A Study of RO7172508 in Patients With Locally Advanced an... | NCT03539484 | Trialant
NCT03539484
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Sep 3, 2020Actual
Enrollment
26Actual
Phase
Phase 1
Conditions
Solid Tumors
Interventions
RO7172508
Obinutuzumab
Tocilizumab
Countries
Belgium
Canada
Denmark
Spain
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03539484
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP40092
Secondary IDs
Not provided
Brief Title
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
Official Title
A First-in-Human, Open-Label, Multicenter, Dose-Escalation Phase I Clinical Study of Single-Agent RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Aug 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated due to change in benefit-risk ratio, driven by high incidence GI toxicity in absence of clinically significant anti-tumor efficacy.
Expanded Access Info
No
Start Date
Jul 4, 2018Actual
Primary Completion Date
Jul 22, 2019Actual
Completion Date
Jul 22, 2019Actual
First Submitted Date
Apr 19, 2018
First Submission Date that Met QC Criteria
May 16, 2018
First Posted Date
May 29, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jun 3, 2020
Results First Submitted that Met QC Criteria
Aug 17, 2020
Results First Posted Date
Sep 3, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 17, 2020
Last Update Posted Date
Sep 3, 2020Actual
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 was to determine the maximum-tolerated dose (MTD) and/or the optimal biological dose (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC) administrations of RO7172508 as monotherapy, with or without obinutuzumab pre-treatment, in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors who have progressed on standard of care (SOC) treatment, are intolerant to SOC, and/or are non-amenable to SOC. This study was conducted in two parts. Part I of the study consisted of an IV single participant cohort/multiple-ascending dose-escalation to evaluate the safety of RO7172508. Part II was a multiple participant cohort/multiple-ascending dose-escalation to define the MTD and/or OBD of RO7172508 administered as single agent, IV and/or SC, in participants with tumors that are expressing high as well as moderate/low-CEA. The study switched from Part I to Part II when the maximum planned dose for Part I was reached or the occurrence of a RO7172508-related Grade >= 2 adverse event (AE) or dose-limiting toxicity (DLT) was observed, whichever comes first. The Sponsor may decide to switch from Part I to Part II in the absence of an observed RO7172508-related Grade >= 2 toxicity or prior to maximum planned dose for Part I.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
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
26Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part I: Single Participant Cohorts IV/MAD-Escalation
Experimental
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W). The starting dose of RO7172508 was 65 microgram (mcg) and the maximum dose explored was 1.6 milligram (mg).
Drug: RO7172508
Drug: Tocilizumab
Part II: Multiple Participant Cohorts IV/MAD-Escalation
Experimental
Multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Dose-escalation was undertaken based on safety until determination of the MTD or the highest safe dose if MTD is not reached. If on-target toxicity was reported in the first cycle of treatment, fractionated dosing may be implemented for the first cycle to improve tolerability.
Drug: RO7172508
Drug: Obinutuzumab
Drug: Tocilizumab
Part II: Multiple Participant Cohorts SC/MAD-Escalation (QW)
Experimental
Multiple ascending dose-escalation of SC-administered RO7172508 in multiple participant cohorts. These will be initiated once the IV schedule has shown RO7172508 preliminary clinical activity or the MTD has been established and is equal to or above 2 mg. The starting-dose and regimen once a week or once every 3 weeks (QW or Q3W) for SC administration will be proposed based on the evaluation of the safety and PK data observed following IV administration but will not exceed the highest safe dose tested in the IV Q3W dose escalation; a minimum dose of 2 mg is defined for a single SC administration. In addition, the QW SC starting-dose will not exceed one third of the IV MTD or of the highest safe IV dose tested. Dose escalation will continue based on safety until determination of the MTD or the planned maximum dose of 400 mg. If on-target toxicity is reported in the first cycle of treatment, fractionated dosing may be implemented for the first cycle to improve tolerability.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7172508
Drug
RO7172508 was administered at a dose and as per the schedule specified in the respective arms.
Part I: Single Participant Cohorts IV/MAD-Escalation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of participants with DLTs.
