1  0/318 (0.00%)  1/317 (0.32%) 
Febrile infection  1  1/318 (0.31%)  0/317 (0.00%) 
Herpes zoster  1  3/318 (0.94%)  2/317 (0.63%) 
Infection  1  2/318 (0.63%)  2/317 (0.63%) 
Listeriosis  1  0/318 (0.00%)  1/317 (0.32%) 
Lower respiratory tract infection  1  4/318 (1.26%)  3/317 (0.95%) 
Periodontitis  1  0/318 (0.00%)  1/317 (0.32%) 
Peritonitis  1  0/318 (0.00%)  1/317 (0.32%) 
Pharyngitis  1  1/318 (0.31%)  1/317 (0.32%) 
Pneumonia  1  35/318 (11.01%)  27/317 (8.52%) 
Septic shock  1  2/318 (0.63%)  5/317 (1.58%) 
Sinusitis  1  2/318 (0.63%)  1/317 (0.32%) 
Implant site abscess  1  0/318 (0.00%)  1/317 (0.32%) 
Influenza  1  2/318 (0.63%)  5/317 (1.58%) 
Pneumocystis jirovecii pneumonia  1  2/318 (0.63%)  1/317 (0.32%) 
Pneumonia bacterial  1  1/318 (0.31%)  0/317 (0.00%) 
Pneumonia influenzal  1  1/318 (0.31%)  2/317 (0.63%) 
Respiratory tract infection  1  10/318 (3.14%)  4/317 (1.26%) 
Sepsis  1  5/318 (1.57%)  6/317 (1.89%) 
Upper respiratory tract infection  1  2/318 (0.63%)  1/317 (0.32%) 
Bronchopulmonary aspergillosis  1  1/318 (0.31%)  0/317 (0.00%) 
Device related infection  1  1/318 (0.31%)  0/317 (0.00%) 
Infectious colitis  1  1/318 (0.31%)  0/317 (0.00%) 
Lung abscess  1  0/318 (0.00%)  1/317 (0.32%) 
Pneumococcal sepsis  1  1/318 (0.31%)  0/317 (0.00%) 
Acute sinusitis  1  0/318 (0.00%)  1/317 (0.32%) 
Arthritis bacterial  1  0/318 (0.00%)  2/317 (0.63%) 
Campylobacter gastroenteritis  1  0/318 (0.00%)  1/317 (0.32%) 
Erythema infectiosum  1  0/318 (0.00%)  1/317 (0.32%) 
Gastroenteritis viral  1  1/318 (0.31%)  4/317 (1.26%) 
H1N1 influenza  1  1/318 (0.31%)  1/317 (0.32%) 
Lobar pneumonia  1  3/318 (0.94%)  3/317 (0.95%) 
Ophthalmic herpes zoster  1  0/318 (0.00%)  1/317 (0.32%) 
Urinary tract infection enterococcal  1  0/318 (0.00%)  1/317 (0.32%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  1/318 (0.31%)  1/317 (0.32%) 
Hip fracture  1  1/318 (0.31%)  2/317 (0.63%) 
Humerus fracture  1  2/318 (0.63%)  0/317 (0.00%) 
Rib fracture  1  2/318 (0.63%)  0/317 (0.00%) 
Subdural haematoma  1  0/318 (0.00%)  1/317 (0.32%) 
Upper limb fracture  1  1/318 (0.31%)  0/317 (0.00%) 
Chemical injury  1  1/318 (0.31%)  0/317 (0.00%) 
Compression fracture  1  0/318 (0.00%)  1/317 (0.32%) 
Fall  1  1/318 (0.31%)  0/317 (0.00%) 
Ilium fracture  1  1/318 (0.31%)  0/317 (0.00%) 
Lumbar vertebral fracture  1  2/318 (0.63%)  1/317 (0.32%) 
Stenosis of vesicourethral anastomosis  1  0/318 (0.00%)  1/317 (0.32%) 
Ankle fracture  1  0/318 (0.00%)  1/317 (0.32%) 
Pelvic fracture  1  1/318 (0.31%)  1/317 (0.32%) 
Seroma  1  0/318 (0.00%)  1/317 (0.32%) 
Spinal compression fracture  1  2/318 (0.63%)  1/317 (0.32%) 
Femur fracture  1  1/318 (0.31%)  1/317 (0.32%) 
