A Phase 2 Study of RO7490677 In Participants With Myelofi... | NCT01981850 | Trialant
NCT01981850
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Jan 5, 2022Actual
Enrollment
125Actual
Phase
Phase 2
Conditions
Primary Myelofibrosis
Polycythemia Vera
Post-Essential Thrombocythemia Myelofibrosis
Interventions
RO7490677
Ruxolitinib
Countries
United States
Canada
France
Germany
Israel
Italy
Netherlands
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01981850
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BO42355
Secondary IDs
ID
Type
Description
Link
PRM-151G-101
Other Identifier
Promedior, Inc.
2015-001718-80
EudraCT Number
Brief Title
A Phase 2 Study of RO7490677 In Participants With Myelofibrosis
Official Title
A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), Or Post-Essential Thrombocythemia MF (Post-ET MF)
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Dec 2021
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
Oct 1, 2013Actual
Primary Completion Date
Jul 10, 2020Actual
Completion Date
Jul 10, 2020Actual
First Submitted Date
Oct 29, 2013
First Submission Date that Met QC Criteria
Nov 5, 2013
First Posted Date
Nov 13, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 30, 2021
Results First Submitted that Met QC Criteria
Dec 7, 2021
Results First Posted Date
Jan 5, 2022Actual
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
Dec 7, 2021
Last Update Posted Date
Jan 5, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue.
The purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.
Detailed Description
Stage 1 of this study has completed. Stage 1 was an open-label, Simon two stage, Phase 2 study to determine the efficacy and safety of two different dose schedules of RO7490677 in participants with PMF and post ET/PV MF. There were two treatment cohorts, each assigned to one of two dose schedules receiving either single-agent RO7490677 or RO7490677 in combination with ruxolitinib. Participants were assigned to a weekly or every four week dosing schedule by the investigator.
Stage 2 is a randomized, double-blind Phase 2 study to determine the efficacy and safety of three different doses of RO7490677 in participants with PMF and post ET/PV MF. Participants will be randomized to one of three doses: 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of RO7490677. This is the second stage of an adaptive design study as defined in FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, February 2010. Modifications to dose levels, schedule, and regimen have been made in Stage 2 based on data from Stage 1.
Conditions Module
Conditions
Primary Myelofibrosis
Polycythemia Vera
Post-Essential Thrombocythemia Myelofibrosis
Keywords
fibrosis
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
125Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: Cohort 1 Weekly
Experimental
Participants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
Biological: RO7490677
Stage 1: Cohort 1 Every 4 Weeks
Experimental
Paricipants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Biological: RO7490677
Stage 1: Cohort 2 Weekly
Experimental
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
Biological: RO7490677
Drug: Ruxolitinib
Stage 1: Cohort 2 Every 4 Weeks
Experimental
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7490677
Biological
IV infusion
Stage 1: Cohort 1 Every 4 Weeks
Stage 1: Cohort 1 Weekly
Stage 1: Cohort 2 Every 4 Weeks
Stage 1: Cohort 2 Weekly
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Stage 1 Main Phase: Overall Response Rate (ORR)
ORR was defined as the percent of participants with a response according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. This was defined as those participants who achieved clinical improvement (CI), partial remission (PR), or complete remission (CR) at a post-baseline assessment of treatment response OR had at least stable disease (SD) for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease.
Up until and including completion of 6 cycles. Each cycle is 28 days.
Stage 2 Main Phase: Bone Marrow Response Rate (BMRR)
Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria from baseline to any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.
Up until and including completion of 9 cycles. Each cycle is 28 days.
Stage 1 Main + Open-Label Extension (OLE): ORR
ORR was defined as the percent of participants with a response according to the IWG-MRT criteria. This was defined as those participants who achieved CI, PR, or CR at a post-baseline assessment of treatment response OR had at least SD for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease. Participants who achieved a clinical benefit in the main phase had the opportunity to remain on treatment. The determination of ORR in the main phase is outlined in the arms description below. Participants who didn't achieve a benefit had the opportunity to switch to a different dosing schedule in the OLE phase. The determination of ORR in the OLE phase is outlined in the arms descriptions below.
From cycle 1 day 1 up until cycle 6, day 29 (Main Phase). From cycle 7 day 1 up until study discontinuation or study termination, up to 83 cycles (OLE). Each cycle is 28 days.
Secondary Outcomes
Measure
Description
Time Frame
Stage 1 Main Phase: BMRR
Bone marrow response was defined as a reduction in bone marrow fibrosis score by at least one grade from baseline at anytime during the study.
