Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors,... | NCT00531284 | Trialant
NCT00531284
Sponsor
Amgen
Status
Completed
Last Update Posted
Aug 15, 2017Actual
Enrollment
184Actual
Phase
Phase 1Phase 2
Conditions
Ovarian Cancer
Renal Cancer
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Solid Tumors
Multiple Myeloma
Lymphoma
Interventions
Carfilzomib
Dexamethasone
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00531284
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PX-171-007
Secondary IDs
Not provided
Brief Title
Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma
Official Title
Phase 1b/2, Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors, Multiple Myeloma or Lymphoma
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Jul 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2007
Primary Completion Date
Oct 2014Actual
Completion Date
May 22, 2017Actual
First Submitted Date
Sep 14, 2007
First Submission Date that Met QC Criteria
Sep 14, 2007
First Posted Date
Sep 18, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 5, 2015
Results First Submitted that Met QC Criteria
Dec 5, 2015
Results First Posted Date
Dec 9, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 14, 2017
Last Update Posted Date
Aug 15, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives of this Phase 1b/2 study were as follows:
Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma.
Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of carfilzomib in patients with relapsed solid tumors.
Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Carfilzomib
Drug
Administered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)
Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding.
The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle.
28 days
Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles
Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: Disappearance of all target and non-target lesions and no new lesions;
PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions.
4 months
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an Overall Response Throughout the Study
Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM.
Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Disease related
Phase 1 Subjects (Bolus and Infusion):
Solid Tumor:
Histologically confirmed advanced solid tumor
1 to 3 prior treatment regimens
At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computed tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor
Multiple Myeloma (MM):
Relapsed and/or refractory multiple myeloma following 2 or more prior treatment regimens.
Measurable disease as indicated by one or more of the following:
Serum M-protein ≥ 1 g/dL
Urine M-protein ≥ 200 mg/24 hr
Serum Free Light Chain: Involved free light chain (FLC) level ≥ 10 mg/dL provided serum FLC ratio is abnormal
Lymphoma:
Histologically or cytologically confirmed lymphoma.
Patients must have had an initial diagnosis of indolent non-Hodgkin lymphoma (NHL) (including follicular, small lymphocytic, lymphoplasmacytoid, and marginal zone lymphoma), indolent disease that transformed to a more aggressive subtype, as previously described or patients may have mantle cell lymphoma.
Patients are required to have received prior rituximab (alone or combined with other treatment) and are considered refractory to (defined as no response, or progression within 6 months of completing therapy) or intolerant of continued rituximab.
Patients may have received up to a maximum of four prior unique chemotherapy regimens, including if not contra-indicated autologous stem-cell transplantation (ASCT).
For patients to enroll in the expanded dose group for lymphoma, patients must have measurable disease
Non-small cell lung cancer (NSCLC): Failed at least 1 prior platinum-based chemotherapy regimen but not more than 3 prior therapies for metastatic disease
Small cell lung cancer (SCLC): Failed 1 to 3 prior chemotherapy regimens
Ovarian: Failed at least 1 prior platinum-based chemotherapy regimen but not more than 4 therapies for metastatic disease
Renal: Failed at least 2 prior chemotherapy regimens for metastatic disease
Other solid tumor types: Failed at least 1 prior chemotherapy regimen for metastatic or relapsed disease and for which standard of care therapy is no longer effective or does not exist
At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional CT scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor
Demographic
Males and females ≥ 18 years of age
Life expectancy of more than 3 months
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Laboratory
Adequate hepatic function, with bilirubin 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) 3 times ULN
Absolute neutrophil count (ANC) > 1000/mm³, hemoglobin ≥ 8 gm/dL for solid tumors or 7.0 gm/dL for MM, and platelet count ≥ 100,000/mm³ for solid tumors or ≥ 30,000/mm³ for MM.
Subjects should not have received platelet transfusions for at least 1 week prior to screening
Screening ANC should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for ≥ 2 weeks
Subjects may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
Calculated or measured creatinine clearance (CrCl) of ≥ 20 mL/minute calculated using the formula of Cockcroft and Gault. Subjects with calculated CrCl < 20 mL/min may be allowed, only with prior approval by the Medical Monitor.