Craniocerebral injury  1  0/318 (0.00%)  2/317 (0.63%) 
Laceration  1  0/318 (0.00%)  1/317 (0.32%) 
Soft tissue injury  1  0/318 (0.00%)  1/317 (0.32%) 
Thoracic vertebral fracture  1  0/318 (0.00%)  1/317 (0.32%) 
Lip injury  1  1/318 (0.31%)  0/317 (0.00%) 
Post procedural haemorrhage  1  0/318 (0.00%)  1/317 (0.32%) 
Tendon rupture  1  0/318 (0.00%)  1/317 (0.32%) 
Traumatic fracture  1  0/318 (0.00%)  2/317 (0.63%) 
Road traffic accident  1  0/318 (0.00%)  1/317 (0.32%) 
Investigations     
International normalised ratio increased  1  1/318 (0.31%)  0/317 (0.00%) 
Laboratory test abnormal  1  0/318 (0.00%)  1/317 (0.32%) 
Blood creatinine increased  1  0/318 (0.00%)  1/317 (0.32%) 
Viral test positive  1  1/318 (0.31%)  0/317 (0.00%) 
Liver function test abnormal  1  1/318 (0.31%)  0/317 (0.00%) 
Escherichia test positive  1  1/318 (0.31%)  0/317 (0.00%) 
Haemoglobin decreased  1  0/318 (0.00%)  1/317 (0.32%) 
Clostridium test positive  1  1/318 (0.31%)  0/317 (0.00%) 
Hepatic enzyme increased  1  0/318 (0.00%)  1/317 (0.32%) 
Metabolism and nutrition disorders     
Dehydration  1  2/318 (0.63%)  1/317 (0.32%) 
Hyponatraemia  1  0/318 (0.00%)  1/317 (0.32%) 
Failure to thrive  1  1/318 (0.31%)  0/317 (0.00%) 
Hypoglycaemia  1  0/318 (0.00%)  1/317 (0.32%) 
Hypocalcaemia  1  0/318 (0.00%)  1/317 (0.32%) 
Hypokalaemia  1  1/318 (0.31%)  2/317 (0.63%) 
Hypercalcaemia  1  3/318 (0.94%)  2/317 (0.63%) 
Tumour lysis syndrome  1  0/318 (0.00%)  1/317 (0.32%) 
Decreased appetite  1  2/318 (0.63%)  1/317 (0.32%) 
Diabetes mellitus  1  1/318 (0.31%)  0/317 (0.00%) 
Hyperglycaemia  1  2/318 (0.63%)  1/317 (0.32%) 
Fluid retention  1  1/318 (0.31%)  0/317 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/318 (0.31%)  1/317 (0.32%) 
Bone pain  1  1/318 (0.31%)  0/317 (0.00%) 
Musculoskeletal pain  1  2/318 (0.63%)  0/317 (0.00%) 
Pathological fracture  1  0/318 (0.00%)  1/317 (0.32%) 
Spinal column stenosis  1  1/318 (0.31%)  0/317 (0.00%) 
Cervical spinal stenosis  1  0/318 (0.00%)  1/317 (0.32%) 
Fistula discharge  1  0/318 (0.00%)  1/317 (0.32%) 
Muscle mass  1  1/318 (0.31%)  0/317 (0.00%) 
Muscular weakness  1  2/318 (0.63%)  0/317 (0.00%) 
Musculoskeletal chest pain  1  1/318 (0.31%)  0/317 (0.00%) 
Pain in extremity  1  1/318 (0.31%)  0/317 (0.00%) 
Rhabdomyolysis  1  0/318 (0.00%)  2/317 (0.63%) 
Back pain  1  5/318 (1.57%)  5/317 (1.58%) 
Bone lesion  1  1/318 (0.31%)  0/317 (0.00%) 
Osteonecrosis of jaw  1  0/318 (0.00%)  3/317 (0.95%) 
Exostosis  1  0/318 (0.00%)  1/317 (0.32%) 
Osteonecrosis  1  1/318 (0.31%)  1/317 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/318 (0.31%)  1/317 (0.32%) 
Bladder transitional cell carcinoma  1  1/318 (0.31%)  0/317 (0.00%) 
