A Study of Weekly Carfilzomib in Combination With Dexamet... | NCT01677858 | Trialant
NCT01677858
Sponsor
Amgen
Status
Completed
Last Update Posted
Sep 23, 2022Actual
Enrollment
116Actual
Phase
Phase 1Phase 2
Conditions
Multiple Myeloma
Interventions
Carfilzomib
Dexamethasone
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01677858
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2012-002
Secondary IDs
ID
Type
Description
Link
20130403
Other Identifier
Amgen Inc.
Brief Title
A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma
Official Title
A Phase 1/2 Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma
Acronym
CHAMPION 1
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Sep 2022
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
Jul 4, 2012
Primary Completion Date
Jul 22, 2016Actual
Completion Date
Oct 31, 2018Actual
First Submitted Date
Aug 30, 2012
First Submission Date that Met QC Criteria
Aug 31, 2012
First Posted Date
Sep 3, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 11, 2017
Results First Submitted that Met QC Criteria
Jul 11, 2017
Results First Posted Date
Aug 9, 2017Actual
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
Sep 12, 2022
Last Update Posted Date
Sep 23, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 study had the following primary objectives:
Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior therapies
Phase 2: to estimate the overall response rate (ORR) for patients with relapsed or refractory multiple myeloma who received 1 to 3 prior therapies treated with carfilzomib and dexamethasone QW at the MTD established in phase 1.
Detailed Description
This is a Phase 1/2, multicenter, single-arm, nonrandomized, open-label and dose-escalation study of weekly carfilzomib and dexamethasone for patients with progressive multiple myeloma. The Phase 1 dose escalation portion will enroll patients into sequential dose-escalating cohorts consisting of 3 patients each to establish the maximum tolerated dose (MTD) of carfilzomib administered weekly as a 30 minute intravenous (IV) infusion with dexamethasone. The Phase 2 portion will enroll patients using the MTD established for carfilzomib from the Phase 1 portion of the study. Dexamethasone will be administered IV or orally at the same dose and schedule as used in the Phase 1 portion of the study.
Conditions Module
Conditions
Multiple Myeloma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
116Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Carfilzomib
Experimental
In phase 1 participants were assigned to one of four sequential dose-escalating cohorts to receive 45, 56, 70 or 88 mg/m² carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
In phase 2 participants received carfilzomib at the maximum tolerated dose (MTD) established in the Phase 1 portion of the study on days 1, 8 and 15 plus 40 mg dexamethasone IV or orally at the same schedule as used in the Phase 1 portion of the study.
Participants were treated until confirmed progressive disease, unacceptable toxicity, withdrew consent for further treatment, were lost to follow-up, died, or the sponsor closed the study.
Drug: Carfilzomib
Drug: Dexamethasone
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Carfilzomib
Drug
Carfilzomib was administered as a 30-minute IV infusion on days 1, 8, and 15 of each 28-day treatment cycle.
Carfilzomib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)
The MTD was defined as the highest carfilzomib dose at which < 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows:
Nonhematologic:
≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting < 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment)
≥ grade 3 acute kidney injury (creatinine > 3 x baseline or > 4.0 mg/dL) lasting > 72 hours
≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy
Hematologic:
grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) for > 7 days
febrile neutropenia (ANC < 1000/mm³ with a fever ≥ 38.3ºC) of any duration
grade 3 or 4 thrombocytopenia (< lower limit of normal) associated with > grade 1 bleeding
28 days
Overall Response Rate (ORR)
Disease response was evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM.
VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.
