A Study of KW-2478 in Combination With Bortezomib in Subj... | NCT01063907 | Trialant
NCT01063907
Sponsor
Kyowa Kirin Co., Ltd.
Status
Completed
Last Update Posted
Apr 25, 2024Actual
Enrollment
95Actual
Phase
Phase 1Phase 2
Conditions
Multiple Myeloma
Interventions
KW-2478
Bortezomib
Countries
United States
Philippines
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01063907
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2478-INT-001
Secondary IDs
ID
Type
Description
Link
2009-016223-56
EudraCT Number
Brief Title
A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Official Title
An Open Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Acronym
Not provided
Organization
Kyowa Kirin Co., Ltd.INDUSTRY
Status Module
Record Verification Date
Apr 2024
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
Mar 2010
Primary Completion Date
Nov 2013Actual
Completion Date
Nov 2013Actual
First Submitted Date
Feb 4, 2010
First Submission Date that Met QC Criteria
Feb 4, 2010
First Posted Date
Feb 5, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 25, 2014
Results First Submitted that Met QC Criteria
Nov 3, 2014
Results First Posted Date
Nov 5, 2014Estimated
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
Apr 23, 2024
Last Update Posted Date
Apr 25, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kyowa Kirin Co., Ltd.INDUSTRY
Collaborators
Name
Class
Kyowa Hakko Kirin Pharma, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM).
The primary objectives:
To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I);
To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II).
The secondary objectives:
To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only);
To evaluate for preliminary evidence of efficacy (Phase I);
To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).
Detailed Description
This is a multicenter, open label, dose escalation, Phase I / II study in subjects with relapsed and/or refractory MM. Up to 24 subjects to be enrolled in the Phase I to determine the RP2D. Up to 77 additional evaluable subjects to be enrolled in Phase II for a maximum up to 101 subjects treated in the study. Study centers in the USA and the UK will participate in Phase I and II. Centers in the Philippines will be participating in Phase II only. The planned enrollment period is 22 months and the planned study duration is 28 months.
Conditions Module
Conditions
Multiple Myeloma
Keywords
Leukemia
Immunoproliferative Disorder
Neoplasma by Histologic Type
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Paraproteinemias
Multiple Myeloma
Hematologic Disorders
Leukemia, Chronic, B-cell
Leukemia, B-cell
Leukemia, Chronic
Neoplasms, Plasma Cell
Monoclonal Gammopathy of unknown significance (MGUS)
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
95Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1: Cohort 1
Experimental
Cohort 1: KW 2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2
Drug: KW-2478
Drug: Bortezomib
Phase 1: Cohort 2
Experimental
Cohort 2: KW 2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2
Drug: KW-2478
Drug: Bortezomib
Phase 1: Cohort 3
Experimental
Cohort 3: KW 2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2
Drug: KW-2478
Drug: Bortezomib
Phase 1: Cohort 4
Experimental
Cohort 4: KW 2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
Drug: KW-2478
Drug: Bortezomib
Phase 2
Experimental
KW 2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2
Drug: KW-2478
Drug: Bortezomib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
KW-2478
Drug
Administered Days 1, 4, 8 and 11 of a 21 day cycle
Phase 1: Cohort 1
Phase 1: Cohort 2
Phase 1: Cohort 3
Phase 1: Cohort 4
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.
The ORR, was defined as the best response over a specified number of cycles (calculated and summarized).
Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).
21 day cycle, up to 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: PK Absorption Tmax hr Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
PK collected Day 11 of 21-day cycle
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Accepts Healthy Volunteers: No
Inclusion Criteria:
Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed.
Signed either an IRB or IEC approved informed consent
ECOG performance status of ≤ 2
Life expectancy of at least 3 months
M protein in either serum or urine, or free light chains if not measurable M protein in serum or urine, and clonal bone marrow plasma cells > 10%, and evidence of end organ damage
Adequate hematologic status, liver and renal function
Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.
Exclusion Criteria:
No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug
Any other severe, acute or chronic illness
No other prior or concurrent malignancy
No immunosuppressant therapy
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Michael Kurman, MD
Kyowa Hakko Kirin Pharma, Inc.
Study Director
Loan Hoang-Sayag, MD
Quintiles, Inc.