Baseline, Weeks 12 and 24
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes
Other Outcomes
Measure
Description
Time Frame
Stage 1 Main Phase: Maximum Drug Concentration (Cmax)
Cmax is the maximum observed RO7490677 plasma concentration.
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
Stage 1 Main Phase: Time to Maximum Concentration (Tmax)
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must be ≥18 years of age at the time of signing the Informed Consent Form (ICF);
Participants must voluntarily sign an ICF;
Participants must have a pathologically confirmed diagnosis of PMF as per the WHO diagnostic criteria or post ET/PV MF;
At least Grade 2 marrow fibrosis according to the WHO Grading of Bone Marrow Fibrosis;
Intermediate-1, intermediate -2, or high risk disease according to the IWG -MRT Dynamic International Prognostic Scoring System
A bone marrow biopsy must be performed within four weeks prior to Cycle 1 Day 1 treatment to establish the baseline fibrosis score;
Participants must not be candidates for ruxolitinib based on EITHER:
Platelet count < 50 x 10e9/L, OR
Hgb < 100 g/L, have received ≥ 2 units PRBC in the 12 weeks prior to study entry, and be intolerant of or had inadequate response to ruxolitinib;
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. (Appendix F);
Life expectancy of at least twelve months;
At least four weeks must have elapsed between the last dose of any MF- directed drug treatments for myelofibrosis (including investigational therapies) and study enrollment;
Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia;
Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤55 years or 12 months if >55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception are outlined in the protocol.
Ability to adhere to the study visit schedule and all protocol requirements;
Must have adequate organ function as demonstrated by the following:
ALT (SGPT) and/or AST (SGOT) ≤ 3x upper limit of normal (ULN), or ≤ 4 x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF);
Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF);
Serum creatinine ≤ 2.5 mg/dL x ULN.
Exclusion Criteria:
White blood cell count > 25 x 10e9/L or > 10% peripheral blood blasts;
Other invasive malignancies within the last 3 years, except non- melanoma skin cancer and localized cured prostate and cervical cancer;
History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months;
Presence of active serious infection;
Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;
Known history of human immunodeficiency virus (HIV), or known active hepatitis A, B, or C infection;
Organ transplant recipients other than bone marrow transplant;
Verstovsek S, Foltz L, Gupta V, Hasserjian R, Manshouri T, Mascarenhas J, Mesa R, Pozdnyakova O, Ritchie E, Veletic I, Gamel K, Hamidi H, Han L, Higgins B, Trunzer K, Uguen M, Wang D, El-Galaly TC, Todorov B, Gotlib J. Safety and efficacy of zinpentraxin alfa as monotherapy or in combination with ruxolitinib in myelofibrosis: stage I of a phase II trial. Haematologica. 2023 Oct 1;108(10):2730-2742. doi: 10.3324/haematol.2022.282411.
One randomized participant in Stage 2 did not receive the study treatment, bringing the total number of treated participants to 124.
Recruitment Details
A total of 125 participants were enrolled at sites in 8 different countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
Participants will be treated with single agent RO7490677 at a dose of 0.3 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Biological: RO7490677
Stage 2: Cohort 2 3mg/kg Every 4 Weeks
Experimental
Participants will be treated with single agent RO7490677 at a dose of 3.0 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Biological: RO7490677
Stage 2: Cohort 3 10mg /kg Every 4 Weeks
Experimental
Participants will be treated with single agent RO7490677 at a dose of 10 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Biological: RO7490677
Stage 2: Cohort 1 0.3mg/kg Every 4 Weeks
Stage 2: Cohort 2 3mg/kg Every 4 Weeks
Stage 2: Cohort 3 10mg /kg Every 4 Weeks
originally called PRM-151, and also known as rhPTX-2
Ruxolitinib
Drug
IV infusion
Stage 1: Cohort 2 Every 4 Weeks
Stage 1: Cohort 2 Weekly
Jakafi
Stage 2 Main + Open-Label Extension (OLE): BMRR
Defined as the percent of participants with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study. As determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy. Participants in the main phase had the opportunity to remain on treatment (as outlined in the arms description below). Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment and receive PRM-151 10 mg/kg/Q4W (as outlined in the arms description below).
From cycle 1 day 1 up until cycle 9 day 29 (main phase). From cycle 10 day 1 up until study discontinuation or study termination, up to 51 cycles (OLE). Each cycle is 28 days.
