Study of INCB053914 in Subjects With Advanced Malignancies | NCT02587598 | Trialant
NCT02587598
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Dec 8, 2021Actual
Enrollment
97Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors
Interventions
INCB053914
I-DAC (Intermediate dose cytarabine)
Azacitidine
Ruxolitinib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02587598
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 53914-101
Secondary IDs
Not provided
Brief Title
Study of INCB053914 in Subjects With Advanced Malignancies
Official Title
A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Nov 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03147742Approved for marketing
Start Date
Dec 29, 2015Actual
Primary Completion Date
Aug 11, 2020Actual
Completion Date
Aug 11, 2020Actual
First Submitted Date
Oct 26, 2015
First Submission Date that Met QC Criteria
Oct 26, 2015
First Posted Date
Oct 27, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 3, 2021
Results First Submitted that Met QC Criteria
Nov 9, 2021
Results First Posted Date
Dec 8, 2021Actual
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
Nov 9, 2021
Last Update Posted Date
Dec 8, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
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
This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).
INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy.
Drug: INCB053914
Parts 3 and 4: INCB053914 + Azacitidine
Experimental
Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
Drug: INCB053914
Drug: Azacitidine
Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)
Experimental
I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
Drug: INCB053914
Drug: I-DAC (Intermediate dose cytarabine)
Parts 3 and 4: INCB053914 + Ruxolitinib
Experimental
Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
Drug: INCB053914
Drug: Ruxolitinib
Parts 1 and 2: INCB053914 50 mg
Experimental
INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB053914
Drug
Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria.
INCB053914 tablets to be administered by mouth.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events
Approximately 7 months
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With the Intermediate-dose Cytarabine (I DAC) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Based on Objective Remission Rate (ORR)
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 in combination with cytarabine in Part 4 was not assessed because Part 4 was not opened for enrollment owing to this combination regimen not being tolerated in Part 3.
Approximately 2 months
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.
Approximately 6 months
Secondary Outcomes
Measure
Description
Time Frame
Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)
Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay
1 month
Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older
Confirmed diagnosis of select advanced malignancy
Parts 1 and 2:
Unresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator.
Not currently a candidate for curative treatment
Parts 3 and 4:
Subjects with relapsed/refractory AML must have received either induction chemotherapy for AML or hypomethylating agents for hematologic disease before AML.
Elderly subjects (≥ 65 years) with newly diagnosed AML must be treatment naive and unfit for intensive chemotherapy.
Myelofibrosis subjects must have been treated with ruxolitinib for ≥ 6 months with a stable dose for ≥ 8 weeks (acceptable doses are 5 mg twice daily [BID] to 25 mg BID).
Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival sample obtained since completion of most recent therapy (as appropriate to subjects with existing bone marrow disease or for whom bone marrow examination is a component of disease status assessment)
Eastern Cooperative Oncology Group (ECOG) performance status
Part 1: 0 or 1
Parts 2, 3 and 4: 0, 1, or 2
Life expectancy > 12 weeks or ≥ 24 weeks for Part 3 and Part 4 MF subjects.
Exclusion Criteria:
Inadequate bone marrow or organ function
Received an investigational agent within 5 half-lives or 14 days, whichever is longer, prior to receiving the first dose of study drug
Received non-biologic anticancer medication within 5 half-lives prior to receiving the first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas), within 28 days for any antibodies or biological therapies
Prior receipt of a PIM inhibitor
Any history of disease involving the central nervous system (Part 1). Known active disease involving the central nervous system (Part 2).
Patel MR, Donnellan W, Byrne M, Asch AS, Zeidan AM, Baer MR, Fathi AT, Kuykendall AT, Zheng F, Walker C, Cheng L, Marando C, Savona MR. Phase 1/2 Study of the Pan-PIM Kinase Inhibitor INCB053914 Alone or in Combination With Standard-of-Care Agents in Patients With Advanced Hematologic Malignancies. Clin Lymphoma Myeloma Leuk. 2023 Sep;23(9):674-686. doi: 10.1016/j.clml.2023.05.002. Epub 2023 May 15.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 58 participants were enrolled and treated in Parts 1 and 2 combined and were included in the safety population and the full analysis set.
A total of 39 participants enrolled and treated in Parts 3 and 4 combined were included in the safety population and the full analysis set.
Recruitment Details
This study was conducted in 18 US centers and consisted of 4 parts: Parts 1 and 2 evaluated INCB053914 as a monotherapy, and Parts 3 and 4 evaluated INCB053914 as part of a combination therapy with select standard-of-care agents (cytarabine, azacitidine, and ruxolitinib) in participants with advanced malignancies. Note:The study was terminated early based on strategic business decisions and not due to concerns with the safety and tolerability of INCB053914.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 was self-administered orally once a day as a 100mg immediate release monotherapy dose.
