Platform Study of Novel Ruxolitinib Combinations in Myelo... | NCT04097821 | Trialant
NCT04097821
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
Aug 7, 2025Actual
Enrollment
45Actual
Phase
Phase 1Phase 2
Conditions
Myelofibrosis
Interventions
Ruxolitinib
Siremadlin
Crizanlizumab
Sabatolimab
Rineterkib
NIS793
Countries
Australia
Canada
Denmark
Germany
Hungary
Italy
Netherlands
Russia
Spain
Sweden
Switzerland
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04097821
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CINC424H12201
Secondary IDs
ID
Type
Description
Link
2019-000373-23
EudraCT Number
Brief Title
Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
Official Title
A Randomized, Open-label, Phase I/II Open Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Myelofibrosis Patients
Acronym
ADORE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor Decision
Expanded Access Info
No
Start Date
Sep 26, 2019Actual
Primary Completion Date
May 3, 2023Actual
Completion Date
Aug 28, 2024Actual
First Submitted Date
Sep 17, 2019
First Submission Date that Met QC Criteria
Sep 19, 2019
First Posted Date
Sep 20, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jul 21, 2025
Results First Submitted that Met QC Criteria
Jul 21, 2025
Results First Posted Date
Aug 7, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 21, 2025
Last Update Posted Date
Aug 7, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
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
The purpose of this study was to investigate the safety, pharmacokinetics and preliminary efficacy of combination treatment of ruxolitinib with 5 novel compounds: siremadlin, crizanlizumab, sabatolimab, rineterkib and NIS793 in myelofibrosis (MF) subjects.
Detailed Description
This open-label, multi-center, Phase Ib/II platform study design consisted of 3 parts. Part 1 was a Phase Ib dose escalation and safety run-in for the 5 novel agents in combination with ruxolitinib to assess safety, tolerability and to confirm a recommended Phase II dose. Dose escalation cohorts were treated with ruxoltinib + siremadlin or ruxolitinib + rineterkib. Safety run-in cohorts were treated with either ruxolitinb + sabatolimab, ruxolitinb + crizanlizumab or ruxolitinib + NIS7913.
Parts 2 and 3 were Phase II selection and expansion, respectively, to assess preliminary efficacy of the combination treatments from Part 1 that were evaluated as safe and tolerable. The number of combination treatment arms opening in Part 2 depended on the results of Part 1. In Part 2, an interim analysis was planned to determine if combination treatment(s) could be expanded in Part 3.
In June 2022, Novartis decided to permanently halt the study enrollment in all ongoing parts (Part 1 and Part 2), and Part 3 (expansion) was not initiated. With Protocol Amendment 8, an extension treatment phase of 12 cycles was added in Part 1 to allow access to the combination treatment for ongoing subjects deriving clinical benefit. In consideration of the enrollment halt, Parts 2 and 3 objectives were not pursued, and Part 1 objectives were updated accordingly.
Conditions Module
Conditions
Myelofibrosis
Keywords
myelofibrosis
ruxolitinib
INC424
siremadlin
HDM201
crizanlizumab
SEG101
sabatolimab
MBG453
rineterkib
LTT462
NIS793
platform study
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
45Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Ruxolitinib + Siremadlin 20 mg
Experimental
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
Drug: Ruxolitinib
Drug: Siremadlin
Part 1: Ruxolitinib + Siremadlin 30 mg
Experimental
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
Drug: Ruxolitinib
Drug: Siremadlin
Part 1: Ruxolitinib + Siremadlin 40 mg
Experimental
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
Drug: Ruxolitinib
Drug: Siremadlin
Part 1: Ruxolitinib + Rineterkib 200 mg
Experimental
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
Drug: Ruxolitinib
Drug: Rineterkib
Part 1: Ruxolitinib + Crizanlizumab
Experimental
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
Drug: Ruxolitinib
Drug: Crizanlizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ruxolitinib
Drug
5 mg tablets for oral use
Part 1: Ruxolitinib + Crizanlizumab
Part 1: Ruxolitinib + NIS793
Part 1: Ruxolitinib + Rineterkib 200 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence and Severity of Dose Limiting Toxicities Within the First 2 Cycles in Part 1
Incidence and severity of dose limiting toxicities within the first 2 cycles (6 or 8 weeks) in Part 1 of the study. DLTs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria Version 5.0. Grade 0 was assigned for all non-missing values not graded as 1 or higher. Higher grade indicated more severity. Grade 5 was not used.