The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable. The values reported are the change from baseline scores.
Baseline, beginning of each cycle (Cycle 2 onward). Each cycle is 28 days.
Stage 2 Main Phase: BMRR
Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria at any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.
Up until and including completion of 9 cycles. Each cycle is 28 days.
Stage 2 Main Phase: BMRR - Reduction of Bone Marrow Fibrosis by Visit
Reduction in bone marrow fibrosis score: Reduction of at least one grade from baseline. Bone marrow fibrosis grades according to WHO criteria (as determined by central adjudication).
Day 1 on Cycles 4, 7, 10 and Cycle 9 Day 29. Each cycle is 28 days.
Stage 2 Main Phase: Duration of Bone Marrow Improvement
Duration of response was defined as time from first decrease from baseline >= 1 grade to time of return to baseline levels.
From first decrease from baseline of one grade to time of return to baseline levels, up to cycle 9 of 28-day cycles.
Stage 2 Main Phase: Hemoglobin Improvement
Hemoglobin improvement was measured by the percent of participants with: Red cell transfusion independence (no transfusions for >= 12 consecutive weeks) OR 50% reduction in red blood cell (RBC) transfusions for >= 12 consecutive weeks OR percent of participants with >= 10 g/L and >= 20 g/L increase in hemoglobin for >= 12 consecutive weeks without transfusions (outcome parameter assessed was dependent on baseline hemoglobin/transfusion status).
Up until and including completion of 9 cycles. Each cycle is 28 days.
Stage 2 Main Phase: Platelet Improvement
Platelet improvement was measured by the percent of participants with: Platelet transfusion independence (no transfusions for >= 12 consecutive weeks) OR 50% reduction in platelets transfusions for >= 12 consecutive weeks OR doubling of baseline platelet count for >= 12 consecutive weeks without platelet transfusions OR platelet count > 50 x 10e9/L for >=12 consecutive weeks without platelet transfusions OR doubling of baseline platelet count for >= 12 consecutive weeks without platelet transfusions OR platelet count > 25 x 10e9/L for >= 12 consecutive weeks without platelet transfusions (outcome parameter assessed is dependent on baseline platelet status).
Up until and including completion of 9 cycles. Each cycle is 28 days.
Stage 2 Main Phase: Symptom Improvement
Symptom improvement was assessed as the percent of participants with 50% reduction in MPN-SAF TSS from baseline over time. The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable.
Up until and including completion of 9 cycles. Each cycle is 28 days.
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria
Best Overall Response: (CR, PR, CI), SD and PD according to the IWG-MRT Criteria.
Up until and including completion of 9 cycles. Each cycle is 28 days.
Time at which the maximum plasma concentration was observed.
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last)
Area under the plasma concentration time curve from time 0 to time of last measurable plasma concentration.
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf)
Area under the plasma concentration-time curve from 0-time extrapolated to infinity.
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2)
Apparent terminal elimination half-life of RO7490677.
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
Stage 1 Main Phase: Clearance (CL)
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
Stage 1 Main Phase: Volume of Distribution (Vd)
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
Percentage of Participants With Adverse Events (AEs) and Infusion Related Reactions (IRRs)
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. IRRs were considerd to be Adverse Events of Special Interest (AESI). Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
Baseline up until 6.75 years
Percentage of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation
An SAE was defined as any AE that occurred at any dose the resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalizations; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly or birth defect. An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
Baseline up until 6.75 years
Palo Alto
California
94304
United States
Emory Hospital
Atlanta
Georgia
30322
United States
University of Maryland Medical Center
Baltimore
Maryland
21201
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan
Ann Arbor
Michigan
48109-2800
United States
Mount Sinai Medical Center
New York
New York
10029
United States
Weill Cornell Medical Center
New York
New York
10065
United States
Wake Forest Baptist Medical Center
Winston-Salem
North Carolina
27157
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Providence Health Care
Vancouver
British Columbia
V6Z 2A5
Canada
The Princess Margaret Cancer Centre
Toronto
Ontario
M5T 2M9
Canada
Hospital Saint-Louis
Paris
75475
France
University Medical Center RWTH Aachen
Aachen
D-52074
Germany
Johannes Wesling Academic Medical Center
Minden
32429
Germany
Hadassah Medical Centre
Jerusalem
91120
Israel
Meir Medical Centre
Kfar Saba
4428164
Israel
Fondazione IRCCS Policlinico San Matteo
Pavia
27100
Italy
Marche Nord Hospital
Pesaro
61122
Italy
Erasmus Medical Center
Rotterdam
South Holland
3015 CE
Netherlands
Radboud University Medical Center
Nijmegen
6525 GA
Netherlands
Guy's and St. Thomas' Hospital
London
United Kingdom
FG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
FG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
FG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
FG004
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
FG005
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
FG006
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
FG007
OLE Stage 1: RO7490677 10 mg/kg IV Q4W
Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
FG008
OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib
Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
FG009
OLE Stage 2: RO7490677 10 mg/kg IV Q4W
Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
FG0008 subjects
FG0017 subjects
FG0026 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Main Study
FG0005 subjects
FG0015 subjects
FG0024 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Informed Consent Withdrawn
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Various reasons
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Main Phase Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00433 subjects
FG00532 subjects
FG00632 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Main Study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open Label Extension (OLE)
Type
Comment
Milestone Data
STARTED
Continued in OLE
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00713 subjects
FG0085 subjects
FG00948 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage 1 & Stage 2 reported separately.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
BG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
BG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
BG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
BG004
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
BG005
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
BG006
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0017
BG0026
BG0036
BG00433
BG00532
BG00632
BG007124
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Participants in the Main Phase Stage 1 part of the study
Main Phase Stage 1 reported separately from Main Phase Stage 2.