Ethical/Other
Written informed consent in accordance with federal, local, and institutional guidelines
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose and agree to use dual methods of contraception during the study and for 3 months following the last dose of study drug. Post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
Exclusion Criteria:
Disease Related
Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose or 6 weeks for antibody therapy
Radiation therapy or immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required); localized radiation therapy within 1 week prior to first dose
Subjects with prior brain metastases are permitted, but must have completed treatment and have no evidence of active central nervous system (CNS) disease for at least 4 weeks prior to first dose
For lymphoma patients; patients with prior stem cell transplant therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-versus-host disease (GVHD)
Evidence of CNS lymphoma
Participation in an investigational therapeutic study within 3 weeks prior to first dose
Prior treatment with carfilzomib
Concurrent Conditions
Major surgery within 3 weeks prior to first dose
Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 3 months prior to first dose
Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
Known or suspected human immunodeficiency virus (HIV) infection or subjects who are HIV seropositive
Active hepatitis A, B, or C infection
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
Subjects with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis
Subjects at risk* in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment
High risk for Tumor Lysis Syndrome.
Ethical / Other
Female subjects who are pregnant or lactating
Any clinically significant psychiatric or medical condition that in the opinion of the Investigator could interfere with protocol adherence or a subject's ability to give informed consent
Papadopoulos KP, Siegel DS, Vesole DH, Lee P, Rosen ST, Zojwalla N, Holahan JR, Lee S, Wang Z, Badros A. Phase I study of 30-minute infusion of carfilzomib as single agent or in combination with low-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma. J Clin Oncol. 2015 Mar 1;33(7):732-9. doi: 10.1200/JCO.2013.52.3522. Epub 2014 Sep 15.
Phase 1b followed a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD). For Phase 2 (bolus), a Simon 2-stage design was planned using the MTD from phase 1b. The first stage of the Simon's 2-stage design was carried out; however, the study did not progress to the second stage.
Recruitment Details
Patients with relapsed solid tumors (non-small and small cell lung, ovarian, renal, any other solid tumor type), multiple myeloma or lymphoma were enrolled at 7 sites in the US.
Under the original protocol patients received a bolus intravenous (IV) infusion of carfilzomib; patients enrolled under Amendments 2 to 4 received a 30-minute IV infusion.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 36 mg/m²
Experimental
Participants received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 45 mg/m²
Experimental
Participants received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/45 mg/m²
Experimental
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/56 mg/m²
Experimental
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/70 mg/m²
Experimental
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Drug: Carfilzomib
Phase 1b Lymphoma: Carfilzomib 20/56 mg/m²
Experimental
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Drug: Carfilzomib
Phase 1b Lymphoma: Carfilzomib 20/70 mg/m²
Experimental
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Duration of Response
Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Progression-Free Survival
Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Time to Progression
Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Maximum Observed Plasma Concentration of Carfilzomib
Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Elimination Half-life (t½) of Carfilzomib
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Clearance (CL) of Carfilzomib
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Volume of Distribution at Steady State (Vss) of Carfilzomib
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Beverly Hills
California
90210
United States
Northwestern University
Chicago
Illinois
60611
United States
University of Maryland Greenebaum Cancer Center
Baltimore
Maryland
21201
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
The Sarah Cannon Research Institute
Nashville
Tennessee
37203-1632
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio
Texas
78229
United States
Derived
Ohshima-Hosoyama S, Davare MA, Hosoyama T, Nelon LD, Keller C. Bortezomib stabilizes NOXA and triggers ROS-associated apoptosis in medulloblastoma. J Neurooncol. 2011 Dec;105(3):475-83. doi: 10.1007/s11060-011-0619-0. Epub 2011 Jun 3.