Study Chair
Noel Pingoy, MD
Gleneagles CRC
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,
Tucson
Arizona
85715
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Study centers in the USA and the UK participated in the Phase 1 portion, and study centers in the USA, UK, and Philippines participated in the Phase 2 portion.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: KW-2478 and Bortezomib
The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group 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
Phase 2
HSP90 Inhibitor
Bortezomib
Drug
Administered on Days 1, 4, 8 and 11 of a 21 day cycle
Phase 1: Cohort 1
Phase 1: Cohort 2
Phase 1: Cohort 3
Phase 1: Cohort 4
Phase 2
Velcade
Phase 1: PK Exposure Cmax ng/mL Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
PK collected Day 11 of 21-day cycle
Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
PK collected Day 11 of 21-day cycle
Phase 1: PK Elimination t½ hr Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
PK collected Day 11 of 21-day cycle
Pacific Shores Medical Group 1043 Elm Ave, Suite 104
Long Beach
California
90813
United States
UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333,
Los Angeles
California
90095-7059
United States
Collaborative Research Group 2320 S Seacrest Blvd, Suite 202
Boynton Beach
Florida
33435
United States
Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834
Chicago
Illinois
60612
United States
Cancer Institute of New Jersey 195 Little Albany Street
New Brunswick
New Jersey
08903-2681
United States
The Jones Clinic 7710 Wolf River Circle
Germantown
Tennessee
38138
United States
UT MD Anderson Cancer Center, 1515 Holcombe Boulevard,
Houston
Texas
77030
United States
Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001,
La Crosse
Wisconsin
54601
United States
The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue,
Pasig
Manila
Philippines
National Kidney and Transplant Institute, Rm 3215 Doctors Clinic, East Avenue
Diliman
Quezon City
Philippines
Makati Medical Center, New Wing Hall C372, #2 Amorsolo Street, Legaspi Village,
Makati City
Philippines
Saint Lukes Medical Center, Rm 222 MAB Saint Lukes Medical Center, E. Rodriguez
Quezon City
Philippines
Darent Valley Hospital Dept of Haematology, Acorn House, Darenth Wood Road
Dartford
Kent
DA2 8DA
United Kingdom
St Bartholomew's Hospital Haematology Department, 1st Floor, Pathology
Barbican
London
EC1 7ED
United Kingdom
Christie Hospital - Department Haematology, 550 Wilmslow Road
Withington
Manchester, Greater Manchester
M20 4BX
United Kingdom
Hillingdon Hospital Dept of Haematology, Pield Health Road
Uxbridge
Middlesex
UB8 3NN
United Kingdom
Royal Marsden Hospital, Orchard House
Sutton
Surrey
SM2 5PT
United Kingdom
Royal Bournemouth Hospital, Dept. of Haematolgy, Castle Lane East,
Bournemouth
BH7 7DW
United Kingdom
Royal Devon & Exeter Hospital Haematology Centre, Barrack Road
Exeter
EX2 5DW
United Kingdom
Northwick Park Hospital Dept of Haematology, Watford Road
Harrow
HA1 3UJ
United Kingdom
St James Hospital, St James' Institute of Oncology, Department of Haematology, Level 03, Bexley Wing,
Leeds
LS9 7TF
United Kingdom
UCL Cancer Institute, Paul O'Gorman Building, University College London,72 Huntley Street
London
WC1E 6DD
United Kingdom
Manchester Royal Infirmary Dept of Haematology, Oxford Road
Manchester
M13 9WL
United Kingdom
Nottingham University Hospitals NHS Trust, Centre for Clinical Haemotology
Nottingham
NG5 1PB
United Kingdom
Royal Cornwall Hospital Haematology Clinic
Truro
TR1 3LS
United Kingdom
FG001
Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2
The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m^2/bortezomib1.3 mg/m^2).
FG00015 subjects
FG00180 subjects
COMPLETED
FG00015 subjects
FG00180 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
A total of up to 101 male and female subjects at least 18 years of age with a confirmed diagnosis of MM, who failed at least 1 and no more than 3 prior chemotherapy regimens and met other inclusion criteria and none of exclusion criteria, were to be enrolled in this study over a period of 22 months (up to 24 subject in P1 and 77 subjects in P2).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
KW-2478 and Bortezomib
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and Bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2 / Bortezomib 1.3 mg/m^2).
