Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)
Official Title
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
Acronym
Not provided
Organization
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)INDUSTRY
Status Module
Record Verification Date
Dec 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 18, 2017Actual
Primary Completion Date
Mar 8, 2022Actual
Completion Date
Mar 8, 2022Actual
First Submitted Date
Apr 18, 2017
First Submission Date that Met QC Criteria
Apr 26, 2017
First Posted Date
May 2, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 22, 2023
Results First Submitted that Met QC Criteria
Dec 19, 2023
Results First Posted Date
Jan 10, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 8, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jan 10, 2024Actual
Last Update Submitted Date
Dec 19, 2023
Last Update Posted Date
Jan 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
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 a Phase 1/2 open-label study to evaluate the safety, tolerability, steady-state pharmacokinetic (PK) and pharmacodynamics (PD) of a lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat (IMG-7289/MK-3543), administered orally once daily in participants with myelofibrosis.
The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with myelofibrosis including primary myelofibrosis (PMF), post-polycythaemia vera-myelofibrosis (PPVMF), and post-essential thrombocythaemia-myelofibrosis (PET-MF) (collectively referred to as 'MF'); inhibition of LSD1 by bomedemstat will reduce spleen size in those with splenomegaly, improve haematopoiesis and reduce constitutional symptoms associated with these disorders.
Detailed Description
This study initiated as a Phase 1/2a study assessing the safety of the starting dose, an 85-day duration of treatment, and the PK and PD effects of bomedemstat, with transition to a Phase 2b study incorporating changes supported by the Phase 1/2a data.
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally every day (qd) for 85 days during the Initial Treatment Period (ITP). Qualifying participants could continue to receive treatment for an additional 85 days during an Additional Treatment Period (ATP) as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
Experimental
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 85 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
Experimental
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 85 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
Experimental
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bomedemstat
Drug
Oral (capsule) administration according to dose allocation.
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any one of the following adverse events (AEs) that occured through Day 7 of the Initial Treatment Period (ITP) and was considered by the Investigator to be possibly, probably or definitely related to bomedemstat:
Thrombocytopenia leading to clinically significant sequelae (i.e., a clinically significant bleeding event or the need for prophylactic transfusions)
A clinically significant bleeding event in a participant with a platelet count >50 x 10^9/L (50 k/μL)
Any Grade 4 or 5 non-haematologic adverse event
Any Grade 3 non-haematologic adverse event with failure to recover to Grade 2 within 7 days of drug cessation, with the following exceptions: ≥ Grade 3 nausea, vomiting or diarrhea that responds to standard medical care; ≥ Grade 3 aesthenia lasting less than 14 days; any Grade 3 electrolyte abnormality unrelated to the underlying malignancy and persisting greater than 24 hours.
The number of participants with a DLT were reported.
Up to Day 7 of the ITP
Number of Participants With Serious Adverse Events
An AE was any undesirable physical, psychological or behavioral effect experienced by a participant, in conjunction with the use of the drug or biologic, whether or not product-related. This included any untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat until completion of the study. Serious AEs (SAEs) were any AE that resulted in death, life-threatening experience, required or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly, or important medical events. The number of participants with at least one treatment-emergent (TE) SAE was reported for each arm.
Up to approximately 30 months
Number of Participants With Adverse Events
An AE was any undesirable physical, psychological or behavioral effect experienced by a participant, in conjunction with the use of the drug or biologic, whether or not product-related. This included any untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat until completion of the study. The number of participants with at least one TE AE was reported for each arm.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
>18 years of age
Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, or PPV-MF or PET-MF per the International Working Group for Myelofibrosis Research and Treatment
High or intermediate-2 risk disease
Exclusion Criteria:
Receiving other treatments for the condition (with exceptions and time limits)
Major surgery in last 4 weeks, any surgery in the last 2 weeks
History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
History of splenectomy
Current use of prohibited medications
A concurrent second active and nonstable malignancy
Known human immunodeficiency virus infection or active Hepatitis B or Hepatitis C virus infection
Other hematologic/biochemistry requirements, as per protocol
Use of an investigational agent within last 14 days
Eighteen participants were enrolled in the Phase 1/2a portion of this study and 72 participants were enrolled in the Phase 2b portion of this study.
Recruitment Details
Participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF) were recruited for this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally every day (qd) for 85 days during the Initial Treatment Period (ITP). Qualifying participants could continue to receive treatment for an additional 169 days during the Additional Treatment Period (ATP) as determined by the investigator.