Up to approximately 12 months
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
60 days after last dose of study treatment (up to approximately 12 months)
Secondary Outcomes
Measure
Description
Time Frame
Maximum Concentration of RO7172508
Cycle 1 following single dose administration of RO7172508
Time of Maximum Concentration of RO7172508
Cycle 1 following single dose administration of RO7172508
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For Part I: participants with locally advanced and/or metastatic solid tumor with confirmed cytoplasmic and/or membranous high CEA expression in tumor tissue is required. Participants must have progressed on a SOC therapy, be intolerant to SOC, and/or are non-amenable to SOC.
For <12 mg dose cohorts, serum CEA levels below a certain threshold is required as follows:
For dose cohorts 65-159 microgram, a sCEA level of < 22 ng/mL
For dose cohorts 160-399 microgram, a sCEA level of < 28 ng/mL
For dose cohorts 400-799 microgram, a sCEA level of < 44 ng/mL
For dose cohorts 800-1599 microgram, a sCEA level of < 70 ng/mL
For the dose cohort of 1.6-3.1 milligram, a sCEA level of < 123 ng/mL
For the dose cohort of 3.2-6.3 milligram, an sCEA level of < 229 ng/mL.
For the dose cohort of 6.4-11.9 milligram, an sCEA level of < 440 ng/mL. If dose fractionation is implemented, the sCEA threshold for inclusion should correspond to the dose range of the first dose administered.
For Part II, participants with locally advanced and/or metastatic solid tumor expressing cytoplasmic and/or membranous high-CEA or moderate/low-CEA on archival material, who have progressed on a SOC therapy, are intolerant to SOC, and/or are non-amenable to SOC. Participants must have a lesion amenable to biopsy (except participants with NSCLC, which may be enrolled with archival tissue available only). For participants with colorectal cancer (CRC) only, the CEA assessment by immunohistochemistry should be performed but the result is not required to enroll the participant.
Radiologically measurable disease according to RECIST v1.1.
Life expectancy of >= 12 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade <= 1 or returned to baseline except alopecia (any grade) and Grade 2 peripheral neuropathy.
Adequate hematological, liver, renal, and lung function
For women: agree to remain abstinent or use two contraceptive methods that result in a failure rate of <1% per year from screening until 2 months after the last dose of RO7172508 and have a negative pregnancy test within one week prior to the first study treatment administration
For men: remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of <1% per year, with partners who are woman of childbearing potential and refrain from donating sperm during the study
Exclusion Criteria:
History or clinical evidence of central nervous system (CNS) primary tumors or metastases unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days before screening.
Non-irradiated lesions > 2 cm at critical sites where tumor swelling induced by RO7172508 is expected to lead to significant complications.
Another invasive malignancy in the last 2 years
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or contraindicate the use of an investigational drug.
Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia that requires treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia, and history of myocardial infarction within 6 months of enrollment.
Active or uncontrolled infections.
Known hepatitis B or C
Major surgery or significant traumatic injury < 28 days prior to the first RO7172508 administration or anticipation of the need for major surgery during study treatment.
Specific Exclusion Criteria if Pre-treatment with Obinutuzumab is Implemented:
Known HIV
Positive test results for HBV infection, HBcAb indicating an active viral infection and positive test results for HCV.
Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
History of progressive multifocal leukoencephalopathy.
Active TB requiring treatment within 3 years prior to baseline.
Latent TB diagnosed during Screening.
Positive test results for human T-lymphotropic virus 1
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
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cliniques Universitaires St-Luc
Brussels
1200
Belgium
Princess Margaret Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PART1 - RO7172508 - Q3W - 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
FG001
PART1 - RO7172508 - Q3W - 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
FG002
PART1 - RO7172508 - Q3W - 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
FG003
PART2 - RO7172508 - Q3W - 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
FG004
PART2 - RO7172508 - Q3W - 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
FG005
PART2 - RO7172508 - Q3W - 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
FG006
PART2 - RO7172508 - Q3W - 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG00413 subjects
FG0055 subjects
FG0062 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PART1 - RO7172508 - Q3W - 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
BG001
PART1 - RO7172508 - Q3W - 160 mcg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of participants with DLTs.
DLT evaluble population included participants who completed the DLT window without a DLT, or participants who reported with a DLT.
Posted
Number
Participants
Up to approximately 12 months
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
Adverse Events Module
Frequency Threshold
5
Time Frame
Baseline up to approximately 12 months
Description
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
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
PART1 - RO7172508 - Q3W - 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 22.0
Systematic Assessment
More Info Module
Limitations and Caveats
RO7172508 SC not initiated; max tolerated dose IV below starting dose for SC. Study terminated due to change in benefit-risk ratio, driven by high incidence GI toxicity in absence of clinically significant anti-tumor efficacy at dose levels tested.
Part II: Multiple Participant Cohorts IV/MAD-Escalation
Part II: Multiple Participant Cohorts SC/MAD-Escalation (QW)
Obinutuzumab
Drug
In the event obinutuzumab treatment is implemented, obinutuzumab will be administered either on Day-7 or on Day-7 and Day-6. If obinutuzumab is given only on one day, then the schedule for Day-7 should be followed including an end of infusion sample.
Part II: Multiple Participant Cohorts IV/MAD-Escalation
Part II: Multiple Participant Cohorts SC/MAD-Escalation (QW)
Tocilizumab
Drug
Tocilizumab was administered if required, for the management of severe CRS (cytokine release syndrome)
Part I: Single Participant Cohorts IV/MAD-Escalation
Part II: Multiple Participant Cohorts IV/MAD-Escalation
Part II: Multiple Participant Cohorts SC/MAD-Escalation (QW)
Clearance or Apparent Clearance of RO7172508
Cycle 1 following single dose administration of RO7172508
Volume of Distribution at Steady State of RO7172508
Cycle 1 following single dose administration of RO7172508
Area Under the Plasma Concentration Time-Curve From Zero to the Last Measured Concentration (AUClast) of RO7172508
Cycle 1 following single dose administration of RO7172508
Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf) of RO7172508
Cycle 1 following single dose administration of RO7172508
Dose Normalized Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf/Dose) of RO7172508
Cycle 1 following single dose administration of RO7172508
Half-Life of RO7172508
Cycle 1 following single dose administration of RO7172508
Presence or Absence and Titer of ADAs
Up to approximately 12 months
Changes in Frequency of Tumor Infiltrating Lymphocytes
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Secondary: Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD8)
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD4)
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
Spatial distribution of TIL's analyzed by performing IHC assay, which measures the density and intra-tumoral location of CD8+ T cells and reports "CD8 T cell immune phenotypes". These are classified as "desert", "excluded" and "inflamed".
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Objective Response Rate (ORR)
Objective response was defined as a Complete Response (CR) or Parital Response (PR), as determined by the Investigator's assessment using RECIST v1.1 and confirmed by repeat assessments >= 4 weeks after initial documentation. To classify a response as SD, measurements are classified as stable (according to RECIST v1.1) at least once after study entry at a minimum of 6 weeks after study entry.
Up to approximately 12 months
Disease Control Rate (DCR)
DCR is determined as the rate of participants with an observed tumor response of CR or PR (ORR) or CR, PR or SD (DCR). DCR is to be derived for RECIST v1.1.
Up to approximately 12 months
Duration of Response (DOR)
Among participants with an objective response (responders), DOR will be defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death within 30 days from last study treatment from any cause during treatment, whichever occurs first. This will be calculated for participants who have a best overall response of CR or PR as defined per RECIST v1.1 and per iRECIST.
Up to approximately 12 month
Progression Free Survival (PFS)
PFS (on-treatment) will be defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented disease progression or death from any cause during treatment (death within 30 days from last study treatment), whichever occurs first.
Up to approxmately 12 months
Toronto
Ontario
M5G 1Z5
Canada
Rigshospitalet; Onkologisk Klinik
København Ø
2100
Denmark
Clinica Universitaria de Navarra
Pamplona
Navarre
31008
Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona
08035
Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid
28050
Spain
0 subjects
FG0050 subjects
FG0060 subjects
13 subjects
FG0055 subjects
FG0062 subjects
2 subjects
FG0048 subjects
FG0053 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0052 subjects
FG0061 subjects
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
BG002
PART1 - RO7172508 - Q3W - 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
BG003
PART2 - RO7172508 - Q3W - 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
BG004
PART2 - RO7172508 - Q3W - 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
BG005
PART2 - RO7172508 - Q3W - 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
BG006
PART2 - RO7172508 - Q3W - 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
BG007
Total
Total of all reporting groups
1
BG0011
BG0021
BG0033
BG00413
BG0055
BG0062
BG00726
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.0± NANot estimable because there was 1 participant.