FG001
Parts 1 and 2: INCB053914 50 mg BID
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 18, 2019
Aug 3, 2021
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
Drug: INCB053914
Parts 1 and 2: INB053914 65 mg
Experimental
INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy.
Drug: INCB053914
Parts 1 and 2: INB053914 80 mg
Experimental
INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy.
Drug: INCB053914
Parts 1 and 2: INB053914 100 mg BID
Experimental
INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy.
Drug: INCB053914
Parts 1 and 2: INB053914 115 mg
Experimental
INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy.
Drug: INCB053914
Parts 1 and 2: INB053914 100 mg BID
Parts 1 and 2: INB053914 115 mg
Parts 1 and 2: INB053914 65 mg
Parts 1 and 2: INB053914 80 mg
Parts 1 and 2: INCB053914 100 mg QD
Parts 1 and 2: INCB053914 50 mg
Parts 3 and 4: INCB053914 + Azacitidine
Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)
Parts 3 and 4: INCB053914 + Ruxolitinib
I-DAC (Intermediate dose cytarabine)
Drug
Cytarabine dose will be 1 g/m^2. Cytarabine will be administered as an intravenous (IV) infusion.
Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)
Azacitidine
Drug
Azacitidine dose will be 75 mg/m^2. Azacitidine will be administered either sub-cutaneously (SC) or intravenously (IV).
Parts 3 and 4: INCB053914 + Azacitidine
Vidaza®
Ruxolitinib
Drug
Starting dose of ruxolitinib will be the dose the subject was on at study entry Ruxolitinib will be administered by mouth.
Parts 3 and 4: INCB053914 + Ruxolitinib
Cycle 1 Day 5
Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Cycle 1 Day 5
Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Cycle 1 Day 5
Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Cycle 1 Day 5
Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Cycle 1 Day 5
Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine
Cycle 1 Day 8
Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine
Cycle 1 Day 8
Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine
Cycle 1 Day 8
Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine
Cycle 1 Day 8
Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine
Cycle 1 Day 8
Pharmacokinetics: Tmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Regimen 2 Week 4
Pharmacokinetics: AUCtau of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Regimen 2 Week 4
Pharmacokinetics: Cl/F of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Regimen 2 Week 4
Pharmacokinetics: Cmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Regimen 2 Week 4
Pharmacokinetics: Cmin of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Regimen 2 Week 4
Pharmacokinetics: Tmax of INCB053914 Monotherapy
Cycle 1 Day 8
Pharmacokinetics: AUCtau of INCB053914 Monotherapy
Cycle 1 Day 8
Pharmacokinetics: CL/F of INCB053914 Monotherapy
Cycle 1 Day 8
Pharmacokinetics: Cmax of INCB053914 Monotherapy
Cycle 1 Day 8
Pharmacokinetics: Ctau of INCB053914 Monotherapy
Cycle 1 Day 8
Sacramento
California
95817
United States
UCLA Medical Hematology & Oncology
Santa Monica
California
90095
United States
Yale University
New Haven
Connecticut
06511
United States
Mayo Clinic Florida
Jacksonville
Florida
32224
United States
Florida Cancer Specialists & Research Institute
Sarasota
Florida
33916
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
33612
United States
Emory University-Winship Cancer Institute
Atlanta
Georgia
30322
United States
University of Maryland
Baltimore
Maryland
21201
United States
Dana-Farber Cancer Center
Boston
Massachusetts
02215
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor
Michigan
48109
United States
University of Nebraska Medical Center
Omaha
Nebraska
69198
United States
Oncology Hematology Care Clinical Trials LLC
Cincinnati
Ohio
45236
United States
Stephenson Cancer Center
Oklahoma City
Oklahoma
73104
United States
Tennessee Oncology
Nashville
Tennessee
37203
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
Texas Oncology
Austin
Texas
78705
United States
Texas Oncology
Tyler
Texas
75702
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
INCB053914 was self-administered orally twice day as a 50mg immediate release monotherapy dose.
FG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 was self-administered orally twice day as a 65mg immediate release monotherapy dose.
FG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 was self-administered orally twice day as a 80mg immediate release monotherapy dose.
FG004
Parts 1 and 2: INB053914 100 mg BID
INCB053914 was self-administered orally twice day as a 100mg immediate release monotherapy dose.
FG005
Parts 1 and 2: INB053914 115 mg BID
INCB053914 was self-administered orally twice day as a 115mg immediate release monotherapy dose.
