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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1177-7936 | Registry Identifier | WHO |
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This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma.
The drug being tested in this study is ixazomib. Ixazomib is being tested to treat people who have multiple myeloma. This study will look at the safety and efficacy of ixazomib and will enroll approximately 60 participants.
Participants will receive ixazomib by oral capsule twice weekly on Days 1, 4, 8, and 11 of a 21-day cycle. The study will consist of a dose escalation phase to determine the MTD, followed by an expansion phase in which participants will be treated at the MTD.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 8 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | Experimental | Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days). |
|
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | Experimental | Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days). |
|
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | Experimental | Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days). |
|
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | Experimental | Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib | Drug | Ixazomib capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
| Number of Participants With Clinically Significant Abnormalities Reported as TEAEs | The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis. | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
| Number of Participants With a TEAE of Peripheral Neuropathy | Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy. | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
| Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Ixazomib | Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
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Inclusion Criteria:
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33617 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28803351 | Derived | Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3. | |
| 24920586 | Derived |
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Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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60 participants with a diagnosis of relapsed and/or refractory (RR) multiple myeloma were enrolled in 1 of 7 ixazomib dose escalation groups (26 participants) and/or 1 of 4 ixazomib dose expansion groups (40 participants). 6 Participants in 2.0 mg/m^2 dose escalation cohort were also included in the expansion group: 5 in RR, 1 in VR arms.
Participants took part in the study at 5 investigative sites in the United States from 12 October 2009 to 23 May 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days). |
| FG001 | Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days). |
| FG002 | Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days). |
| FG003 | Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days). |
| FG004 | Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days). |
| FG005 | Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days). |
| FG006 | Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days). |
| FG007 | Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days). |
| FG008 | Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days). |
| FG009 | Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days). |
| FG010 | Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Dose Escalation) |
|
| ||||||||||||||||||
| Part 2 (Dose Expansion) |
|
Safety population included all participants who received at least 1 dose of ixazomib. A total of 60 participants participated in the study. There were 7 participants in Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 arm group, 6 out of 7 participated in both phases of the study and were counted once in the expansion cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. | Safety population included all participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| ID | Term |
|---|---|
| C548400 | ixazomib |
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|
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | Experimental | Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days). |
|
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | Experimental | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days). |
|
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | Experimental | Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days). |
|
| Relapsed and Refractory Expansion Cohort: Ixazomib 2 mg/m^2 | Experimental | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days). |
|
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | Experimental | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days). |
|
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | Experimental | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days). |
|
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | Experimental | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days). |
|
|
The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs. Measurement of vital signs, included oral temperature, blood pressure, and heart rate. |
| From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
| Maximum Tolerated Dose (MTD) of Ixazomib | MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc >500 millisecond [msec]);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >2 weeks; other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation. | Cycle 1 (21 days) |
| Recommended Phase 2 Dose (RP2D) of Ixazomib | The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond. | Cycle 1 through Cycle 39 (Up to 28.3 months) |
| AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
| AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose |
| λz: Terminal Disposition Phase Rate Constant for Ixazomib | Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose |
| T1/2: Terminal Disposition Phase Elimination Half-life for Ixazomib | Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose |
| CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib | CL/F is apparent clearance of the drug from the plasma. | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
| Emax: Maximum Observed Effect for Ixazomib | Emax was determined to characterize the whole blood 20S proteasome inhibition parameters. | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
| TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib | TEmax was determined to characterize the whole blood 20S proteasome inhibition parameters. | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
| Overall Response Rate (ORR) | ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg /24 h. MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks; 25-49% reduction in the size of soft tissue plasmacytomas; no increase in the size or number of lytic bone lesions. | Cycle 1 through Cycle 115 (Up to 80.1 months) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Richardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD, Talpaz M, Berg D, Liu G, Yu J, Gupta N, Di Bacco A, Hui AM, Lonial S. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood. 2014 Aug 14;124(7):1038-46. doi: 10.1182/blood-2014-01-548826. Epub 2014 Jun 11. |
| Withdrawal by Participant |
|
| Adverse Event |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 |
Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days). |
| BG002 | Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days). |
| BG003 | Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days). |
| BG004 | Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days). |
| BG005 | Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days). |
| BG006 | Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days). |
| BG007 | Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days). |
| BG008 | Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days). |
| BG009 | Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days). |
| BG010 | Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days). |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Here, number analyzed are the participants who were evaluated for this baseline measure. | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Surface Area | Body Surface Area (m^2)=[Height(cm) * Weight (kg)]/3600)^1/2. | Here, number analyzed are the participants who were evaluated for this baseline measure. | Mean | Standard Deviation | meter square |
|
| Time Since Primary Diagnosis to First Dose | Median | Full Range | months |
|
|
|
|
| Primary | Number of Participants With Clinically Significant Abnormalities Reported as TEAEs | The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis. | Safety population included all participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
|
|
|
| Primary | Number of Participants With a TEAE of Peripheral Neuropathy | Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy. | Safety population included all participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs | The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs. Measurement of vital signs, included oral temperature, blood pressure, and heart rate. | Safety population included all participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months) |
|
|
|
| Primary | Maximum Tolerated Dose (MTD) of Ixazomib | MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc >500 millisecond [msec]);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >2 weeks; other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation. | DLT-evaluable population was defined as all participants who received all Cycle 1 doses of ixazomib and completed Cycle 1 or who experienced DLT in Cycle 1. | Posted | Number | mg/m^2 | Cycle 1 (21 days) |
|
|
|
| Primary | Recommended Phase 2 Dose (RP2D) of Ixazomib | The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond. | Safety population included all participants who received at least 1 dose of ixazomib. | Posted | Number | mg/m^2 | Cycle 1 through Cycle 39 (Up to 28.3 months) |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for Ixazomib | PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Median | Full Range | hours | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
|
|
|
| Secondary | AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib | PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
|
|
|
| Secondary | AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib | PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose |
|
|
|
| Secondary | λz: Terminal Disposition Phase Rate Constant for Ixazomib | PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | 1/hr | Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose |
|
|
|
| Secondary | T1/2: Terminal Disposition Phase Elimination Half-life for Ixazomib | PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | hr | Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose |
|
|
|
| Secondary | CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib | CL/F is apparent clearance of the drug from the plasma. | CL/F was not reported as this PK parameter could not be calculated. | Posted | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
|
|
| Secondary | Emax: Maximum Observed Effect for Ixazomib | Emax was determined to characterize the whole blood 20S proteasome inhibition parameters. | No data is reported due to concerns about the third-party laboratory's performance of the 20S assay that precluded the ability to confirm the accuracy of the data generated. The data was not considered reliable. | Posted | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
|
|
| Secondary | TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib | TEmax was determined to characterize the whole blood 20S proteasome inhibition parameters. | No data is reported due to concerns about the third-party laboratory's performance of the 20S assay that precluded the ability to confirm the accuracy of the data generated. The data was not considered reliable. | Posted | Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose |
|
|
| Secondary | Overall Response Rate (ORR) | ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg /24 h. MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks; 25-49% reduction in the size of soft tissue plasmacytomas; no increase in the size or number of lytic bone lesions. | Response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post baseline disease assessment. | Posted | Number | percentage of participants | Cycle 1 through Cycle 115 (Up to 80.1 months) |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days). | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days). | 1 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days). | 0 | 3 | 2 | 3 | 3 | 3 |
| EG004 | Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days). | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days). | 0 | 7 | 5 | 7 | 7 | 7 |
| EG006 | Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days). | 0 | 4 | 3 | 4 | 4 | 4 |
| EG007 | Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days). | 1 | 20 | 14 | 20 | 20 | 20 |
| EG008 | Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days). | 0 | 12 | 6 | 12 | 12 | 12 |
| EG009 | Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days). | 0 | 6 | 3 | 6 | 6 | 6 |
| EG010 | Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days). | 0 | 2 | 2 | 2 | 2 | 2 |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Fungal test positive | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nodule | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vasculitic rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mouth cyst | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Catheter site cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Infected cyst | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Post procedural cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cranial nerve disorder | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eustachian tube obstruction | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Testicular swelling | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pseudofolliculitis barbae | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Soft tissue swelling | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Blood testosterone decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Missing |
|
| Black or African American |
|
| Other |
|
| Blood Urea Increased |
|
| White Blood Cell Count Decreased |
|
| Neutrophil Count Decreased |
|
| Alanine Aminotransferase Increased |
|
| Liver Function Test Increased |
|
| Blood Calcium Increased |
|
| Platelet Count Decreased |
|
| Haematocrit Decreased |
|
| Haemoglobin Decreased |
|
| Peripheral Sensory Neuropathy |
|
|
| Day 11 |
|
|
|
| Day 11 |
|
|
|
| Day 11 |
|
|
|
| Day 11 |
|
|
| CR+PR+MR |
|