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
Jun 23, 2020
Nov 17, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
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: Bomedemstat
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
Experimental
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
Experimental
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
Experimental
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
Experimental
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
Experimental
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during an ATP as determined by the investigator. The ATP could repeat indefinitely in participants that continued to derive clinical benefit.
Drug: Bomedemstat
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
IMG-7289
MK-3543
LSD1 inhibitor
Up to approximately 30 months
Number of Participants That Discontinued Study Treatment Due To AEs
An AE was any undesirable physical, psychological or behavioral effect experienced by a participant, in conjunction with the use of the drug or biologic, whether or not product-related. This included any untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat until completion of the study. The number of participants that discontinued study treatment with bomedemstat due to a TE AE was reported for each arm.
Up to approximately 29 months
Phase 1/2a Portion: Observed Maximum Concentration (Cmax) of Bomedemstat
Cmax was defined as the maximum observed concentration after administration obtained directly from the concentration time profile. Blood and plasma samples were collected at pre-specified timepoints to calculate Cmax in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Time to Maximum Concentration (Tmax) of Bomedemstat
Tmax was defined as the time to maximum concentration after administration obtained by inspection. Blood and plasma samples were collected at pre-specified timepoints to calculate Tmax in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Area Under the Concentration-time Curve of Bomedemstat From Time 0 to 24 Hours Post-dose (AUC0-24)
AUC0-24 was defined as the area under the concentration versus time curve calculated using the linear trapezoidal rule from the zero time-point to the 24-hour time-point concentration. Blood and plasma samples were collected at pre-specified timepoints to calculate AUC0-24 in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Apparent Total Clearance (CL/F) of Bomedemstat After Oral Administration
CL/F was defined as the apparent total clearance of drug after oral administration. Blood and plasma samples were collected at pre-specified timepoints to calculate CL/F in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Percentage Change From Baseline in Spleen Volume
Change in spleen volume was assessed based on calculated spleen volume (ml) measured by magnetic resonance imaging (MRI), or computerized tomography (CT) scan (where locally permitted) if the participant was not a candidate for MRI from Day 0. Percentage change from baseline in spleen volume was reported at Initial Treatment Period (ITP) Day 84, ITP Day 168, Additional Treatment Period 1 (ATP1) Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337).
Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337)
Percentage Change From Baseline in Spleen Size
Change in spleen size was assessed based on spleen palpation (in cm) at each visit. Percentage change from baseline in spleen size was reported at ITP Day 84, ITP Day 168, ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591). As prespecified by the Statistical Analysis Plan, assessments for the Phase 1/2 groups were summarized using visit windowing after the Day 84 visit of the ITP to allow for comparison with the Phase 2b groups at ITP Day 168.
Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591)
Adelaide
South Australia
Australia
Universitatsklinikum Essen
Essen
45147
Germany
Azienda Ospedaliero Universitaria Careggi
Florence
Italy
Guy's and St Thomas' Hospitals
London
United Kingdom
FG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
FG0009 subjects
FG0013 subjects
FG0026 subjects
FG0038 subjects
FG0045 subjects
FG00511 subjects
FG00624 subjects
FG00711 subjects
FG00813 subjects
Treated
FG0009 subjects
FG0013 subjects
FG0026 subjects
FG0038 subjects
FG0045 subjects
FG00511 subjects
FG00624 subjects
FG00711 subjects
FG00813 subjects
Entered Additional Treatment Period (ATP)
FG0006 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0041 subjects
FG0054 subjects
FG00617 subjects
FG0075 subjects
FG0089 subjects
Completed Initial Treatment Period (ITP)
FG0007 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0041 subjects
FG0054 subjects
FG00618 subjects
FG0078 subjects
FG00810 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0053 subjects
FG00614 subjects
FG0075 subjects
FG0087 subjects
NOT COMPLETED
FG0008 subjects
FG0013 subjects
FG0026 subjects
FG0036 subjects
FG0045 subjects
FG0058 subjects
FG00610 subjects
FG0076 subjects
FG0086 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG0042 subjects
FG0052 subjects
FG0065 subjects
FG0071 subjects
FG0081 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Protocol Defined Disease Progression
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Not Reported
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG0013
BG0026
BG0038
BG0045
BG00511
BG00624
BG00711
BG00813
BG00990
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
BG00062.6± 12.43
BG00174.7± 5.51
BG00264.7± 6.59
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
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
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any one of the following adverse events (AEs) that occured through Day 7 of the Initial Treatment Period (ITP) and was considered by the Investigator to be possibly, probably or definitely related to bomedemstat:
Thrombocytopenia leading to clinically significant sequelae (i.e., a clinically significant bleeding event or the need for prophylactic transfusions)
A clinically significant bleeding event in a participant with a platelet count >50 x 10^9/L (50 k/μL)
Any Grade 4 or 5 non-haematologic adverse event
Any Grade 3 non-haematologic adverse event with failure to recover to Grade 2 within 7 days of drug cessation, with the following exceptions: ≥ Grade 3 nausea, vomiting or diarrhea that responds to standard medical care; ≥ Grade 3 aesthenia lasting less than 14 days; any Grade 3 electrolyte abnormality unrelated to the underlying malignancy and persisting greater than 24 hours.