FG006
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: 50 mg twice a day + I-DAC (intermediate dose cytarabine) was administered at a dose of 1 g/m2 as an infusion as a combination therapy with INCB053914.
FG007
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg twice a day + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
FG008
Part 3 and 4 - INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
FG009
Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
FG010
Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
FG0004 subjects
FG00111 subjects
FG0024 subjects
FG00321 subjects
FG00412 subjects
FG0056 subjects
FG0066 subjects
FG0077 subjects
FG0089 subjects
FG0093 subjects
FG01014 subjects
COMPLETED
All participants in each arm discontinued study treatment and withdrew from the study.
FG0000 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0010 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0020 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0030 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0040 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0050 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0060 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0070 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0080 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0090 subjectsAll participants discontinued study treatment and withdrew from the study.
FG0100 subjectsAll participants discontinued study treatment and withdrew from the study.
NOT COMPLETED
FG0004 subjects
FG00111 subjects
FG0024 subjects
FG00321 subjects
FG00412 subjects
FG0056 subjects
FG0066 subjects
FG0077 subjects
FG0089 subjects
FG0093 subjects
FG01014 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0018 subjects
FG0024 subjects
FG00316 subjects
FG0049 subjects
FG0054 subjects
FG0066 subjects
FG0077 subjects
FG0089 subjects
FG0091 subjects
FG0103 subjects
Study Terminated by the Sponsor
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG004
Reason for study withdrawal not specified
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
BG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
BG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day as a 65mg immediate release monotherapy dose.
BG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day as a 80mg immediate release monotherapy dose.
BG004
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day s a 100mg immediate release monotherapy dose.
BG005
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
BG006
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: 50 mg BID + I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
BG007
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914 50 mg BID.
BG008
Part 3 and 4 - INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
BG009
Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
BG010
Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG00111
BG0024
BG00321
BG00412
BG0056
BG0066
BG0077
BG0089
BG0093
BG01014
BG01197
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
BG00059.5± 14.25
BG00167.1± 14.64
BG00267.3± 9.18
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG0004
BG00111
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0001
BG0010
BG002
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
Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events
Posted
Number
Participants
Approximately 7 months
ID
Title
Description
OG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
OG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
OG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
OG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
OG004
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
OG005
Parts 1 and 2: INB053914 115 mg BID
INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
OG006
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
OG007
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
OG008
Parts 3 and 4: INCB053914 80 mg BID + Azacitine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
OG009
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With the Intermediate-dose Cytarabine (I DAC) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Based on Objective Remission Rate (ORR)
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 in combination with cytarabine in Part 4 was not assessed because Part 4 was not opened for enrollment owing to this combination regimen not being tolerated in Part 3.
Part 4 was not opened for enrollment owing to combination regimen not being tolerated in Part 3.
Posted
Approximately 2 months
ID
Title
Description
OG000
Part 4: INCB053914 50 mg BID + Cytarabine)
Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
Units
Counts
Participants
OG000
Primary
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.
Part 4 was not opened for enrollment.
Posted
Approximately 6 months
ID
Title
Description
OG000
Part 4: INCB053914 50 mg BID + Azacitidine
Combination Treatment Group B INCB053914 50 mg BID + Azacitidine
OG001
Part 4: INB053914 80 mg BID + Azactidine
Combination Treatment Group B: B053914 80 mg BID + Azactidine
Units
Counts
Participants
OG000
Secondary
Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)
Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay
The PD evaluable population includes those in the safety population who have at least 1 valid PD measurements at both pre- and postdose.
Posted
Mean
Full Range
Percentage of Inhibition
1 month
ID
Title
Description
OG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy.
OG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy.
OG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy.
OG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy.