Baseline to the end of Cycle 2 (6 or 8 weeks)
Response Rate at the End of Cycle 6 or Cycle 8 in Part 1
Composite of anemia improvement (hemoglobin level) and no spleen volume progression and no symptom worsening in Part 2 and Part 3 of the study. For a subject to be considered a responder, all three components of the composite had to be fulfilled.
Baseline to the end of Cycle 6 or 8 (24 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of ≥ 1.5 g/dL From Baseline in Part 1
Week 24, Week 48
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of at Least >= 2.0 g/dL From Baseline in Part 1
Week 24, Week 48
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Core treatment phase Inclusion Criteria:
Subjects have diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-essential thrombocythemia (ET) (PET-MF) or post-polycythemia vera (PV) myelofibrosis (PPV-MF) according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) 2007 criteria
Palpable spleen of at least 5 cm from the left costal margin (LCM) to the point of greatest splenic protrusion or enlarged spleen volume of at least 450 cm3 per MRI or CT scan at baseline (a MRI/CT scan up to 8 weeks prior to first dose of study treatment can be accepted).
Have been treated with ruxolitinib for at least 12 weeks prior to first dose of study treatment
Are stable (no dose adjustments) on the prescribed ruxolitinib dose (between 5 and 25 mg twice a day (BID)) for ≥ 4 weeks prior to first dose of study treatment
Extension treatment phase inclusion criteria:
Signed consent for the extension treatment phase
ongoing in the core treatment phase
demonstrates clinical benefit of treatment in core treatment phase per investigator's assessment.
Core treatment phase Exclusion Criteria:
Not able to understand and to comply with study instructions and requirements.
Received any investigational agent for the treatment of MF (except ruxolitinib) within 30 days of first dose of study treatment or within 5 half-lives of the study treatment, whichever is greater
Peripheral blood blasts count of > 10%.
has documented severe hypersensitivity reactions/immunogenicity (IG) to a prior biologic product or Received a monoclonal antibody (Ab) or immunoglobulin-based agent within 1 year of screening in NIS793, crizanlizumab or sabatolimab arms, or in rineterkib or siremadlin arms within <=4 weeks of screening or <=5 half-lives whichever is shorter
Splenic irradiation within 6 months prior to the first dose of study drug
Received blood platelet transfusion within 28 days prior to first dose of study treatment.
Extension treatment phase Exclusion Criteria:
meets any of study treatment discontinuation criteria
current evidence of treatment failure per investigator, following treatment in core treatment phase
enrolled in another interventional study
evidence of non-compliance to study procedures or withdrew consent in core treatment phase
currently has unresolved toxicities for which study treatment has been interrupted in the core treatment phase
local access to alternative myelofibrosis treatment including those currently under investigation in clinical trials as assessed suitable in the opinion of the investigator.
Ross DM, Heidel FH, Perkins AC, Reiter A, Crodel C, Riley C, Gomez-Casares MT, Takacs I, Becker H, Lehmann T, Vinogradova O, Burbury K, Vannucchi AM, Gupta V, Wondergem M, Kiladjian JJ, Cleary G, Zhang A, Kota J, Prahallad A, Wroclawska M, Lu M, Harrison CN. ADORE: an open platform study of ruxolitinib in combination with other novel therapies in patients with myelofibrosis. Blood Adv. 2025 Aug 26;9(16):4195-4205. doi: 10.1182/bloodadvances.2025015860.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
All inclusion and exclusion criteria were checked at screening.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
FG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 5, 2023
Jul 21, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Belgium
China
Israel
Japan
Romania
South Korea
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This open-label, multi-center, phase Ib/II platform study design consisted of 3 parts. Part 1 was a phase Ib dose escalation and safety run-in for the 5 novel agents in combination with ruxolitinib to assess safety, tolerability and to confirm recommended Phase II dose.
Parts 2 and 3 were phase II selection and expansion respectively, to assess preliminary efficacy of the combination treatments from Part 1 that were evaluated as safe and tolerable.