FG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG002
P1B ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG003
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG004
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG005
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG006
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG007
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG008
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG009
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG010
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG011
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG012
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG013
P1B LYM: CFZ 20/56 mg/m²
Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG014
P1B LYM: CFZ 20/70 mg/m²
Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG015
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG016
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
FG0003 subjects
FG0014 subjects
FG0027 subjects
FG00365 subjects
FG0046 subjects
FG0057 subjects
FG0066 subjects
FG00710 subjects
FG00811 subjects
FG0094 subjects
FG0103 subjects
FG01124 subjects
FG0122 subjects
FG0133 subjects
FG0147 subjects
FG01514 subjects
FG0168 subjects
COMPLETED
FG0000 subjectsIndicates participants who completed 12 cycles of study drug
FG0010 subjectsIndicates participants who completed 12 cycles of study drug
FG0021 subjectsIndicates participants who completed 12 cycles of study drug
FG0032 subjectsIndicates participants who completed 12 cycles of study drug
FG0040 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0050 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0060 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0070 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0080 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0090 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0100 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0110 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0120 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0130 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0143 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0152 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
FG0160 subjectsIndicates participants receiving treatment as of the data cut-off date of 07 October 2014
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0026 subjects
FG00363 subjects
FG0046 subjects
FG0057 subjects
FG0066 subjects
FG00710 subjects
FG00811 subjects
FG0094 subjects
FG0103 subjects
FG01124 subjects
FG0122 subjects
FG0133 subjects
FG0144 subjects
FG01512 subjects
FG0168 subjects
Type
Comment
Reasons
Progressive Disease
FG0001 subjects
FG0013 subjects
FG0025 subjects
FG00342 subjects
FG0044 subjects
FG0054 subjects
FG0063 subjects
FG0078 subjects
FG0086 subjects
FG0093 subjects
FG0103 subjects
FG01114 subjects
FG0122 subjects
FG0131 subjects
FG0142 subjects
FG01511 subjects
FG0165 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0037 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG002
P1B ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG003
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG004
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG005
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG006
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG007
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG008
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG009
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG010
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG011
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG012
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG013
P1B LYM: CFZ 20/56 mg/m²
Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG014
P1B LYM: CFZ 20/70 mg/m²
Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG015
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG016
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0027
BG00365
BG0046
BG0057
BG0066
BG00710
BG00811
BG0094
BG0103
BG01124
BG0122
BG0133
BG0147
BG01514
BG0168
BG017184
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Bolus Groups
Title
Measurements
BG00047.3± 14.74
BG00160.8± 8.81
BG00260.0± 11.72
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
Number
participants
Title
Denominators
Categories
0
Title
Measurements
BG0001
BG001
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
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)
Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding.
The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle.
Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.
Posted
Number
participants
28 days
ID
Title
Description
OG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG002
P1B ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG003
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG004
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG005
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG006
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG007
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG008
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG009
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG010
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG011
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG012
P1B LYM: CFZ 20/56 mg/m²
Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG013
P1B LYM: CFZ 20/70 mg/m²
Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles
Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: Disappearance of all target and non-target lesions and no new lesions;
PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions.
Phase 2 Safety population
Posted
Number
95% Confidence Interval
percentage of participants
4 months
ID
Title
Description
OG000
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment.
Units
Counts
Secondary
Percentage of Participants With an Overall Response Throughout the Study
Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM.
Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.
Safety Population
Posted
Number
95% Confidence Interval
percentage of participants
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
ID
Title
Description
OG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Secondary
Duration of Response
Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.
Safety Population with a partial response or better
Posted
Median
95% Confidence Interval
months
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
ID
Title
Description
OG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Secondary
Progression-Free Survival
Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.
Safety population
Posted
Median
95% Confidence Interval
months
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
ID
Title
Description
OG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG002
P1B ST: CFZ 20/36 mg/m² Bolus
Secondary
Time to Progression
Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.
Safety population.
Posted
Median
95% Confidence Interval
months
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
ID
Title
Description
OG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG002
P1B ST: CFZ 20/36 mg/m² Bolus
Secondary
Maximum Observed Plasma Concentration of Carfilzomib
Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Secondary
Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Median
Full Range
hours
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
ST: CFZ 45 mg/m²
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
Secondary
Elimination Half-life (t½) of Carfilzomib
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Median
Full Range
hours
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
ST: CFZ 45 mg/m²
Secondary
Clearance (CL) of Carfilzomib
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Mean
Standard Deviation
liters/hour
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
ST: CFZ 45 mg/m²
Secondary
Volume of Distribution at Steady State (Vss) of Carfilzomib
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Mean
Standard Deviation
liters
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
ST: CFZ 45 mg/m²
Secondary
Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib
Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).