Secondary Outcomes
Measure
Description
Time Frame
Clinical Benefit Response Rate
Clinical benefit rate was defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a 25% to 49% reduction in the level of serum M-protein or a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour, maintained for a minimum of 8 weeks.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Multiple myeloma with relapsing or progressive disease at study entry
Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to enrollment):
Serum M-protein ≥ 0.5 g/dL, or
Urine M-protein ≥ 200 mg/24 hours, or
Only in patients who do not meet a or b, then use serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa/lambda ratio
Prior treatment with 1 to 3 prior regimens for multiple myeloma for Phase 1 and Phase 2 (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy
Age ≥ 18 years
Life expectancy ≥ 6 months
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hepatic function within 21 days prior to enrollment, with bilirubin < 1.5 × the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 × ULN
Left ventricular ejection fraction (LVEF) ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated acquisition scan (MUGA) is acceptable if ECHO is not available
Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to enrollment. Screening ANC is to be independent of growth factor support for ≥ 1 week
Hemoglobin ≥ 8.0 g/dL within 21 days prior to enrollment. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed; however, most recent RBC transfusion must have been at least 7 days prior to obtaining screening hemoglobin
Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%) within 21 days prior to enrollment. Patients must not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count
Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/min within 21 days prior to enrollment. Calculation based on standard formula, such as the Cockcroft and Gault: [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female
Written informed consent in accordance with federal, local, and institutional guidelines
Female patients of childbearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). Postmenopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
Male patients must agree to use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with an FCBP
Exclusion Criteria:
Multiple myeloma of Immunoglobulin M (IgM) subtype
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
Waldenström's macroglobulinemia
Amyloidosis
Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to enrollment
Cytotoxic chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to enrollment
Treatment with bortezomib (Velcade®), thalidomide (Thalomid®) or lenalidomide (Revlimid®) within 21 days prior to enrollment
Focal radiation therapy within 7 days prior to enrollment. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (ie, prior radiation must have been to < 30% of the bone marrow)
Immunotherapy within 21 days prior to enrollment
Major surgery within 21 days prior to enrollment
Active congestive heart failure (New York Heart Association [NYHA] Classes III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment
Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B virus [HBV]), or antifungal agents within 14 days prior to enrollment
Known human immunodeficiency virus (HIV) seropositivity
Known hepatitis B or C virus infection (except for patients with HBV who are receiving and responding to HBV antiviral therapy: these patients are allowed)
Patients with known cirrhosis
Second malignancy within the past 3 years, except:
Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
Breast carcinoma in situ with full surgical resection
Treated medullary or papillary thyroid cancer
Patients with myelodysplastic syndrome
Significant neuropathy (Grades 3 to 4) within 14 days prior to enrollment
Female patients who are pregnant or lactating
Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
Prior carfilzomib treatment
Prior participation in any Onyx-sponsored Phase 3 trial
Patients with contraindication to dexamethasone
Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
Ongoing graft-versus-host disease
Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
Any other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.
In phase 1 participants were enrolled into 1 of 4 sequential dose-escalating cohorts to establish the maximum tolerated dose (MTD) of carfilzomib plus dexamethasone. In phase 2 participants were enrolled to evaluate the efficacy and safety of carfilzomib plus dexamethasone at the MTD established in phase 1.
Recruitment Details
This study was conducted at 32 centers in the United States. Participants were enrolled from September 2012 to September 2014.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
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
N/A
Intervention Model
Sequential 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
Krypolis
Dexamethasone
Drug
Dexamethasone was administered at a dose of 40 mg IV or orally (PO) on days 1, 8, 15, and 22 for the first 8 cycles; starting with cycle 9 dexamethasone was administered on days 1, 8, and 15.
Carfilzomib
Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.
Progression-free Survival
Progression-free survival (PFS) was defined as the time from first dose to the earlier of disease progression or death due to any cause. The duration of PFS was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.
Participants were evaluated for disease response and progression by the investigator according to the IMWG-URC.
From randomization until the data cut-off date of 22 July 2016; median follow-up time for PFS was 13.8 months
Time To Progression
Time to progression (TTP) was defined as the time from first dose to disease progression evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). TTP was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.
From randomization until the data cut-off date of 22 July 2016; median follow-up time for TTP was 13.4 months
Duration of Response
Duration of response (DOR) was defined as the time from first evidence of PR or better to disease progression or death due to any cause. DOR was calculated using Kaplan-Meier methods; Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
From randomization until the data cut-off date of 22 July 2016; median follow-up time for DOR was 14.3 months
Number of Participants With Adverse Events
Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).
From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Time to Maximum Plasma Concentration of Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Maximum Plasma Concentration of Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) fo Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve During the Dosing Interval (0-168 Hours) for Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Volume of Distribution Observed at Steady State (Vss) for Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Terminal Half-life (T1/2,z) for Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Clearance of Carfilzomib After IV Infusion
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Mean Residence Time Observed From Time Zero to Infinity (MRT0-∞) for Carfilzomib
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
Bakersfield
California
United States
California Cancer Associates for Research and Excellence
Encinitas
California
United States
Robert A. Moss, M.D., FACP, Inc.