The number of combination treatment arms opening in Part 2 depended on the results of Part 1. In Part 2, interim analysis was planned to determine if combination treatment(s) could be expanded in Part 3.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Open label
Who Masked
Not provided
Part 1: Ruxolitinib + Sabatolimab
Experimental
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
Drug: Ruxolitinib
Drug: Sabatolimab
Part 1: Ruxolitinib + NIS793
Experimental
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
Drug: Ruxolitinib
Drug: NIS793
Part 2: Ruxolitinib
Active Comparator
Existing stable dose of ruxolitinib as control for Part 2
Drug: Ruxolitinib
Part 1: Ruxolitinib + Sabatolimab
Part 1: Ruxolitinib + Siremadlin 20 mg
Part 1: Ruxolitinib + Siremadlin 30 mg
Part 1: Ruxolitinib + Siremadlin 40 mg
Part 2: Ruxolitinib
INC424, Jakavi
Siremadlin
Drug
10 mg, 20 mg, or 40 mg capsules for oral use
Part 1: Ruxolitinib + Siremadlin 20 mg
Part 1: Ruxolitinib + Siremadlin 30 mg
Part 1: Ruxolitinib + Siremadlin 40 mg
HDM201
Crizanlizumab
Drug
100 mg/10 mL concentrate for infusion for intravenous use
Part 1: Ruxolitinib + Crizanlizumab
SEG101
Sabatolimab
Drug
100 mg/mL or 400 mg/4 mL concentrate for infusion for intravenous use
Part 1: Ruxolitinib + Sabatolimab
MBG453
Rineterkib
Drug
100 mg capsule for oral use
Part 1: Ruxolitinib + Rineterkib 200 mg
LTT462
NIS793
Drug
700 mg/7 mL concentrate for infusion for intravenous use
Part 1: Ruxolitinib + NIS793
Change in Spleen Length From Baseline in Part 1
Change in spleen length measured in centimeters by manual palpation.
Baseline, Week 24, Week 48
Percentage of Subjects With >=35% Reduction in Spleen Volume From Baseline in Part 1
Change in spleen volume measured by magnetic resonance imaging (MRI) or computed tomography (CT) from baseline.
Week 24, Week 48
Percentage of Subjects With >=25% Reduction in Spleen Volume From Baseline in Part 1
Change in spleen volume measured by magnetic resonance imaging (MRI) or computed tomography (CT) from baseline.
Week 24, Week 48
Percentage of Subjects in Part 1 With >=50% Reduction From Baseline in Myelofibrosis Symptom Assessment Form, Version 4.0 (MFSAF v4.0)
The MFSAF v4.0 questionnaire focuses on the 7 core symptoms of MF: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety and bone pain. Subjects record symptom severity at it worst for each of the 7 symptoms on an 11-point numeric rating scale, from 0 (absent) to 10 (worst imaginable). The Total Symptom Score (TSS) is the sum of all the scores for all 7 symptoms.
Week 12, Week 24, Week 48
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkib
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkib
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkib
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1
Concentration Versus Time Profile for Siremadlin in Part 1
Day 1 of Cycles 1 and 2; Day 6 of Cycle 1; Days 2 and 5 of Cycles 1, 2, 3, 4, 5, and 6. Each cycle was 28 days.
Concentration Versus Time Profile for Rineterkib in Part 1
Days 1, 2, 15, and 16 of Cycle 1; Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle was 28 days.
Concentration Versus Time Profile for Crizanlizumab in Part 1
EOI = end of infusion
Days 1, 2, 8, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4, 5, 6, and 9. Each cycle was 28 days.
Concentration Versus Time Profile for Sabatolimab in Part 1
EOI = end of infusion
Days 1, 2, 8, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4 and 5. Each cycle was 28 days.
Concentration Versus Time Profile for NIS793 in Part 1
EOI = end of infusion
Days 1, 2, 4, 8, 11, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4 and 5. Each cycle was 28 days.
Concentration Versus Time Profile for Ruxolitinib in Part 1
Days 1, 2, 5, 6, and 15 of Cycles 1 and 2; Day 16 of Cycle 1; Days 1, 2, and 15 of Cycle 3; Days 1 and 5 of Cycles 4, 5, and 6. Each cycle was 28 days.
