First in Human Study of M6223 | NCT04457778 | Trialant
NCT04457778
Sponsor
EMD Serono Research & Development Institute, Inc.
Status
Completed
Last Update Posted
May 4, 2026Actual
Enrollment
58Actual
Phase
Phase 1
Conditions
Metastatic Solid Tumors
Interventions
M6223
Bintrafusp alfa
M6223
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04457778
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MS201430_0001
Secondary IDs
Not provided
Brief Title
First in Human Study of M6223
Official Title
Phase I, First-in-Human, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M6223, an Inhibitor of TIGIT, as Single Agent and in Combination With Bintrafusp Alfa (Anti-PDL1/ TGFß Trap) in Participants With Metastatic or Locally Advanced Solid Unresectable Tumors
Acronym
Not provided
Organization
EMD SeronoINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 10, 2020Actual
Primary Completion Date
Jun 23, 2023Actual
Completion Date
Jun 23, 2023Actual
First Submitted Date
Jun 30, 2020
First Submission Date that Met QC Criteria
Jun 30, 2020
First Posted Date
Jul 7, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Dec 11, 2025
Results First Submitted that Met QC Criteria
Apr 13, 2026
Results First Posted Date
May 4, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 13, 2026
Last Update Posted Date
May 4, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
EMD Serono Research & Development Institute, Inc.INDUSTRY
Collaborators
Name
Class
Merck KGaA, Darmstadt, Germany
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks (Q2W) regimen and the every 3 weeks (Q3W) regimen and of M6223 combined with bintrafusp alfa (Part 1B) for Q2W regimen in participants with metastatic or locally advanced solid unresectable tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Metastatic Solid Tumors
Keywords
M6223
Bintrafusp alfa
Metastatic Solid Tumors
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
58Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1A: M6223 Monotherapy
Experimental
Drug: M6223
Part1B: M6223 + Bintrafusp alfa
Experimental
Drug: Bintrafusp alfa
Drug: M6223
Interventions
Name
Type
Description
Arm Group Labels
Other Names
M6223
Drug
Participants received an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) or every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1A and 1B: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0
A DLT is defined as any Grade ≥ 3 non-hematologic AE or any Grade ≥ 4 hematologic AE according to the NCI-CTCAE, occurring during the DLT observation period (28 days from first administration of study intervention) that is not clearly related to the underlying disease or any previous or concomitant medication, concomitant disease or unrelated illness. A DLT must be confirmed by the Safety Monitoring Committee. DLT is considered if the following related AEs occur: • Grade ≥ 3 neutropenia with clinical signs/symptoms (e.g., febrile neutropenia). • Grade ≥ 3 thrombocytopenia with medically concerning bleeding. • A study intervention-related treatment-emergent AE that in the opinion of the SMC is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk. • Grade ≥ 3 hematological AE with symptoms that require growth factor support or transfusion to prevent further damage to the participant.
Day 1 to Day 28
Part 1A and 1B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events that started or worsened after first dose of study intervention until 30 days after last dose. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With TEAES With Severity of Grade Greater or Equal to 3 and TEAEs Leading to Deaths
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of the study intervention, regardless of causality. A serious AE results in death, is life-threatening, requires/prolongs hospitalization, causes disability/incapacity, leads to a congenital anomaly/birth defect, or is otherwise medically significant. Treatment-emergent adverse events (TEAEs) are those that begin or worsen after the first dose through 30 days post-treatment, and include both serious and non-serious events. Treatment-related TEAEs are those reasonably related to the study intervention. Severity is graded per CTCAE v24.1: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe/medically significant), Grade 4 (life-threatening/disabling), Grade 5 (death related to AE).
