A Study Evaluating The Safety And Pharmacokinetics Of Esc... | NCT04434469 | Trialant
NCT04434469
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Jul 3, 2024Actual
Enrollment
27Actual
Phase
Phase 1
Conditions
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Interventions
RO7297089
Countries
Australia
Belgium
Denmark
Norway
Protocol Section
Identification Module
NCT ID
NCT04434469
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO41582
Secondary IDs
Not provided
Brief Title
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Official Title
An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Jun 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 8, 2020Actual
Primary Completion Date
Feb 23, 2022Actual
Completion Date
Feb 23, 2022Actual
First Submitted Date
Jun 12, 2020
First Submission Date that Met QC Criteria
Jun 12, 2020
First Posted Date
Jun 16, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Feb 23, 2023
Results First Submitted that Met QC Criteria
Jun 28, 2024
Results First Posted Date
Jul 3, 2024Actual
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
Jun 28, 2024
Last Update Posted Date
Jul 3, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.
Detailed Description
Not provided
Conditions Module
Conditions
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Keywords
Not provided
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
27Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A Flat Dose Escalation: RO7297089
Experimental
Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Drug: RO7297089
Arm B Split Dose Escalation: RO7297089
Experimental
Participants in Arm B will receive the first target dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose will be administered at subsequent study drug administration visits.
Drug: RO7297089
Arm C Step Dose Escalation: RO7297089
Experimental
No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
Drug: RO7297089
Phase I Expansion Stage: RO7297089
Experimental
No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
Drug: RO7297089
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7297089
Drug
RO7297089 will be given via intravenous (IV) infusion
Arm A Flat Dose Escalation: RO7297089
Arm B Split Dose Escalation: RO7297089
Arm C Step Dose Escalation: RO7297089
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
Adverse event severity graded according to NCI CTCAE v5.0
Baseline up to 1 year 7 months
Secondary Outcomes
Measure
Description
Time Frame
Time to Maximum Concentration Observed (Tmax) of RO7297089
Cycle 1 Day 1
Area Under the Curve (AUC) of RO7297089
Cycle 1 Day 1
Maximum Concentration Observed (Cmax) of RO7297089
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 12 weeks
R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
Measurable disease
Exclusion criteria:
Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first RO7297089 infusion
Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
Prior treatment with CAR-T therapy within 90 days before first study drug administration
Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first RO7297089 infusion
Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
Primary or secondary plasma cell leukemia
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
Significant cardiovascular disease
Current CNS involvement by MM
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Concord Repatriation General Hospital
Concord
New South Wales
2139
Australia
LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
Plesner T, Harrison SJ, Quach H, Lee C, Bryant A, Vangsted A, Estell J, Delforge M, Offner F, Twomey P, Choeurng V, Li J, Hendricks R, Ruppert SM, Sumiyoshi T, Miller K, Cho E, Schjesvold F. Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma. Clin Hematol Int. 2023 Mar;5(1):43-51. doi: 10.1007/s44228-022-00023-5. Epub 2023 Jan 19.
The study consisted of a screening period of up to 28 days and a minimum follow-up period of 90 days after treatment. Following confirmation of eligibility, patients received RO7297089 by intravenous (IV) infusion. Patients were enrolled in two stages: a dose escalation stage and an expansion stage.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
FG001
Dose Escalation Cohort 2: RO7297089
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Nov 10, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phase I Expansion Stage: RO7297089
Cycle 1 Day 1, Cycle 2 Day 8
Minimum Concentration Observed (Cmin) of RO7297089
Cycle 1 Day 1, Cycle 2 Day 8
Half-life (t1/2) of RO7297089
Cycle 1 Day 1
Objective Response Rate (ORR)
ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria
Baseline up to approximately 19 months
Liverpool
New South Wales
2170
Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide
South Australia
5000
Australia
St. Vincent's Hospital Melbourne
Fitzroy
South Australia
3065
Australia
Peter Mac Callum Cancer Center
East Melbourne
Victoria
3002
Australia
UZ Gent
Ghent
9000
Belgium
UZ Leuven
Leuven
3000
Belgium
Rigshospitalet
København Ø
2100
Denmark
Vejle Sygehus; Onkologisk Afdeling
Vejle
7100
Denmark
Oslo Universitetssykehus HF; Ullevål sykehus
Oslo
0450
Norway
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
FG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
FG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
FG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
FG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
FG0003 subjects
FG0015 subjects
FG0024 subjects
FG0036 subjects
FG0046 subjects
FG0053 subjects
COMPLETED
Alive: In Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG0035 subjects
FG0046 subjects
FG0053 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Study terminated by sponsor
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
BG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
BG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
BG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
BG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
BG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0015
BG0024
BG0036
BG0046
BG0053
BG00627
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00066.3± 1.2
BG00162.6± 9.2
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
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
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
Adverse event severity graded according to NCI CTCAE v5.0
Safety-Evaluable Patients
Posted
Number
Percentage of Participants
Baseline up to 1 year 7 months
ID
Title
Description
OG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
OG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
Units
Counts
Participants
OG0003
OG0015
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG00275
OG003
Secondary
Time to Maximum Concentration Observed (Tmax) of RO7297089
Cohorts reported with participants excluded from descriptive statistics due to not receiving the full dose:
Cohort 2: 1 participant Cohort 3: 1 participant Cohort 4A: 2 participants Cohort 4B reported with 1 participant excluded from descriptive statistics due to apparent outlier and 1 participant due to or missing sample.
