A Study to Evaluate the Safety and Tolerability of RO7296... | NCT04642365 | Trialant
NCT04642365
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
May 21, 2025Actual
Enrollment
49Actual
Phase
Phase 1
Conditions
Solid Tumors
Interventions
RO7296682
Atezolizumab
Countries
United States
Australia
Belgium
Canada
Denmark
Spain
Protocol Section
Identification Module
NCT ID
NCT04642365
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP42595
Secondary IDs
ID
Type
Description
Link
2020-003164-82
EudraCT Number
Brief Title
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
Official Title
An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The sponsor decided to terminate the study early, due to recruitment challenges for Part II and, based on the totality of data generated with a low likelihood of achieving the targeted efficacy, to open Part III.
Expanded Access Info
No
Start Date
Jan 4, 2021Actual
Primary Completion Date
Jan 4, 2024Actual
Completion Date
Jan 4, 2024Actual
First Submitted Date
Nov 23, 2020
First Submission Date that Met QC Criteria
Nov 23, 2020
First Posted Date
Nov 24, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jan 2, 2025
Results First Submitted that Met QC Criteria
May 6, 2025
Results First Posted Date
May 21, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 6, 2025
Last Update Posted Date
May 21, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
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 study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Keywords
RG6292
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
49Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part I
Experimental
Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.
Drug: RO7296682
Drug: Atezolizumab
Part II
Experimental
Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab.
Drug: RO7296682
Drug: Atezolizumab
Part III (Exploratory)
Experimental
Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I.
Drug: RO7296682
Drug: Atezolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7296682
Drug
RO7296682 will be administered as per the schedules specified in the respective arms.
Part I
Part II
Part III (Exploratory)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
From Day 1 up to the end of safety follow-up (up to 28.5 months)
Part 2: Number of Participants With AEs
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
From Day 1 up to the end of safety follow-up (up to 9.3 months)
Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following toxicities related to RO7296682 and atezolizumab that occurs during the DLT assessment window and not attributable to the underlying disease or an intercurrent illness: Any Grade ≥ 3 hematologic toxicity; Any Grade ≥ 3 non-hematologic toxicity; any other RO7296682-related toxicity considered significant enough to qualify as a DLT in the opinion of the Investigator and after discussion with the Sponsor.
From Cycle 1 Day 1 up Cycle 2 Day 8 (1 Cycle = 21 days)
Part 2: Objective Response Rate (ORR)
ORR was determined as the percentage of participants with an overall response (OR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: ORR
ORR was determined as the percentage of participants with an OR of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.
Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.
Measurable disease according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Able to provide the most recent archival tumor tissue samples.
Adequate cardiovascular, haematological, liver and renal function.
Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.
Exclusion Criteria:
Pregnancy, lactation, or breastfeeding.
Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
Participants with another invasive malignancy in the last two years.
Participants with known active or uncontrolled infection.
Positive HIV test at screening.
Positive for Hepatitis B and C.
Vaccination with live vaccines within 28 days prior to C1D1.
Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion.
Participants with wound healing complications.
Dementia or altered mental status that would prohibit informed consent.
History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
Active or history of autoimmune disease or immune deficiency.
Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).
Participants with advanced and/or metastatic non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), esophageal cancer (EsC), triple-negative breast cancer (TNBC), and ovarian cancer (OvCa) who progressed on all standard therapies, were intolerant to standard of care (SoC), and/or were non-amenable to SoC/for whom SoC did not exist were enrolled in Part 1 cohorts.
Recruitment Details
A total of 49 participants took part in the study across 10 investigative sites in 6 countries. This study was planned to be conducted in 3 parts. Part 1 (Dose-escalation): ascending doses of RO7296682 + fixed dose of atezolizumab, Part 2 (Dose expansion): fixed dose of RO7296682 + atezolizumab and Part 3 (Exploratory). Part 2 was prematurely terminated and Part 3 was not opened for enrollment due to study termination.
Participants received RO7296682, 0.3 milligrams (mg) as an intravenous (IV) infusion in combination with atezolizumab, 1200 mg, as an IV infusion every 3 week (Q3W) for a maximum of 13.2 months.
