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Trial record 77 of 1320 for:    Hematologic neoplasm

A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00742560
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hematologic Cancer
Interventions Biological: elotuzumab
Drug: lenalidomide
Drug: dexamethasone oral
Drug: dexamethasone injection
Enrollment 101
Recruitment Details  
Pre-assignment Details A total of 101 participants were randomized (intent-to-treat [ITT] population); 1 subject did not receive study drug and is excluded from the analyses.
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Hide Arm/Group Description Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Period Title: Overall Study
Started [1] 3 3 22 36 37
Completed 0 0 0 0 0
Not Completed 3 3 22 36 37
Reason Not Completed
Adverse Event             0             0             1             1             1
Death             0             2             0             2             3
Subject's Decision             1             0             2             3             3
Investigator's Decision             0             0             4             1             0
Disease Progression             1             0             5             17             16
New Multiple Myeloma Therapy             1             0             2             3             4
Not Specified             0             1             8             9             9
MIssing             0             0             0             0             1
[1]
Safety population: all randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Total
Hide Arm/Group Description Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Total of all reporting groups
Overall Number of Baseline Participants 3 3 22 36 37 101
Hide Baseline Analysis Population Description
Safety population: all randomized participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 22 participants 36 participants 37 participants 101 participants
68.3  (7.23) 64.7  (6.94) 59.3  (10.87) 60.6  (9.70) 63.3  (9.76) 61.7  (9.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 22 participants 36 participants 37 participants 101 participants
Female
2
  66.7%
1
  33.3%
10
  45.5%
19
  52.8%
24
  64.9%
56
  55.4%
Male
1
  33.3%
2
  66.7%
12
  54.5%
17
  47.2%
13
  35.1%
45
  44.6%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)
Hide Description MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity [DLT]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets < 10,000 cells/mm^3 that do not recover to 25,000 cells/mm^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the safety population (all randomized participants who received at least 1 dose of study drug) in the escalation cohorts (Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; and Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone [Phase 1]).
Arm/Group Title Phase 1 Elotuzumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: mg/kg
20
2.Primary Outcome
Title Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)
Hide Description ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).
Time Frame From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
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Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Total (Phase 2)
Hide Arm/Group Description:
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 36 37 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.7
(77.5 to 98.2)
75.7
(58.8 to 88.2)
83.6
(73.0 to 91.2)
3.Secondary Outcome
Title Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)
Hide Description ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).
Time Frame From first dose of elotuzumab until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months
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Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Total (Phase 1)
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 3 3 22 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(29.2 to 100.0)
100
(29.2 to 100.0)
77.3
(54.6 to 92.2)
82.1
(63.1 to 93.9)
4.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)
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Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 3 3 22 36 37
Measure Type: Number
Unit of Measure: participants
Any TEAE 3 3 22 36 37
Any TESAE 0 3 12 21 21
TEAEs ≥ Grade 3 2 3 19 32 25
TEAEs related to study drug 3 3 16 29 26
TESAEs related to study drug 0 0 2 2 5
5.Secondary Outcome
Title Number of Participants With Infusion Reactions
Hide Description During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).
Time Frame Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 3 3 22 36 37
Measure Type: Number
Unit of Measure: participants
Any reaction 2 3 20 5 3
Grade 5 0 0 0 0 0
Grade 4 0 0 1 0 0
Grade 3 0 0 2 1 0
Grade 2 0 1 5 1 1
Grade 1 2 2 12 3 2
6.Secondary Outcome
Title Mean Serum Concentrations of Elotuzumab During Cycle 1
Hide Description Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose.
Time Frame Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point.