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0017
ParticipantsBG0026
ParticipantsBG003
Age, Continuous
Participants in the Main Phase Stage 2 part of the study
Main Phase Stage 2 reported separately from Main Phase Stage 1.
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Sex: Female, Male
Participants in the Main Phase Stage 1 part of the study
Main Phase Stage 1 reported separately from Main Phase Stage 2.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0017
ParticipantsBG002
Sex: Female, Male
Participants in the Main Phase Stage 2 part of the study
Main Phase Stage 2 reported separately from Main Phase Stage 1.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Ethnicity (NIH/OMB)
Participants in the Main Phase Stage 1 part of the study
Main Phase Stage 1 reported separately from Main Phase Stage 2.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0017
ParticipantsBG002
Race (NIH/OMB)
Participants in the Main Phase Stage 1 part of the study
Main Phase Stage 1 reported separately from Main Phase Stage 2.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0017
ParticipantsBG002
Race (NIH/OMB)
Participants in the Main Phase Stage 2 part of the study
Main Phase Stage 2 reported separately from Main Phase Stage 1.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
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
Stage 1 Main Phase: Overall Response Rate (ORR)
ORR was defined as the percent of participants with a response according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. This was defined as those participants who achieved clinical improvement (CI), partial remission (PR), or complete remission (CR) at a post-baseline assessment of treatment response OR had at least stable disease (SD) for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease.
The all treated population included all participants who received at least one dose of RO7490667.
Posted
Number
90% Confidence Interval
Percentage of Participants
Up until and including completion of 6 cycles. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00037.5(11.11 to 71.08)
OG00114.3(0.73 to 52.07)
OG00233.3(6.28 to 72.87)
OG003
Primary
Stage 2 Main Phase: Bone Marrow Response Rate (BMRR)
Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria from baseline to any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up until and including completion of 9 cycles. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Primary
Stage 1 Main + Open-Label Extension (OLE): ORR
ORR was defined as the percent of participants with a response according to the IWG-MRT criteria. This was defined as those participants who achieved CI, PR, or CR at a post-baseline assessment of treatment response OR had at least SD for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease. Participants who achieved a clinical benefit in the main phase had the opportunity to remain on treatment. The determination of ORR in the main phase is outlined in the arms description below. Participants who didn't achieve a benefit had the opportunity to switch to a different dosing schedule in the OLE phase. The determination of ORR in the OLE phase is outlined in the arms descriptions below.
The all treated population (main phase + OLE) included all participants who received at least one dose of RO7490667.
Posted
Number
90% Confidence Interval
Percentage of Participants
From cycle 1 day 1 up until cycle 6, day 29 (Main Phase). From cycle 7 day 1 up until study discontinuation or study termination, up to 83 cycles (OLE). Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV QW; OLE: RO7490677 10 mg/kg IV Q4W
Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE).
Primary
Stage 2 Main + Open-Label Extension (OLE): BMRR
Defined as the percent of participants with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study. As determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy. Participants in the main phase had the opportunity to remain on treatment (as outlined in the arms description below). Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment and receive PRM-151 10 mg/kg/Q4W (as outlined in the arms description below).