Denominators
Units
Counts
Participants
BG00095
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
BG00064.3± 9.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00041
Male
BG00054
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
Asian
BG00022
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00018
Philippines
Title
Measurements
BG000
Body Surface Area (BSA)
Mean
Standard Deviation
m^2
Title
Denominators
Categories
Title
Measurements
BG0001.87± 0.27
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
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.
The ORR, was defined as the best response over a specified number of cycles (calculated and summarized).
Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).
All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.
Posted
Number
participants
21 day cycle, up to 52 weeks
ID
Title
Description
OG000
Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m^2) and Bortezomib (1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2).
OG001
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG002
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG003
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG004
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG005
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2).
Units
Counts
Participants
OG00095
OG0013
OG0023
OG003
Title
Denominators
Categories
Subjects with Any TEAE
Title
Measurements
OG00095
OG0013
OG0023
OG003
Secondary
Phase 1: PK Absorption Tmax hr Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.
Posted
Mean
Standard Deviation
hr
PK collected Day 11 of 21-day cycle
ID
Title
Description
OG000
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
OG001
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
OG002
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
OG003
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Secondary
Phase 1: PK Exposure Cmax ng/mL Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.
Posted
Mean
Standard Deviation
ng/mL
PK collected Day 11 of 21-day cycle
ID
Title
Description
OG000
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG001
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG002
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Secondary
Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.
Posted
Mean
Standard Deviation
hr*ng/mL
PK collected Day 11 of 21-day cycle
ID
Title
Description
OG000
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG001
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
OG002
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Secondary
Phase 1: PK Elimination t½ hr Day 11
Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.
Posted
Mean
Standard Deviation
hr
PK collected Day 11 of 21-day cycle
ID
Title
Description
OG000
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
OG001
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
OG002
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
OG003
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Time Frame
Not provided
Description
Not provided
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 and 2: KW-2478 and Bortezomib
KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
4
6
6
6
EG005
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m^2/BTZ 1.3 mg/m^2).
36
80
80
80
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected6 at risk
EG0054 events4 affected80 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter sepsis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Listeriosis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lung infection pseudomonal
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0007 events7 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Troponin T increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Viral test positive
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Multiple myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG00030 events17 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected3 at risk
EG0041 events1 affected6 at risk
EG00527 events14 affected80 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG00037 events15 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 12.1
Systematic Assessment
EG00041 events19 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye discharge
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye pruritus
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye swelling
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid disorder
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eyelids pruritus
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Foreign body sensation in eyes
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG00015 events12 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Macular degeneration
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Metamorphopsia
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retinal disorder
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG00019 events16 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events5 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00019 events13 affected95 at risk
EG0016 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00031 events17 affected95 at risk
EG0015 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00012 events11 affected95 at risk
EG0013 events3 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00071 events42 affected95 at risk
EG0018 events3 affected3 at risk
EG0024 events2 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG000199 events70 affected95 at risk
EG00129 events3 affected3 at risk
EG0029 events2 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0007 events7 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00020 events13 affected95 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events3 affected95 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal hypermotility
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG000114 events55 affected95 at risk
EG00111 events3 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumatosis intestinalis
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tongue coated
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00072 events38 affected95 at risk
EG0011 events1 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Asthenia
General disorders
MedDRA Version 12.1
Systematic Assessment
EG00017 events15 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site erythema
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site related reaction
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter thrombosis
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Cyst
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Facial pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA Version 12.1
Systematic Assessment
EG000101 events51 affected95 at risk
EG0016 events2 affected3 at risk
EG00210 events3 affected3 at risk
EG003
Feeling cold
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion site haematoma
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion site pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Injection site haematoma
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Irritability
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0006 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mass
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 12.1
Systematic Assessment
EG00017 events12 affected95 at risk
EG0012 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Pain
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA Version 12.1
Systematic Assessment
EG00015 events12 affected95 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Swelling
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bronchiectasis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis infective
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gingival infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Localised infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG00019 events14 affected95 at risk
EG0014 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0008 events7 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Orchitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG00013 events7 affected95 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin candida