The number of participants with a DLT were reported.
All participants receiving at least one dose of bomedemstat were included in the DLT analysis.
Posted
Count of Participants
Participants
Up to Day 7 of the ITP
ID
Title
Description
OG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG0009
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Serious Adverse Events
An AE was any undesirable physical, psychological or behavioral effect experienced by a participant, in conjunction with the use of the drug or biologic, whether or not product-related. This included any untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat until completion of the study. Serious AEs (SAEs) were any AE that resulted in death, life-threatening experience, required or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly, or important medical events. The number of participants with at least one treatment-emergent (TE) SAE was reported for each arm.
All participants receiving at least one dose of bomedemstat were included in the safety analysis.
Posted
Count of Participants
Participants
Up to approximately 30 months
ID
Title
Description
OG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Primary
Number of Participants With Adverse Events
An AE was any undesirable physical, psychological or behavioral effect experienced by a participant, in conjunction with the use of the drug or biologic, whether or not product-related. This included any untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat until completion of the study. The number of participants with at least one TE AE was reported for each arm.
All participants receiving at least one dose of bomedemstat were included in the safety analysis.
Posted
Count of Participants
Participants
Up to approximately 30 months
ID
Title
Description
OG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
Primary
Number of Participants That Discontinued Study Treatment Due To AEs
An AE was any undesirable physical, psychological or behavioral effect experienced by a participant, in conjunction with the use of the drug or biologic, whether or not product-related. This included any untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat until completion of the study. The number of participants that discontinued study treatment with bomedemstat due to a TE AE was reported for each arm.
All participants receiving at least one dose of bomedemstat were included in the safety analysis.
Posted
Count of Participants
Participants
Up to approximately 29 months
ID
Title
Description
OG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG002
Primary
Phase 1/2a Portion: Observed Maximum Concentration (Cmax) of Bomedemstat
Cmax was defined as the maximum observed concentration after administration obtained directly from the concentration time profile. Blood and plasma samples were collected at pre-specified timepoints to calculate Cmax in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
As pre-specified by the PAP, all participants in the Phase 1/2a portion of the study who received bomedemstat and completed a sufficient portion of the study with enough data for the determination of pharmacokinetic parameters were analyzed. For the purposes of the analysis, Phase 1/2a participants were analyzed irrespective of myelofibrosis disorder (PMF, PPV-MF, or PET-MF) per protocol. Phase 2b participants were excluded from this analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
ID
Title
Description
OG000
Ph 1/2a Portion: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Primary
Phase 1/2a Portion: Time to Maximum Concentration (Tmax) of Bomedemstat
Tmax was defined as the time to maximum concentration after administration obtained by inspection. Blood and plasma samples were collected at pre-specified timepoints to calculate Tmax in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
As pre-specified by the PAP, all participants in the Phase 1/2a portion of the study who received bomedemstat and completed a sufficient portion of the study with enough data for the determination of pharmacokinetic parameters were analyzed. For the purposes of the analysis, Phase 1/2a participants were analyzed irrespective of myelofibrosis disorder (PMF, PPV-MF, or PET-MF) per protocol. Phase 2b participants were excluded from this analysis.