The all treated population (main phase + OLE) included all participants randomized and who received at least one administration of the drug.
Posted
Number
95% Confidence Interval
Percentage of Participants
From cycle 1 day 1 up until cycle 9 day 29 (main phase). From cycle 10 day 1 up until study discontinuation or study termination, up to 51 cycles (OLE). Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W
Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and PRM-151 at a dose of 10 mg/kg on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE).
Secondary
Stage 1 Main Phase: BMRR
Bone marrow response was defined as a reduction in bone marrow fibrosis score by at least one grade from baseline at anytime during the study.
The all treated population included all participants who received at least one dose of RO7490667.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline, Weeks 12 and 24
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Secondary
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes
The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable. The values reported are the change from baseline scores.
The all treated population included all participants who received at least one dose of RO7490667.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, beginning of each cycle (Cycle 2 onward). Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Secondary
Stage 2 Main Phase: BMRR
Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria at any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up until and including completion of 9 cycles. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Secondary
Stage 2 Main Phase: BMRR - Reduction of Bone Marrow Fibrosis by Visit
Reduction in bone marrow fibrosis score: Reduction of at least one grade from baseline. Bone marrow fibrosis grades according to WHO criteria (as determined by central adjudication).
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Number
Percentage of Participants
Day 1 on Cycles 4, 7, 10 and Cycle 9 Day 29. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Secondary
Stage 2 Main Phase: Duration of Bone Marrow Improvement
Duration of response was defined as time from first decrease from baseline >= 1 grade to time of return to baseline levels.
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Median
95% Confidence Interval
Weeks
From first decrease from baseline of one grade to time of return to baseline levels, up to cycle 9 of 28-day cycles.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Secondary
Stage 2 Main Phase: Hemoglobin Improvement
Hemoglobin improvement was measured by the percent of participants with: Red cell transfusion independence (no transfusions for >= 12 consecutive weeks) OR 50% reduction in red blood cell (RBC) transfusions for >= 12 consecutive weeks OR percent of participants with >= 10 g/L and >= 20 g/L increase in hemoglobin for >= 12 consecutive weeks without transfusions (outcome parameter assessed was dependent on baseline hemoglobin/transfusion status).
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Number
Percentage of Participants
Up until and including completion of 9 cycles. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Secondary
Stage 2 Main Phase: Platelet Improvement
Platelet improvement was measured by the percent of participants with: Platelet transfusion independence (no transfusions for >= 12 consecutive weeks) OR 50% reduction in platelets transfusions for >= 12 consecutive weeks OR doubling of baseline platelet count for >= 12 consecutive weeks without platelet transfusions OR platelet count > 50 x 10e9/L for >=12 consecutive weeks without platelet transfusions OR doubling of baseline platelet count for >= 12 consecutive weeks without platelet transfusions OR platelet count > 25 x 10e9/L for >= 12 consecutive weeks without platelet transfusions (outcome parameter assessed is dependent on baseline platelet status).
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Number
Percentage of Participants
Up until and including completion of 9 cycles. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Secondary
Stage 2 Main Phase: Symptom Improvement
Symptom improvement was assessed as the percent of participants with 50% reduction in MPN-SAF TSS from baseline over time. The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable.
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Count of Participants
Participants
Up until and including completion of 9 cycles. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG002
Secondary
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria
Best Overall Response: (CR, PR, CI), SD and PD according to the IWG-MRT Criteria.
The all treated population included all participants randomized and who received at least one administration of the drug.
Posted
Count of Participants
Participants
Up until and including completion of 9 cycles. Each cycle is 28 days.
ID
Title
Description
OG000
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Other Pre-specified
Stage 1 Main Phase: Maximum Drug Concentration (Cmax)
Cmax is the maximum observed RO7490677 plasma concentration.
The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per Milliliter (ug/mL)
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Other Pre-specified
Stage 1 Main Phase: Time to Maximum Concentration (Tmax)
Time at which the maximum plasma concentration was observed.
The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.
Posted
Median
Full Range
Hour (hr)
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Other Pre-specified
Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last)
Area under the plasma concentration time curve from time 0 to time of last measurable plasma concentration.
The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug*hour/mL
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Other Pre-specified
Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf)
Area under the plasma concentration-time curve from 0-time extrapolated to infinity.
The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug*hour/mL
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Other Pre-specified
Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2)
Apparent terminal elimination half-life of RO7490677.