Atezolizumab will be administered as per the schedules specified in the respective arms.
Part I
Part II
Part III (Exploratory)
Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
From Day 1 up to end of safety follow-up (up to 28.5 months)
Part 1 and 2: Disease Control Rate (DCR)
DCR was determined as the rate of participants with an OR of either CR, PR, or stable disease (SD) rate as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off to the nearest decimal point.
Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Duration of Response (DoR)
DOR was calculated for participants who had a best OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD/death (within 30 days from last treatment) were censored on the last day of tumor assessment. Participants without post-baseline (PB) or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.
Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Progression-Free Survival (PFS)
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD (per RECIST v1.1) or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD or death (within 30 days from last treatment) were censored at the last day of tumor assessment. Participants without PB or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.
Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up).
Part 1: From Day 1 up to end of survival follow-up (36 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Area Under the Curve From Time of Dosing to the Last Timepoint at the End of the Dosing Period (AUClast) of RO7296682
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Maximum Concentration (Cmax) of RO7296682
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Time of Maximum Concentration (Tmax) of RO7296682
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Volume of Distribution at Steady State Conditions (Vss) of RO7296682
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Half-life (t~1/2) of RO7296682
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1: Serum Concentration of Atezolizumab
1 Cycle = 21 days.
Predose on Day 1 of Cycles 1 to 9, 12, 14, and 17; End of infusion (EOI) on Day 1 of Cycles 1 and 4; end of study/early discontinuation (up to 28.5 months)
Part 1 and 2: Number of Participants With Treatment-induced Changes in T Regulatory C Ells (Treg) Levels in Blood and/or Tumor as Compared to Baseline
Treg depletion was defined as a reduction to 25% of baseline. As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.
Baseline up to 28 days post last dose (up to 24.9 months)
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline
As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.
Cycle 1 Day 1 (end of infusion [EOI]); Cycle 1 Day 4 (72 hours post dose); Cycle 1 Day 8 (168 hours post dose); Cycle 1 Day 15 (336 hours post dose)
Melbourne
Victoria
3000
Australia
Cliniques Universitaires St-Luc
Brussels
1200
Belgium
BC Cancer Agency - Vancouver
Vancouver
British Columbia
V5Z 4E6
Canada
The Ottawa Hospital Cancer Centre
Ottawa
Ontario
K2H 6C2
Canada
Princess Margaret Cancer Centre
Toronto
Ontario
M5G 2M9
Canada
Rigshospitalet
København Ø
2100
Denmark
Clinica Universitaria de Navarra
Pamplona
Navarre
31008
Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona
08035
Spain
Hospital Clinico Universitario de Valencia
Valencia
46010
Spain
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
FG0006 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
FG0047 subjects
FG0056 subjects
FG0067 subjects
FG0073 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0006 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
FG0046 subjects
FG0056 subjects
FG0067 subjects
FG0073 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0012 subjects
FG0024 subjects
FG0035 subjects
FG0045 subjects
FG0053 subjects
FG0062 subjects
FG0071 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Study Terminated By Sponsor
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Symptomatic Deterioration
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0027
BG0037
BG0047
BG0056
BG0067
BG0073
BG00849
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.5± 12.4
BG00161.7± 10.5
BG00262.6± 10.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
From Day 1 up to the end of safety follow-up (up to 28.5 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0016
OG0027
OG003
Primary
Part 2: Number of Participants With AEs
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
From Day 1 up to the end of safety follow-up (up to 9.3 months)
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Units
Counts
Participants
OG000
Primary
Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following toxicities related to RO7296682 and atezolizumab that occurs during the DLT assessment window and not attributable to the underlying disease or an intercurrent illness: Any Grade ≥ 3 hematologic toxicity; Any Grade ≥ 3 non-hematologic toxicity; any other RO7296682-related toxicity considered significant enough to qualify as a DLT in the opinion of the Investigator and after discussion with the Sponsor.
DLT evaluable population included participants who completed the DLT period with two administrations of RO7296682/atezolizumab without DLT, or participants reported with a DLT.
Posted
Count of Participants
Participants
From Cycle 1 Day 1 up Cycle 2 Day 8 (1 Cycle = 21 days)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
ORR was determined as the percentage of participants with an overall response (OR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.
Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.
Posted
Number
95% Confidence Interval
percentage of participants
Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Secondary
Part 1: ORR
ORR was determined as the percentage of participants with an OR of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.
Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.
Posted
Number
95% Confidence Interval
percentage of participants
From Day 1 up to end of safety follow-up (up to 28.5 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Secondary
Part 1 and 2: Disease Control Rate (DCR)
DCR was determined as the rate of participants with an OR of either CR, PR, or stable disease (SD) rate as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off to the nearest decimal point.
Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.
Posted
Number
95% Confidence Interval
percentage of participants
Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Secondary
Part 1 and 2: Duration of Response (DoR)
DOR was calculated for participants who had a best OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD/death (within 30 days from last treatment) were censored on the last day of tumor assessment. Participants without post-baseline (PB) or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.
Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.
Posted
Median
Full Range
days
Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Secondary
Part 1 and 2: Progression-Free Survival (PFS)
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD (per RECIST v1.1) or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD or death (within 30 days from last treatment) were censored at the last day of tumor assessment. Participants without PB or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.
Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable. Overall number analyzed is the number of participants with data available for analysis.
Posted
Median
95% Confidence Interval
days
Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
OG001
Secondary
Part 1 and 2: Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up).
Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable. Overall number analyzed is the number of participants with data available for analysis.
Posted
Median
95% Confidence Interval
days
Part 1: From Day 1 up to end of survival follow-up (36 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Secondary
Part 1 and 2: Area Under the Curve From Time of Dosing to the Last Timepoint at the End of the Dosing Period (AUClast) of RO7296682
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*micrograms/milliliters (h*μg/mL)
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.
Secondary
Part 1 and 2: Maximum Concentration (Cmax) of RO7296682
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms/milliliters (μg/mL)
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.
Secondary
Part 1 and 2: Time of Maximum Concentration (Tmax) of RO7296682
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Median
Full Range
hours
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.
OG003
Secondary
Part 1 and 2: Volume of Distribution at Steady State Conditions (Vss) of RO7296682
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
Litre (L)
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.
Secondary
Part 1 and 2: Half-life (t~1/2) of RO7296682
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
days
Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.
Secondary
Part 1: Serum Concentration of Atezolizumab
1 Cycle = 21 days.
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose on Day 1 of Cycles 1 to 9, 12, 14, and 17; End of infusion (EOI) on Day 1 of Cycles 1 and 4; end of study/early discontinuation (up to 28.5 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.
Secondary
Part 1 and 2: Number of Participants With Treatment-induced Changes in T Regulatory C Ells (Treg) Levels in Blood and/or Tumor as Compared to Baseline
Treg depletion was defined as a reduction to 25% of baseline. As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.
Pharmacodynamic (PD) evaluable population included all participants who had at least one pre-dose and one post-dose PD assessment were included and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Baseline up to 28 days post last dose (up to 24.9 months)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Secondary
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline
As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.
Pharmacodynamic (PD) evaluable population included all participants who had at least one pre-dose and one post-dose PD assessment were included and analyzed according to the treatment they actually received. Number analyzed per timepoint are unique number of participants out all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.
Posted
Mean
Standard Deviation
ratio
Cycle 1 Day 1 (end of infusion [EOI]); Cycle 1 Day 4 (72 hours post dose); Cycle 1 Day 8 (168 hours post dose); Cycle 1 Day 15 (336 hours post dose)
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Time Frame
Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months)
Description
Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
2
3
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
Colitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected7 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Immune system disorder
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Enterocolitis bacterial
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0023 events1 affected7 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Carotid sinus syndrome
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected7 at risk
EG0033 events3 affected7 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected3 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Cataract
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Scleral haemorrhage
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Visual impairment
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected7 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected6 at risk
EG0015 events2 affected6 at risk
EG0024 events2 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected7 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events3 affected6 at risk
EG0024 events3 affected7 at risk
EG003
Oral pruritus
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0007 events3 affected6 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events2 affected6 at risk
EG0023 events3 affected7 at risk
EG003
Chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Chills
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Face oedema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0013 events2 affected6 at risk
EG0022 events2 affected7 at risk
EG003
Mucosal dryness
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Necrosis
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Body tinea
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Candida infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Groin infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Vascular access site erythema
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
White blood cell count increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0023 events2 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Secondary cerebellar degeneration
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Tonsillar ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0015 events2 affected6 at risk
EG0027 events5 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events1 affected6 at risk
EG0023 events2 affected7 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0025 events3 affected7 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Skin hypertrophy
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Flushing
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hot flush
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0037
OG0047
OG0054
OG0066
OG0073
Title
Denominators
Categories
Title
Measurements
OG00052.0(23.0 to NA)The upper limit of the 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
OG00158.0(56.0 to 103.0)
OG002121.0(70.0 to 148.0)
OG00359.0(31.0 to 225.0)
OG004135.0(53.0 to 182.0)
OG005111.0(105.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG00651.5(46.0 to 57.0)
OG00769.0(57.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Units
Counts
Participants
OG0005
OG0014
OG0024
OG0035
OG0045
OG0053
OG0063
OG0072
Title
Denominators
Categories
Title
Measurements
OG000181.0(36.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG001295.0(84.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG002352.0(263.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG003237.0(213.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG004353.0(129.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG005230.0(111.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG006304.0(137.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
OG00773.0(69.0 to NA)The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0035
OG0047
OG0056
OG0065
OG0072
Title
Denominators
Categories
Cycle 1 Day 1 Predose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0035
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0072
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation was not estimable as samples were below limit of quantification (BLQ).
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.
Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.
Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.
Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG0037
OG0047
OG0056
OG0067
OG0070
Title
Denominators
Categories
Cycle 1 Day 1 (EOI)
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0062
ParticipantsOG0070
Title
Measurements
OG0001.59± 1.43
OG0010.83± 0.67
OG0020.41± 0.15
OG003
Cycle 1 Day 4 (72 hours Post-dose)
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0036
Cycle 1 Day 8 (168 hours Post-dose)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0036
Cycle 1 Day 15 (336 hours Post-dose)
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0034
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0052 events2 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
2 events
2 affected
7 at risk
EG0042 events1 affected7 at risk
EG0054 events3 affected6 at risk
EG0063 events3 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0044 events3 affected7 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
2 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
3 events
3 affected
7 at risk
EG0042 events2 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
2 events
2 affected
7 at risk
EG0044 events3 affected7 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0042 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
5 events
5 affected
7 at risk
EG0041 events1 affected7 at risk
EG0056 events4 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
3 events
2 affected
7 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
6 events
2 affected
7 at risk
EG0042 events1 affected7 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
3 events
2 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
2 events
2 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
2 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0043 events3 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0042 events2 affected7 at risk
EG0053 events2 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
2 events
2 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
3 events
2 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
2 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0055 events2 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
5 events
4 affected
7 at risk
EG0044 events4 affected7 at risk
EG0056 events3 affected6 at risk
EG0061 events1 affected7 at risk
EG0072 events1 affected3 at risk
8 events
6 affected
7 at risk
EG0042 events2 affected7 at risk
EG0056 events3 affected6 at risk
EG0062 events1 affected7 at risk
EG0073 events2 affected3 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0042 events2 affected7 at risk
EG0054 events2 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected3 at risk
1050
± 26.9
OG0042100± 50.8
OG0053860± 22.3
OG0069890± 23.8
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Participants
OG004
5
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG00019.4± 79.8
OG001109± 34.9
OG002599± 45.3
OG0031130± 146
OG0042780± 82.5
OG0055460± 8.20
OG00616700± 0.708
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
8.23
± 32.8
OG00412.7± 40.9
OG00527.3± 34.5
OG00661.7± 17.5
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Participants
OG004
5
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG0000.119± 66.3
OG0010.544± 28.8
OG0023.27± 21.0
OG0037.82± 40.4
OG00415.3± 43.9
OG00534.2± 27.8
OG00685.2± 4.32
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
4.92
(4.00 to 6.67)
OG0044.07(4.00 to 7.00)
OG0054.07(4.00 to 26.0)
OG0064.13(4.00 to 5.67)
OG007NA(NA to NA)Samples were below the limit of quantification, hence median and full range were unevaluable.
Participants
OG004
5
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG0001.41(1.00 to 4.00)
OG0011.17(1.00 to 4.08)
OG0021.15(1.05 to 2.93)
OG003NA(1.05 to 23.0)Median values cannot be derived for two participants.
OG0041.17(1.00 to 3.75)
OG005NA(1.22 to 3.50)Median values cannot be derived for two participants.
OG006NA(1.08 to 1.27)Median values cannot be derived for two participants.
OG007NA(NA to NA)Samples were below the limit of quantification, hence median and full range were unevaluable.
5.94
± 12.8
OG0047.29± 45.3
OG0056.14± 50.7
OG0065.84± 42.1
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Participants
OG004
5
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG0005.75± 142
OG0016.12± 19.4
OG0025.59± 41.3
OG0036.50± 10.5
OG0045.59± 44.8
OG0053.96± 24.2
OG0065.22± 5.82
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
9.43
± 31.1
OG00410.8± 21.6
OG0059.15± 42.4
OG00611.2± 49.7
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Participants
OG004
5
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG00010.3± 25.3
OG00113.2± 53.0
OG00210.8± 51.2
OG00312.1± 109
OG0049.65± 32.1
OG0057.92± 3.64
OG00615.3± 4.28
OG007NA± NASamples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
NA
± NA
Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
OG007NA± NAGeometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0072
Title
Measurements
OG000432± 25.9
OG001387± 17.7
OG002427± 32.4
OG003374± 19.5
OG004363± 29.5
OG005379± 23.3
OG006492± 13.1
OG007410± 25.8
ParticipantsOG0047
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0070
Title
Measurements
OG00065.7± 91.5
OG00174.6± 44.6
OG00298.2± 39.4
OG00365.8± 21.6
OG00458.0± 72.2
OG00567.4± 50.0
OG00687.9± 46.3
ParticipantsOG0047
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0070
Title
Measurements
OG000153± 32.4
OG001177± 75.2
OG00289.9± 98.8
OG00384.0± 49.1
OG004121± 35.5
OG00582.4± 39.8
OG006181± 35.1
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0070
Title
Measurements
OG000180± 29.2
OG001131± 29.1
OG002130± 41.7
OG003NA± NASince only 1 participant was evaluable, Geometric mean (GM) and Geometric Coefficient of Variation could not be estimated.
OG004159± 42.5
OG005115± 56.4
OG006260± 16.9
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0070
Title
Measurements
OG000566± 15.7
OG001527± 8.40
OG002450± 28.0
OG003NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG004512± 35.9
OG005510± 14.8
OG006NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000194± 40.9
OG001153± 33.0
OG002151± 60.0
OG003NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG004190± 31.6
OG005162± 26.4
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000194± 11.7
OG001139± 112
OG002160± 51.1
OG003NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG004237± 23.4
OG005169± 44.8
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG001201± 52.4
OG002154± 64.5
OG004265± 9.61
OG005NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG001209± 36.0
OG002NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG004238± 39.0
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG001NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG002NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG004NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0070
Title
Measurements
OG000135± 37.9
OG001105± 37.4
OG002141± 34.0
OG00374.1± 21.1
OG004112± 16.4
OG005NA± NASince only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.
OG00661.3± 13.0
0.27
± 0.20
OG0040.37± 0.60
OG0050.68± 0.92
OG0060.32± 0.12
ParticipantsOG0044
ParticipantsOG0056
ParticipantsOG0062
ParticipantsOG0070
Title
Measurements
OG0000.69± 0.78
OG0010.17± NASince only 1 participant was evaluated, standard deviation could not be calculated.