Fountain Valley
California
United States
California Cancer Associates for Research and Excellence
Fresno
California
United States
Cedars-Sinai Medical Center
Los Angeles
California
United States
Monterey Bay Oncology
Salinas
California
United States
Sansum Clinic
Santa Barbara
California
United States
Central Coast Medical Oncology Corporation
Santa Maria
California
United States
James R. Berenson M.D. Inc.
West Hollywood
California
United States
The Oncology Insititute of Hope and Innovation
Whittier
California
United States
Rocky Mountain Cancer Centers
Denver
Colorado
United States
Florida Cancer Specialists - South
Fort Myers
Florida
United States
Florida Cancer Specialists - North
Tampa
Florida
United States
Illinois Cancer Care
Galesburg
Illinois
United States
Illinois Cancer Specialists
Hinsdale
Illinois
United States
Illinois Cancer Specialists
Niles
Illinois
United States
Fort Wayne Oncology & Hematology
Fort Wayne
Indiana
United States
Horizon Oncology Research, Inc.
Lafayette
Indiana
United States
Center for Cancer and Blood Disorders (CCBD)
Bethesda
Maryland
United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown
New Jersey
United States
New Mexico Cancer Care Alliance
Albuquerque
New Mexico
United States
Clinical Research Alliance
New York
New York
United States
Hudson Valley Hematology Oncology Associates
Poughkeepsie
New York
United States
Willamette Valley Cancer Institute and Research Center
Eugene
Oregon
United States
Tennessee Oncology, PLLC
Chattanooga
Tennessee
United States
St. Joseph Regional Cancer Center
Bryan
Texas
United States
Millennium Oncology
Houston
Texas
United States
Waldron Medical Research and Development Center
Houston
Texas
United States
Cancer Care Centers of South Texas
San Antonio
Texas
United States
Center at Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio
San Antonio
Texas
United States
Blood and Cancer Center of East Texas
Tyler
Texas
United States
Shenandoah Oncology, PC
Winchester
Virginia
United States
Northwest Cancer Specialists
Vancouver
Washington
United States
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima
Washington
United States
Derived
Berenson JR, Cartmell A, Bessudo A, Lyons RM, Harb W, Tzachanis D, Agajanian R, Boccia R, Coleman M, Moss RA, Rifkin RM, Patel P, Dixon S, Ou Y, Anderl J, Aggarwal S, Berdeja JG. CHAMPION-1: a phase 1/2 study of once-weekly carfilzomib and dexamethasone for relapsed or refractory multiple myeloma. Blood. 2016 Jun 30;127(26):3360-8. doi: 10.1182/blood-2015-11-683854. Epub 2016 May 12.
FG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
FG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
FG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
FG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
FG0003 subjects
FG0013 subjects
FG00215 subjects
FG0036 subjects
FG00489 subjects
COMPLETED
FG0000 subjectsCompleted indicates participants ongoing in study
FG0011 subjectsCompleted indicates participants ongoing in study
FG0021 subjectsCompleted indicates participants ongoing in study
FG0030 subjectsCompleted indicates participants ongoing in study
FG0044 subjectsCompleted indicates participants ongoing in study
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG00214 subjects
FG0036 subjects
FG00485 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG00413 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Progressive Disease
FG0002 subjects
FG0011 subjects
FG0029 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
BG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
BG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
BG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
BG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG00215
BG0036
BG00489
BG005116
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
Title
Measurements
BG00069.3± 15.6
BG00173.7± 2.1
BG00262.4± 10.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0003
BG0012
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, confined to bed or chair; 5 = Dead.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0 (Fully active)
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 1: Number of Participants With Dose-limiting Toxicities (DLTs)
The MTD was defined as the highest carfilzomib dose at which < 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows:
Nonhematologic:
≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting < 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment)
≥ grade 3 acute kidney injury (creatinine > 3 x baseline or > 4.0 mg/dL) lasting > 72 hours
≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy
Hematologic:
grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) for > 7 days
febrile neutropenia (ANC < 1000/mm³ with a fever ≥ 38.3ºC) of any duration
grade 3 or 4 thrombocytopenia (< lower limit of normal) associated with > grade 1 bleeding
Participants in phase 1 who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Posted
Number
participants
28 days
ID
Title
Description
OG000
Phase 1 Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Units
Counts
Participants
OG0003
OG0013
OG00215
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Maximum Tolerated Dose (mg/m²)
70
2-Sided
Other
Primary
Overall Response Rate (ORR)
Disease response was evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM.
VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Posted
Number
95% Confidence Interval
percentage of participants
Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.
ID
Title
Description
OG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Secondary
Clinical Benefit Response Rate
Clinical benefit rate was defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a 25% to 49% reduction in the level of serum M-protein or a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour, maintained for a minimum of 8 weeks.
Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Posted
Number
95% Confidence Interval
percentage of participants
Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.
ID
Title
Description
OG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Secondary
Progression-free Survival
Progression-free survival (PFS) was defined as the time from first dose to the earlier of disease progression or death due to any cause. The duration of PFS was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.
Participants were evaluated for disease response and progression by the investigator according to the IMWG-URC.
Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Posted
Median
95% Confidence Interval
months
From randomization until the data cut-off date of 22 July 2016; median follow-up time for PFS was 13.8 months
ID
Title
Description
OG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG001
Phase 1: Carfilzomib 56 mg/m²
Secondary
Time To Progression
Time to progression (TTP) was defined as the time from first dose to disease progression evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). TTP was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.
Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Posted
Median
95% Confidence Interval
months
From randomization until the data cut-off date of 22 July 2016; median follow-up time for TTP was 13.4 months
ID
Title
Description
OG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Secondary
Duration of Response
Duration of response (DOR) was defined as the time from first evidence of PR or better to disease progression or death due to any cause. DOR was calculated using Kaplan-Meier methods; Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone) with a best overall response of sCR, CR, VGPR, or PR.
Posted
Median
95% Confidence Interval
months
From randomization until the data cut-off date of 22 July 2016; median follow-up time for DOR was 14.3 months
ID
Title
Description
OG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Secondary
Number of Participants With Adverse Events
Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).
Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Posted
Count of Participants
Participants
From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
ID
Title
Description
OG000
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Secondary
Time to Maximum Plasma Concentration of Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Median
Full Range
hours
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Maximum Plasma Concentration of Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) fo Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Area Under the Plasma Concentration-time Curve During the Dosing Interval (0-168 Hours) for Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Volume of Distribution Observed at Steady State (Vss) for Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Terminal Half-life (T1/2,z) for Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Clearance of Carfilzomib After IV Infusion
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters/hour
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Secondary
Mean Residence Time Observed From Time Zero to Infinity (MRT0-∞) for Carfilzomib
Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.
ID
Title
Description
OG000
Carfilzomib 20 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
OG001
Carfilzomib 70 mg/m²
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
OG002
Carfilzomib 88 mg/m²
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
Time Frame
From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
1
3
3
3
EG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
0
3
3
3
EG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
4
15
15
15
EG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
1
6
6
6
EG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
35
89
87
89
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG0030 affected6 at risk
EG0041 affected89 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Disease progression
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Septic shock
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Haematuria traumatic
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Acute lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Hypertensive encephalopathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0025 affected15 at risk
EG0031 affected6 at risk
EG00425 affected89 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected15 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Porokeratosis
Congenital, familial and genetic disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Amblyopia
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Blindness
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Cataract
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Dry eye
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Eye discharge
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Eye irritation
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Glaucoma
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Photophobia
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Vision blurred
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected15 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Visual impairment
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0026 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0029 affected15 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Gastrointestinal tract irritation
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Loose tooth
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0027 affected15 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Sensitivity of teeth
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0024 affected15 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0024 affected15 at risk
EG003
Chest discomfort
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Chills
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0024 affected15 at risk
EG003
Cyst
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0003 affected3 at risk
EG0012 affected3 at risk
EG0029 affected15 at risk
EG003
Feeling hot
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected15 at risk
EG003
Infusion site pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0023 affected15 at risk