Posted
Median
Full Range
hour
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
ID
Title
Description
OG000
Ph 1/2a Portion: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Primary
Phase 1/2a Portion: Area Under the Concentration-time Curve of Bomedemstat From Time 0 to 24 Hours Post-dose (AUC0-24)
AUC0-24 was defined as the area under the concentration versus time curve calculated using the linear trapezoidal rule from the zero time-point to the 24-hour time-point concentration. Blood and plasma samples were collected at pre-specified timepoints to calculate AUC0-24 in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
As pre-specified by the PAP, all participants in the Phase 1/2a portion of the study who received bomedemstat and completed a sufficient portion of the study with enough data for the determination of pharmacokinetic parameters were analyzed. For the purposes of the analysis, Phase 1/2a participants were analyzed irrespective of myelofibrosis disorder (PMF, PPV-MF, or PET-MF) per protocol. Phase 2b participants were excluded from this analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour•ng/mL
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
ID
Title
Description
OG000
Ph 1/2a Portion: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
Primary
Phase 1/2a Portion: Apparent Total Clearance (CL/F) of Bomedemstat After Oral Administration
CL/F was defined as the apparent total clearance of drug after oral administration. Blood and plasma samples were collected at pre-specified timepoints to calculate CL/F in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.
As pre-specified by the PAP, only participants in the Phase 1/2a portion of the study who received bomedemstat and completed a sufficient portion of the study with enough data for the determination of pharmacokinetic parameters were analyzed. For the purposes of the analysis, Phase 1/2a participants were analyzed irrespective of myelofibrosis disorder (PMF, PPV-MF, or PET-MF) per protocol. Phase 2b participants were excluded from this analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/min
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
ID
Title
Description
OG000
Ph 1/2a Portion: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Primary
Percentage Change From Baseline in Spleen Volume
Change in spleen volume was assessed based on calculated spleen volume (ml) measured by magnetic resonance imaging (MRI), or computerized tomography (CT) scan (where locally permitted) if the participant was not a candidate for MRI from Day 0. Percentage change from baseline in spleen volume was reported at Initial Treatment Period (ITP) Day 84, ITP Day 168, Additional Treatment Period 1 (ATP1) Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337).
All allocated participants who received at least one dose of treatment and had available spleen volume data.
Posted
Mean
95% Confidence Interval
Percentage Change
Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337)
ID
Title
Description
OG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Primary
Percentage Change From Baseline in Spleen Size
Change in spleen size was assessed based on spleen palpation (in cm) at each visit. Percentage change from baseline in spleen size was reported at ITP Day 84, ITP Day 168, ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591). As prespecified by the Statistical Analysis Plan, assessments for the Phase 1/2 groups were summarized using visit windowing after the Day 84 visit of the ITP to allow for comparison with the Phase 2b groups at ITP Day 168.
All allocated participants who received at least one dose of treatment and had available spleen size data.
Posted
Mean
95% Confidence Interval
Percentage Change
Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591)
ID
Title
Description
OG000
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Time Frame
Up to approximately 30 months
Description
All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
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
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally every day (qd) for 85 days during the Initial Treatment Period (ITP). Qualifying participants could continue to receive treatment for an additional 169 days during the Additional Treatment Period (ATP) as determined by the investigator.
0
9
4
9
9
9
EG001
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
0
3
2
3
3
3
EG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
0
6
5
6
6
6
EG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
1
8
4
8
8
8
EG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
1
5
4
5
5
5
EG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
0
11
7
11
11
11
EG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
1
24
12
24
23
24
EG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
0
11
3
11
10
11
EG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
0
13
3
13
12
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0028 events3 affected6 at risk
EG00320 events2 affected8 at risk
EG0042 events2 affected5 at risk
EG00526 events5 affected11 at risk
EG0062 events2 affected24 at risk
EG0073 events2 affected11 at risk
EG0086 events2 affected13 at risk
Splenomegaly
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0006 events2 affected9 at risk
EG0012 events1 affected3 at risk
EG00217 events3 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected3 at risk
EG0025 events3 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0004 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Renal abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Spontaneous bacterial peritonitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0026 events3 affected6 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0006 events2 affected9 at risk
EG0011 events1 affected3 at risk
EG0025 events3 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pyoderma gangrenosum
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0004 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG00023 events7 affected9 at risk
EG0019 events2 affected3 at risk
EG00234 events5 affected6 at risk
EG00320 events2 affected8 at risk
EG0048 events3 affected5 at risk
EG00526 events5 affected11 at risk
EG0065 events5 affected24 at risk
EG0074 events3 affected11 at risk
EG0087 events3 affected13 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0004 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0009 events5 affected9 at risk
EG0016 events2 affected3 at risk
EG00219 events4 affected6 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac valve disease
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Blepharitis
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Eye oedema
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Photophobia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Photopsia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0024 events3 affected6 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0005 events4 affected9 at risk