Posted
Mean
Standard Deviation
hours
Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
ID
Title
Description
OG000
ST: CFZ 20 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
OG001
ST: CFZ 20 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
OG002
ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
ST: CFZ 45 mg/m²
Time Frame
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
Description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1
3
3
3
EG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1
4
4
4
EG002
P1B ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
4
7
7
7
EG003
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
27
65
65
65
EG004
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
2
6
6
6
EG005
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
4
7
7
7
EG006
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
5
6
6
6
EG007
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
5
10
10
10
EG008
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
6
11
11
11
EG009
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
2
4
4
4
EG010
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
0
3
3
3
EG011
P1B MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
11
24
24
24
EG012
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
2
2
2
2
EG013
P1B LYM: CFZ 20/56 mg/m²
Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1
3
3
3
EG014
P1B LYM: CFZ 20/70 mg/m²
Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
5
7
7
7
EG015
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
5
14
14
14
EG016
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
3
8
8
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG0030 affected65 at risk
EG0040 affected6 at risk
EG0050 affected7 at risk
EG0060 affected6 at risk
EG0070 affected10 at risk
EG0081 affected11 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected24 at risk
EG0120 affected2 at risk
EG0130 affected3 at risk
EG0140 affected7 at risk
EG0150 affected14 at risk
EG0160 affected8 at risk
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chest pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chills
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Disease progression
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Infusion related reaction
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hepatorenal failure
Hepatobiliary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Localised infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pneumococcal bacteraemia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Sepsis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Septic shock
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Troponin I increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Brain cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Tumour lysis syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Neuritis
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hydropneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Laryngeal mass
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG00317 affected65 at risk
EG0041 affected6 at risk
EG0051 affected7 at risk
EG0062 affected6 at risk
EG0074 affected10 at risk
EG0083 affected11 at risk
EG0092 affected4 at risk
EG0101 affected3 at risk
EG01110 affected24 at risk
EG0121 affected2 at risk
EG0131 affected3 at risk
EG0142 affected7 at risk
EG0155 affected14 at risk
EG0163 affected8 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0023 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Intracardiac thrombus
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Asthenopia
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Diplopia
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dry eye
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Eye irritation
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Vision blurred
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Visual disturbance
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Faeces pale
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Gastric outlet obstruction
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Gingival swelling
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0024 affected7 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Oral soft tissue disorder
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0024 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0024 affected7 at risk
EG003
Axillary pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Breakthrough pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Catheter related complication
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Catheter site erythema
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chest discomfort
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chest pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chills
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Difficulty in walking
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Disease progression
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected4 at risk
EG0023 affected7 at risk
EG003
Feeling abnormal
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Gait disturbance
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Implant site pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Inflammation
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Infusion related reaction
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Infusion site erythema
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Infusion site pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Infusion site swelling
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Injection site reaction
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Irritability
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Malaise
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Oedema
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pain
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0023 affected7 at risk
EG003
Temperature intolerance
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Thirst
General disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Conjunctivitis infective
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dental caries
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Ear infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Fungaemia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Fungal rash
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Gastrointestinal fungal infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Viral infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Wound infection
Infections and infestations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Contrast media reaction
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Feeding tube complication
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Incision site complication
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Renal injury
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Alanine aminotransferase decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood pressure increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Blood pressure orthostatic decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood urea increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Body temperature increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Electrocardiogram QT corrected interval prolonged
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Heart rate increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Influenza serology positive
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Methicillin-resistant staphylococcal aureus test positive
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Transaminases increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Weight increased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0023 affected7 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected4 at risk
EG0022 affected7 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Buttock pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chest wall pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Shoulder pain
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Areflexia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dysphasia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0024 affected7 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Neuropathic pain
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Neuropathy
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Tremor
Nervous system disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected7 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Depression
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0023 affected7 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 8.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Crackles lung
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Dyspnoea exacerbated
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Nasal mucosal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Leukoplakia
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Skin tightness
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Flushing
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Haematoma
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Hot flush
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected7 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 8.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Amgen, Inc.