The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Other Pre-specified
Stage 1 Main Phase: Clearance (CL)
The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres per hour (L/hr)
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
Other Pre-specified
Stage 1 Main Phase: Volume of Distribution (Vd)
The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres (L)
Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
Other Pre-specified
Percentage of Participants With Adverse Events (AEs) and Infusion Related Reactions (IRRs)
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. IRRs were considerd to be Adverse Events of Special Interest (AESI). Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
The safety population included all participants who received at least one dose of study drug.
Posted
Number
Percentage of Participants
Baseline up until 6.75 years
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Other Pre-specified
Percentage of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation
An SAE was defined as any AE that occurred at any dose the resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalizations; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly or birth defect. An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
The safety population included all participants who received at least one dose of study drug.
Posted
Number
Percentage of Participants
Baseline up until 6.75 years
ID
Title
Description
OG000
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG001
Time Frame
Baseline up until 6.75 years
Description
Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
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
Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
2
8
2
8
8
8
EG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
0
7
1
7
6
7
EG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
1
6
2
6
6
6
EG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
0
6
0
6
6
6
EG004
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
7
33
11
33
32
33
EG005
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
6
32
14
32
30
32
EG006
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
9
32
14
32
31
32
EG007
OLE Stage 1: RO7490677 10 mg/kg IV Q4W
Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
0
13
5
13
12
13
EG008
OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib
Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
0
5
2
5
5
5
EG009
OLE Stage 2: RO7490677 10 mg/kg IV Q4W
Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
7
48
22
48
32
48
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0013 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
Infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Extramedullary haemopoiesis
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Femoral hernia, obstructive
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Death
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Disease progression
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Inflammation
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Unevaluable event
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abscess limb
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Endocarditis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Osteoradionecrosis
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma muscle
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Myelofibrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Primary myelofibrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Transformation to acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Aortic valve replacement
Surgical and medical procedures
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dry gangrene
Vascular disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Organ failure
General disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Portal hypertension
Hepatobiliary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Wound infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Metastatic squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Urinary bladder haemorrhage
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Urinary bladder rupture
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected6 at risk
EG00411 events5 affected33 at risk
EG0058 events6 affected32 at risk
EG0066 events3 affected32 at risk
EG0072 events1 affected13 at risk
EG0081 events1 affected5 at risk
EG00912 events6 affected48 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Asthenia
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Chills
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA version 23.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0011 events1 affected7 at risk
EG0023 events1 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Weight increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events2 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood sodium decreased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Delirium
Psychiatric disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Early satiety
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Extravasation
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Ill-defined disorder
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Pain
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Swelling
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0025 events2 affected6 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hepatosplenomegaly
Hepatobiliary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Laryngitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Localised infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Lyme disease
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood urea increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood uric acid increased
Investigations
MedDRA version 23.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Iron overload
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Joint lock
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Sciatic nerve neuropathy
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Blood product transfusion dependent
Social circumstances
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA version 23.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 23.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 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
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Title
Measurements
OG00030.3(14.62 to 45.98)
OG00131.3(15.19 to 47.31)
OG00225.0(10.00 to 40.00)
OG001
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W
Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE).
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib; OLE: RO7490677 10 mg/kg IV Q4W + Ruxo.
Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants could drop ruxolitinib in the OLE, but were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE).
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib; OLE: RO7490677 10 mg/kg IV Q4W + Ruxo.
Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants could drop ruxolitinib in the OLE, but were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE).
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
Title
Measurements
OG00050.0(19.29 to 80.71)
OG00171.4(34.13 to 94.66)
OG00250.0(15.32 to 84.68)
OG00366.7(27.13 to 93.72)
OG001
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W
Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and PRM-151 at a dose of 10 mg/kg on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE).
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W
Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.
Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE).
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Title
Measurements
OG00030.3(14.62 to 45.98)
OG00134.4(17.92 to 50.83)
OG00225.0(10.00 to 40.00)
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
Title
Measurements
OG00037.5(3.95 to 71.05)
OG00114.3(0.00 to 40.21)
OG00216.7(0.00 to 46.49)
OG00350.0(9.99 to 90.01)
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
Title
Measurements
OG00023.1± 19.1
OG00116.9± 7.2
OG00226.8± 17.1
OG003
Cycle(C)2 Day(D)1
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
C3D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0035
C4D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
C5D1
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
C6D1
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0036
C6D29
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Title
Measurements
OG00030.3(14.62 to 45.98)
OG00131.3(15.19 to 47.31)
OG00225.0(10.0 to 40.00)
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Cycle(C) 4 Day(D) 1
ParticipantsOG00028
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG00010.7
OG00124.0
OG00219.2
C7D1
ParticipantsOG00021
ParticipantsOG00117
ParticipantsOG00219
Title
Measurements
OG000
C9D29/C10D1
ParticipantsOG00020
ParticipantsOG00114
ParticipantsOG00215
Title
Measurements
OG000
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Title
Measurements
OG000NA(12.0 to NA)Data was not evaluable as the participants who had bone marrow improvement but did not return to baseline levels at the end of main phase were censored at their last bone marrow assessment in the main phase (the last timepoint in the main phase at which the improvement was still observed).