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Overall Number of Participants Analyzed 3 39 58
Mean (Standard Deviation)
Unit of Measure: μg/mL
Day 1: 0 hours Number Analyzed 3 participants 39 participants 58 participants
0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
Day 1: 0.5 hours Number Analyzed 3 participants 39 participants 57 participants
78.48  (21.33) 217.90  (99.31) 434.20  (202.74)
Day 1: 2 hours Number Analyzed 0 participants 36 participants 43 participants
213.31  (91.30) 388.58  (112.94)
Day 1: 4 hours Number Analyzed 3 participants 3 participants 12 participants
85.56  (23.54) 251.34  (31.92) 525.98  (188.46)
Day 8: 0 hours Number Analyzed 3 participants 37 participants 55 participants
32.44  (8.91) 92.47  (61.16) 168.55  (56.43)
Day 8: 0.5 hours Number Analyzed 3 participants 22 participants 44 participants
133.37  (40.87) 281.53  (117.35) 593.80  (192.70)
Day 8: 2 hours Number Analyzed 0 participants 12 participants 9 participants
268.35  (107.44) 520.97  (207.28)
Day 15: 0 hours Number Analyzed 3 participants 37 participants 58 participants
49.84  (28.28) 111.11  (56.36) 298.82  (231.17)
Day 15: 0.5 hours Number Analyzed 3 participants 36 participants 55 participants
140.09  (32.28) 282.29  (100.29) 661.91  (251.08)
Day 22: 0 hours Number Analyzed 3 participants 38 participants 54 participants
61.93  (53.66) 135.92  (106.83) 308.02  (144.61)
Day 22: 0.5 hours Number Analyzed 3 participants 38 participants 54 participants
168.61  (59.31) 310.03  (165.14) 699.70  (230.41)
Day 22: 2 hours Number Analyzed 1 participants 35 participants 40 participants
268.53 [1]   (NA) 298.85  (114.35) 704.48  (234.98)
Day 22: 4 hours Number Analyzed 2 participants 3 participants 10 participants
128.94  (42.04) 538.88  (195.35) 981.16  (280.28)
[1]
The estimated standard deviation of one sample is undefined
7.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of Elotuzumab
Hide Description The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.
Time Frame Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab
Hide Description The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.
Time Frame Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Systemic Clearance (CL) of Elotuzumab
Hide Description Systemic clearance (CL, measured in mL/kg/hr) is a measure of the efficiency with which a drug is irreversibly removed from the body. The CL of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.
Time Frame Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Volume of Distribution (V) of Elotuzumab
Hide Description Volume of distribution (V, measured in L/kg) is the hypothetical volume of body fluid that would be required to dissolve the amount of drug needed to achieve the same concentration in the blood. The V of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.
Time Frame Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Serum Half-life (t1/2) of Elotuzumab
Hide Description The serum half-life of a drug (t1/2, measured in hours) is the time necessary to reduce the plasma concentration by half. The t1/2 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.
Time Frame Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 5 mg/kg Administered as an IV Infusion in Combinati Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided.
Time Frame From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Total (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Total (Phase 2)
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
Overall Number of Participants Analyzed 3 3 22 28 36 37 73
Median (95% Confidence Interval)
Unit of Measure: months
4.47
(1.45 to 4.47)
9.92 [1] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
34.83 [1] 
(14.6 to NA)
29.01 [1] 
(15.0 to NA)
29.24 [1] 
(18.2 to NA)
[1]
NA=Not calculable due to insufficient response events
[2]
NA=Median was not reached (max value was 58.22)
13.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression. The distribution of TTP was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the TTP distribution are provided.
Time Frame From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Total (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Total (Phase 2)
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 3 3 22 28 36 37 73
Median (95% Confidence Interval)
Unit of Measure: months
6.08
(6.05 to 6.08)
11.53 [1] 
(NA to NA)
52.93 [1] 
(7.43 to NA)
52.93 [1] 
(7.43 to NA)
32.49 [1] 
(14.9 to NA)
19.94
(12.9 to 35.7)
28.16
(15.4 to 35.8)
[1]
NA=Not calculable due to insufficient progression events
14.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided.
Time Frame From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Total (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat Total (Phase 2)
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 3 3 22 28 36 37 73
Median (95% Confidence Interval)
Unit of Measure: months
6.08
(6.05 to 6.08)
22.23
(11.5 to 32.9)
NA [1] 
(NA to NA)
32.92 [2] 
(7.43 to NA)
32.49 [2] 
(14.9 to NA)
25.00
(14.0 to 35.7)
28.62
(16.6 to 43.1)
[1]
NA=Median was not reached (max value was 58.91)
[2]
NA=Not calculable due to insufficient survival events
15.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)
Hide Description Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided.