Breast cancer  1  1/318 (0.31%)  0/317 (0.00%) 
Haemangioma of bone  1  0/318 (0.00%)  1/317 (0.32%) 
Malignant melanoma in situ  1  0/318 (0.00%)  1/317 (0.32%) 
Malignant neoplasm of unknown primary site  1  0/318 (0.00%)  1/317 (0.32%) 
Squamous cell carcinoma  1  1/318 (0.31%)  0/317 (0.00%) 
Lung neoplasm malignant  1  2/318 (0.63%)  0/317 (0.00%) 
Malignant neoplasm progression  1  5/318 (1.57%)  4/317 (1.26%) 
Myelodysplastic syndrome  1  2/318 (0.63%)  3/317 (0.95%) 
Plasmacytoma  1  2/318 (0.63%)  2/317 (0.63%) 
Prostatic adenoma  1  1/318 (0.31%)  1/317 (0.32%) 
Tumour associated fever  1  0/318 (0.00%)  1/317 (0.32%) 
Basal cell carcinoma  1  4/318 (1.26%)  3/317 (0.95%) 
Endometrial cancer  1  0/318 (0.00%)  1/317 (0.32%) 
Gastrointestinal neoplasm  1  1/318 (0.31%)  0/317 (0.00%) 
Meningioma  1  1/318 (0.31%)  0/317 (0.00%) 
Prostate cancer  1  0/318 (0.00%)  1/317 (0.32%) 
Plasma cell myeloma  1  5/318 (1.57%)  5/317 (1.58%) 
Erythroleukaemia  1  1/318 (0.31%)  0/317 (0.00%) 
Haemangioma  1  0/318 (0.00%)  1/317 (0.32%) 
Squamous cell carcinoma of skin  1  6/318 (1.89%)  2/317 (0.63%) 
Tonsil cancer  1  0/318 (0.00%)  1/317 (0.32%) 
Chronic lymphocytic leukaemia  1  1/318 (0.31%)  0/317 (0.00%) 
Lung cancer metastatic  1  0/318 (0.00%)  1/317 (0.32%) 
Malignant pleural effusion  1  1/318 (0.31%)  0/317 (0.00%) 
Mesothelioma  1  1/318 (0.31%)  0/317 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/318 (0.31%)  2/317 (0.63%) 
Hemiparesis  1  0/318 (0.00%)  1/317 (0.32%) 
Hypoaesthesia  1  1/318 (0.31%)  0/317 (0.00%) 
Syncope  1  3/318 (0.94%)  1/317 (0.32%) 
Paraesthesia  1  0/318 (0.00%)  1/317 (0.32%) 
Somnolence  1  1/318 (0.31%)  0/317 (0.00%) 
Transient ischaemic attack  1  1/318 (0.31%)  1/317 (0.32%) 
Cerebral ischaemia  1  0/318 (0.00%)  1/317 (0.32%) 
Dementia  1  1/318 (0.31%)  0/317 (0.00%) 
Dizziness  1  2/318 (0.63%)  0/317 (0.00%) 
Presyncope  1  1/318 (0.31%)  0/317 (0.00%) 
Status epilepticus  1  0/318 (0.00%)  1/317 (0.32%) 
Optic neuritis  1  1/318 (0.31%)  0/317 (0.00%) 
Encephalopathy  1  0/318 (0.00%)  2/317 (0.63%) 
Paraparesis  1  1/318 (0.31%)  1/317 (0.32%) 
Cerebral infarction  1  1/318 (0.31%)  0/317 (0.00%) 
Convulsion  1  1/318 (0.31%)  0/317 (0.00%) 
Neuropathy peripheral  1  0/318 (0.00%)  1/317 (0.32%) 
Spinal cord disorder  1  0/318 (0.00%)  1/317 (0.32%) 
Cerebral haemorrhage  1  0/318 (0.00%)  1/317 (0.32%) 
Neurological symptom  1  1/318 (0.31%)  0/317 (0.00%) 
Spinal cord compression  1  1/318 (0.31%)  2/317 (0.63%) 
Psychiatric disorders     
Completed suicide  1  1/318 (0.31%)  0/317 (0.00%) 
Depression  1  1/318 (0.31%)  0/317 (0.00%) 
Mental status changes  1  1/318 (0.31%)  0/317 (0.00%) 
Confusional state  1  4/318 (1.26%)  1/317 (0.32%) 