BG00160.0± NANot estimable because there was 1 participant.
BG00260.0± NANot estimable because there was 1 participant.
BG00353.7± 9.6
BG00462.2± 9.0
BG00558.8± 13.5
BG00655.5± 16.3
BG00759.5± 9.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0031
BG0047
BG0054
BG0062
BG00714
Male
BG0001
BG0011
BG0021
BG0032
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Not Hispanic or Latino
BG0001
BG0011
BG0021
BG0033
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0001
BG0011
BG0021
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0033
OG00413
OG0055
OG0062
Title
Denominators
Categories
Title
Measurements
OG0020
OG0030
OG0041
OG0050
OG0061
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
OG004
OG005
OG006
Regression, Logistic
There is no p-value derived; logistic regression is used to estimate the probability of DLT.
Posterior probability at dose 1.8 mg
10.6
2-Sided
95
2.10
26.5
Other
A Bayesian approach is used to estimate the maximum tolerated dose (MTD).
Primary
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Safety population included all participants enrolled in the study who received at least one dose of study treatment.
Posted
Number
Percentage of participants
60 days after last dose of study treatment (up to approximately 12 months)
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
OG003
Secondary
Maximum Concentration of RO7172508
Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Time of Maximum Concentration of RO7172508
Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Posted
Median
Full Range
Hour
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Clearance or Apparent Clearance of RO7172508
Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/hr
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Volume of Distribution at Steady State of RO7172508
Analysis not conducted due to participants not reaching steady state due to early withdrawal or loss of exposure due to immunogenicity.
Posted
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
Baseline sCEA >20 ng/mL
Secondary
Area Under the Plasma Concentration Time-Curve From Zero to the Last Measured Concentration (AUClast) of RO7172508
Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ng/mL
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf) of RO7172508
Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ng/mL
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Dose Normalized Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf/Dose) of RO7172508
Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ng/mL
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Half-Life of RO7172508
Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour
Cycle 1 following single dose administration of RO7172508
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I and Part II: Participant Cohorts IV 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG003
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG004
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Baseline sCEA <=20 ng/mL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Presence or Absence and Titer of ADAs
Participants were considered as evaluable for immunogenicity analysis if they had at least 3 cycles of treatment to allow for development of potential ADAs.
Posted
Number
Participants
Up to approximately 12 months
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcgEdit
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Presence of ADAs
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Changes in Frequency of Tumor Infiltrating Lymphocytes
Biopsies were not mandatory in part 1. Results from 2 participants are excluded as measured using a different assay.
Posted
Median
Full Range
% of CD3
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Results
Results
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
CD8 TIL Pre-treatment (Cycle 1 Day 1)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Secondary: Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD8)
Biopsies were not mandatory in part 1. Results from 2 participants are excluded as measured using a different assay.
Posted
Median
Full Range
% of CD8
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Results
Results
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
CD8+CD25+ Pre-treatment (Cycle 1 Day 1)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD4)
Biopsies were not mandatory in part 1. Results from 2 participants are excluded as measured using a different assay.
Posted
Median
Full Range
% of CD4
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Results
Results
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
CD4+CD25+ Pre-treatment (Cycle 1 Day 1)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
Spatial distribution of TIL's analyzed by performing IHC assay, which measures the density and intra-tumoral location of CD8+ T cells and reports "CD8 T cell immune phenotypes". These are classified as "desert", "excluded" and "inflamed".
Paired included participant's with different dose and actual exposure levels. Data were pooled across all dose levels because the number of biopsy evaluable participants was overall small, and no dose/response relationship was found.
Posted
Number
CD8 immune phenotype
Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)
Results
Results
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Pre-treatment (Cycle 1 Day 1) Desert
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Objective Response Rate (ORR)
Objective response was defined as a Complete Response (CR) or Parital Response (PR), as determined by the Investigator's assessment using RECIST v1.1 and confirmed by repeat assessments >= 4 weeks after initial documentation. To classify a response as SD, measurements are classified as stable (according to RECIST v1.1) at least once after study entry at a minimum of 6 weeks after study entry.