866-572-6436
ID
Term
D010051
Ovarian Neoplasms
D007680
Kidney Neoplasms
D002289
Carcinoma, Non-Small-Cell Lung
D055752
Small Cell Lung Carcinoma
D009101
Multiple Myeloma
D008223
Lymphoma
Ancestor Terms
ID
Term
D004701
Endocrine Gland Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D010049
Ovarian Diseases
D000291
Adnexal Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D014571
Urologic Neoplasms
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract 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
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D006474
Hemorrhagic Disorders
D008232
Lymphoproliferative Disorders
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C524865
carfilzomib
D003907
Dexamethasone
Ancestor Terms
ID
Term
D011246
Pregnadienetriols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D013259
Steroids, Fluorinated
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0052 subjects
FG0063 subjects
FG0072 subjects
FG0083 subjects
FG0090 subjects
FG0100 subjects
FG0115 subjects
FG0120 subjects
FG0131 subjects
FG0141 subjects
FG0150 subjects
FG0162 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0151 subjects
FG0161 subjects
2 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
62.0
± 9.97
BG004NA± NANot applicable for infusion arms
BG005NA± NANot applicable for infusion arms
BG006NA± NANot applicable for infusion arms
BG007NA± NANot applicable for infusion arms
BG008NA± NANot applicable for infusion arms
BG009NA± NANot applicable for infusion arms
BG010NA± NANot applicable for infusion arms
BG011NA± NANot applicable for infusion arms
BG012NA± NANot applicable for infusion arms
BG013NA± NANot applicable for infusion arms
BG014NA± NANot applicable for infusion arms
BG015NA± NANot applicable for infusion arms
BG016NA± NANot applicable for infusion arms
BG01762.20± 10.43
30-minute Infusion Groups
Title
Measurements
BG000NA± NANot applicable for bolus arms
BG001NA± NANot applicable for bolus arms
BG002NA± NANot applicable for bolus arms
BG003NA± NANot applicable for bolus arms
BG00460.0± 5.18
BG00569.9± 11.10
BG00661.2± 10.38
BG00761.4± 7.40
BG00861.6± 11.58
BG00963.3± 3.77
BG01072.0± 5.57
BG01162.7± 9.88
BG01269.5± 12.02
BG01358.7± 10.69
BG01465.4± 10.31
BG01558.6± 9.54
BG01658.3± 6.14
BG01762.3± 9.47
4
BG00338
BG0040
BG0054
BG0063
BG0075
BG0084
BG0092
BG0101
BG0117
BG0121
BG0131
BG0143
BG0154
BG0161
BG01780
Male
BG0002
BG0013
BG0023
BG00327
BG0046
BG0053
BG0063
BG0075
BG0087
BG0092
BG0102
BG01117
BG0121
BG0132
BG0144
BG01510
BG0167
BG017104
3
BG0024
BG00327
BG0042
BG0051
BG0060
BG0072
BG0084
BG0094
BG0100
BG0118
BG0120
BG0132
BG0143
BG0157
BG0165
BG01773
1
Title
Measurements
BG0002
BG0011
BG0023
BG00335
BG0044
BG0054
BG0066
BG0077
BG0087
BG0090
BG0102
BG01115
BG0121
BG0130
BG0143
BG0156
BG0163
BG01799
2
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0052
BG0060
BG0071
BG0080
BG0090
BG0101
BG0111
BG0121
BG0131
BG0141
BG0151
BG0160
BG0179
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0033
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0173
6
OG0046
OG0056
OG0063
OG0076
OG0084
OG0093
OG0106
OG0112
OG0123
OG0137
0
OG0042
OG0050
OG0060
OG0071
OG0080
OG0090
OG0101
OG0112
OG0120
OG0131
Participants
OG00065
Title
Denominators
Categories
Title
Measurements
OG00015.4(7.6 to 26.5)
OG001
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG002
P1B ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG003
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG004
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG005
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG006
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG007
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG008
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG009
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG010
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG011
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG012
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG013
P1B NHL: CFZ 20/56 mg/m²
Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG014
P1B NHL: CFZ 20/70 mg/m²
Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG015
P1B WM: CFZ 20/56 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG016
P1B WM: CFZ 20/70 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG017