OG00112.0(12.0 to NA)Data was not evaluable as the participants who had bone marrow improvement but did not return to baseline levels at the end of main phase were censored at their last bone marrow assessment in the main phase (the last timepoint in the main phase at which the improvement was still observed).
OG00212.1(11.4 to 13.0)
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Title
Measurements
OG00015.2
OG00115.6
OG0026.3
OG002
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Title
Measurements
OG00027.3
OG00134.4
OG00237.5
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
Cycle(C) 2 Day(D) 1
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00229
Title
Measurements
OG0005
OG0012
OG0021
C3D1
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00228
Title
Measurements
OG000
C4D1
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00228
Title
Measurements
OG000
C5D1
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00225
Title
Measurements
OG000
C6D1
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG00225
Title
Measurements
OG000
C7D1
ParticipantsOG00021
ParticipantsOG00118
ParticipantsOG00220
Title
Measurements
OG000
C8D1
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00219
Title
Measurements
OG000
C9D1
ParticipantsOG00021
ParticipantsOG00117
ParticipantsOG00217
Title
Measurements
OG000
C9D29/C10D1
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00213
Title
Measurements
OG000
Units
Counts
Participants
OG00033
OG00132
OG00232
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
PR
Title
Measurements
OG0000
OG0010
OG0020
CI
Title
Measurements
OG0008
OG0016
OG0022
SD
Title
Measurements
OG00020
OG00121
OG00226
PD
Title
Measurements
OG0003
OG0013
OG0024
Not evaluable
Title
Measurements
OG0002
OG0012
OG0020
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
C1D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
Title
Measurements
OG000133± 48.4
OG001113± 28.1
OG002164± 23.9
OG003
C1D15
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0030
C2D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
C6D1
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0036
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
C1D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
Title
Measurements
OG0001.12(1.00 to 2.00)
OG0011.10(1.00 to 2.08)
OG0021.14(1.00 to 2.25)
OG003
C1D15
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0030
C2D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
C6D1
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0036
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
C1D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
Title
Measurements
OG0001810± 72.0
OG0011690± 26.1
OG0022590± 28.7
OG003
C1D15
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0030
C2D1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
C6D1
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0036
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0033
Title
Measurements
OG0002830± 12.9
OG0012050± 29.5
OG0022970± 34.9
OG003
C1D15
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
C2D1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
C6D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0033
Title
Measurements
OG00014.7± 19.2
OG00117.2± 23.7
OG00216.8± 17.7
OG003
C1D15
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
C2D1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
C6D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0033
Title
Measurements
OG0000.258± 9.0
OG0010.362± 31.5
OG0020.269± 32.9
OG003
C1D15
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
C2D1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
C6D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0033
Title
Measurements
OG0005.47± 10.9
OG0019.00± 28.8
OG0026.52± 26.4
OG003
C1D15
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
C2D1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
C6D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG004
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG005
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG006
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG007
OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG008
OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG009
OLE Stage 2: RO7490677 10 mg/kg IV Q4W
Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
OG00433
OG00532
OG00632
OG00713
OG0085
OG00948
Title
Denominators
Categories
AEs
Title
Measurements
OG000100
OG00185.7
OG002100
OG003100
OG004100
OG005100
OG006100
OG00792.3
OG008100
OG00989.6
IRRs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG002
Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
OG003
Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG004
Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG005
Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG006
Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W
Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
OG007
OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)
Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG008
OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib
Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
OG009
OLE Stage 2: RO7490677 10 mg/kg IV Q4W
Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
Units
Counts
Participants
OG0008
OG0017
OG0026
OG0036
OG00433
OG00532
OG00632
OG00713
OG0085
OG00948
Title
Denominators
Categories
SAEs
Title
Measurements
OG00025.0
OG0010
OG0020
OG0030
OG00415.2
OG00515.6
OG00628.1
OG0077.7
OG0080
OG00922.9
AEs
Title
Measurements
OG00025.0
OG0010
OG0020
OG003
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0043 events2 affected33 at risk
EG0051 events1 affected32 at risk
EG0062 events2 affected32 at risk
EG0070 events0 affected13 at risk
EG0082 events1 affected5 at risk
EG0093 events3 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0043 events1 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0092 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0052 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0062 events2 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0092 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0052 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0053 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0052 events2 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0052 events2 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0061 events1 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
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EG0060 events0 affected32 at risk
EG0071 events1 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0071 events1 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0071 events1 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0071 events1 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected48 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected32 at risk
EG0060 events0 affected32 at risk
EG0070 events0 affected13 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected48 at risk
12
25
1
1
0
2
23
0
0
15.3
± 10.4
Title
Measurements
OG000-5.3± 12.6
OG0015.7± 11.8
OG0020.5± 8.8
OG003-2.0± 5.0
Title
Measurements
OG000-9.1± 10.9
OG0011.9± 5.3
OG002-2.7± 14.8
OG0034.2± 8.0
Title
Measurements
OG000-8.7± 10.7
OG0011.0± 8.0
OG002-7.5± 6.0
OG0035.7± 20.9
Title
Measurements
OG000-13.2± 13.2
OG0012.6± 6.9
OG002-6.7± 10.6
OG0031.5± 13.6
Title
Measurements
OG000-12.2± 9.5
OG001-0.8± 8.3
OG002-5.4± 6.2
OG0034.3± 11.5
Title
Measurements
OG000-15.0± 13.7
OG001-2.2± 5.3
OG002-5.3± 4.6
OG0032.3± 8.8
23.8
OG00111.8
OG00210.5
30.0
OG00121.4
OG00213.3
6
OG0013
OG0022
3
OG0014
OG0022
5
OG0012
OG0021
8
OG0013
OG0023
8
OG0015
OG0020
5
OG0013
OG0020
5
OG0013
OG0021
5
OG0012
OG0020
112
± 90.4
Title
Measurements
OG000127± 31.9
OG002126± 27.5
Title
Measurements
OG000107± 26.9
OG001110± 20.9
OG002149± 29.1
OG003130± 80.2
Title
Measurements
OG000142± 70.0
OG001111± 28.0
OG002136± 34.1
OG003142± 27.4
1.13
(1.00 to 5.00)
Title
Measurements
OG0001.13(1.03 to 1.80)
OG0021.65(1.02 to 2.50)
Title
Measurements
OG0001.10(1.00 to 3.17)
OG0011.08(1.03 to 1.08)
OG0021.05(1.00 to 1.32)
OG0031.44(1.00 to 9.00)
Title
Measurements
OG0002.00(1.03 to 5.20)
OG0011.07(1.00 to 2.03)
OG0021.17(1.05 to 5.00)
OG0031.01(1.00 to 1.08)
1500
± 158.3
Title
Measurements
OG0001460± 142.0
OG0022590± 187.6
Title
Measurements
OG000127.3± 904
OG001504± 84.7
OG0022990± 92.0
OG003663± 79.5
Title
Measurements
OG000698± 63.0
OG001570± 44.8
OG002764± 28.9
OG003703± 33.8
3130
± 8.6
Title
Measurements
OG0003450± 2.8
OG0026060± 23.2
Title
Measurements
OG0002170± 170.9
OG0024230± 34.8
Title
Measurements
OG002819± NAGeometric Coefficient of Variation could not be calculated from data for a single participant.
18.4
± 7.9
Title
Measurements
OG00031.2± 45.0
OG00240.4± 12.6
Title
Measurements
OG00018.0± 220.6
OG00230.0± 48.6
Title
Measurements
OG0021.95± NAGeometric Coefficient of Variation could not be calculated from data for a single participant.
0.233
± 33.3
Title
Measurements
OG0000.233± 24.9
OG0020.147± 35.0
Title
Measurements
OG0000.382± 229.9
OG0020.189± 55.5
Title
Measurements
OG0021.42± NAGeometric Coefficient of Variation could not be calculated from data for a single participant.
6.17
± 38.9
Title
Measurements
OG00010.5± 62.4
OG0028.57± 47.6
Title
Measurements
OG0009.93± 63.0
OG0028.18± 24.5
Title
Measurements
OG0024.01± NAGeometric Coefficient of Variation could not be calculated from data for a single participant.