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG00015 events14 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0007 events6 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Viral infection
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Human bite
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Medical device site reaction
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Narcotic intoxication
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood potassium decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0005 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Blood pressure increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood sodium decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Body temperature increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
C-reactive protein increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eosinophil count increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Heart rate decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG00011 events5 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0005 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Protein total increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG00010 events9 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Weight increased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG00044 events28 affected95 at risk
EG0014 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0006 events6 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fluid intake reduced
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0007 events5 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG00013 events8 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG00010 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG00015 events12 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG00013 events12 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Bone disorder
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0006 events5 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dactylitis
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fasciitis
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG00013 events10 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG00010 events10 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG00017 events12 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0006 events5 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG00019 events15 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ageusia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Areflexia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00033 events25 affected95 at risk
EG0018 events3 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness exertional
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00013 events13 affected95 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00041 events23 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperreflexia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00011 events8 affected95 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected3 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0008 events6 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00013 events8 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00048 events28 affected95 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00017 events11 affected95 at risk
EG0010 events0 affected3 at risk
EG0025 events2 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG00036 events15 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events5 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG00015 events13 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Epididymitis
Reproductive system and breast disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Genital pain
Reproductive system and breast disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Testicular cyst
Reproductive system and breast disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00029 events21 affected95 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00025 events19 affected95 at risk
EG0012 events2 affected3 at risk
EG0025 events1 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0009 events6 affected95 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0009 events8 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events1 affected95 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG00011 events11 affected95 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0007 events6 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0007 events6 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0007 events7 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events4 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0009 events8 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG00017 events13 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 events4 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Subcutaneous nodule
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events2 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events3 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0009 events5 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0003 events2 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Phlebitis
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 events4 affected95 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vasculitis
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vein discolouration
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Senior VP Drug Development
Kyowa Hakko Kirin Pharma, Inc.
609-919-1100
clinical.info@kyowa-kirin-pharma.com
ID
Term
D009101
Multiple Myeloma
D007938
Leukemia
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D006402
Hematologic Diseases
D001796
Blood Protein Disorders
D010265
Paraproteinemias
D015448
Leukemia, B-Cell
D000092122
Bronchiolitis Obliterans Syndrome
D054219
Neoplasms, Plasma Cell
D008998
Monoclonal Gammopathy of Undetermined Significance
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D020141
Hemostatic Disorders
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D006425
Hemic and Lymphatic Diseases
D006474
Hemorrhagic Disorders
D008232
Lymphoproliferative Disorders
D007945
Leukemia, Lymphoid
D008206
Lymphatic Diseases
D000092124
Organizing Pneumonia
D001989
Bronchiolitis Obliterans
D001988
Bronchiolitis
D001991
Bronchitis
D001982
Bronchial Diseases
D012140
Respiratory Tract Diseases
D008173
Lung Diseases, Obstructive
D008171
Lung Diseases
D006086
Graft vs Host Disease
D006942
Hypergammaglobulinemia
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C551428
KW-2478
C000716949
Hsp90 inhibitor KU757
D000069286
Bortezomib
Ancestor Terms
ID
Term
D001897
Boronic Acids
D000148
Acids, Noncarboxylic
D000143
Acids
D007287
Inorganic Chemicals
D001896
Boron Compounds
D009930
Organic Chemicals
D011719
Pyrazines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Native Hawaiian or Other Pacific Islander
BG0000
Black or African American
BG0008
White
BG00061
More than one race
BG0000
Unknown or Not Reported
BG0004
20
United Kingdom
Title
Measurements
BG00057
3
OG0046
OG00580
3
OG0046
OG00580
Related TEAE
Title
Measurements
OG00088
OG0013
OG0023
OG0032
OG0046
OG00574
Moderate (CTCAE 2) TEAE
Title
Measurements
OG00022
OG0010
OG0020
OG0030
OG0040
OG00522
Severe (CTCAE 3) TEAE
Title
Measurements
OG00054
OG0013
OG0022
OG0032
OG0045
OG00542
Life Threatening TEAE
Title
Measurements
OG00013
OG0010
OG0021
OG0030
OG0040
OG00512
Serious Treatment-Emergent AE
Title
Measurements
OG00048
OG0012
OG0023
OG0033
OG0044
OG00536
Subjects with Any DLT
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Title
Measurements
OG0001.03± 0.0441
OG0011.03± 0.0481
OG0021.11± 0.129
OG0031.07± 0.0638
OG003
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Title
Measurements
OG0007910± 5360
OG00141000± 64100
OG0025990± 2720
OG0035280± 2290
OG003
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Title
Measurements
OG0007940± 2580
OG00126200± 36700
OG0027190± 2150
OG0036040± 2280
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle