Sym013 (Pan-HER) in Patients With Advanced Epithelial Mal... | NCT02906670 | Trialant
NCT02906670
Sponsor
Symphogen A/S
Status
Terminated
Last Update Posted
Aug 28, 2020Actual
Enrollment
32Actual
Phase
Phase 1Phase 2
Conditions
Oncology
Interventions
Sym013
Countries
United States
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
NCT02906670
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
Sym013-01
Secondary IDs
Not provided
Brief Title
Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies
Official Title
An Open-label, Multicenter, Phase 1a/2a Trial Investigating the Safety, Tolerability and Antitumor Activity of Multiple Doses of Sym013, a mAb Mixture Targeting EGFR, HER2 and HER3, in Patients With Advanced Epithelial Malignancies
Acronym
Not provided
Organization
Symphogen A/SINDUSTRY
Status Module
Record Verification Date
Aug 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business reasons
Expanded Access Info
No
Start Date
Nov 1, 2016Actual
Primary Completion Date
Jun 2019Actual
Completion Date
Jun 2019Actual
First Submitted Date
Sep 8, 2016
First Submission Date that Met QC Criteria
Sep 14, 2016
First Posted Date
Sep 20, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 7, 2020
Results First Submitted that Met QC Criteria
Aug 27, 2020
Results First Posted Date
Aug 28, 2020Actual
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
Aug 27, 2020
Last Update Posted Date
Aug 28, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Symphogen A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study is to see if Sym013 is safe and effective for patients with advanced epithelial malignancies without available therapeutic options.
Detailed Description
This is an open-label, multicenter trial composed of 2 parts in which Sym013 will be evaluated when administered by intravenous infusion in patients with advanced epithelial malignancies without available therapeutic options.
Part 1 is a Phase 1a dose-escalation evaluating weekly (Q1W) and every second week (Q2W) schedules of administration in separate dose-escalation cohorts to determine the recommended phase 2 dose (RP2D) and regimen of Sym013.
Part 2 is a Phase 2a dose-expansion at the RP2D and regimen. Four (4) dose-expansion cohorts will be evaluated in this part of the trial and will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets. Patients will be entered, depending upon either a defined molecular profile or profiles, or their underlying malignancy, to 1 of 4 corresponding expansion cohorts: Cohort A, Cohort B, Cohort C, or Cohort D.
Conditions Module
Conditions
Oncology
Keywords
Epithelial malignancies
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
32Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1 mg/kg Q1W
Experimental
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Drug: Sym013
2 mg/kg Q1W
Experimental
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Drug: Sym013
4 mg/kg Q1W
Experimental
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Drug: Sym013
6 mg/kg Q1W + Prophylaxis
Experimental
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Drug: Sym013
9 mg/kg Q1W + Prophylaxis
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sym013
Drug
Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.
Assess the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of Sym013 administration.
24 months
Part 2: Evaluate the Antitumor Effect of Sym013 When Administered at the RP2D and Regimen to Patients.
No data were collected for this Outcome Measures as Part 2 of the trial was never initiated.
24 months
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Determine the RP2D and Regimen of Sym013.
No RP2D or regimen of Sym013 was determined as the trial was prematurely terminated
24 months
Parts 1 and 2: Evaluate the Immunogenicity of Sym013.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Main inclusion criteria all patients, Part 1 and Part 2:
Male or female, at least 18 years of age at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Life expectancy >3 months assessed during Screening
Documented (histologically- or cytologically-proven) epithelial malignancy that is locally advanced or metastatic, having received all therapy known to confer clinical benefit
Additional inclusion criteria applicable to Part 2 ONLY:
Epithelial malignancy (tumor types to be determined), measurable according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to C1/D1
Willingness to undergo a pre-and post-dosing biopsy (total of 2 biopsies) from primary or metastatic tumor site(s) considered safe for biopsy
Exclusion Criteria:
Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives (whichever is shortest) prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1.
Part 2 ONLY: Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following radiotherapy
Immunosuppressive or systemic hormonal therapy (>10 mg daily prednisone equivalent) within 2 weeks prior to C1/D1 with exceptions
Use of hematopoietic growth factors within 2 weeks prior to C1/D1
Active second malignancy or history of another malignancy within the last 3 years, with allowed exceptions
Central nervous system (CNS) malignancies including:
Primary malignancies of the CNS
Known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS metastatic involvement for which treatment is required
Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy
Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure
Non-healing wounds on any part of the body
Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to C1/D1, unless adequately treated and stable
Active uncontrolled bleeding or a known bleeding diathesis
Significant gastrointestinal abnormalities
Significant cardiovascular disease or condition
Abnormal hematologic, renal or hepatic function
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
Jordan Berlin, MD
Vanderbilt University Medical Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
South Texas Accelerated Research Therapeutics, LLC
Berlin J, Tolcher AW, Ding C, Whisenant JG, Horak ID, Wood DL, Nadler PI, Hansen UH, Lantto J, Skartved NJO, Pedersen MW, Patnaik A. First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies. Invest New Drugs. 2022 Jun;40(3):586-595. doi: 10.1007/s10637-022-01217-7. Epub 2022 Feb 3.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Patients were only recruited for Part 1; a recommended Phase 2 dose (RP2D) could not be established and the part 2 cohorts A, B, C and were not initiated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
FG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
FG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
FG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
FG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
FG005
6 mg/kg Q2W
Phase 1a: Patients are administered 6 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
FG006
9 mg/kg Q2W
Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
FG007
9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
FG008
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered 12 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
FG009
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered 15 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Periods
Title
Milestones
Reasons Not Completed
Cohort 1, QW
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Radiological Progression
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort 2, QW
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Cohort 3, QW
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG003
Cohort 4, Q2W
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort 5, Q2W
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort 5P, Q2W
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort 6P, Q2W
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort 4P, QW
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort 7P, Q2W
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort 5P, QW
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
BG001
2 mg/kg Q1W
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, Categorical
Count of Participants
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 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.
Assess the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of Sym013 administration.
Pts 84001-007 (9mg/kg Q2W) and 84002-01 (12 mg/kg +P Q2W) did not complete C1 and hence is not considered eligible for DLT assessments.
Posted
Count of Participants
Participants
24 months
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG001
2 mg/kg Q1W
Adverse Events Module
Frequency Threshold
0
Time Frame
All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
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
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Drug: Sym013
6 mg/kg Q2W
Experimental
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Drug: Sym013
9 mg/kg Q2W
Experimental
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Drug: Sym013
9 mg/kg Q2W + Prophylaxis
Experimental
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Drug: Sym013
12 mg/kg Q2W + Prophylaxis
Experimental
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Drug: Sym013
15 mg/kg Q2W + Prophylaxis
Experimental
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Drug: Sym013
Phase 2a Dose-Expansion Cohort A
Experimental
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Drug: Sym013
Phase 2a Dose-Expansion Cohort B
Experimental
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Drug: Sym013
Phase 2a Dose-Expansion Cohort C
Experimental
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Drug: Sym013
Phase 2a Dose-Expansion Cohort D
Experimental
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Drug: Sym013
1 mg/kg Q1W
12 mg/kg Q2W + Prophylaxis
15 mg/kg Q2W + Prophylaxis
2 mg/kg Q1W
4 mg/kg Q1W
6 mg/kg Q1W + Prophylaxis
6 mg/kg Q2W
9 mg/kg Q1W + Prophylaxis
9 mg/kg Q2W
9 mg/kg Q2W + Prophylaxis
Phase 2a Dose-Expansion Cohort A
Phase 2a Dose-Expansion Cohort B
Phase 2a Dose-Expansion Cohort C
Phase 2a Dose-Expansion Cohort D
Pan-HER
Serum sampling to assess the potential for anti-drug antibody (ADA) formation was not analyzed as the trial was prematurely terminated
42 months
Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).
Will be estimated using non-compartmental methods and actual time points.
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.
Will be derived from observed data.
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).
Will be derived from observed data. End of infusion was defined as time zero (0)
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
Parts 1 and 2: Elimination Half-life (T½).
Will be estimated using non-compartmental methods and actual time points
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
Parts 1 and 2: Clearance (CL).
Will be estimated using non-compartmental methods and actual time points.
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
San Antonio
Texas
78229
United States
NEXT Oncology
San Antonio
Texas
78240
United States
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lack of Clinical Benefit
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Clinical Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0050 subjects
FG0067 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0067 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Clinical Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Clinical Benefit
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Clinical Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
3 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
More than 3 Dose-reduction of Pan-Her
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Radiological Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
BG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
BG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
BG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
BG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
BG006
9 mg/kg Q2W
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
BG007
9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
BG008
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
BG009
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
BG010
Total
Total of all reporting groups
1
BG0011
BG0024
BG0033
BG0043
BG0053
BG0067
BG0073
BG0084
BG0093
BG01032
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Between 18 and 65 years
BG0001
BG0011
BG0023
BG0032
BG004
>=65 years
BG0000
BG0010
BG0021
BG0031
BG004
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00054.0
BG00157.0
BG00259.3± 9.74
BG00358.0± 6.08
BG00463.3± 11.24
BG00556.0± 12.12
BG00651.6± 11.59
BG00767.3± 10.02
BG00863.8± 13.77
BG00959.7± 8.02
BG01058.7± 10.48
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0021
BG0030
BG0042
BG0051
BG0063
BG0073
BG0081
BG0091
BG01012
Male
BG0001
BG0011
BG0023
BG0033
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0021
BG0032
BG0040
BG0050
BG0061
BG0071
BG0080
BG0091
BG0106
Not Hispanic or Latino
BG0001
BG0011
BG0023
BG0031
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Asian
BG0000
BG0010
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0001
BG0011
BG0023
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0001
BG0011
BG0024
BG0033
BG0043
BG0053
BG0067
BG0073
BG0084
BG0093
BG01032
Body Mass Index (BMI)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00036.2
BG00126.30
BG00227.45± 7.543
BG00326.00± 2.893
BG00426.93± 2.409
BG00527.13± 2.122
BG00626.84± 5.828
BG00724.03± 6.584
BG00821.98± 1.981
BG00931.83± 9.178
BG01026.75± 5.575
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG006
9 mg/kg Q2W
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG007
9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG008
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG009
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0033
OG0043
OG0053
OG0066
OG0073
OG0083
OG0093
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0070
OG0080
OG0092
Primary
Part 2: Evaluate the Antitumor Effect of Sym013 When Administered at the RP2D and Regimen to Patients.
No data were collected for this Outcome Measures as Part 2 of the trial was never initiated.
The outcome measure was not analyzed, because the study was stopped during Part 1 of the study before initiating Part 2 of the study for business reasons. No data were collected in Part 2
Posted
24 months
ID
Title
Description
OG000
Phase 2a Dose-Expansion Cohort A
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG001
Phase 2a Dose-Expansion Cohort B
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG002
Phase 2a Dose-Expansion Cohort C
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG003
Phase 2a Dose-Expansion Cohort D
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 1: Determine the RP2D and Regimen of Sym013.
No RP2D or regimen of Sym013 was determined as the trial was prematurely terminated
No data were collected for this Outcome Measure for Parts 1 and 2
Posted
24 months
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG006
9 mg/kg Q2W
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG007
9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG008
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG009
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG010
Phase 2a Dose-Expansion Cohort A
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG011
Phase 2a Dose-Expansion Cohort B
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG012
Phase 2a Dose-Expansion Cohort C
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG013
Phase 2a Dose-Expansion Cohort D
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Parts 1 and 2: Evaluate the Immunogenicity of Sym013.
Serum sampling to assess the potential for anti-drug antibody (ADA) formation was not analyzed as the trial was prematurely terminated
No data were collected for this Outcome Measure for Parts 1 and 2
Posted
42 months
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG006
9 mg/kg Q2W
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG007
9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG008
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG009
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG010
Phase 2a Dose-Expansion Cohort A
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG011
Phase 2a Dose-Expansion Cohort B
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG012
Phase 2a Dose-Expansion Cohort C
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG013
Phase 2a Dose-Expansion Cohort D
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).
Will be estimated using non-compartmental methods and actual time points.
No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile
Posted
Mean
Standard Deviation
h*µg/mL
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG006
9 mg/kg Q2W and 9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 (+ premedication) every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG007
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG008
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG009
Phase 2a Dose-Expansion Cohort A
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG010
Phase 2a Dose-Expansion Cohort B
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG011
Phase 2a Dose-Expansion Cohort C
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG012
Phase 2a Dose-Expansion Cohort D
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Hu1277, 1st dose (1st PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
Secondary
Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.
Will be derived from observed data.
No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile
Posted
Mean
Standard Deviation
µg/mL
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
OG006
9 mg/kg Q2W and 9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 (+ premedication) every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG007
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
OG008
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Hu1277, 1st dose (1st PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
Secondary
Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).
Will be derived from observed data. End of infusion was defined as time zero (0)
No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile
Posted
Mean
Standard Deviation
h
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG006
9 mg/kg Q2W and 9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 (+ premedication) every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG007
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG008
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG009
Phase 2a Dose-Expansion Cohort A
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG010
Phase 2a Dose-Expansion Cohort B
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG011
Phase 2a Dose-Expansion Cohort C
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG012
Phase 2a Dose-Expansion Cohort D
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Hu1277, 1st dose (1st PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
Secondary
Parts 1 and 2: Elimination Half-life (T½).
Will be estimated using non-compartmental methods and actual time points
No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile
Posted
Mean
Standard Deviation
H
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG006
9 mg/kg Q2W and 9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 (+ premedication) every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG007
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG008
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG009
Phase 2a Dose-Expansion Cohort A
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG010
Phase 2a Dose-Expansion Cohort B
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG011
Phase 2a Dose-Expansion Cohort C
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG012
Phase 2a Dose-Expansion Cohort D
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Hu1277, 1st dose (1st PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
Secondary
Parts 1 and 2: Clearance (CL).
Will be estimated using non-compartmental methods and actual time points.
No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile
Posted
Mean
Standard Deviation
mL/h/kg
0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W
ID
Title
Description
OG000
1 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG006
9 mg/kg Q2W and 9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 (+ premedication) every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG007
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG008
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG009
Phase 2a Dose-Expansion Cohort A
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG010
Phase 2a Dose-Expansion Cohort B
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG011
Phase 2a Dose-Expansion Cohort C
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
OG012
Phase 2a Dose-Expansion Cohort D
Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.
Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Hu1277, 1st dose (1st PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
0
1
0
1
1
1
EG001
2 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
0
1
0
1
1
1
EG002
4 mg/kg Q1W
Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
0
4
0
4
4
4
EG003
6 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
0
3
0
3
3
3
EG004
9 mg/kg Q1W + Prophylaxis
Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
0
3
1
3
3
3
EG005
6 mg/kg Q2W
Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
1
3
1
3
3
3
EG006
9 mg/kg Q2W
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
0
7
3
7
7
7
EG007
9 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
0
3
1
3
3
3
EG008
12 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
0
4
2
4
4
4
EG009
15 mg/kg Q2W + Prophylaxis
Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
0
3
2
7
3
3
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0094 events2 affected7 at risk
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected7 at risk
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected7 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected7 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected7 at risk
Stomatitis
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected7 at risk
Pericardial effusion
Cardiac disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected7 at risk
Sepsis
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected7 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected7 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected7 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected7 at risk
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected7 at risk
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG00210 events4 affected4 at risk
EG0032 events2 affected3 at risk
EG0049 events2 affected3 at risk
EG0054 events2 affected3 at risk
EG0069 events6 affected7 at risk
EG0072 events1 affected3 at risk
EG0085 events3 affected4 at risk
EG0093 events2 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0024 events3 affected4 at risk
EG0031 events1 affected3 at risk
EG0042 events1 affected3 at risk
EG0054 events2 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0094 events2 affected3 at risk
Nausea
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0093 events3 affected3 at risk
Vomiting
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0054 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events2 affected3 at risk
Oral pain
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0072 events1 affected3 at risk
EG0083 events1 affected4 at risk
EG0091 events1 affected3 at risk
Constipation
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Anal inflammation
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected3 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Cheilitis
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Flatulence
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0093 events1 affected3 at risk
Lip pain
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events1 affected3 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events1 affected3 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Glossitis
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Lip oedema
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Proctalgia
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Dysphagai
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Oesophageal spasm
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0025 events2 affected4 at risk
EG0034 events3 affected3 at risk
EG0047 events3 affected3 at risk
EG0056 events2 affected3 at risk
EG0068 events5 affected7 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
EG0097 events2 affected3 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected4 at risk
EG0090 events0 affected3 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0023 events1 affected4 at risk
EG0032 events2 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0093 events1 affected3 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Skin oedema
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0053 events2 affected3 at risk
EG0065 events3 affected7 at risk
EG0073 events1 affected3 at risk
EG0083 events3 affected4 at risk
EG0094 events2 affected3 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events1 affected3 at risk
Eyelid injury
Injury, poisoning and procedural complications
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Fall
Injury, poisoning and procedural complications
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Incision site erythema
Injury, poisoning and procedural complications
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Fatigue
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected4 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0083 events3 affected4 at risk
EG0090 events0 affected3 at risk
Oedema peripheral
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0082 events1 affected4 at risk
EG0090 events0 affected3 at risk
Disease progression
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Early satiety
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Gait disturbance
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Localised oedema
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Malaise
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Pyrexia
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Influenza like illness
General disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Weight decreased
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected7 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Blood bilirubin increased
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0072 events2 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Aspartate aminotransferase increased
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Lymphocyte count decreased
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected4 at risk
EG0090 events0 affected3 at risk
Blood creatinine increased
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Lipase increased
Investigations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0064 events3 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events2 affected3 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0074 events1 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected4 at risk
EG0090 events0 affected3 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events1 affected3 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Muscle weakness
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected4 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected4 at risk
EG0090 events0 affected3 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Oropharyngeal
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected4 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Oral candidiasis
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Paronychia
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Eye infection
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Hordeolum
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Sepsis
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Sinusitis
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Urinary tract infection
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Tinea cruris
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (19.1)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Flushing
Vascular disorders
MedDRA (19.1)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hypotension
Vascular disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Haematoma
Vascular disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Dysgeusia
Nervous system disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Dysaesthesia
Nervous system disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Headache
Nervous system disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Dizziness
Nervous system disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Paraesthesia
Nervous system disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA (19.1)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Depression
Psychiatric disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0091 events1 affected3 at risk
Insomnia
Psychiatric disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Confusional state
Psychiatric disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Sinus tachycardia
Cardiac disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected4 at risk
EG0090 events0 affected3 at risk
Atrial fibrillation
Cardiac disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Cardiac tamponade
Cardiac disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Palpitations
Cardiac disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
Pericardial effusion
Cardiac disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0083 events1 affected4 at risk
EG0090 events0 affected3 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Dry eye
Eye disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Episcleritis
Eye disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
Periorbital
Eye disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0093 events1 affected3 at risk
Vision blurred
Eye disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Diplopia
Eye disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Renal vein thrombosis
Renal and urinary disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Middle ear inflammation
Ear and labyrinth disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
Hepatobiliary disorders
Hepatobiliary disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
1
BG0052
BG0066
BG0071
BG0081
BG0092
BG01020
2
BG0051
BG0061
BG0072
BG0083
BG0091
BG01012
1
BG0052
BG0064
BG0070
BG0083
BG0092
BG01020
3
BG0053
BG0066
BG0072
BG0084
BG0092
BG01026
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
1
BG0051
BG0060
BG0071
BG0080
BG0090
BG0103
2
BG0052
BG0066
BG0072
BG0084
BG0093
BG01027
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0061
BG0070
BG0080
BG0090
BG0101
0
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
3
OG0043
OG0053
OG00610
OG0074
OG0083
OG0090
OG0100
OG0110
OG0120
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG00122
OG002270± 43
OG003NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG004550± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG005280± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG006440± 24
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0088600± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
Hu1565, 1st dose (1st PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG001NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG002NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG003
Hu4384, 1st dose (1st PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG001NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG002750± 110
OG003
Hu4517, 1st dose (1st PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG001267
OG002880± 130
OG003
Hu5038, 1st dose (1st PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG001NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG002860± 85
OG003
Hu5082, 1st dose (1st PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG001628
OG0022900± 230
OG003
Hu1277, 3rd/4th dose (2nd PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG001NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG002NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG003
Hu1565, 3rd/4th dose (2nd PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG001NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0021300± 720
OG003
Hu4384, 3rd/4th dose (2nd PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG001NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0021600± 1000
OG003
Hu4517, 3rd/4th dose (2nd PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG001340
OG0021800± 1200
OG003
Hu5038, 3rd/4th dose (2nd PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG001NAPatient analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0021600± 870
OG003
Hu5082, 3rd/4th dose (2nd PK profile), AUC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed; not reportable due to not meeting the criteria for reporting (no apparent profile; to few data points)
OG001880
OG0022600± 740
OG003
3
OG0043
OG0053
OG00610
OG0074
OG0083
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000.78
OG0011.8
OG00210± 3.0
OG00315± 3.1
OG00423± 2.6
OG00512± 2.5
OG00620± 9.0
OG00725± 3.7
OG00866± 21
Hu1277, 1st dose (1st PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG001NAPatient analyzed; not reportable due to values below detection limit
OG002NA± NAAll patients analyzed; not reportable due to values below detection limit
OG003
Hu1565, 1st dose (1st PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0003.2
OG0014.9
OG00221± 4.3
OG003
Hu1565, 1st dose (1st PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG001NAPatient analyzed; not reportable due to values below detection limit
OG002NA± NAAll patients analyzed; not reportable due to values below detection limit
OG003
Hu4384, 1st dose (1st PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0002.5
OG0014.1
OG00216± 6.2
OG003
Hu4384, 1st dose (1st PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG0010.32
OG0020.59± 0.36
OG003
Hu4517, 1st dose (1st PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0003.0
OG0014.7
OG00217± 2.2
OG003
Hu4517, 1st dose (1st PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG0010.38
OG0020.72± 0.31
OG003
Hu5038, 1st dose (1st PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0002.9
OG0015.6
OG00216± 2.3
OG003
Hu5038, 1st dose (1st PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG001NAPatient analyzed; not reportable due to values below detection limit
OG0020.79± 0.24
OG003
Hu5082, 1st dose (1st PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0007.2
OG0019.8
OG00242± 6.5
OG003
Hu5082, 1st dose (1st PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG0010.92
OG0024.8± 0.7
OG003
Hu1277, 3rd/4th dose (2nd PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG0002.5
OG0013.0
OG00211± 1.3
OG003
Hu1277, 3rd/4th dose (2nd PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG001NAPatient analyzed; not reportable due to values below detection limit
OG002NA± NAAll patients analyzed; not reportable due to values below detection limit
OG003
Hu1565, 3rd/4th dose (2nd PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG0009.5
OG0017.0
OG00222± 3.0
OG003
Hu1565, 3rd/4th dose (2nd PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG001NAPatient analyzed; not reportable due to values below detection limit
OG0020.49± NAAll patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
OG003
Hu4384, 3rd/4th dose (2nd PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG0008.3
OG0016.1
OG00217± 2.6
OG003
Hu4384, 3rd/4th dose (2nd PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG001NAPatient analyzed; not reportable due to values below detection limit
OG0021.9± 0.8
OG003
Hu4517, 3rd/4th dose (2nd PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG0008.4
OG0017.5
OG00219± 2.5
OG003
Hu4517, 3rd/4th dose (2nd PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG0010.59
OG0022.1± 0.9
OG003
Hu5038, 3rd/4th dose (2nd PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG0007.7
OG0018.3
OG00218± 2.1
OG003
Hu5038, 3rd/4th dose (2nd PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG001NAPatient analyzed; not reportable due to values below detection limit
OG0021.9± 0.4
OG003
Hu5082, 3rd/4th dose (2nd PK profile), Cmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG00010
OG00115
OG00247± 9.6
OG003
Hu5082, 3rd/4th dose (2nd PK profile), Ctrough
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG000NAPatient analyzed; not reportable due to values below detection limit
OG0011.9
OG0027.1± 6.1
OG003
3
OG0043
OG0053
OG00610
OG0074
OG0083
OG0090
OG0100
OG0110
OG0120
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000
OG0010
OG0022.5± 1.9
OG0032.0± 2.0
OG0041.1± 1.0
OG0050.69± 1.2
OG0061.7± 1.9
OG0070.91± 1.1
OG0080.94± 1.6
Hu1565, 1st dose (1st PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000
OG0010
OG0022.5± 1.9
OG003
Hu4384, 1st dose (1st PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000
OG0010
OG0022.5± 1.9
OG003
Hu4517, 1st dose (1st PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000
OG0010
OG0022.5± 1.9
OG003
Hu5038, 1st dose (1st PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0002.0
OG0010
OG0022.5± 1.9
OG003
Hu5082, 1st dose (1st PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000
OG0010
OG0022.5± 1.9
OG003
Hu1277, 3rd/4th dose (2nd PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0007.0
OG0010
OG0020.48± 0.96
OG003
Hu1565, 3rd/4th dose (2nd PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0007.0
OG0010
OG0020± 0
OG003
Hu4384, 3rd/4th dose (2nd PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0007.0
OG0010
OG0021.0± 2.0
OG003
Hu4517, 3rd/4th dose (2nd PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0007.0
OG0010
OG0021.4± 1.8
OG003
Hu5038, 3rd/4th dose (2nd PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0007.0
OG0010
OG0020.48± 0.96
OG003
Hu5082, 3rd/4th dose (2nd PK profile), Tmax
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000
OG0010
OG0022.9± 2.4
OG003
3
OG0043
OG0053
OG00610
OG0074
OG0083
OG0090
OG0100
OG0110
OG0120
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG0018.3
OG00218± 4.1
OG00326± 6.0
OG00425± 5.8
OG00521± 9.2
OG00630± 20
OG00739± 7.2
OG00856± 18
Hu1565, 1st dose (1st PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG00020
OG00129
OG00236± 5.8
OG003
Hu4384, 1st dose (1st PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG00031
OG00150
OG00239± 5.6
OG003
Hu4517, 1st dose (1st PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG00029
OG00150
OG00239± 4.7
OG003
Hu5038, 1st dose (1st PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG00027
OG00139
OG00242± 4.0
OG003
Hu5082, 1st dose (1st PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG00153
OG00266± 7.0
OG003