Time Frame From screening through 60-day follow up period (up to 101 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and with at least one evaluable post-dose sample.
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 3 39 57
Measure Type: Number
Unit of Measure: percentage of participants
0 6 5
16.Secondary Outcome
Title Plasma Cell Myeloma Cytogenetic Subtype
Hide Description Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System [ISS] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age < 55).
Time Frame Screening (up to 14 days prior to dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Hide Arm/Group Description:
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Overall Number of Participants Analyzed 3 3 22 36 37
Measure Type: Number
Unit of Measure: participants
High Risk 1 0 0 1 3
Standard Risk 2 3 17 30 24
Low Risk 0 0 3 2 3
Not Reported 0 0 2 3 7
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
 
Arm/Group Title Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Hide Arm/Group Description Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
All-Cause Mortality
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   3/3 (100.00%)   12/22 (54.55%)   21/36 (58.33%)   21/37 (56.76%) 
Blood and lymphatic system disorders           
FEBRILE NEUTROPENIA  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  1/36 (2.78%)  2/37 (5.41%) 
LYMPHOPENIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
NEUTROPENIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  1/37 (2.70%) 
PANCYTOPENIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Cardiac disorders           
ANGINA PECTORIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
ATRIAL FIBRILLATION  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  0/36 (0.00%)  1/37 (2.70%) 
BRADYCARDIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
TACHYCARDIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Gastrointestinal disorders           
CONSTIPATION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
DIARRHOEA  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
DIVERTICULAR PERFORATION  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
GASTROINTESTINAL PERFORATION  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
HAEMATEMESIS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
NAUSEA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
VARICES OESOPHAGEAL  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
VOMITING  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
General disorders           
CHEST PAIN  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  1/37 (2.70%) 
MULTIPLE ORGAN DYSFUNCTION SYNDROME  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
PYREXIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
Hepatobiliary disorders           
CHOLECYSTITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Immune system disorders           
ANAPHYLACTIC REACTION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
Infections and infestations           
ASPERGILLUS INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
BRONCHITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
CELLULITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
H1N1 INFLUENZA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
HERPES ZOSTER  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
INFLUENZA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
LOCALISED INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
LUNG INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
MENINGITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
PNEUMONIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  4/36 (11.11%)  5/37 (13.51%) 
PNEUMONIA KLEBSIELLA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
PNEUMONIA VIRAL  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
POSTOPERATIVE WOUND INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
PYELONEPHRITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
SEPSIS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  2/37 (5.41%) 
URINARY TRACT INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
VISCERAL LEISHMANIASIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Injury, poisoning and procedural complications           
GASTROENTERITIS RADIATION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
Metabolism and nutrition disorders           
ELECTROLYTE IMBALANCE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
HYPERCALCAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
HYPOKALAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
METABOLIC ACIDOSIS  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders           
ARTHRALGIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
BACK PAIN  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
BONE PAIN  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
MUSCULOSKELETAL PAIN  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
PAIN IN EXTREMITY  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
BLADDER TRANSITIONAL CELL CARCINOMA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
LOBULAR BREAST CARCINOMA IN SITU  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
MALIGNANT MELANOMA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
MYELODYSPLASTIC SYNDROME  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  1/37 (2.70%) 
PROSTATE CANCER  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
SQUAMOUS CELL CARCINOMA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  1/37 (2.70%) 
Nervous system disorders           
CEREBROVASCULAR ACCIDENT  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
GENERALISED TONIC-CLONIC SEIZURE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
SYNCOPE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
TRANSIENT GLOBAL AMNESIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  1/37 (2.70%) 
Psychiatric disorders           
CONFUSIONAL STATE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
Renal and urinary disorders           
ACUTE KIDNEY INJURY  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
RENAL COLIC  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
RENAL FAILURE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
Reproductive system and breast disorders           
BENIGN PROSTATIC HYPERPLASIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
PROSTATITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders           
ACUTE RESPIRATORY FAILURE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
ASTHMA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
LUNG DISORDER  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  1/36 (2.78%)  0/37 (0.00%) 
PNEUMONITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
PULMONARY EMBOLISM  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  1/36 (2.78%)  1/37 (2.70%) 
STRIDOR  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders           
RASH  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Vascular disorders           
ACCELERATED HYPERTENSION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
DEEP VEIN THROMBOSIS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  1/37 (2.70%) 
PHLEBITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
PHLEBITIS SUPERFICIAL  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   22/22 (100.00%)   36/36 (100.00%)   37/37 (100.00%) 
Blood and lymphatic system disorders           
ANAEMIA  1  2/3 (66.67%)  2/3 (66.67%)  10/22 (45.45%)  17/36 (47.22%)  13/37 (35.14%) 
FEBRILE NEUTROPENIA  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  2/36 (5.56%)  3/37 (8.11%) 
HAEMOGLOBINAEMIA  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
INCREASED TENDENCY TO BRUISE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
IRON DEFICIENCY ANAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
LEUKOPENIA  1  1/3 (33.33%)  1/3 (33.33%)  2/22 (9.09%)  8/36 (22.22%)  6/37 (16.22%) 
LYMPHADENOPATHY  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  2/37 (5.41%) 
LYMPHOPENIA  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  12/36 (33.33%)  8/37 (21.62%) 
NEUTROPENIA  1  2/3 (66.67%)  3/3 (100.00%)  7/22 (31.82%)  12/36 (33.33%)  9/37 (24.32%) 
PANCYTOPENIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  3/37 (8.11%) 
THROMBOCYTOPENIA  1  1/3 (33.33%)  2/3 (66.67%)  5/22 (22.73%)  12/36 (33.33%)  10/37 (27.03%) 
Cardiac disorders           
ATRIAL FIBRILLATION  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  1/36 (2.78%)  3/37 (8.11%) 
PALPITATIONS  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  2/37 (5.41%) 
Ear and labyrinth disorders           
HYPOACUSIS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  1/36 (2.78%)  3/37 (8.11%) 
TINNITUS  1  1/3 (33.33%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
VERTIGO  1  1/3 (33.33%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  3/37 (8.11%) 
Eye disorders           
CATARACT  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  4/36 (11.11%)  6/37 (16.22%) 
DRY EYE  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  2/37 (5.41%) 
EYE IRRITATION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  3/37 (8.11%) 
OCULAR HYPERAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  3/37 (8.11%) 
VISION BLURRED  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  9/36 (25.00%)  5/37 (13.51%) 
VISUAL ACUITY REDUCED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  1/37 (2.70%) 
VITREOUS FLOATERS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  2/37 (5.41%) 
Gastrointestinal disorders           
ABDOMINAL DISTENSION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  4/36 (11.11%)  2/37 (5.41%) 
ABDOMINAL PAIN  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  7/36 (19.44%)  7/37 (18.92%) 
ABDOMINAL PAIN UPPER  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  5/36 (13.89%)  4/37 (10.81%) 
CONSTIPATION  1  1/3 (33.33%)  2/3 (66.67%)  11/22 (50.00%)  18/36 (50.00%)  19/37 (51.35%) 
DIARRHOEA  1  1/3 (33.33%)  2/3 (66.67%)  14/22 (63.64%)  24/36 (66.67%)  25/37 (67.57%) 
DIVERTICULAR PERFORATION  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
DRY MOUTH  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  2/37 (5.41%) 
DYSPEPSIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  8/36 (22.22%)  2/37 (5.41%) 
FLATULENCE  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  1/37 (2.70%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
GASTROINTESTINAL MOTILITY DISORDER  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  0/36 (0.00%)  0/37 (0.00%) 
GASTROINTESTINAL PERFORATION  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  4/37 (10.81%) 
HAEMATOCHEZIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  0/37 (0.00%) 
HAEMORRHOIDS  1  0/3 (0.00%)  1/3 (33.33%)  2/22 (9.09%)  2/36 (5.56%)  1/37 (2.70%) 
NAUSEA  1  0/3 (0.00%)  3/3 (100.00%)  11/22 (50.00%)  18/36 (50.00%)  17/37 (45.95%) 
PARAESTHESIA ORAL  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  0/37 (0.00%) 
STOMATITIS  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  3/36 (8.33%)  1/37 (2.70%) 
TOOTH DISORDER  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
TOOTHACHE  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  3/36 (8.33%)  0/37 (0.00%) 
VOMITING  1  0/3 (0.00%)  0/3 (0.00%)  6/22 (27.27%)  11/36 (30.56%)  6/37 (16.22%) 
General disorders           
ASTHENIA  1  0/3 (0.00%)  1/3 (33.33%)  6/22 (27.27%)  7/36 (19.44%)  12/37 (32.43%) 
CHEST DISCOMFORT  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  1/36 (2.78%)  2/37 (5.41%) 
CHEST PAIN  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  3/37 (8.11%) 
CHILLS  1  2/3 (66.67%)  2/3 (66.67%)  1/22 (4.55%)  6/36 (16.67%)  2/37 (5.41%) 
FATIGUE  1  1/3 (33.33%)  2/3 (66.67%)  15/22 (68.18%)  24/36 (66.67%)  18/37 (48.65%) 
FEELING HOT  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
GAIT DISTURBANCE  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  2/37 (5.41%) 
INFLAMMATION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  0/37 (0.00%) 
IRRITABILITY  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
NON-CARDIAC CHEST PAIN  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  5/36 (13.89%)  2/37 (5.41%) 
OEDEMA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  5/36 (13.89%)  1/37 (2.70%) 
OEDEMA PERIPHERAL  1  0/3 (0.00%)  1/3 (33.33%)  6/22 (27.27%)  14/36 (38.89%)  9/37 (24.32%) 
PAIN  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  1/36 (2.78%)  5/37 (13.51%) 
PERIPHERAL SWELLING  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  5/36 (13.89%)  7/37 (18.92%) 
PYREXIA  1  0/3 (0.00%)  0/3 (0.00%)  10/22 (45.45%)  14/36 (38.89%)  17/37 (45.95%) 
Hepatobiliary disorders           
HYPERBILIRUBINAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  0/37 (0.00%) 
Immune system disorders           
DRUG HYPERSENSITIVITY  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
SEASONAL ALLERGY  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  3/36 (8.33%)  0/37 (0.00%) 
Infections and infestations           
BRONCHITIS  1  0/3 (0.00%)  0/3 (0.00%)  5/22 (22.73%)  8/36 (22.22%)  10/37 (27.03%) 
CELLULITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  4/36 (11.11%)  4/37 (10.81%) 
CONJUNCTIVITIS  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  1/36 (2.78%)  2/37 (5.41%) 
EAR INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
FUNGAL INFECTION  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
GASTROENTERITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  3/37 (8.11%) 
GASTROENTERITIS VIRAL  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  0/37 (0.00%) 
GINGIVITIS  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  1/36 (2.78%)  0/37 (0.00%) 
HERPES ZOSTER  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  4/36 (11.11%)  0/37 (0.00%) 
INFLUENZA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  8/36 (22.22%)  3/37 (8.11%) 
LOCALISED INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  2/37 (5.41%) 
LUNG INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  3/37 (8.11%) 
NASOPHARYNGITIS  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  10/36 (27.78%)  9/37 (24.32%) 
ORAL CANDIDIASIS  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  1/36 (2.78%)  5/37 (13.51%) 
ORAL HERPES  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
PHARYNGITIS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  2/37 (5.41%) 
PNEUMONIA  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  7/36 (19.44%)  9/37 (24.32%) 
PNEUMONIA VIRAL  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
RHINITIS  1  1/3 (33.33%)  0/3 (0.00%)  1/22 (4.55%)  5/36 (13.89%)  8/37 (21.62%) 
SEPSIS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  2/37 (5.41%) 
SINUSITIS  1  1/3 (33.33%)  0/3 (0.00%)  3/22 (13.64%)  5/36 (13.89%)  3/37 (8.11%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/3 (0.00%)  1/3 (33.33%)  7/22 (31.82%)  19/36 (52.78%)  15/37 (40.54%) 
UPPER RESPIRATORY TRACT INFECTION BACTERIAL  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
URINARY TRACT INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  6/36 (16.67%)  5/37 (13.51%) 
VIRAL INFECTION  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  2/37 (5.41%) 
Injury, poisoning and procedural complications           
ARTHROPOD BITE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
CONTUSION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  4/36 (11.11%)  4/37 (10.81%) 
FALL  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  5/36 (13.89%)  4/37 (10.81%) 
JOINT DISLOCATION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
LIGAMENT SPRAIN  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
SKIN ABRASION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  2/37 (5.41%) 
STOMA SITE PAIN  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
SUNBURN  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  0/37 (0.00%) 
Investigations           
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
ALANINE AMINOTRANSFERASE INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  5/36 (13.89%)  4/37 (10.81%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  4/37 (10.81%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  3/36 (8.33%)  1/37 (2.70%) 
BLOOD BICARBONATE DECREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  7/36 (19.44%)  4/37 (10.81%) 
BLOOD CREATININE INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  5/36 (13.89%)  4/37 (10.81%) 
BLOOD LACTATE DEHYDROGENASE INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  4/36 (11.11%)  1/37 (2.70%) 
BLOOD MAGNESIUM DECREASED  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  0/37 (0.00%) 
BLOOD PHOSPHORUS DECREASED  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
BLOOD POTASSIUM DECREASED  1  0/3 (0.00%)  1/3 (33.33%)  1/22 (4.55%)  0/36 (0.00%)  0/37 (0.00%) 
BLOOD UREA INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  2/37 (5.41%) 
CARDIAC MURMUR  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  1/37 (2.70%) 
EJECTION FRACTION DECREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
IMMUNOGLOBULINS DECREASED  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
INTERNATIONAL NORMALISED RATIO INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  1/37 (2.70%) 
NEUTROPHIL COUNT INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  1/37 (2.70%) 
PROTEIN TOTAL INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
PROTHROMBIN TIME PROLONGED  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
WEIGHT DECREASED  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  7/36 (19.44%)  4/37 (10.81%) 
WEIGHT INCREASED  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  1/36 (2.78%)  3/37 (8.11%) 
WHITE BLOOD CELL COUNT DECREASED  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  2/37 (5.41%) 
Metabolism and nutrition disorders           
DECREASED APPETITE  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  10/36 (27.78%)  8/37 (21.62%) 
DEHYDRATION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  2/37 (5.41%) 
DIABETES MELLITUS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  2/37 (5.41%) 
GOUT  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  2/37 (5.41%) 
HYPERCALCAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  3/37 (8.11%) 
HYPERGLYCAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  9/36 (25.00%)  12/37 (32.43%) 
HYPERKALAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  1/37 (2.70%) 
HYPERNATRAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  0/37 (0.00%) 
HYPOALBUMINAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  5/36 (13.89%)  3/37 (8.11%) 
HYPOCALCAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  3/37 (8.11%) 
HYPOKALAEMIA  1  0/3 (0.00%)  1/3 (33.33%)  6/22 (27.27%)  7/36 (19.44%)  7/37 (18.92%) 
HYPOMAGNESAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  2/37 (5.41%) 
HYPONATRAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  2/37 (5.41%) 
HYPOPHOSPHATAEMIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  5/37 (13.51%) 
METABOLIC ACIDOSIS  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
VITAMIN D DEFICIENCY  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  3/37 (8.11%) 
Musculoskeletal and connective tissue disorders           
ARTHRALGIA  1  0/3 (0.00%)  2/3 (66.67%)  7/22 (31.82%)  12/36 (33.33%)  8/37 (21.62%) 
BACK PAIN  1  0/3 (0.00%)  1/3 (33.33%)  7/22 (31.82%)  17/36 (47.22%)  14/37 (37.84%) 
BONE PAIN  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  4/36 (11.11%)  8/37 (21.62%) 
MUSCLE SPASMS  1  1/3 (33.33%)  1/3 (33.33%)  10/22 (45.45%)  22/36 (61.11%)  23/37 (62.16%) 
MUSCULAR WEAKNESS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  1/37 (2.70%) 
MUSCULOSKELETAL CHEST PAIN  1  0/3 (0.00%)  0/3 (0.00%)  5/22 (22.73%)  4/36 (11.11%)  3/37 (8.11%) 
MUSCULOSKELETAL DISCOMFORT  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
MUSCULOSKELETAL PAIN  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  6/36 (16.67%)  4/37 (10.81%) 
MUSCULOSKELETAL STIFFNESS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
MYALGIA  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  6/36 (16.67%)  1/37 (2.70%) 
NECK PAIN  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  4/36 (11.11%)  3/37 (8.11%) 
OSTEONECROSIS OF JAW  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
PAIN IN EXTREMITY  1  0/3 (0.00%)  1/3 (33.33%)  5/22 (22.73%)  10/36 (27.78%)  13/37 (35.14%) 
PAIN IN JAW  1  1/3 (33.33%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  1/37 (2.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
BASAL CELL CARCINOMA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  2/37 (5.41%) 
Nervous system disorders           
AMNESIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  0/36 (0.00%)  2/37 (5.41%) 
BALANCE DISORDER  1  1/3 (33.33%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  1/37 (2.70%) 
CARPAL TUNNEL SYNDROME  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  0/36 (0.00%)  0/37 (0.00%) 
DISTURBANCE IN ATTENTION  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  0/36 (0.00%)  0/37 (0.00%) 
DIZZINESS  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  12/36 (33.33%)  7/37 (18.92%) 
DYSGEUSIA  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  9/36 (25.00%)  6/37 (16.22%) 
HEADACHE  1  1/3 (33.33%)  0/3 (0.00%)  5/22 (22.73%)  14/36 (38.89%)  7/37 (18.92%) 
HYPOAESTHESIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  5/36 (13.89%)  3/37 (8.11%) 
HYPOGEUSIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
MEMORY IMPAIRMENT  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  2/37 (5.41%) 
NEURALGIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
NEUROPATHY PERIPHERAL  1  0/3 (0.00%)  0/3 (0.00%)  7/22 (31.82%)  8/36 (22.22%)  7/37 (18.92%) 
PARAESTHESIA  1  1/3 (33.33%)  0/3 (0.00%)  3/22 (13.64%)  6/36 (16.67%)  3/37 (8.11%) 
PERIPHERAL SENSORY NEUROPATHY  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  5/37 (13.51%) 
PSYCHOMOTOR HYPERACTIVITY  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  0/37 (0.00%) 
SCIATICA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
SINUS HEADACHE  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  1/37 (2.70%) 
SOMNOLENCE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
SYNCOPE  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  6/36 (16.67%)  1/37 (2.70%) 
TREMOR  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  5/37 (13.51%) 
Psychiatric disorders           
AGGRESSION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
ANXIETY  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  5/36 (13.89%)  1/37 (2.70%) 
CONFUSIONAL STATE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  3/37 (8.11%) 
DEPRESSED MOOD  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  1/37 (2.70%) 
DEPRESSION  1  1/3 (33.33%)  0/3 (0.00%)  2/22 (9.09%)  4/36 (11.11%)  3/37 (8.11%) 
INSOMNIA  1  2/3 (66.67%)  1/3 (33.33%)  7/22 (31.82%)  10/36 (27.78%)  15/37 (40.54%) 
MOOD SWINGS  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  1/36 (2.78%)  2/37 (5.41%) 
Renal and urinary disorders           
ACUTE KIDNEY INJURY  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
DYSURIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  4/36 (11.11%)  2/37 (5.41%) 
HAEMATURIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  2/37 (5.41%) 
POLLAKIURIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
RENAL FAILURE  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  2/37 (5.41%) 
Reproductive system and breast disorders           
BENIGN PROSTATIC HYPERPLASIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  3/37 (8.11%) 
VULVOVAGINAL PRURITUS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
ASTHMA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
COUGH  1  0/3 (0.00%)  0/3 (0.00%)  7/22 (31.82%)  12/36 (33.33%)  13/37 (35.14%) 
DYSPHONIA  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  6/36 (16.67%)  3/37 (8.11%) 
DYSPNOEA  1  0/3 (0.00%)  0/3 (0.00%)  5/22 (22.73%)  11/36 (30.56%)  10/37 (27.03%) 
DYSPNOEA EXERTIONAL  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  9/36 (25.00%)  5/37 (13.51%) 
EPISTAXIS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  6/36 (16.67%)  6/37 (16.22%) 
HICCUPS  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  1/36 (2.78%)  3/37 (8.11%) 
LUNG DISORDER  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  1/36 (2.78%)  2/37 (5.41%) 
NASAL CONGESTION  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  5/37 (13.51%) 
OROPHARYNGEAL PAIN  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  5/36 (13.89%)  4/37 (10.81%) 
PARANASAL SINUS HYPERSECRETION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  1/37 (2.70%) 
PRODUCTIVE COUGH  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  5/36 (13.89%)  2/37 (5.41%) 
PULMONARY EMBOLISM  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  2/37 (5.41%) 
RALES  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
RHINORRHOEA  1  0/3 (0.00%)  0/3 (0.00%)  4/22 (18.18%)  4/36 (11.11%)  5/37 (13.51%) 
SINUS CONGESTION  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  4/36 (11.11%)  2/37 (5.41%) 
THROAT IRRITATION  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  0/36 (0.00%)  1/37 (2.70%) 
UPPER-AIRWAY COUGH SYNDROME  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  1/37 (2.70%) 
Skin and subcutaneous tissue disorders           
ALOPECIA  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  3/36 (8.33%)  0/37 (0.00%) 
BLISTER  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
DRY SKIN  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  1/36 (2.78%)  1/37 (2.70%) 
ECCHYMOSIS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  3/36 (8.33%)  3/37 (8.11%) 
ERYTHEMA  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  3/36 (8.33%)  4/37 (10.81%) 
HYPERHIDROSIS  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  4/36 (11.11%)  5/37 (13.51%) 
INGROWING NAIL  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  0/36 (0.00%)  0/37 (0.00%) 
NIGHT SWEATS  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  8/36 (22.22%)  10/37 (27.03%) 
PRURITUS  1  1/3 (33.33%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  2/37 (5.41%) 
RASH  1  1/3 (33.33%)  1/3 (33.33%)  3/22 (13.64%)  9/36 (25.00%)  9/37 (24.32%) 
RASH GENERALISED  1  1/3 (33.33%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  2/37 (5.41%) 
RASH MACULAR  1  0/3 (0.00%)  1/3 (33.33%)  0/22 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
RASH MACULO-PAPULAR  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  2/36 (5.56%)  1/37 (2.70%) 
SCAB  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
SKIN DISCOLOURATION  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  0/36 (0.00%)  2/37 (5.41%) 
SKIN LESION  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  0/36 (0.00%)  1/37 (2.70%) 
URTICARIA  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  1/36 (2.78%)  0/37 (0.00%) 
Vascular disorders           
DEEP VEIN THROMBOSIS  1  1/3 (33.33%)  0/3 (0.00%)  3/22 (13.64%)  2/36 (5.56%)  2/37 (5.41%) 
FLUSHING  1  0/3 (0.00%)  0/3 (0.00%)  1/22 (4.55%)  4/36 (11.11%)  2/37 (5.41%) 
HOT FLUSH  1  0/3 (0.00%)  1/3 (33.33%)  2/22 (9.09%)  2/36 (5.56%)  2/37 (5.41%) 
HYPERTENSION  1  0/3 (0.00%)  0/3 (0.00%)  2/22 (9.09%)  2/36 (5.56%)  2/37 (5.41%) 
HYPOTENSION  1  0/3 (0.00%)  0/3 (0.00%)  3/22 (13.64%)  4/36 (11.11%)  4/37 (10.81%) 
PHLEBITIS SUPERFICIAL  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
THROMBOPHLEBITIS SUPERFICIAL  1  0/3 (0.00%)  0/3 (0.00%)  0/22 (0.00%)  2/36 (5.56%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00742560     History of Changes
Other Study ID Numbers: HuLuc63-1703
2007-006677-83 ( EudraCT Number )
First Submitted: August 25, 2008
First Posted: August 27, 2008
Results First Submitted: October 11, 2017
Results First Posted: January 10, 2018
Last Update Posted: January 10, 2018