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG018
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0014
OG0027
OG00365
OG0046
OG0057
OG0066
OG00710
OG00811
OG0094
OG0103
OG01124
OG0122
OG0132
OG0143
OG0151
OG0164
OG01714
OG0188
Title
Denominators
Categories
Title
Measurements
OG000100.0(29.2 to 100.0)
OG0010.0(0.0 to 60.2)
OG00242.9(9.9 to 81.6)
OG00338.5(26.7 to 51.4)
OG00433.3(4.3 to 77.7)
OG00528.6(3.7 to 71.0)
OG00650.0(11.8 to 88.2)
OG00710.0(0.3 to 44.5)
OG00836.4(10.9 to 69.2)
OG00950.0(6.8 to 93.2)
OG01033.3(0.8 to 90.6)
OG01150.0(29.1 to 70.9)
OG01250.0(1.3 to 98.7)
OG0130.0(0.0 to 0.0)
OG0140.0(0.0 to 0.0)
OG015100.0(2.5 to 100.0)
OG016100.0(39.8 to 100.0)
OG01764.3(35.1 to 87.2)
OG01837.5(8.5 to 75.5)
OG002
P1B ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG003
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG004
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG005
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG006
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG007
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG008
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG009
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG010
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG011
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG012
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG013
P1B NHL: CFZ 20/56 mg/m²
Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG014
P1B NHL: CFZ 20/70 mg/m²
Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG015
P1B WM: CFZ 20/56 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG016
P1B WM: CFZ 20/70 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG017
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG018
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
OG0101
OG01112
OG0121
OG0130
OG0140
OG0151
OG0164
OG0179
OG0183
Title
Denominators
Categories
Title
Measurements
OG0026.2(NA to NA)Not estimable due to the low number of progression events
OG0099.3(3.9 to 14.7)
OG0105.5(NA to NA)Could not be calculated since there was only 1 participant with a response
OG0118.0(4.1 to 32.5)
OG01214.8(NA to NA)Could not be calculated since there was only 1 participant with a response
OG015NA(NA to NA)Not estimable due to the low number of progression events
OG016NA(NA to NA)Not estimable due to the low number of progression events
OG0179.0(1.9 to NA)Not estimable due to the low number of progression events
OG01822.6(17.5 to 27.6)
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG003
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG004
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG005
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG006
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG007
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG008
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG009
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG010
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG011
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG012
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG013
P1B NHL: CFZ 20/56 mg/m²
Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG014
P1B NHL: CFZ 20/70 mg/m²
Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG015
P1B WM: CFZ 20/56 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG016
P1B WM: CFZ 20/70 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG017
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG018
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0014
OG0027
OG00365
OG0046
OG0057
OG0066
OG00710
OG00811
OG0094
OG0103
OG01124
OG0122
OG0132
OG0143
OG0151
OG0164
OG01714
OG0188
Title
Denominators
Categories
Title
Measurements
OG0005.1(NA to NA)Could not be estimated due to the low number of events
OG0011.8(1.6 to 1.9)
OG0021.8(1.0 to NA)Could not be estimated due to the low number of events
OG0031.8(1.7 to 2.1)
OG0041.7(1.1 to NA)Could not be estimated due to the low number of events
OG0052.9(0.9 to 15.4)
OG0061.4(0.3 to 24.6)
OG0071.5(0.3 to 2.0)
OG0081.6(0.4 to 5.4)
OG0095.2(4.4 to 15.1)
OG0104.6(1.4 to 5.9)
OG0116.9(1.2 to 8.4)
OG0129.4(1.9 to 16.8)
OG013NA(1.6 to NA)Could not be estimated due to the low number of events