Melbourne
Victoria
3000
Australia
Novartis Investigative Site
Melbourne
Victoria
3004
Australia
Novartis Investigative Site
Toronto
Ontario
M5G 2M9
Canada
Novartis Investigative Site
Copenhagen
DK-2100
Denmark
Novartis Investigative Site
Mannheim
Baden-Wurttemberg
68305
Germany
Novartis Investigative Site
Freiburg im Breisgau
79106
Germany
Novartis Investigative Site
Greifswald
17475
Germany
Novartis Investigative Site
Jena
07740
Germany
Novartis Investigative Site
Budapest
H-1083
Hungary
Novartis Investigative Site
Florence
FI
50134
Italy
Novartis Investigative Site
Amsterdam
1081 HV
Netherlands
Novartis Investigative Site
Moscow
125284
Russia
Novartis Investigative Site
Salamanca
Castille and León
37007
Spain
Novartis Investigative Site
Alicante
03010
Spain
Novartis Investigative Site
Las Palmas de Gran Canaria
35010
Spain
Novartis Investigative Site
Madrid
28034
Spain
Novartis Investigative Site
Stockholm
14186
Sweden
Novartis Investigative Site
Sankt Gallen
9007
Switzerland
Novartis Investigative Site
Zurich
8091
Switzerland
Novartis Investigative Site
Kocaeli
41380
Turkey (Türkiye)
Novartis Investigative Site
London
SE1 9RT
United Kingdom
FG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
FG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
FG004
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
FG005
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
FG006
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
FG007
Part 2: Ruxolitinib
Existing stable dose of ruxolitinib as control for Part 2
FG0007 subjects
FG00110 subjects
FG0026 subjects
FG0039 subjects
FG0046 subjects
FG0052 subjects
FG0064 subjects
FG0071 subjects
COMPLETED
FG0006 subjects
FG0018 subjects
FG0022 subjects
FG0036 subjects
FG0044 subjects
FG0050 subjects
FG0063 subjects
FG0070 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0033 subjects
FG0042 subjects
FG0052 subjects
FG0061 subjects
FG0071 subjects
Type
Comment
Reasons
Subject Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0052 subjects
FG0060 subjects
FG0071 subjects
Death
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
New Therapy For Study Indication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The full analysis set included all subjects who received any study drug. Part 2 enrollment included 1 participant. Data are not reported for this participant in order to protect participant privacy and confidentiality.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
BG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
BG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
BG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
BG004
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
BG005
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
BG006
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
BG007
Part 2: Ruxolitinib
Existing stable dose of ruxolitinib as control for Part 2
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG00110
BG0026
BG0039
BG0046
BG0052
BG0064
BG0070
BG00844
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
BG00070.6± 6.5
BG00162.3± 10.7
BG00274.3± 9.9
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<65
Title
Measurements
BG0001
BG0015
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0007
BG00110
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
Incidence and Severity of Dose Limiting Toxicities Within the First 2 Cycles in Part 1
Incidence and severity of dose limiting toxicities within the first 2 cycles (6 or 8 weeks) in Part 1 of the study. DLTs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria Version 5.0. Grade 0 was assigned for all non-missing values not graded as 1 or higher. Higher grade indicated more severity. Grade 5 was not used.
The dose-determining set included all subjects from the safety run-in and dose escalation part (Part 1) of the study who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT between C1D1 and C3D1. Number analyzed is the number of participants with available data.
Posted
Number
participants
Baseline to the end of Cycle 2 (6 or 8 weeks)
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
OG004
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
OG005
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
OG006
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
Units
Counts
Participants
OG0006
OG0017
OG0025
OG003
Title
Denominators
Categories
Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Response Rate at the End of Cycle 6 or Cycle 8 in Part 1
Composite of anemia improvement (hemoglobin level) and no spleen volume progression and no symptom worsening in Part 2 and Part 3 of the study. For a subject to be considered a responder, all three components of the composite had to be fulfilled.
Enrollment was permanently halted; therefore, data were not collected for this outcome measure.
Posted
Baseline to the end of Cycle 6 or 8 (24 weeks)
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
Secondary
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of ≥ 1.5 g/dL From Baseline in Part 1
The full analysis set included all subjects who received any study drug.