Secondary Outcomes
Measure
Description
Time Frame
Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M6223
Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule. The full form of unit of measure h*mcg/mL is hours · micrograms per milliliter.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants have histologically or cytologically proven locally advanced or advanced solid malignancies who are refractory to or have progressed under standard treatment and have no other treatment options known to confer clinical benefit
Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at Screening
Participant has a formalin-fixed paraffin-embedded block containing tumor tissue or a minimum of 15 (preferably 25) unstained tumor slides suitable for immunohistochemistry-based staining of protein expression
Participants with life expectancy of at least 12 weeks
Participants with measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Adequate hematological, hepatic and renal function as defined in the protocol
Other protocol defined inclusion criteria may apply
Exclusion Criteria:
Participants with persisting toxicity related to prior therapy Grade greater than (>) 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, however, alopecia, sensory neuropathy Grade less than or equal to (<=) 2, or other non-immune-related Grade <= 2 not constituting a safety risk
Participants with prior organ transplantation including allogeneic stem cell transplantation
Participants with prior toxicity related to an immune checkpoint inhibitor Grade greater than equal to (>=) 3 NCI-CTCAE Version 5.0 unless resolved to Grade <= 1 prior to study inclusion
Participants with current significant cardiac conduction abnormalities, including corrected QT interval (QTcF, corrected with Fridericia formula) prolongation of > 450 milli seconds (ms) on triplicate 12-lead ECG or impaired cardiovascular function, ventricular tachycardia, hypokalemia or a history of paroxysmal atrial fibrillation, serious cardiac arrhythmia and family history of sudden death or long QT syndrome
A history of vascular, cardiovascular or cerebrovascular disease like, cerebral vascular accident/stroke (less than [<] 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >= II), deep vein thrombosis (< 3 months prior to enrollment) or pulmonary thrombosis/embolism (< 3 months prior to enrollment)
Other protocol defined exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Naing A, McKean M, Tolcher A, Victor A, Hu P, Gao W, Nogueira Filho MAF, Kitzing T, Gleicher S, Holland D, Richter E, Tadjalli-Mehr K, Siu LL. TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa in patients with advanced solid tumors: a first-in-human, phase 1, dose-escalation trial. J Immunother Cancer. 2025 Feb 10;13(2):e010584. doi: 10.1136/jitc-2024-010584.
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
FG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
FG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
FG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
FG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
FG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
FG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
FG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG0049 subjects
FG00511 subjects
FG0064 subjects
FG0078 subjects
FG0087 subjects
FG0094 subjects
FG0107 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Part 1A and 1B: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0
A DLT is defined as any Grade ≥ 3 non-hematologic AE or any Grade ≥ 4 hematologic AE according to the NCI-CTCAE, occurring during the DLT observation period (28 days from first administration of study intervention) that is not clearly related to the underlying disease or any previous or concomitant medication, concomitant disease or unrelated illness. A DLT must be confirmed by the Safety Monitoring Committee. DLT is considered if the following related AEs occur: • Grade ≥ 3 neutropenia with clinical signs/symptoms (e.g., febrile neutropenia). • Grade ≥ 3 thrombocytopenia with medically concerning bleeding. • A study intervention-related treatment-emergent AE that in the opinion of the SMC is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk. • Grade ≥ 3 hematological AE with symptoms that require growth factor support or transfusion to prevent further damage to the participant.
The Dose Limiting Toxicity (DLT) set included all participants experiencing at least one DLT or considered evaluable for DLT by the safety monitoring committee (SMC).
Posted
Count of Participants
Participants
Day 1 to Day 28
Adverse Events Module
Frequency Threshold
5
Time Frame
Approximately 2 years 11 months
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1A: Monotherapy M6223 Q2W/ 10mg
IV administered until confirmed disease progression
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Communication Center
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Participants received an IV infusion of bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) until confirmed disease progression.
Part1B: M6223 + Bintrafusp alfa
M6223
Drug
Participants received an IV infusion of M6223 at escalated doses Q2W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression.
Part1B: M6223 + Bintrafusp alfa
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values
Number of participants with clinically meaningful change from baseline in laboratory parameters were reported. Clinically meaningful abnormalities (identified as laboratory values having CTCAE grades >= 3). Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)
Number of participants with clinically significant change from baseline in ECG parameters were reported. Clinical Significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical Relevance was decided by the investigator. Number of participants with clinically relevant change from baseline in vital signs were reported. Clinical relevance was defined as increase more than equal to (>=) 3° temperature, >40 beats heart rate increase, >40 mmHG increase in systolic or diastolic blood pressure, >10 breaths in respiratory rate increase.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Worsened Post Baseline Shift in Eastern Cooperative Oncology Group Performance Status
The number of participants who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.