EG0011 events1 affected3 at risk
EG0026 events5 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lip haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected3 at risk
EG0025 events3 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral mucosal blistering
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Tongue discolouration
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Furuncle
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nasal herpes
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events2 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Viral pericarditis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Cataract operation complication
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Periorbital haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Blast cell count increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Blood glucose increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Body temperature increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac murmur
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Troponin T increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0024 events2 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0008 events4 affected9 at risk
EG0012 events2 affected3 at risk
EG0025 events3 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0005 events2 affected9 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vertebral osteophyte
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0014 events2 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0007 events6 affected9 at risk
EG0012 events2 affected3 at risk
EG0026 events3 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flat affect
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Phonophobia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sleep terror
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Diaphragmalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected3 at risk
EG0024 events2 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Granulomatous dermatitis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Koilonychia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0004 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pallor
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chills
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Early satiety
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0006 events5 affected9 at risk
EG0013 events1 affected3 at risk
EG0024 events3 affected6 at risk
EG003
Generalised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypothermia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0004 events2 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Temperature intolerance
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Thirst
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Anal ulcer
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Calcium ionised decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haematocrit increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Heart rate irregular
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Catathrenia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Drooling
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Uterine mass
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperactive pharyngeal reflex
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Aortic arteriosclerosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Sponsor will actively pursue publication of the results of the study in cooperation with the Lead Investigators subject to the terms and conditions of the clinical trial agreement between the Sponsor and Investigators. The Lead/Coordinating Investigator will have the right to submit for publication any results arising from the study subject to the terms and conditions of the Clinical Trial and Confidentiality Disclosure Agreements and the agreement of the Sponsor.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
8
OG0045
OG00511
OG00624
OG00711
OG00813
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG0009
OG0013
OG0026
OG0038
OG0045
OG00511
OG00624
OG00711
OG00813
Title
Denominators
Categories
Title
Measurements
OG0004
OG0012
OG0025
OG0034
OG0044
OG0057
OG00612
OG0073
OG0083
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG0009
OG0013
OG0026
OG0038
OG0045
OG00511
OG00624
OG00711
OG00813
Title
Denominators
Categories
Title
Measurements
OG0009
OG0013
OG0026
OG0038
OG0045
OG00511
OG00623
OG00710
OG00812
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG0009
OG0013
OG0026
OG0038
OG0045
OG00511
OG00624
OG00711
OG00813
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0025
OG0031
OG0042
OG0054
OG0065
OG0072
OG0083
OG002
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG00012
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Plasma
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00012.63± 104.41
Blood
ParticipantsOG00011
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG00012
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Plasma
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0001.00(0.50 to 2.85)
Blood
ParticipantsOG00011
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG002
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG00012
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Plasma
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00063.90± 68.56
Blood
ParticipantsOG00011
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG00012
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Plasma
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00012787.43± 63.72
Blood
ParticipantsOG00011
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG0003
OG0013
OG0022
OG0035
OG0043
OG0056
OG00617
OG0078
OG0088
Title
Denominators
Categories
ITP Day 84 (Study Day 84)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0035
ParticipantsOG0043
ParticipantsOG0056
ParticipantsOG00617
ParticipantsOG0078
ParticipantsOG0088
Title
Measurements
OG0003.3(-50.5 to 57.0)
OG001-13.7(-49.6 to 22.2)
OG0022.2(-110.3 to 114.8)
OG003
ITP Day 168 (Study Day 168)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
ATP1 Day 84 (Study Day 253)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ATP1 Day 168 (Study Day 337)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG002
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG003
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG004
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG005
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG006
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG007
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
OG008
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0033
OG0042
OG0056