Posted
Number
percentage of participants
Week 24, Week 48
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
OG004
Part 1: Ruxolitinib + Crizanlizumab
Secondary
Percentage of Subjects Achieving an Improvement in Hemoglobin Level of at Least >= 2.0 g/dL From Baseline in Part 1
The full analysis set included all subjects who received any study drug.
Posted
Number
percentage of participants
Week 24, Week 48
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
OG004
Part 1: Ruxolitinib + Crizanlizumab
Secondary
Change in Spleen Length From Baseline in Part 1
Change in spleen length measured in centimeters by manual palpation.
The full analysis set included all subjects who received any study drug. Number analyzed is the number of participants with available data.
Posted
Mean
Standard Deviation
centimeters
Baseline, Week 24, Week 48
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
Secondary
Percentage of Subjects With >=35% Reduction in Spleen Volume From Baseline in Part 1
Change in spleen volume measured by magnetic resonance imaging (MRI) or computed tomography (CT) from baseline.
The full analysis set included all subjects who received any study drug.
Posted
Number
percentage of participants
Week 24, Week 48
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
Secondary
Percentage of Subjects With >=25% Reduction in Spleen Volume From Baseline in Part 1
Change in spleen volume measured by magnetic resonance imaging (MRI) or computed tomography (CT) from baseline.
The full analysis set included all subjects who received any study drug.
Posted
Number
percentage of participants
Week 24, Week 48
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
Secondary
Percentage of Subjects in Part 1 With >=50% Reduction From Baseline in Myelofibrosis Symptom Assessment Form, Version 4.0 (MFSAF v4.0)
The MFSAF v4.0 questionnaire focuses on the 7 core symptoms of MF: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety and bone pain. Subjects record symptom severity at it worst for each of the 7 symptoms on an 11-point numeric rating scale, from 0 (absent) to 10 (worst imaginable). The Total Symptom Score (TSS) is the sum of all the scores for all 7 symptoms.
The full analysis set included all subjects who received any study drug.
Posted
Number
percentage of participants
Week 12, Week 24, Week 48
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng*hr/mL
Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkib
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg (AUClast for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg (AUClast for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg (AUClast for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg (AUClast for Rineterkib)
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) for Ruxolitinib in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng*hr/mL
Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
OG004
Secondary
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkib
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg (Cmax for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg (Cmax for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg (Cmax for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg (Cmax for Rineterkib)
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
Secondary
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) for Ruxolitinib in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
OG004
Part 1: Ruxolitinib + Crizanlizumab
Secondary
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Siremadlin, Rineterkib, Crizanlizumab, Sabatolimab, and NIS793 in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Median
Full Range
hours
Days 1 and 5 of Cycles 1 and 2 for siremadlin and Cycles 1 and 3 for crizanlizumab, sabatolimab, and NIS793; Days 1 and 15 of Cycle 1 for rineterkib
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg (Tmax for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg (Tmax for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg (Tmax for Siremadlin)
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg (Tmax for Rineterkib)
Secondary
Time to Reach Maximum (Peak) Plasma, Blood, Serum or Other Body Fluid Drug Concentration After Single Dose Administration (Tmax) for Ruxolitinib in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Median
Full Range
hours
Days 1 and 5 of Cycles 1 and 2; Day 15 of Cycle 1
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
OG004
Secondary
Concentration Versus Time Profile for Siremadlin in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Day 1 of Cycles 1 and 2; Day 6 of Cycle 1; Days 2 and 5 of Cycles 1, 2, 3, 4, 5, and 6. Each cycle was 28 days.
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
Units
Counts
Participants
Secondary
Concentration Versus Time Profile for Rineterkib in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Days 1, 2, 15, and 16 of Cycle 1; Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle was 28 days.
ID
Title
Description
OG000
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
Units
Counts
Participants
OG0009
Secondary
Concentration Versus Time Profile for Crizanlizumab in Part 1
EOI = end of infusion
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Days 1, 2, 8, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4, 5, 6, and 9. Each cycle was 28 days.