Approximately 2 years 11 months
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of M6223
Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Area Under Serum Concentration-Time Curve Over a Dosing Interval From Time Zero to Tau (AUC-tau) of M6223
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycle 1 (Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Maximum Observed Serum Concentration (Cmax) of M6223
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of M6223
Ctrough is the concentration prior to study drug administration.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Time to Reach Maximum Serum Concentration (Tmax) of M6223
Time taken to reach maximum concentration of M66223 after admistration is reported.
Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
Part 1A and Part 1B: Apparent Terminal Half-Life (t1/2) of M6223
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
Part 1A and Part 1B: Elimination Rate Constant (Lambda z) of M6223
Elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1B: Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp Alfa
Ctrough is the concentration prior to study drug administration.
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Part IA and 1B: Number of Participants With Positive Antidrug Antibody (ADA) Assays
Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.
Pre-dose of Day 1 Cycle 1 (Each Cycle is of 14 days in Q2W regimen and 21 days in Q3W regimen) up to end of safety follow-up visit ( approximately 2 years 11 months)
Part 1A and IB: Best Overall Response According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
The ORR is defined as the number of participants with a documented BOR (complete response (CR) or partial response (PR)) by the investigator during treatment with avelumab plus axitinib as firstline therapy. The BOR is defined as the best tumor response recorded during the observation period. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD], not Evaluable [NE]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
Part 1A and 1B: Duration of Response (DOR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
Part 1A and 1B: Time to Tumor Response (TTR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
TTR was defined for participants who achieved objective response as time from first study drug administration to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as a score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
Part 1A and 1B: Disease Control According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Disease control rate was defined as percentage of participants with disease control. Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD). CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than <mediastinum but <=liver) with or without a residual mass on Positron Emission Tomography 5-Point Scale, for lymph nodes and extra lymphatic sites; no new lesions; no evidence of fluorodeoxyglucose -avid disease in bone marrow. PR: >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in Sum of the Products of Diameters of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
Part 1A and 1B: Progression-free Survival Time According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Progression Free Survival (PFS) time is defined as the time from start date of treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first. The tumor response will be determined according to RECIST 1.1 and assessed by the investigator.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
Part 1A and 1B: Overall Survival
Overall survival was defined as the time (in months) from first study drug administration to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
BG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
BG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
BG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
BG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
BG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
BG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
BG011
Total
Total of all reporting groups
1
BG0011
BG0023
BG0033
BG0049
BG00511
BG0064
BG0078
BG0087
BG0094
BG0107
BG01158
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00069
BG00146
BG00251± 22.2
BG00362± 2.6
BG00459± 14.7
BG00560± 13.7
BG00661± 14.5
BG00763± 11.2
BG00863± 12.9
BG00958± 13
BG01058± 13.2
BG01160± 12.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG0023
BG0031
BG0044
BG0055
BG0063
BG0072
BG0085
BG0092
BG0104
BG01130
Male
BG0000
BG0011
BG0020
BG0032
BG004
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Ethnicity-Hispanic or Latino
Title
Measurements
BG0000
BG0010
BG0022
BG0031
BG0040
BG0052
BG0060
BG0070
BG0081
BG0090
BG0100
BG0116
Ethnicity-Not Hispanic or Latino
Title
Measurements
BG0001
BG0011
BG0021
BG003
Ethnicity-Unknown or Not Reported
Title
Measurements
BG0000
BG0010
BG0020
BG003
Race-Asian
Title
Measurements
BG0000
BG0010
BG0020
BG003
Race-Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG003
Race-Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG003
Race-Other
Title
Measurements
BG0000
BG0010
BG0020
BG003
Race-White
Title
Measurements
BG0001
BG0011
BG0023
BG003
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG0048
OG00510
OG0063
OG0077
OG0086
OG0093
OG0106
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0081
OG0090
OG0100
Primary
Part 1A and 1B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events that started or worsened after first dose of study intervention until 30 days after last dose. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention.