Efficacy population included all participants who received at least one dose of RO7172508.
Posted
Number
Participants
Up to approximately 12 months
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Disease Control Rate (DCR)
DCR is determined as the rate of participants with an observed tumor response of CR or PR (ORR) or CR, PR or SD (DCR). DCR is to be derived for RECIST v1.1.
Efficacy population included all participants who received at least one dose of RO7172508.
Posted
Count of Participants
Participants
Up to approximately 12 months
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Duration of Response (DOR)
Among participants with an objective response (responders), DOR will be defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death within 30 days from last study treatment from any cause during treatment, whichever occurs first. This will be calculated for participants who have a best overall response of CR or PR as defined per RECIST v1.1 and per iRECIST.
Efficacy population included all participants who received at least one dose of RO7172508. DOR was not calculated because none of the participants had a response (complete or partial).
Posted
Up to approximately 12 month
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Progression Free Survival (PFS)
PFS (on-treatment) will be defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented disease progression or death from any cause during treatment (death within 30 days from last study treatment), whichever occurs first.
Efficacy population included all participants who received at least one dose of RO7172508. PFS was not calculated because number of evaluable participants in each cohort respectively was too small to obtain reliable estimates for this endpoint.
Posted
Up to approxmately 12 months
ID
Title
Description
OG000
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
OG001
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
OG002
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
OG003
Part II: Multiple Participant Cohorts IV 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
OG004
Part II: Multiple Participant Cohorts IV 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
OG005
Part II: Multiple Participant Cohorts IV 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
OG006
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
1
1
0
1
1
1
EG001
PART1 - RO7172508 - Q3W - 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
0
1
1
1
1
1
EG002
PART1 - RO7172508 - Q3W - 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
0
1
1
1
1
1
EG003
PART2 - RO7172508 - Q3W - 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
2
3
0
3
3
3
EG004
PART2 - RO7172508 - Q3W - 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
8
13
8
13
13
13
EG005
PART2 - RO7172508 - Q3W - 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
3
5
3
5
5
5
EG006
PART2 - RO7172508 - Q3W - 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
0
2
2
2
2
2
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0054 events2 affected5 at risk
EG0060 events0 affected2 at risk
Enteritis
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Ileus
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Cholangitis
Hepatobiliary disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected2 at risk
Cytokine release syndrome
Immune system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Peritonitis
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Aspartate aminotransferase increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Blood bilirubin increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Spinal cord compression
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Confusional state
Psychiatric disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected2 at risk
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0031 events1 affected3 at risk
EG00412 events6 affected13 at risk
EG0054 events2 affected5 at risk
EG0060 events0 affected2 at risk
Sinus tachycardia
Cardiac disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Vertigo
Ear and labyrinth disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Episcleritis
Eye disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Eye haematoma
Eye disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0046 events5 affected13 at risk
EG0050 events0 affected5 at risk
EG0063 events1 affected2 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0052 events2 affected5 at risk
EG0060 events0 affected2 at risk
Aerophagia
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Constipation
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG0031 events1 affected3 at risk
EG0046 events3 affected13 at risk
EG0055 events3 affected5 at risk
EG0064 events2 affected2 at risk
Dry mouth
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Enteritis
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Intra-abdominal fluid collection
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0047 events4 affected13 at risk
EG0056 events3 affected5 at risk
EG0061 events1 affected2 at risk
Stomatitis
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0025 events1 affected1 at risk
EG0031 events1 affected3 at risk
EG0048 events3 affected13 at risk
EG00511 events3 affected5 at risk
EG0060 events0 affected2 at risk
Asthenia
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0031 events1 affected3 at risk
EG0042 events2 affected13 at risk
EG0052 events2 affected5 at risk
EG0060 events0 affected2 at risk
Chest pain
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Chills
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Early satiety
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Fatigue
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0032 events2 affected3 at risk
EG0044 events4 affected13 at risk
EG0052 events2 affected5 at risk
EG0062 events2 affected2 at risk
Infusion site extravasation
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Non-cardiac chest pain
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Oedema
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Oedema peripheral
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0052 events2 affected5 at risk