ID
Title
Description
OG000
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
Units
Counts
Participants
OG0005
Secondary
Concentration Versus Time Profile for Sabatolimab in Part 1
EOI = end of infusion
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Days 1, 2, 8, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4 and 5. Each cycle was 28 days.
ID
Title
Description
OG000
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
Units
Counts
Participants
OG0002
Secondary
Concentration Versus Time Profile for NIS793 in Part 1
EOI = end of infusion
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Days 1, 2, 4, 8, 11, and 15 of Cycles 1, 2, and 3; Day 1 of Cycles 4 and 5. Each cycle was 28 days.
ID
Title
Description
OG000
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
Units
Counts
Participants
OG0004
Secondary
Concentration Versus Time Profile for Ruxolitinib in Part 1
The pharmacokinetic (PK) analysis set included all enrolled subjects who had an evaluable PK profile.
Posted
Mean
Standard Deviation
ng/mL
Days 1, 2, 5, 6, and 15 of Cycles 1 and 2; Day 16 of Cycle 1; Days 1, 2, and 15 of Cycle 3; Days 1 and 5 of Cycles 4, 5, and 6. Each cycle was 28 days.
ID
Title
Description
OG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
OG003
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
OG004
Time Frame
Adverse events were reported from first dose of study treatment until end of study treatment plus post-treatment safety follow-up, up to a maximum duration of approximately 44 months.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Ruxolitinib + Siremadlin 20 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
0
7
2
7
7
7
EG001
Part 1: Ruxolitinib + Siremadlin 30 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
0
10
3
10
10
10
EG002
Part 1: Ruxolitinib + Siremadlin 40 mg
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
3
6
4
6
6
6
EG003
Part 1: Ruxolitinib + Siremadlin Total
Total
3
23
9
23
23
23
EG004
Part 1: Ruxolitinib + Rineterkib 200 mg
Dose escalation of rineterkib added to existing stable dose of ruxolitinib
1
9
3
9
9
9
EG005
Part 1: Ruxolitinib + Crizanlizumab
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
0
6
1
6
6
6
EG006
Part 1: Ruxolitinib + Sabatolimab
Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
0
2
1
2
2
2
EG007
Part 1: Ruxolitinib + NIS793
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
0
4
1
4
3
4
EG008
Part 2: Ruxolitinib
Existing stable dose of ruxolitinib as control for Part 2
0
1
0
1
0
1
EG009
All Subjects
All Subjects
4
45
15
45
43
45
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG0031 affected23 at risk
EG0040 affected9 at risk
EG0050 affected6 at risk
EG0060 affected2 at risk
EG0070 affected4 at risk
EG0080 affected1 at risk
EG0091 affected45 at risk
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Epididymitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Product administration error
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Body temperature increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0003 affected7 at risk
EG0017 affected10 at risk
EG0025 affected6 at risk
EG00315 affected23 at risk
EG0041 affected9 at risk
EG0051 affected6 at risk
EG0060 affected2 at risk
EG0072 affected4 at risk
EG0080 affected1 at risk
EG00919 affected45 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0018 affected10 at risk
EG0023 affected6 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0017 affected10 at risk
EG0026 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Eye pain
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Macular oedema
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Photopsia
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Presbyopia
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Retinal detachment
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Retinopathy
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Serous retinopathy
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0012 affected10 at risk
EG0021 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0003 affected7 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0006 affected7 at risk
EG0014 affected10 at risk
EG0023 affected6 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Discomfort
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Fatigue
General disorders
MedDRA (27.0)
Systematic Assessment
EG0005 affected7 at risk
EG0011 affected10 at risk
EG0022 affected6 at risk
EG003
Malaise
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected10 at risk
EG0021 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0013 affected10 at risk
EG0022 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0012 affected10 at risk
EG0021 affected6 at risk
EG003
Candida infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Eye infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Furuncle
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Wound infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Incorrect dose administered
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0021 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Blood folate decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Blood potassium increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Cardiac murmur
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Heart rate decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Heart sounds abnormal
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Weight increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0021 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0003 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0012 affected10 at risk
EG0021 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Iron overload
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Sacroiliac joint dysfunction
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0022 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0003 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0022 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Nasal cavity mass
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Trichodysplasia spinulosa
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Angiopathy
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0004 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected10 at risk
EG0021 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
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.