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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006677-83 | EudraCT Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to evaluate the combination of elotuzumab, lenalidomide, and dexamethasone in subjects with relapsed multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Experimental | Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
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| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Experimental | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
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| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Experimental | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
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| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Experimental | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elotuzumab | Biological | Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1) | 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. | 4 weeks |
| Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2) | 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). | From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1) | 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). |
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Inclusion Criteria:
Age 18 years or older with a confirmed diagnosis of multiple myeloma (MM) and documentation of one to three prior therapies.
Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment.
Measurable monoclonal (M-) protein component in serum (≥ 0.5 g/dL) and/or urine (if present), (≥ 0.2 g excreted in a 24 hour collection sample). Subjects with free light chain only disease are excluded.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Creatinine clearance ≥ 50 mL/min measured by Cockcroft-Gault method.
Hematologic parameters defined by:
Alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) < 3 × upper limit of normal.
Total bilirubin < 2 × upper limit of normal, direct bilirubin < 2.0 mg/dL.
Negative urine pregnancy test in women of childbearing potential at screening and prior to prescribing lenalidomide. Females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin acceptable methods of birth control for 28 days prior to prescribing lenalidomide. Men must agree to use a latex condom during sexual contact with FCBP even if they have had a successful vasectomy, and must agree not to donate semen during study drug therapy and for a period of time after therapy.
Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject's privacy regulations).
Able to take aspirin daily as prophylactic anticoagulation therapy (subjects intolerant to aspirin may use warfarin or low-molecular-weight heparin).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26686406 | Derived | Richardson PG, Jagannath S, Moreau P, Jakubowiak AJ, Raab MS, Facon T, Vij R, White D, Reece DE, Benboubker L, Zonder J, Tsao LC, Anderson KC, Bleickardt E, Singhal AK, Lonial S; 1703 study investigators. Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase 2 results from the randomised, open-label, phase 1b-2 dose-escalation study. Lancet Haematol. 2015 Dec;2(12):e516-27. doi: 10.1016/S2352-3026(15)00197-0. Epub 2015 Nov 16. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| FG001 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Experimental | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
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| lenalidomide | Drug | Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle |
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| dexamethasone oral | Drug | Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously) |
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| dexamethasone injection | Drug | Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously) |
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| From first dose of elotuzumab until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | 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) |
| Number of Participants With Infusion Reactions | 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). | 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) |
| Mean Serum Concentrations of Elotuzumab During Cycle 1 | 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. | 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) |
| Maximum Serum Concentration (Cmax) of Elotuzumab | 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. | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
| Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab | 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. | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
| Systemic Clearance (CL) of Elotuzumab | 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. | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
| Volume of Distribution (V) of Elotuzumab | 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. | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
| Serum Half-life (t1/2) of Elotuzumab | 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. | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
| Duration of Response | 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. | 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 |
| Time to Progression (TTP) | 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. | 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 |
| Progression-free Survival (PFS) | 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. | 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 |
| Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA) | 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. | From screening through 60-day follow up period (up to 101 months) |
| Plasma Cell Myeloma Cytogenetic Subtype | 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). | Screening (up to 14 days prior to dosing) |
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| FG002 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| FG003 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| FG004 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population: all randomized participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| BG001 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| BG002 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| BG003 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| BG004 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1) | 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. | 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]). | Posted | Number | mg/kg | 4 weeks |
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| Primary | Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2) | 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). | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | 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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| Secondary | Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1) | 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). | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | 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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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Number | participants | 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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| Secondary | Number of Participants With Infusion Reactions | 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). | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Number | participants | 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) |
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| Secondary | Mean Serum Concentrations of Elotuzumab During Cycle 1 | 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. | Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point. | Posted | Mean | Standard Deviation | μg/mL | 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) |
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| Secondary | Maximum Serum Concentration (Cmax) of Elotuzumab | 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. | 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). | Posted | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
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| Secondary | Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab | 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. | 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). | Posted | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
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| Secondary | Systemic Clearance (CL) of Elotuzumab | 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. | 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). | Posted | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
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| Secondary | Volume of Distribution (V) of Elotuzumab | 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. | 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). | Posted | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
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| Secondary | Serum Half-life (t1/2) of Elotuzumab | 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. | 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). | Posted | Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1 |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response | 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. | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | months | 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 |
| |||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | 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. | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | months | 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 |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | 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. | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | months | 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 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA) | 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. | All participants who received at least one dose of study drug and with at least one evaluable post-dose sample. | Posted | Number | percentage of participants | From screening through 60-day follow up period (up to 101 months) |
| ||||||||||||||||||||||||||||
| Secondary | Plasma Cell Myeloma Cytogenetic Subtype | 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). | Safety population: All randomized participants who received at least 1 dose of study drug | Posted | Number | participants | Screening (up to 14 days prior to dosing) |
|
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).
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. | 0 | 3 | 3 | 3 | ||
| EG001 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. | 3 | 3 | 3 | 3 | ||
| EG002 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. | 12 | 22 | 22 | 22 | ||
| EG003 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. | 21 | 36 | 36 | 36 | ||
| EG004 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. | 21 | 37 | 37 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ASPERGILLUS INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| H1N1 INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONIA KLEBSIELLA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| VISCERAL LEISHMANIASIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROENTERITIS RADIATION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| LOBULAR BREAST CARCINOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GENERALISED TONIC-CLONIC SEIZURE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TRANSIENT GLOBAL AMNESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| STRIDOR | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ACCELERATED HYPERTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMOGLOBINAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOACUSIS | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| EYE IRRITATION | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| OCULAR HYPERAEMIA | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VITREOUS FLOATERS | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROINTESTINAL MOTILITY DISORDER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARAESTHESIA ORAL | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TOOTH DISORDER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FEELING HOT | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INFLAMMATION | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| IRRITABILITY | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| FUNGAL INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| GINGIVITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| STOMA SITE PAIN | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| SUNBURN | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD BICARBONATE DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD MAGNESIUM DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD UREA INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| CARDIAC MURMUR | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| IMMUNOGLOBULINS DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| PROTEIN TOTAL INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| PROTHROMBIN TIME PROLONGED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERNATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOGEUSIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PSYCHOMOTOR HYPERACTIVITY | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SINUS HEADACHE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| AGGRESSION | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MOOD SWINGS | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VULVOVAGINAL PRURITUS | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARANASAL SINUS HYPERSECRETION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RALES | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| UPPER-AIRWAY COUGH SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INGROWING NAIL | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SCAB | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SKIN DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C546027 | elotuzumab |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| OG001 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) |
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG002 | Total (Phase 2) | Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
|
|
| OG001 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) |
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG002 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally |
| OG003 | Total (Phase 1) | 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 + Lenalidomide and Dexamethasone (Phase 1) |
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG002 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG003 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG004 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
|
|
| OG002 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG003 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG004 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 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 in Phase 1 and Phase 2. |
| OG002 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone | 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. |
|
|
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.
|
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. |
|
|
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. |
|
|
| OG003 | Total (Phase 1) | Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG004 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG005 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG006 | Total (Phase 2) | Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally |
|
|
| OG003 | Total (Phase 1) | Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG004 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG005 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG006 | Total (Phase 2) | Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
|
|
| OG003 | Total (Phase 1) | Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG004 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG005 | Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG006 | Total (Phase 2) | Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
|
|
|
|
| OG003 | Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| OG004 | Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
|
|