Safety Analysis set included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
Approximately 2 years 11 months
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0001
OG0011
OG0023
OG003
Primary
Part 1A and 1B: Number of Participants With TEAES With Severity of Grade Greater or Equal to 3 and TEAEs Leading to Deaths
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of the study intervention, regardless of causality. A serious AE results in death, is life-threatening, requires/prolongs hospitalization, causes disability/incapacity, leads to a congenital anomaly/birth defect, or is otherwise medically significant. Treatment-emergent adverse events (TEAEs) are those that begin or worsen after the first dose through 30 days post-treatment, and include both serious and non-serious events. Treatment-related TEAEs are those reasonably related to the study intervention. Severity is graded per CTCAE v24.1: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe/medically significant), Grade 4 (life-threatening/disabling), Grade 5 (death related to AE).
Safety Analysis set included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
Approximately 2 years 11 months
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
TEAE of Grade ≥ 3 (severe)
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values
Number of participants with clinically meaningful change from baseline in laboratory parameters were reported. Clinically meaningful abnormalities (identified as laboratory values having CTCAE grades >= 3). Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation.
Safety Analysis set included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
Approximately 2 years 11 months
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)
Number of participants with clinically significant change from baseline in ECG parameters were reported. Clinical Significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula.
Safety Analysis set included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
Approximately 2 years 11 months
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1A and 1B: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical Relevance was decided by the investigator. Number of participants with clinically relevant change from baseline in vital signs were reported. Clinical relevance was defined as increase more than equal to (>=) 3° temperature, >40 beats heart rate increase, >40 mmHG increase in systolic or diastolic blood pressure, >10 breaths in respiratory rate increase.
Safety Analysis set included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
Approximately 2 years 11 months
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1A and 1B: Number of Participants With Worsened Post Baseline Shift in Eastern Cooperative Oncology Group Performance Status
The number of participants who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.
Safety Analysis set included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
Approximately 2 years 11 months
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M6223
Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule. The full form of unit of measure h*mcg/mL is hours · micrograms per milliliter.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG002
Secondary
Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of M6223
Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG002
Secondary
Part 1A and Part 1B: Area Under Serum Concentration-Time Curve Over a Dosing Interval From Time Zero to Tau (AUC-tau) of M6223
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycle 1 (Cycle is of 21 days in Q3W regimen)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG002
Secondary
Part 1A and Part 1B: Maximum Observed Serum Concentration (Cmax) of M6223
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliters
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.01± NAGeoCV not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics.
OG0016.83± NAGeoCV not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics.
OG002
Secondary
Part 1A and Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of M6223
Ctrough is the concentration prior to study drug administration.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.01± NAStandard deviation not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics.
OG0016.83± NAStandard deviation not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics
OG002
Secondary
Part 1A and Part 1B: Time to Reach Maximum Serum Concentration (Tmax) of M6223
Time taken to reach maximum concentration of M66223 after admistration is reported.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Median
Full Range
hour
Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.57(NA to NA)Upper and Lower limit not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics
OG0014.08(NA to NA)Upper and Lower limit not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics
OG002
Secondary
Part 1A and Part 1B: Apparent Terminal Half-Life (t1/2) of M6223
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour
Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG002
Secondary
Part 1A and Part 1B: Elimination Rate Constant (Lambda z) of M6223
Elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Mean
Standard Deviation
1(per)/hour
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAMean and Standard Deviation not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics
OG001NA± NAMean and Standard Deviation not calculated as N\<=2, per SAP-defined criteria requiring \>2 participants for descriptive statistics
OG002
Secondary
Part 1B: Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0003
OG0014
OG0025
Title
Denominators
Categories
Title
Measurements
OG000420± 24.4
OG001353± 28.9
OG002387± 29.0
Secondary
Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp Alfa
Ctrough is the concentration prior to study drug administration.