Posted
Median
Full Range
EOI, day
Cycle 1 Day 1
ID
Title
Description
OG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG003
Dose Escalation Cohort 4: RO7297089
Secondary
Area Under the Curve (AUC) of RO7297089
Only those participants who received full dose were included in the results summary
Posted
Geometric Mean
Standard Deviation
ug/mL*day
Cycle 1 Day 1
ID
Title
Description
OG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG004
Secondary
Maximum Concentration Observed (Cmax) of RO7297089
Only those participants who received full dose were included in the results summary
Posted
Geometric Mean
Standard Deviation
ug/mL
Cycle 1 Day 1, Cycle 2 Day 8
ID
Title
Description
OG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Secondary
Minimum Concentration Observed (Cmin) of RO7297089
Only those participants who received full dose were included in the results summary
Posted
Geometric Mean
Standard Deviation
ug/mL
Cycle 1 Day 1, Cycle 2 Day 8
ID
Title
Description
OG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Secondary
Half-life (t1/2) of RO7297089
Only those participants who received full dose were included in the results summary
Posted
Geometric Mean
Standard Deviation
day
Cycle 1 Day 1
ID
Title
Description
OG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG004
Secondary
Objective Response Rate (ORR)
ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria
Posted
Count of Participants
Participants
No
Baseline up to approximately 19 months
ID
Title
Description
OG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Time Frame
Baseline up to 1 year and 7 months
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
2
3
1
3
2
3
EG001
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
3
5
5
5
5
5
EG002
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
2
4
3
4
3
4
EG003
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
2
6
5
6
6
6
EG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
2
6
4
6
5
6
EG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
0
3
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected6 at risk
EG004
Retinal haemorrhage
Eye disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0025 events2 affected4 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oral infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events3 affected5 at risk
EG0025 events3 affected4 at risk
EG0034 events3 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Diplopia
Eye disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oedema
General disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Candida infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Wound infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected4 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
C-reactive protein increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Calcium ionised increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Escherichia test positive
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Fracture pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0024 events1 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Haematoma
Vascular disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 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 in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
OG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
OG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0034
OG0044
OG0053
Title
Denominators
Categories
Title
Measurements
OG0000.25(0.08 to 0.25)
OG0010.17(0.08 to 0.25)
OG0020.08(0.08 to 0.08)
OG0030.25(0.25 to 0.25)
OG0041.08(1.08 to 1.17)
OG0051.08(1.08 to 2.11)
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
OG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0031
OG0044
OG0053
Title
Denominators
Categories
Title
Measurements
OG00012.7± 26.3
OG00178.7± 31.3
OG002280± 73.6
OG0031347± NAOnly 1 participant analyzed
OG0041046± 28.0
OG0051920± 25.4
OG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
OG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0031
OG0044
OG0053
Title
Denominators
Categories
C1D1
Title
Measurements
OG0007.79± 21.6
OG00140.9± 46.3
OG00295.9± 35.8
OG003314± NAOnly 1 participant analyzed
OG004305± 15.5
OG005404± 12.4
C2D8
Title
Measurements
OG0009.50± 24.1
OG00148.6± 23.6
OG002153± 47.5
OG003
OG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
OG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0031
OG0044
OG0053
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0031
ParticipantsOG0044
ParticipantsOG0053
Title
Measurements
OG0000.19± 22.3
OG0010.96± 42.5
OG0029.19± 500
OG003
C2D8
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
OG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0031
OG0044
OG0053
Title
Denominators
Categories
Title
Measurements
OG0001.39± 8.33
OG0011.25± 14.9
OG0022.39± 89.5
OG0036.73± NAOnly 1 participant analyzed
OG0044.22± 83.7
OG0056.52± 24.5
OG004
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
OG005
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.