Hu1277, 3rd/4th dose (2nd PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG001NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG00228± 9.6
OG003
Hu1565, 3rd/4th dose (2nd PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG00120
OG00243± 26
OG003
Hu4384, 3rd/4th dose (2nd PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG00125
OG00269± 50
OG003
Hu4517, 3rd/4th dose (2nd PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG00134
OG00277± 50
OG003
Hu5038, 3rd/4th dose (2nd PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG00120
OG00269± 40
OG003
Hu5082, 3rd/4th dose (2nd PK profile), T½
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatient analyzed, not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85)
OG00142
OG002111± 90
OG003
3
OG0043
OG0053
OG00610
OG0074
OG0083
OG0090
OG0100
OG0110
OG0120
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0019.8
OG0021.6± 0.26
OG003NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0041.8± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG0052.3± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG0062.2± 0.12
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0080.19± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
Hu1565, 1st dose (1st PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG002NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG003
Hu4384, 1st dose (1st PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0020.63± 0.092
OG003
Hu4517, 1st dose (1st PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0020.67± 0.11
OG003
Hu5038, 1st dose (1st PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0020.60± 0.059
OG003
Hu5082, 1st dose (1st PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0010.97
OG0020.42± 0.033
OG003
6Hu1277, 3rd/4th dose (2nd PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG002NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG003
Hu1565, 3rd/4th dose (2nd PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0020.79± 0.37
OG003
Hu4384, 3rd/4th dose (2nd PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0020.36± 0.16
OG003
Hu4517, 3rd/4th dose (2nd PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0010.86
OG0020.41± 0.20
OG003
Hu5038, 3rd/4th dose (2nd PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG001NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0020.37± 0.15
OG003
Hu5082, 3rd/4th dose (2nd PK profile), CL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000NAPatients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0010.69
OG0020.49± 0.14
OG003
1480
± NA
All patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG0042200± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0062900± 1100
OG0073900± 670
OG008NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
1200
± 230
OG0042100± 640
OG0051000± 310
OG0062200± 960
OG0072600± 570
OG00819000± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
1400
± 320
OG0042300± 680
OG0051200± 250
OG0062200± 690
OG0072600± 710
OG00817000± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
1200
± 280
OG0042000± 680
OG0051100± 310
OG0062000± 580
OG0072500± 1000
OG00813500± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
3900
± 1100
OG0043900± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG0054000± 1500
OG0066000± 1800
OG0078900± 3700
OG00819800± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
NA
± NA
All patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG004NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG006760± 300
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
NA
± NA
All patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0042100± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG006NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
NA
± NA
All patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG004NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0061800± 570
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
2100
± 200
OG0045600± 4600
OG0051700± 400
OG0062500± 1200
OG0073100± 870
1500
± 470
OG0044000± 3100
OG0051800± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG0062500± 1200
OG0074800± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
6800
± NA
All patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG004NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high)
OG0053800± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
OG0069900± 2600
OG0079700± NAAll patients analyzed; 1 patient fulfilled criteria for reporting; rest was not reportable due to not meeting the criteria for reporting (extrapolation per cent for AUC was to high), thus no SD
NA
± NA
All patients analyzed; not reportable due to values below detection limit
OG004NA± NAAll patients analyzed; not reportable due to values below detection limit
OG005NA± NAAll patients analyzed; not reportable due to values below detection limit
OG006NA± NAAll patients analyzed; not reportable due to values below detection limit
OG007NA± NAAll patients analyzed; not reportable due to values below detection limit
OG00816± NAAll patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
31
± 5.6
OG00444± 3.1
OG00525± 3.9
OG00643± 17
OG00748± 6.3
OG008130± 34
0.82
± NA
All patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
OG0040.85± NAAll patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
OG005NA± NAAll patients analyzed; not reportable due to values below detection limit
OG006NA± NAAll patients analyzed; not reportable due to values below detection limit
OG007NA± NAAll patients analyzed; not reportable due to values below detection limit
OG00850± NAAll patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
22
± 3.2
OG00430± 2.3
OG00516± 3.0
OG00630± 11
OG00731± 3.7
OG00892± 45
1.5
± 0.9
OG0043.3± 1.9
OG005NA± NAAll patients analyzed; not reportable due to values below detection limit
OG0060.69± 0.55
OG0071.4± NAAll patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
OG00819± 23
27
± 4.5
OG00436± 4.2
OG00520± 2.9
OG00637± 16
OG00738± 3.9
OG008110± 55
1.4
± 0.9
OG0043.0± 1.5
OG0050.43± 0.05
OG0060.66± 0.22
OG0070.61± 0.21