Pharmacokinetics Analysis Set included all participants, who received at least one dose of study intervention and provide at least one measurable post-dose concentration. Here "Number of Participants analyzed" signifies those participants who were evaluable for this outcome measure for each arm, respectively.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram/milliliter
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0006
OG0013
OG0024
Title
Denominators
Categories
Title
Measurements
OG00062.8± 25.1
OG00174.9± 25.8
OG00261.6± 4.1
Secondary
Part IA and 1B: Number of Participants With Positive Antidrug Antibody (ADA) Assays
Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.
Immunogenicity analysis set will include all participants who receive at least one dose of study intervention and have at least one valid antidrug antibody (ADA) result.
Posted
Count of Participants
Participants
Pre-dose of Day 1 Cycle 1 (Each Cycle is of 14 days in Q2W regimen and 21 days in Q3W regimen) up to end of safety follow-up visit ( approximately 2 years 11 months)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG003
Secondary
Part 1A and IB: Best Overall Response According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
The ORR is defined as the number of participants with a documented BOR (complete response (CR) or partial response (PR)) by the investigator during treatment with avelumab plus axitinib as firstline therapy. The BOR is defined as the best tumor response recorded during the observation period. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD], not Evaluable [NE]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
Immunogenicity analysis set will include all participants who receive at least one dose of study intervention and have at least one valid antidrug antibody (ADA) result.
Posted
Count of Participants
Participants
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Part 1A and 1B: Duration of Response (DOR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC.
No participant achieved a response; therefore, no DOR could be analyzed.
Posted
From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 1A and 1B: Time to Tumor Response (TTR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
TTR was defined for participants who achieved objective response as time from first study drug administration to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as a score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.
No part achieved OR therefore no time to response could be analyzed.
Posted
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 1A and 1B: Disease Control According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Disease control rate was defined as percentage of participants with disease control. Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD). CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than <mediastinum but <=liver) with or without a residual mass on Positron Emission Tomography 5-Point Scale, for lymph nodes and extra lymphatic sites; no new lesions; no evidence of fluorodeoxyglucose -avid disease in bone marrow. PR: >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in Sum of the Products of Diameters of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met.
Safety Analysis set included all participants, who were administered any dose of any study intervention.
Posted
Number
95% Confidence Interval
percentage of participants
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
ID
Title
Description
OG000
Part 1A (Monotherapy): M6223 10mg Q2W
Participants received an intravenous (IV) infusion of M6223 at 10 milligrams (mg) every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG001
Part 1A (Monotherapy): M6233 30mg Q2W
Participants received an IV infusion of M6223 at 30 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG002
Part 1A (Monotherapy): M6223 100mg Q2W
Participants received an IV infusion of M6223 at 100 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG003
Part 1A (Monotherapy): M6223 300mg Q2W
Participants received an IV infusion of M6223 at 300 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG004
Part 1A (Monotherapy): M6223 900mg Q2W
Participants received an IV infusion of M6223 at 900 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
OG005
Part 1A (Monotherapy): M6223 1600mg Q2W
Participants received an IV infusion of M6223 at 1600 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG006
Part 1A (Monotherapy): M6223 2400mg Q2W
Participants received an IV infusion of M6223 at 2400 mg Q2W on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
OG007
Part 1A (Monotherapy): M6223 2400mg Q3W
Participants received an IV infusion of M6223 at 2400 mg every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses every Q2W along with bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 97.5)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
OG003
Secondary
Part 1A and 1B: Progression-free Survival Time According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Progression Free Survival (PFS) time is defined as the time from start date of treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first. The tumor response will be determined according to RECIST 1.1 and assessed by the investigator.
Safety Analysis set included all participants, who were administered any dose of any study intervention. As per predefined crieteria in statistical analysis plan kaplan-meier estimates (product-limit estimates) were presented by study part together.
Posted
Median
95% Confidence Interval
months
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
ID
Title
Description
OG000
Part 1A: M6223 Monotherapy
Participants received intravenous (IV) infusions of M6223 on Day 1 of each 14-day cycle at dose levels of 10 mg, 30 mg, 100 mg, 300 mg, 900 mg, 1600 mg, and 2400 mg every 2 weeks (Q2W), or 2400 mg every 3 weeks (Q3W). Dosing was administered per protocol and guided by recommendations from the Safety Monitoring Committee (SMC). Treatment continued until the maximum tolerated dose (MTD) was reached or confirmed disease progression occurred.
OG001
Part1B: M6223 + Bintrafusp Alfa
Participants received intravenous (IV) infusions of M6223 at escalating doses of 300 mg, 900 mg, and 1600 mg every 2 weeks (Q2W), in combination with bintrafusp alfa at a fixed dose of 1200 mg Q2W. Both agents were administered on Day 1 of each 14-day cycle. Dosing was guided by recommendations from the Safety Monitoring Committee (SMC) and continued until the maximum tolerated dose (MTD) was reached or confirmed disease progression occurred.
Units
Counts
Participants
OG00040
OG00118
Title
Denominators
Categories
Title
Measurements
OG0001.7(1.3 to 1.9)
OG0011.3(0.8 to 1.3)
Secondary
Part 1A and 1B: Overall Survival
Overall survival was defined as the time (in months) from first study drug administration to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Safety Analysis set included all participants, who were administered any dose of any study intervention. As per predefined crieteria in statistical analysis plan kaplan-meier estimates (product-limit estimates) were presented by study part together.
Posted
Median
95% Confidence Interval
months
From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)
ID
Title
Description
OG000
Part 1A: M6223 Monotherapy
Participants received intravenous (IV) infusions of M6223 on Day 1 of each 14-day cycle at dose levels of 10 mg, 30 mg, 100 mg, 300 mg, 900 mg, 1600 mg, and 2400 mg every 2 weeks (Q2W), or 2400 mg every 3 weeks (Q3W). Dosing was administered per protocol and guided by recommendations from the Safety Monitoring Committee (SMC). Treatment continued until the maximum tolerated dose (MTD) was reached or confirmed disease progression occurred.
OG001
Part1B: M6223 + Bintrafusp Alfa
Participants received intravenous (IV) infusions of M6223 at escalating doses of 300 mg, 900 mg, and 1600 mg every 2 weeks (Q2W), in combination with bintrafusp alfa at a fixed dose of 1200 mg Q2W. Both agents were administered on Day 1 of each 14-day cycle. Dosing was guided by recommendations from the Safety Monitoring Committee (SMC) and continued until the maximum tolerated dose (MTD) was reached or confirmed disease progression occurred.
Units
Counts
Participants
OG00040
OG00118
Title
Denominators
Categories
Title
Measurements
OG0007.6(4.9 to 12.3)
OG0015.8(3.0 to 14.2)
0
1
0
1
1
1
EG001
Part 1A: Monotherapy M6223/ Q2W/ 30mg
IV administered until confirmed disease progression
1
1
0
1
1
1
EG002
Part 1A: Monotherapy M223/ Q2W/ 100mg
IV administered until confirmed disease progression
3
3
0
3
3
3
EG003
Part 1A: Monotherapy M6223/ Q2W/ 300mg
IV administered until confirmed disease progression
1
3
0
3
3
3
EG004
Part 1A: Monotherapy M6223/ Q2W/ 900mg
IV administered until confirmed disease progression
4
9
2
9
9
9
EG005
Part 1A: Monotherapy M6223/ Q2W/ 1600mg
IV administered until confirmed disease progression
5
11
4
11
11
11
EG006
Part 1A: Monotherapy M6223/ Q2W/ 2400mg
IV administered until confirmed disease progression
3
4
2
4
3
4
EG007
Part 1A: Monotherapy M6223/ Q3W/ 2400mg
IV administered until confirmed disease progression
IV administered until confirmed disease progression
2
4
4
4
3
4
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Adrenal insufficiency
Endocrine disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Constipation
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Asthenia
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Death
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Disease progression
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Pyrexia
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Cholangitis
Hepatobiliary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Abdominal sepsis
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Biliary tract infection
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Influenza
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Peritonitis bacterial
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hip fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Blood bilirubin increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Lipase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Syncope
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Confusional state
Psychiatric disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Renal haemorrhage
Renal and urinary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Embolism
Vascular disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected9 at risk
EG0052 events2 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected7 at risk
EG0094 events4 affected7 at risk
EG0101 events1 affected4 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Adrenal insufficiency
Endocrine disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Hypothyroidism
Endocrine disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Dry eye
Eye disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0042 events1 affected9 at risk
EG0052 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Ascites
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Coeliac artery aneurysm
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Constipation
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected7 at risk
EG0092 events2 affected7 at risk
EG0101 events1 affected4 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG0032 events2 affected3 at risk
EG0042 events2 affected9 at risk
EG0051 events1 affected11 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0093 events3 affected7 at risk
EG0101 events1 affected4 at risk
Oral pain
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Periodontal disease
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Rectal discharge
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Chest pain
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Chills
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Fatigue
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0032 events2 affected3 at risk
EG0043 events3 affected9 at risk
EG0053 events3 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected7 at risk
EG0096 events4 affected7 at risk
EG0100 events0 affected4 at risk
Medical device site pruritus
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Nodule
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Non-cardiac chest pain
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Oedema peripheral
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Peripheral swelling
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pyrexia
General disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0062 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events1 affected7 at risk
EG0092 events2 affected7 at risk
EG0100 events0 affected4 at risk
Hepatic pain
Hepatobiliary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
COVID-19
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Cellulitis
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Gingivitis
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0092 events1 affected7 at risk
EG0100 events0 affected4 at risk
Klebsiella infection
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pneumonia
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Skin infection
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Urinary tract infection
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0053 events2 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Vascular device infection
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Delayed serologic transfusion reaction
Injury, poisoning and procedural complications
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0062 events2 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0084 events2 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Amylase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0085 events2 affected7 at risk
EG0092 events1 affected7 at risk
EG0100 events0 affected4 at risk
Blood bilirubin increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Blood creatinine increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected3 at risk
EG0042 events2 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Lipase increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Platelet count decreased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Urine analysis abnormal
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Weight decreased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
White blood cell count increased
Investigations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0092 events2 affected7 at risk
EG0100 events0 affected4 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0094 events1 affected7 at risk
EG0100 events0 affected4 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0102 events2 affected4 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0052 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0101 events1 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events2 affected9 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0092 events2 affected7 at risk
EG0100 events0 affected4 at risk
Amnesia
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Aphasia
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Dizziness
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Dysgeusia
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Headache
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Paraesthesia
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Sciatica
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Tremor
Nervous system disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Anxiety
Psychiatric disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Confusional state
Psychiatric disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Insomnia
Psychiatric disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0092 events2 affected7 at risk
EG0101 events1 affected4 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Chromaturia
Renal and urinary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Dysuria
Renal and urinary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Urinary retention
Renal and urinary disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Breast pain
Reproductive system and breast disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Oedema genital
Reproductive system and breast disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0032 events2 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0083 events3 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0062 events2 affected4 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Ingrown hair
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected4 at risk
Pemphigoid
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
EG0085 events2 affected7 at risk
EG0094 events2 affected7 at risk
EG0100 events0 affected4 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected9 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0085 events3 affected7 at risk
EG0094 events3 affected7 at risk
EG0100 events0 affected4 at risk
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Flushing
Vascular disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events1 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hot flush
Vascular disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected4 at risk
Hypotension
Vascular disorders
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected11 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected4 at risk
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
5
BG0056
BG0061
BG0076
BG0082
BG0092
BG0103
BG01128
2
BG0048
BG0059
BG0064
BG0078
BG0085
BG0094
BG0106
BG01149
0
BG0041
BG0050
BG0060
BG0070
BG0081
BG0090
BG0101
BG0113
1
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
BG0102
BG0115
0
BG0040
BG0052
BG0060
BG0070
BG0081
BG0091
BG0102
BG0116
0
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
0
BG0040
BG0051
BG0060
BG0070
BG0081
BG0090
BG0100
BG0112
2
BG0047
BG0058
BG0064
BG0078
BG0085
BG0092
BG0103
BG01144
3
OG0049
OG00511
OG0064
OG0078
OG0087
OG0094
OG0107
3
OG0049
OG00511
OG0063
OG0077
OG0087
OG0094
OG0107
Treatment-related TEAEs
Title
Measurements
OG0001
OG0010
OG0022
OG0032
OG0047
OG0056
OG0060
OG0071
OG0086
OG0091
OG0104
3
OG0049
OG00511
OG0064
OG0078
OG0087
OG0094
OG0107
1
OG0044
OG0054
OG0062
OG0072
OG0085
OG0094
OG0105
TEAEs Leading to Death
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0081
OG0091
OG0100
3
OG0049
OG00511
OG0064
OG0078
OG0087
OG0094
OG0107
1
OG0042
OG0053
OG0062
OG0072
OG0080
OG0091
OG0104
3
OG0049
OG00511
OG0064
OG0078
OG0087
OG0094
OG0107
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
3
OG0049
OG00511
OG0064
OG0078
OG0087
OG0094
OG0107
0
OG0040
OG0052
OG0060
OG0070
OG0081
OG0090
OG0102
3
OG0049
OG00511
OG0064
OG0078
OG0087
OG0094
OG0107
1
OG0043
OG0053
OG0060
OG0073
OG0081
OG0090
OG0101
3
OG0047
OG00510
OG0062
OG0078
OG0085
OG0092
OG0102
2950
± 26.1
OG0039640± 9.4
OG00430100± 16.2
OG00550000± 27.4
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG00796800± 26.4
OG00810600± 10.2
OG009NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG010NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
3
OG0049
OG00511
OG0063
OG0078
OG0086
OG0092
OG0103
4000
± 55.4
OG00313800± 34.9
OG00437400± 20.0
OG00576600± 39.5
OG006153000± 40.1
OG007148000± 35.8
OG00815100± 35.8
OG009NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG01070800± 43.4
3
OG0049
OG00511
OG0063
OG0078
OG0086
OG0092
OG0103
2950
± 26.3
OG0039600± 5.3
OG00428100± 16.1
OG00550100± 25.8
OG00689300± 22.7
OG00794500± 23.4
OG0089760± 18.3
OG009NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG01050700± 27.3
3
OG0049
OG00511
OG0064
OG0078
OG0086
OG0093
OG0103
20.9
± 11.5
OG00365.5± 15.4
OG004217± 24.5
OG005329± 29.9
OG006523± 21.4
OG007475± 16.0
OG00865.1± 9.1
OG009199± 8.3
OG010335± 17.9
3
OG0049
OG00511
OG0064
OG0078
OG0086
OG0093
OG0103
20.9
± 11.5
OG00365.5± 15.4
OG004217± 24.5
OG005329± 29.9
OG006523± 21.4
OG007475± 16.0
OG00865.1± 9.1
OG009199± 8.3
OG010335± 17.9
3
OG0049
OG00511
OG0064
OG0078
OG0086
OG0093
OG0103
1.50
(1.02 to 4.10)
OG0031.12(1.00 to 1.63)
OG0041.28(1.00 to 4.02)
OG0051.25(1.00 to 5.37)
OG0064.12(1.33 to 5.42)
OG0071.31(1.05 to 4.02)
OG0082.73(1.00 to 4.17)
OG0094.0(1.17 to 4.05)
OG0104.0(1.05 to 4.07)
3
OG0049
OG00511
OG0063
OG0078
OG0087
OG0092
OG0105
144
± 101.6
OG003182± 71.4
OG004166± 26.9
OG005216± 37.3
OG006265± 27.6
OG007351± 25.2
OG008206± 39.7
OG009NA± NAGeometric Mean and Geometric Coefficient of Variation (GeoCV) not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.
OG010178± 26.3
3
OG0049
OG00511
OG0063
OG0078
OG0087
OG0092
OG0105
0.00618
± 0.005486
OG0030.00433± 0.002539
OG0040.00433± 0.001301
OG0050.00340± 0.001169
OG0060.00268± 0.0007438
OG0070.00203± 0.0005595
OG0080.00356± 0.001246
OG009NA± NAMean and Standard Deviation not calculated as number of participants analyzed (N) less than (\<=) 2 per arm, per SAP-defined criteria requiring more than (\>2) participants for descriptive statistics.