OG00613
OG0076
OG0085
Title
Denominators
Categories
ITP Day 84 (Study Day 84)
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0056
ParticipantsOG00613
ParticipantsOG0076
ParticipantsOG0084
Title
Measurements
OG000-36.5(-68.0 to -5.0)
OG0019.6(-95.1 to 114.2)
OG00224.1(-79.4 to 127.7)
OG003
ITP Day 168 (Study Day 168)
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
ATP1 Day 84 (Study Day 253)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
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ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
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ParticipantsOG0010
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ParticipantsOG0030
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ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
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ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
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0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0052 events2 affected11 at risk
EG0062 events2 affected24 at risk
EG0072 events2 affected11 at risk
EG0080 events0 affected13 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected11 at risk
EG0061 events1 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0062 events2 affected24 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected13 at risk
1 events
1 affected
8 at risk
EG0043 events3 affected5 at risk
EG0053 events2 affected11 at risk
EG0063 events2 affected24 at risk
EG00723 events2 affected11 at risk
EG0082 events1 affected13 at risk
2 events
1 affected
8 at risk
EG0040 events0 affected5 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected24 at risk
EG0072 events1 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
1 events
1 affected
8 at risk
EG0041 events1 affected5 at risk
EG0053 events2 affected11 at risk
EG0060 events0 affected24 at risk
EG0073 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0055 events3 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
2 events
2 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected24 at risk
EG0074 events2 affected11 at risk
EG0080 events0 affected13 at risk
2 events
2 affected
8 at risk
EG0041 events1 affected5 at risk
EG0052 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected24 at risk
EG0074 events2 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0061 events1 affected24 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
4 events
2 affected
8 at risk
EG0043 events2 affected5 at risk
EG0053 events3 affected11 at risk
EG0062 events2 affected24 at risk
EG00726 events2 affected11 at risk
EG0083 events3 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0074 events1 affected11 at risk
EG0080 events0 affected13 at risk
10 events
4 affected
8 at risk
EG0043 events3 affected5 at risk
EG0051 events1 affected11 at risk
EG0066 events4 affected24 at risk
EG0078 events3 affected11 at risk
EG0085 events3 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected13 at risk
2 events
2 affected
8 at risk
EG0041 events1 affected5 at risk
EG0056 events4 affected11 at risk
EG0061 events1 affected24 at risk
EG0072 events1 affected11 at risk
EG0082 events1 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0063 events3 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
3 events
2 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0076 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0073 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0074 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0076 events2 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG00710 events3 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0073 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0072 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0073 events3 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0072 events2 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0072 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0072 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0072 events1 affected11 at risk
EG0080 events0 affected13 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected24 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected13 at risk
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00026.27± 66.76
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0001.05(0.50 to 3.02)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000265.92± 68.92
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0003067.57± 85.78
-9.1
(-27.9 to 9.6)
OG004-7.2(-80.2 to 65.8)
OG0050.3(-32.3 to 32.9)
OG00610.0(1.2 to 18.8)
OG007-2.3(-31.5 to 26.9)
OG0081.2(-10.9 to 13.2)
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG00616
ParticipantsOG0075
ParticipantsOG0088
Title
Measurements
OG003-23.9(-43.2 to -4.6)
OG004-19.6(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG005-33.7(-43.8 to -23.6)
OG00612.3(-4.1 to 28.6)
OG007-15.4(-56.7 to 25.8)
OG008-4.4(-20.6 to 11.8)
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG005-27.7(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0065
ParticipantsOG0072
ParticipantsOG0085
Title
Measurements
OG003-36.5(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG005-38.9(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG00637.4(-55.6 to 130.5)
OG0076.0(-302.0 to 313.9)
OG008-15.0(-39.0 to 9.0)
20.7
(-132.2 to 173.7)
OG004-28.1(-257.8 to 201.6)
OG00511.0(-70.7 to 92.7)
OG006-34.7(-58.1 to -11.3)
OG007-38.2(-53.4 to -23.1)
OG008-59.6(-113.4 to -5.7)
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG00611
ParticipantsOG0076
ParticipantsOG0084
Title
Measurements
OG000-20.7(-48.3 to 6.9)
OG001-39.6(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG002116.3(-1794.8 to 2027.4)
OG003-27.8(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG005-36.1(-212.6 to 140.4)
OG006-24.8(-74.2 to 24.5)
OG007-28.5(-60.1 to 3.0)
OG008-41.2(-102.9 to 20.6)
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0068
ParticipantsOG0073
ParticipantsOG0085
Title
Measurements
OG003-27.8(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG005-36.1(-212.6 to 140.4)
OG006-27.9(-84.8 to 29.0)
OG007-50.4(-101.7 to 0.9)
OG008-28.4(-97.7 to 40.9)
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0071
ParticipantsOG0084
Title
Measurements
OG000-19.0(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG003-27.8(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG005-38.9(-180.1 to 102.3)
OG006-1.9(-151.0 to 147.3)
OG007-38.9(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG008-82.4(-117.4 to -47.4)
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
Title
Measurements
OG000-4.8(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
OG005-37.5(-196.3 to 121.3)
OG007-44.4(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG005-22.0(NA to NA)95% confidence intervals could not be calculated for arms with n\<2 participants.