EG003
Malaise
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0024 affected15 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0024 affected15 at risk
EG003
Pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0027 affected15 at risk
EG003
Sluggishness
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Submandibular mass
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected15 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Cystitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Joint abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Localised infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Paronychia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0023 affected15 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG00212 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0022 affected15 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Blood glucose increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Blood pressure increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Blood urea increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Cardiac murmur
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected15 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Heart rate increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Platelet count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Protein total decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Urine output decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Weight increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
White blood cell count increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0025 affected15 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0025 affected15 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0026 affected15 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0025 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected15 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0024 affected15 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0025 affected15 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0026 affected15 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Migraine
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0024 affected15 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Anger
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0025 affected15 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Bradypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0025 affected15 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0025 affected15 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected15 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected15 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected15 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0023 affected15 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected15 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected15 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
D009101
Multiple Myeloma
Ancestor Terms
ID
Term
D054219
Neoplasms, Plasma Cell
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D020141
Hemostatic Disorders
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D010265
Paraproteinemias
D001796
Blood Protein Disorders
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D006474
Hemorrhagic Disorders
D008232
Lymphoproliferative Disorders
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
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
1 subjects
12 subjects
43 subjects
15 subjects
1 subjects
58.2
± 8.8
BG00468.7± 9.6
BG00567.5± 10.1
4
BG0035
BG00440
BG00552
Male
BG0002
BG0011
BG00211
BG0031
BG00449
BG00564
0
BG0031
BG00410
BG00511
Not Hispanic or Latino
BG0003
BG0013
BG00215
BG0035
BG00479
BG005105
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
11
BG0036
BG00479
BG005101
Black or African American
Title
Measurements
BG0000
BG0011
BG0022
BG0030
BG0046
BG0059
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
American Indian or Alaskan Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
Other
Title
Measurements
BG0000
BG0010
BG0022
BG0030
BG0041
BG0053
Unknown
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
2
BG0026
BG0033
BG00439
BG00551
1 (Restrictive but ambulatory)
BG0002
BG0011
BG0029
BG0033
BG00450
BG00565
6
2
OG001
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG005
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0036
OG00489
OG005104
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.8 to 90.6)
OG001100(29.2 to 100.0)
OG00293.3(68.1 to 99.8)
OG00366.7(22.3 to 95.7)
OG00474.2(63.8 to 82.9)
OG00576.9(67.6 to 84.6)
OG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG005
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0036
OG00489
OG005104
Title
Denominators
Categories
Title
Measurements
OG00066.7(9.4 to 99.2)
OG001100.0(29.2 to 100.0)
OG002100.0(78.2 to 100.0)
OG00383.3(35.9 to 99.6)
OG00480.9(71.2 to 88.5)
OG00583.7(75.1 to 90.2)
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG005
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0036
OG00489
OG005104
Title
Denominators
Categories
Title
Measurements
OG00013.6(6.4 to 20.7)
OG001NA(41.7 to NA)Could not be estimated due to the low number of events
OG00221.0(4.2 to NA)Could not be estimated due to the low number of events
OG00312.9(3.9 to 20.0)
OG00415.3(10.0 to 20.2)
OG00516.2(10.2 to 21.0)
OG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG005
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0036
OG00489
OG005104
Title
Denominators
Categories
Title
Measurements
OG00013.6(6.4 to 20.7)
OG001NA(41.7 to NA)Could not be estimated due to the low number of events
OG00221.0(4.2 to NA)Could not be estimated due to the low number of events
OG00312.9(3.9 to 20.0)
OG00416.2(10.2 to 20.2)
OG00517.2(10.6 to 21.7)
OG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG005
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Units
Counts
Participants
OG0001
OG0013
OG00214
OG0034
OG00466
OG00580
Title
Denominators
Categories
Title
Measurements
OG00018.9(NA to NA)Could not be estimated due to the low number of events
OG001NA(39.9 to NA)Could not be estimated due to the low number of events
OG00216.3(3.3 to NA)Could not be estimated due to the low number of events
OG00311.9(11.1 to 18.9)
OG00418.0(13.7 to 21.9)
OG00518.0(14.5 to 21.9)
OG002
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG003
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
OG004
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0036
OG00489
Title
Denominators
Categories
All adverse events
Title
Measurements
OG0003
OG0013
OG00215
OG0036
OG00489
Adverse events ≥ grade 3
Title
Measurements
OG0001
OG0012
OG0029
OG003
Serious adverse events
Title
Measurements
OG0001
OG0010
OG0024
OG003
AE leading to discontinuation of carfilzomib & dex