OG0141.0(0.6 to NA)Could not be estimated due to the low number of events
OG015NA(NA to NA)Could not be estimated due to the low number of events
OG016NA(NA to NA)Could not be estimated due to the low number of events
OG0174.6(1.9 to 12.7)
OG01811.5(1.8 to 28.0)
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG003
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG004
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG005
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG006
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG007
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG008
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG009
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG010
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG011
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG012
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG013
P1B NHL: CFZ 20/56 mg/m²
Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG014
P1B NHL: CFZ 20/70 mg/m²
Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG015
P1B WM: CFZ 20/56 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG016
P1B WM: CFZ 20/70 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG017
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
OG018
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0014
OG0027
OG00365
OG0046
OG0057
OG0066
OG00710
OG00811
OG0094
OG0103
OG01124
OG0122
OG0132
OG0143
OG0151
OG0164
OG01714
OG0188
Title
Denominators
Categories
Title
Measurements
OG0005.1(NA to NA)Could not be estimated due to the low number of events
OG0011.8(1.6 to 1.9)
OG0021.8(1.6 to NA)Could not be estimated due to the low number of events
OG0031.8(1.7 to 2.1)
OG0041.7(1.1 to NA)Could not be estimated due to the low number of events
OG0051.6(0.9 to 4.1)
OG0061.6(1.1 to NA)Could not be estimated due to the low number of events
OG0071.6(0.5 to 2.0)
OG0081.6(0.3 to 5.6)
OG0095.2(4.4 to 15.1)
OG0104.6(1.4 to 5.9)
OG0116.9(1.2 to 8.4)
OG0129.4(1.9 to 16.8)
OG013NA(1.6 to NA)Could not be estimated due to the low number of events
OG0141.0(0.6 to NA)Could not be estimated due to the low number of events
OG015NA(NA to NA)Could not be estimated due to the low number of events
OG016NA(NA to NA)Could not be estimated due to the low number of events
OG0174.6(1.9 to 12.7)
OG01811.5(1.8 to 28.0)
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG003
ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
Units
Counts
Participants
OG00030
OG00121
OG0026
OG0036
OG00430
Title
Denominators
Categories
Title
Measurements
OG0002390± 104
OG001914± 58.2
OG0021061± 50.7
OG0031193± 197.3
OG004722± 62.1
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
Units
Counts
Participants
OG00030
OG00121
OG0026
OG0036
OG00430
Title
Denominators
Categories
Title
Measurements
OG0000.0500(0 to 0.167)
OG0010.500(0.0833 to 0.7500)
OG0020.258(0.0833 to 0.500)
OG0030.275(0.100 to 0.550)
OG0040.250(0.0833 to 0.750)
ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
Units
Counts
Participants
OG00030
OG00121
OG0026
OG0036
OG00430
Title
Denominators
Categories
Title
Measurements
OG000251± 92.0
OG001346± 57.4
OG002426± 70.1
OG003536± 150.4
OG004269± 54.3
ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
Units
Counts
Participants
OG00023
OG00118
OG0026
OG0036
OG00428
Title
Denominators
Categories
Title
Measurements
OG000223± 104
OG001324± 52.8
OG002426± 70.1
OG003538± 150.1
OG004273± 55.3
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
Units
Counts
Participants
OG00023
OG00118
OG0026
OG0036
OG00428
Title
Denominators
Categories
Title
Measurements
OG0000.444(0.152 to 2.20)
OG0010.888(0.368 to 2.33)
OG0020.917(0.359 to 1.23)
OG0030.952(0.810 to 2.11)
OG0040.888(0.411 to 1.57)
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
Units
Counts
Participants
OG00023
OG00118
OG0026
OG0036
OG00428
Title
Denominators
Categories
Title
Measurements
OG000263± 398
OG001139± 70.1
OG002182± 88.8
OG003302± 438
OG004164± 89.6
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
Units
Counts
Participants
OG00023
OG00118
OG0026
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG00027.7± 48.6
OG00131.0± 21.9
OG00222.7± 24.2
OG003113± 230
OG00421.8± 24.6
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
OG004
MM: CFZ 20 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.