Renal and urinary disorders     
Haemorrhage urinary tract  1  1/318 (0.31%)  0/317 (0.00%) 
Nephrolithiasis  1  0/318 (0.00%)  1/317 (0.32%) 
Urinary retention  1  1/318 (0.31%)  3/317 (0.95%) 
Renal failure acute  1  8/318 (2.52%)  6/317 (1.89%) 
Neurogenic bladder  1  1/318 (0.31%)  0/317 (0.00%) 
Obstructive uropathy  1  1/318 (0.31%)  0/317 (0.00%) 
Renal tubular acidosis  1  1/318 (0.31%)  0/317 (0.00%) 
Prerenal failure  1  1/318 (0.31%)  0/317 (0.00%) 
Renal failure  1  4/318 (1.26%)  5/317 (1.58%) 
Renal impairment  1  2/318 (0.63%)  0/317 (0.00%) 
Urinary tract obstruction  1  0/318 (0.00%)  1/317 (0.32%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/318 (0.00%)  1/317 (0.32%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/318 (0.31%)  0/317 (0.00%) 
Pulmonary alveolar haemorrhage  1  1/318 (0.31%)  0/317 (0.00%) 
Obliterative bronchiolitis  1  1/318 (0.31%)  0/317 (0.00%) 
Cough  1  1/318 (0.31%)  0/317 (0.00%) 
Dyspnoea  1  4/318 (1.26%)  4/317 (1.26%) 
Haemoptysis  1  0/318 (0.00%)  1/317 (0.32%) 
Organising pneumonia  1  1/318 (0.31%)  0/317 (0.00%) 
Pleural effusion  1  2/318 (0.63%)  1/317 (0.32%) 
Respiratory failure  1  1/318 (0.31%)  1/317 (0.32%) 
Acute respiratory failure  1  1/318 (0.31%)  0/317 (0.00%) 
Bronchial disorder  1  0/318 (0.00%)  1/317 (0.32%) 
Chronic obstructive pulmonary disease  1  3/318 (0.94%)  1/317 (0.32%) 
Lung disorder  1  4/318 (1.26%)  1/317 (0.32%) 
Bronchial hyperreactivity  1  1/318 (0.31%)  0/317 (0.00%) 
Pneumonitis  1  1/318 (0.31%)  2/317 (0.63%) 
Pulmonary embolism  1  10/318 (3.14%)  8/317 (2.52%) 
Hypoxia  1  0/318 (0.00%)  1/317 (0.32%) 
Interstitial lung disease  1  0/318 (0.00%)  2/317 (0.63%) 
Acute pulmonary oedema  1  0/318 (0.00%)  1/317 (0.32%) 
Asthma  1  1/318 (0.31%)  0/317 (0.00%) 
Skin and subcutaneous tissue disorders     
Pustular psoriasis  1  1/318 (0.31%)  0/317 (0.00%) 
Skin haemorrhage  1  1/318 (0.31%)  0/317 (0.00%) 
Rash maculo-papular  1  1/318 (0.31%)  0/317 (0.00%) 
Skin ulcer  1  0/318 (0.00%)  1/317 (0.32%) 
Surgical and medical procedures     
Skin neoplasm excision  1  1/318 (0.31%)  0/317 (0.00%) 
Vascular disorders     
Aortic aneurysm rupture  1  1/318 (0.31%)  0/317 (0.00%) 
Orthostatic hypotension  1  0/318 (0.00%)  1/317 (0.32%) 
Thrombosis  1  0/318 (0.00%)  1/317 (0.32%) 
Deep vein thrombosis  1  5/318 (1.57%)  4/317 (1.26%) 
Subclavian vein thrombosis  1  1/318 (0.31%)  0/317 (0.00%) 
Thrombophlebitis  1  0/318 (0.00%)  2/317 (0.63%) 
Peripheral ischaemia  1  1/318 (0.31%)  0/317 (0.00%) 
Thrombophlebitis superficial  1  0/318 (0.00%)  1/317 (0.32%) 
Embolism  1  0/318 (0.00%)  1/317 (0.32%) 
Hypotension  1  1/318 (0.31%)  1/317 (0.32%) 
Peripheral artery thrombosis  1  1/318 (0.31%)  0/317 (0.00%) 
Venous thrombosis  1  0/318 (0.00%)  1/317 (0.32%) 
Pelvic venous thrombosis  1  1/318 (0.31%)  0/317 (0.00%) 
Venous thrombosis limb  1  1/318 (0.31%)  0/317 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   313/318 (98.43%)   309/317 (97.48%) 
Blood and lymphatic system disorders     
Leukopenia  1  24/318 (7.55%)  25/317 (7.89%) 
Neutropenia  1  107/318 (33.65%)  135/317 (42.59%) 
Anaemia  1  122/318 (38.36%)  116/317 (36.59%) 
Thrombocytopenia  1  84/318 (26.42%)  72/317 (22.71%) 
Lymphopenia  1  42/318 (13.21%)  22/317 (6.94%) 
Eye disorders     
Vision blurred  1  27/318 (8.49%)  16/317 (5.05%) 
Cataract  1  38/318 (11.95%)  20/317 (6.31%) 
Gastrointestinal disorders     
Abdominal pain  1  38/318 (11.95%)  27/317 (8.52%) 
Constipation  1  113/318 (35.53%)  85/317 (26.81%) 
Dyspepsia  1  32/318 (10.06%)  19/317 (5.99%) 
Stomatitis  1  27/318 (8.49%)  14/317 (4.42%) 
Vomiting  1  46/318 (14.47%)  27/317 (8.52%) 
Nausea  1  76/318 (23.90%)  68/317 (21.45%) 
Abdominal pain upper  1  22/318 (6.92%)  17/317 (5.36%) 
Diarrhoea  1  148/318 (46.54%)  111/317 (35.02%) 
General disorders     
Oedema peripheral  1  82/318 (25.79%)  70/317 (22.08%) 
Chest pain  1  25/318 (7.86%)  11/317 (3.47%) 
Influenza like illness  1  19/318 (5.97%)  15/317 (4.73%) 
Pyrexia  1  111/318 (34.91%)  70/317 (22.08%) 
Asthenia  1  69/318 (21.70%)  53/317 (16.72%) 
Chills  1  24/318 (7.55%)  12/317 (3.79%) 
Fatigue  1  149/318 (46.86%)  123/317 (38.80%) 
Malaise  1  17/318 (5.35%)  11/317 (3.47%) 
Infections and infestations     
Bronchitis  1  50/318 (15.72%)  47/317 (14.83%) 
Nasopharyngitis  1  78/318 (24.53%)  61/317 (19.24%) 
Urinary tract infection  1  25/318 (7.86%)  30/317 (9.46%) 
Rhinitis  1  23/318 (7.23%)  12/317 (3.79%) 
Herpes zoster  1  16/318 (5.03%)  7/317 (2.21%) 
Lower respiratory tract infection  1  24/318 (7.55%)  15/317 (4.73%) 
Pharyngitis  1  16/318 (5.03%)  11/317 (3.47%) 
Pneumonia  1  19/318 (5.97%)  14/317 (4.42%) 
Sinusitis  1  19/318 (5.97%)  14/317 (4.42%) 
Influenza  1  18/318 (5.66%)  17/317 (5.36%) 
Respiratory tract infection  1  27/318 (8.49%)  28/317 (8.83%) 
Upper respiratory tract infection  1  72/318 (22.64%)  55/317 (17.35%) 
Oral herpes  1  17/318 (5.35%)  13/317 (4.10%) 
Injury, poisoning and procedural complications     
Contusion  1  36/318 (11.32%)  26/317 (8.20%) 
Investigations     
Blood creatinine increased  1  30/318 (9.43%)  21/317 (6.62%) 
Aspartate aminotransferase increased  1  20/318 (6.29%)  28/317 (8.83%) 
Weight decreased  1  44/318 (13.84%)  19/317 (5.99%) 
Alanine aminotransferase increased  1  24/318 (7.55%)  32/317 (10.09%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  19/318 (5.97%)  11/317 (3.47%) 
Hypomagnesaemia  1  16/318 (5.03%)  6/317 (1.89%) 
Hypocalcaemia  1  43/318 (13.52%)  31/317 (9.78%) 
Hypokalaemia  1  53/318 (16.67%)  46/317 (14.51%) 
Decreased appetite  1  66/318 (20.75%)  39/317 (12.30%) 
Hyperglycaemia  1  55/318 (17.30%)  43/317 (13.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  52/318 (16.35%)  39/317 (12.30%) 
Bone pain  1  32/318 (10.06%)  40/317 (12.62%) 
Musculoskeletal pain  1  40/318 (12.58%)  28/317 (8.83%) 
Myalgia  1  22/318 (6.92%)  23/317 (7.26%) 
Muscle spasms  1  95/318 (29.87%)  84/317 (26.50%) 
Neck pain  1  16/318 (5.03%)  11/317 (3.47%) 
Muscular weakness  1  35/318 (11.01%)  25/317 (7.89%) 
Musculoskeletal chest pain  1  31/318 (9.75%)  26/317 (8.20%) 
Pain in extremity  1  52/318 (16.35%)  32/317 (10.09%) 
Back pain  1  88/318 (27.67%)  87/317 (27.44%) 
Nervous system disorders     
Hypoaesthesia  1  21/318 (6.60%)  11/317 (3.47%) 
Headache  1  49/318 (15.41%)  24/317 (7.57%) 
Paraesthesia  1  32/318 (10.06%)  28/317 (8.83%) 
Peripheral sensory neuropathy  1  29/318 (9.12%)  35/317 (11.04%) 
Dizziness  1  43/318 (13.52%)  37/317 (11.67%) 
Tremor  1  29/318 (9.12%)  29/317 (9.15%) 
Dysgeusia  1  32/318 (10.06%)  20/317 (6.31%) 
Neuropathy peripheral  1  45/318 (14.15%)  26/317 (8.20%) 
Psychiatric disorders     
Mood altered  1  22/318 (6.92%)  8/317 (2.52%) 
Depression  1  16/318 (5.03%)  14/317 (4.42%) 
Insomnia  1  73/318 (22.96%)  82/317 (25.87%) 
Anxiety  1  23/318 (7.23%)  21/317 (6.62%) 
Confusional state  1  17/318 (5.35%)  10/317 (3.15%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea exertional  1  18/318 (5.66%)  13/317 (4.10%) 
Epistaxis  1  18/318 (5.66%)  19/317 (5.99%) 
Oropharyngeal pain  1  32/318 (10.06%)  14/317 (4.42%) 
Cough  1  100/318 (31.45%)  57/317 (17.98%) 
Dyspnoea  1  66/318 (20.75%)  58/317 (18.30%) 
Productive cough  1  19/318 (5.97%)  4/317 (1.26%) 
Dysphonia  1  24/318 (7.55%)  30/317 (9.46%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  32/318 (10.06%)  28/317 (8.83%) 
Rash  1  58/318 (18.24%)  58/317 (18.30%) 
Hyperhidrosis  1  37/318 (11.64%)  22/317 (6.94%) 
Erythema  1  22/318 (6.92%)  17/317 (5.36%) 
Night sweats  1  22/318 (6.92%)  9/317 (2.84%) 
Vascular disorders     
Hypertension  1  29/318 (9.12%)  19/317 (5.99%) 
Deep vein thrombosis  1  19/318 (5.97%)  9/317 (2.84%) 
Hypotension  1  29/318 (9.12%)  11/317 (3.47%) 
Flushing  1  16/318 (5.03%)  6/317 (1.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01239797     History of Changes
Other Study ID Numbers: CA204-004
2010-020347-12 ( EudraCT Number )
First Submitted: November 8, 2010
First Posted: November 11, 2010
Results First Submitted: August 4, 2016
Results First Posted: January 5, 2017
Last Update Posted: November 1, 2018