Secondary
Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Posted
Median
Full Range
h
Cycle 1 Day 5
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
Combination Group A: INCB053914 50 mg BID + Cytarabine
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Posted
Mean
Standard Deviation
nM*h
Cycle 1 Day 5
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
Combination Group A: INCB053914 50 mg BID + Cytarabine
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Posted
Mean
Standard Deviation
L/hr
Cycle 1 Day 5
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
Combination Group A: INCB053914 50 mg BID + Cytarabine
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Posted
Mean
Standard Deviation
nM
Cycle 1 Day 5
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
Combination Group A: INCB053914 50 mg BID + Cytarabine
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Posted
Mean
Standard Deviation
nM
Cycle 1 Day 5
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
Combination Group A: INCB053914 50 mg BID + Cytarabine
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine
Posted
Median
Full Range
h
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Secondary
Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine
Posted
Mean
Standard Deviation
nM*h
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine
Posted
Mean
Standard Deviation
L/h
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine
Posted
Mean
Standard Deviation
nM
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine
Posted
Mean
Standard Deviation
nM
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Secondary
Pharmacokinetics: Tmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Posted
Median
Full Range
h
Regimen 2 Week 4
ID
Title
Description
OG000
Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: AUCtau of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Posted
Mean
Standard Deviation
nM*h
Regimen 2 Week 4
ID
Title
Description
OG000
Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cl/F of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Posted
Mean
Standard Deviation
L/h
Regimen 2 Week 4
ID
Title
Description
OG000
Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Posted
Mean
Standard Deviation
nM
Regimen 2 Week 4
ID
Title
Description
OG000
Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Cmin of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Posted
Mean
Standard Deviation
nM
Regimen 2 Week 4
ID
Title
Description
OG000
Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Secondary
Pharmacokinetics: Tmax of INCB053914 Monotherapy
Posted
Median
Full Range
hour
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
OG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
OG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
OG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
OG004
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
Secondary
Pharmacokinetics: AUCtau of INCB053914 Monotherapy
Posted
Mean
Standard Deviation
nM*h
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
OG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
OG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
OG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
OG004
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
Secondary
Pharmacokinetics: CL/F of INCB053914 Monotherapy
Posted
Mean
Standard Deviation
L/h
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
OG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
OG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
OG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
OG004
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
Secondary
Pharmacokinetics: Cmax of INCB053914 Monotherapy
Posted
Mean
Standard Deviation
nM
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
OG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
OG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
OG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
OG004
Parts 1 and 2: INB053914 100 mg BID
INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
Secondary
Pharmacokinetics: Ctau of INCB053914 Monotherapy
Ctau was calculated using the predose value on C1D8
Posted
Mean
Standard Deviation
L/h
Cycle 1 Day 8
ID
Title
Description
OG000
Parts 1 and 2: INCB053914 100 mg QD
INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
OG001
Parts 1 and 2: INCB053914 50 mg BID
INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
OG002
Parts 1 and 2: INB053914 65 mg BID
INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
OG003
Parts 1 and 2: INB053914 80 mg BID
INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
OG004
Parts 1 and 2: INB053914 100 mg BID
Time Frame
up to approximately 6 months
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
Part 1 and 2 - INCB053914: 100 mg QD
Part 1 and 2 - INCB053914: 100 mg QD
4
4
3
4
4
4
EG001
Part 1 and 2 - INCB053914: 50 mg BID
Part 1 and 2 - INCB053914: 50 mg BID
8
11
6
11
11
11
EG002
Part 1 and 2 - INCB053914: 65 mg BID
Part 1 and 2 - INCB053914: 65 mg BID
4
4
3
4
4
4
EG003
Part 1 and 2 - INCB053914: 80 mg BID
Part 1 and 2 - INCB053914: 80 mg BID
19
21
6
21
20
21
EG004
Part 1 and 2 - INCB053914: 100 mg BID
Part 1 and 2 - INCB053914: 100 mg BID
9
12
8
12
12
12
EG005
Part 1 and 2 - INCB053914: 115 mg BID
Part 1 and 2 - INCB053914: 115 mg BID
4
6
5
6
6
6
EG006
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
6
6
5
6
6
6
EG007
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
7
7
5
7
7
7
EG008
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
9
9
6
9
8
9
EG009
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
1
3
0
3
3
3
EG010
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
3
14
5
14
14
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected21 at risk
EG004
Alanine aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Carotid artery occlusion
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Disease progression
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0014 events3 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Haemorrhagic infarction
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Infective myositis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Multi-organ failure
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Plasmacytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0013 events3 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Blast cell crisis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Bursitis infective
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected21 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected14 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0012 events2 affected11 at risk
EG0022 events1 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0003 events2 affected4 at risk
EG0012 events2 affected11 at risk
EG0024 events3 affected4 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0022 events2 affected4 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0013 events2 affected11 at risk
EG0022 events1 affected4 at risk
EG003
Asthenia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events2 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0012 events2 affected11 at risk
EG0022 events2 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0012 events2 affected11 at risk
EG0022 events1 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0022 events1 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0004 events4 affected4 at risk
EG0014 events4 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0023 events1 affected4 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Incision site infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Medical device complication
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0003 events3 affected4 at risk
EG0016 events4 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0011 events1 affected11 at risk
EG0022 events2 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Sensitivity of teeth
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Wound infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Breast cyst
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Cerebellar haemorrhage
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Early satiety
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Furuncle
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Gouty tophus
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haematoma
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Injection site pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Injection site reaction
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Iron overload
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Localised oedema
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pallor
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus allergic
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Retinal tear
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Skin neoplasm excision
Surgical and medical procedures
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Skin tightness
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)