EG0061 events1 affected2 at risk
Pyrexia
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected1 at risk
EG0032 events1 affected3 at risk
EG0045 events4 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Bacteraemia
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Cystitis
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Mucosal infection
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0032 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Paronychia
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Pneumonia
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Respiratory tract infection
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Skin infection
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Incorrect dose administered
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0043 events2 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Intercepted medication error
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Alanine aminotransferase increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected2 at risk
Amylase increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected2 at risk
Aspartate aminotransferase increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected13 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected2 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Blood bilirubin increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Blood creatinine increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Body temperature increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Lipase increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected13 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected2 at risk
Lymphocyte count decreased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Platelet count decreased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Weight decreased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0033 events2 affected3 at risk
EG0045 events5 affected13 at risk
EG0054 events3 affected5 at risk
EG0061 events1 affected2 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected2 at risk
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0053 events1 affected5 at risk
EG0060 events0 affected2 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0045 events4 affected13 at risk
EG0052 events1 affected5 at risk
EG0063 events1 affected2 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0063 events2 affected2 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0052 events2 affected5 at risk
EG0060 events0 affected2 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected2 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0032 events1 affected3 at risk
EG0041 events1 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected2 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected2 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Dysgeusia
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Headache
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0053 events2 affected5 at risk
EG0060 events0 affected2 at risk
Anxiety
Psychiatric disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Confusional state
Psychiatric disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Depression
Psychiatric disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Insomnia
Psychiatric disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Urinary retention
Renal and urinary disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Embolism
Vascular disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
Hot flush
Vascular disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Hypertension
Vascular disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Hypotension
Vascular disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected2 at risk
Jugular vein thrombosis
Vascular disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
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.
6
BG0051
BG0060
BG00712
13
BG0055
BG0062
BG00726
0
BG0050
BG0060
BG0070
0
BG0050
BG0060
BG0070
0
BG0050
BG0060
BG0070
0
BG0050
BG0060
BG0070
13
BG0055
BG0062
BG00726
0
BG0050
BG0060
BG0070
0
BG0050
BG0060
BG0070
3
OG00413
OG0055
OG0062
100
OG004100
OG005100
OG006100
13
OG0045
OG0052
6
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG0009.19
OG00121.5
OG00273.3± 54.4
OG003252± 138
OG004370± 29.2
OG005937
Baseline sCEA >20 ng/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG00285.0± 17.3
OG003184± 167
OG004290± 2.9
OG005
13
OG0045
OG0052
6
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG0002.58
OG0012.07
OG0023.30(2.20 to 4.40)
OG0033.79(1.80 to 4.10)
OG0042.13(2.10 to 3.80)
OG0054.48
Baseline sCEA >20 ng/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0022.16(2.16 to 2.16)
OG0032.18(2.00 to 4.30)
OG0043.09(2.00 to 4.20)
OG005
8
OG0044
OG0052
5
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG000332
OG001NANot determined because
λz was not estimable.
OG002111± 34.4
OG00355.4± 61.5
OG00467.4± 49.2
OG00534.8
Baseline sCEA >20 ng/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG002453
OG003340± 527
OG00468.8
OG005
0
OG0040
OG0050
13
OG0045
OG0052
6
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG0006.93
OG0011.91
OG002143± 38.4
OG003411± 137
OG004740± 49.4
OG0052140
Baseline sCEA >20 ng/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG00245.4± 34.4
OG00383.5± 178
OG004370± 121
OG005
8
OG0044
OG0052
5
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG0008.15
OG001NANot determined because
λz was not estimable.
OG002150± 34.7
OG003602± 61.7
OG004740± 49.2
OG0052160
Baseline sCEA >20 ng/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG00236.8
OG00398.1± 527
OG004727
OG005
8
OG0044
OG0052
5
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG000125
OG001NANot determined because
λz was not estimable.
OG002375± 34.2
OG003753± 61.6
OG004618± 49.3
OG0051200
Baseline sCEA >20 ng/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG00292.0
OG003122± 526
OG004606
OG005
8
OG0044
OG0052
5
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG00017.1
OG001NANot determined because
λz was not estimable.