OG00816± 22
24
± 4.0
OG00431± 2.4
OG00518± 2.9
OG00629± 12
OG00734± 3.9
OG00887± 32
1.3
± 1.1
OG0042.8± 1.8
OG005NA± NAAll patients analyzed; not reportable due to values below detection limit
OG0060.57± 0.24
OG0070.86± 0.29
OG00815± 19
55
± 11
OG00467± 6.3
OG00539± 12
OG00677± 32
OG00789± 14
OG008160± 45
9.3
± 6.3
OG00416± 11
OG0052.5± 2.2
OG0064.3± 2.0
OG0077.8± 3.7
OG00834± 43
17
± 2.3
OG00430± 6.6
OG00513± 1.6
OG00628± 11
OG00729± 3.9
NA
± NA
All patients analyzed; not reportable due to values below detection limit
OG004NA± NAAll patients analyzed; not reportable due to values below detection limit
OG005NA± NAAll patients analyzed; not reportable due to values below detection limit
OG006NA± NAAll patients analyzed; not reportable due to values below detection limit
OG007NA± NAAll patients analyzed; not reportable due to values below detection limit
35
± 8.7
OG00454± 10
OG00529± 5.7
OG00657± 21
OG00760± 8.8
8.9
± NA
All patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
OG0042.5± 0.3
OG005NA± NAAll patients analyzed; not reportable due to values below detection limit
OG006NA± NAAll patients analyzed; not reportable due to values below detection limit
OG007NA± NAAll patients analyzed; not reportable due to values below detection limit
30
± 4.2
OG00448± 21
OG00519± 3.6
OG00637± 13
OG00734± 3.6
6.6
± 4.7
OG00410± 7.0
OG005NA± NAAll patients analyzed; not reportable due to values below detection limit
OG0061.5± 1.8
OG007NA± NAAll patients analyzed; not reportable due to values below detection limit
31
± 8.1
OG00457± 19
OG00521± 0.8
OG00643± 13
OG00745± 5.6
4.9
± 3.4
OG0045.4± 1.0
OG0050.66± 0.22
OG0061.3± 1.1
OG0070.75± 0.41
29
± 4.0
OG00444± 9.1
OG00521± 4.1
OG00642± 14
OG00741± 3.9
3.8
± 2.7
OG0044.5± 1.9
OG0050.81± NAAll patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
OG0061.4± 1.2
OG0072.6± NAAll patients analyzed; only 1 result above level of detection, rest not reportable due to values below detection limit
97
± 42
OG00482± 23
OG00551± 6.8
OG00699± 31
OG007120± 21
28
± 16
OG00431± 20
OG0056.8± 6.8
OG0066.2± 6.2
OG00722± 22
0.65
± 1.1
OG0042.3± 1.1
OG0050.69± 1.2
OG0061.9± 1.8
OG0071.4± 1.0
OG0082.2± 1.9
0.65
± 1.1
OG0042.3± 1.1
OG0050± 0
OG0063.1± 5.4
OG0071.3± 0.89
OG0081.2± 2.1
2.0
± 2.0
OG0041.1± 0.97
OG0050± 0
OG0061.3± 1.1
OG0071.0± 1.1
OG0080± 0
2.0
± 2.0
OG0041.1± 0.97
OG0050± 0
OG0061.4± 1.3
OG0071.0± 1.2
OG0081.2± 2.1
0.65
± 1.1
OG0041.1± 0.97
OG0050.97± 1.2
OG0061.1± 1.2
OG0070.52± 1.0
OG0086.4± 11
0
± 0
OG0041.3± 2.3
OG0050.97± 1.4
OG0060.94± 1.0
OG0070± 0
0
± 0
OG0042.5± 2.2
OG0050.67± 1.4
OG0061.5± 2.0
OG0071.7± 2.4
0
± 0
OG0042.5± 2.2
OG0050.97± 1.4
OG0061.2± 2.1
OG0070± 0
1.3
± 2.3
OG0041.3± 2.3
OG0050.97± 1.4
OG0060.91± 1.5
OG0070± 0
0
± 0
OG0041.3± 2.3
OG0050.97± 1.4
OG0060.94± 1.0
OG0070± 0
1.9
± 2.0
OG0042.5± 2.2
OG0050.97± 1.4
OG0064.0± 8.3
OG0070.95± 1.3
29
± 2.4
OG00433± 10
OG00535± 5.0
OG00645± 14
OG00752± 8.2
OG00866± 24
51
± 7.9
OG00462± 12
OG00547± 16
OG00656± 19
OG00773± 13
OG00892± 48
43
± 5.0
OG00456± 9.8
OG00559± 18
OG00654± 15
OG00755± 11
OG00873± 32
42
± 6.5
OG00455± 11
OG00550± 16
OG00651± 12
OG00754± 23
OG00878± 44
83
± 30
OG00496± 33
OG00590± 33
OG00696± 29
OG00797± 34
OG00893± 62
37
± 1.5
OG00435± 7.7
OG00527± 5.5
OG00626± 7
OG00731± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85); thus no SD
50
± 22
OG00443± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85); thus no SD
OG00539± 3.6
OG00639± 8.3
OG00748± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85); thus no SD
94
± 25
OG004152± 105
OG00544± 3.7
OG00684± 49
OG00748± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (to few data points available, time span for lambda Z to short or R2 \< 0.85); thus no SD
64
± 21
OG00485± 27
OG00570± 3.0
OG00679± 35
OG00761± 7.4
62
± 11
OG00477± 28
OG00559± 22
OG00678± 41
OG00764± 35
137
± 73
OG004175± 71
OG005119± 54
OG006103± 30
OG007177± 122
0.82
± NA
All patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG0040.82± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0060.72± 0.31
OG0070.64± 0.11
OG008NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
0.6
± 0.12
OG0040.53± 0.19
OG0050.72± 0.19
OG0060.59± 0.31
OG0070.55± 0.12
OG0080.093± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
0.64
± 0.15
OG0040.62± 0.22
OG0050.77± 0.15
OG0060.67± 0.29
OG0070.69± 0.15
OG0080.13± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
0.68
± 0.17
OG0040.62± 0.26
OG0050.74± 0.18
OG0060.64± 0.21
OG0070.68± 0.24
OG0080.14± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
0.49
± 0.14
OG0040.70± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG0050.50± 0.17
OG0060.49± 0.13
OG0070.46± 0.17
OG0080.23± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
NA
± NA
All patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG004NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0061.4± 0.54
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
NA
± NA
All patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0040.86± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG006NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
NA
± NA
All patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG004NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG005NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0060.63± 0.20
OG007NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
0.42
± 0.041
OG0040.35± 0.29
OG0050.54± 0.13
OG0060.62± 0.29
OG0070.59± 0.17
0.55
± 0.18
OG0040.41± 0.31
OG0050.42± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG0060.55± 0.25
OG0070.32± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
0.27
± NA
All patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG004NA± NAAll patients analyzed; not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high)
OG0050.48± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD
OG0060.29± 0.08
OG0070.38± NAAll patients analyzed; only 1 patient fulfilled criteria for reporting, rest not reportable due to not meeting the criteria for reporting (parameter derived from AUC and extrapolation per cent for AUC was to high); thus no SD