A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combinatio... | NCT03601897 | Trialant
NCT03601897
Sponsor
Deciphera Pharmaceuticals, LLC
Status
Terminated
Last Update Posted
Dec 27, 2024Actual
Enrollment
177Actual
Phase
Phase 1Phase 2
Conditions
Locally Advanced or Metastatic Solid Tumor
Interventions
Rebastinib
Paclitaxel
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03601897
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DCC-2036-01-003
Secondary IDs
Not provided
Brief Title
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors
Official Title
An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
Deciphera Pharmaceuticals, LLCINDUSTRY
Status Module
Record Verification Date
Dec 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Development program terminated.
Expanded Access Info
No
Start Date
Oct 25, 2018Actual
Primary Completion Date
May 23, 2022Actual
Completion Date
May 23, 2022Actual
First Submitted Date
Jul 5, 2018
First Submission Date that Met QC Criteria
Jul 25, 2018
First Posted Date
Jul 26, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 3, 2024
Results First Submitted that Met QC Criteria
Dec 3, 2024
Results First Posted Date
Dec 27, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 3, 2024
Last Update Posted Date
Dec 27, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Deciphera Pharmaceuticals, LLCINDUSTRY
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 is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Locally Advanced or Metastatic Solid Tumor
Keywords
rebastinib
paclitaxel
breast cancer
ovarian cancer
endometrial cancer
gynecological carcinosarcoma
malignant mixed Mullerian tumor (MMMT)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
177Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Experimental
Dose escalation of rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in combination with paclitaxel administered by intravenous (IV) infusion at 80 mg/meter squared (m^2) on days 1, 8, and 15 of repeated 28-day cycles.
Drug: Rebastinib
Drug: Paclitaxel
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Experimental
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
Baseline up to 2.89 years
Objective Response Rate (ORR) (Part 2 Expansion)
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.
Baseline to PD or Death due to Any Cause (Up to 1.54 years)
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) (Part 1 Escalation)
Percentage of pts who achieved an objective response of Complete Response (CR) or Partial Response (PR). Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Modified RECIST (mRECIST) used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target les
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥18 years of age at the time of informed consent
Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment
Part 2
Triple-negative and Stage IV inflammatory breast cancer
Recurrent ovarian cancer
Recurrent, metastatic or high-risk endometrial cancer
Advanced (stage III or IV), or recurrent gynecological carcinosarcoma
Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor [MMMT] allowed
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2
Able to provide an archival tumor tissue sample
Adequate organ function and bone marrow reserve
If a female of childbearing potential, must have a negative pregnancy test prior to enrollment
Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures
Exclusion Criteria:
Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose
Not recovered from prior-treatment toxicities to Grade ≤1
Peripheral neuropathy of any etiology >Grade 1
Concurrent malignancy
Known active central nervous system (CNS) metastases
Use of systemic corticosteroids
Known retinal neovascularization, macular edema or macular degeneration
History or presence of clinically relevant cardiovascular abnormalities
QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females
Left ventricular ejection fraction (LVEF) <50% at screening
Arterial thrombotic or embolic events
Venous thrombotic event
Active infection ≥Grade 3
Human immunodeficiency virus (HIV) or hepatitis C (HCV) infection only if taking medications excluded per protocol, active hepatitis B (HBV), or active HCV infection
Use of proton pump inhibitors
If female, the patient is pregnant or lactating
Major surgery 4 weeks prior to the first dose of study drug
Malabsorption syndrome or other illness which could affect oral absorption
Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
Any other clinically significant comorbidities
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
University of Alabama Comprehensive Cancer Center
Birmingham
Alabama
35233
United States
University of Colorado Denver- Anschutz Medical Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in combination with paclitaxel administered by intravenous (IV) infusion at 80 mg/meter squared (m^2) on days 1, 8, and 15 of repeated 28-day cycles.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 7, 2020
Dec 2, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Baseline to PD or Death due to Any Cause (Up to 0.92 years)
Duration of Response (DOR)
Time from CR or PR to the earliest documented evidence of PD or death due to any cause. Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)
Time to Progression (TTP)
Time from first dose of study drug to the earliest documented evidence of PD. Per RECIST v1.1, PD defined as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
First Dose of Study Drug to PD (Up to 2.61 years)
Progression-free-survival (PFS)
Time from first dose of study drug to the earliest documented evidence of PD or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. PD per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
First Dose of Study Drug to PD or Death due to Any Cause (Up to 2.61 years)
Overall Survival (OS)
Time from first dose of study drug to date of death due to any cause. Participants who were still alive or who were lost to follow-up will be censored at the date of last contact.
First Dose of Study Drug to Death due to Any Cause (Up to 2.82 years)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Measure the Cmax
Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)
Measure the AUC 0-6 hours
Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
Aurora
Colorado
80045
United States
Northwestern University Feinberg School of Medicine
Chicago
Illinois
60611
United States
The University of Kansas Clinical Research Center
Kansas City
Kansas
66160
United States
Dana-Farber
Boston
Massachusetts
02215
United States
Northwell Health/Monter Cancer Center
Lake Success
New York
11042
United States
Montefiore Medical Center
The Bronx
New York
10467
United States
Ohio State University Wexner Medical Center
Columbus
Ohio
43210
United States
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma
73104
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
Women & Infants Hospital
Providence
Rhode Island
02905
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Oncology Consultants- Texas Medical Center
Houston
Texas
77030
United States
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
FG00024 subjects
FG00119 subjects
FG00212 subjects
FG0036 subjects
FG00415 subjects
FG0055 subjects
FG00628 subjects
FG00710 subjects
FG00822 subjects
FG00916 subjects
FG01020 subjects
mITT Population
Modified Intent-to-Treat (mITT) Population includes all participants who had at least one dose of the combined study drugs, had measurable disease at baseline, and had at least one post-baseline assessment. Participants without a post-baseline assessment who discontinued study treatment due to clinical progression, death, or a rebastinib-related AE will also be included in the mITT population.
FG00018 subjects
FG00114 subjects
FG00210 subjects
FG0036 subjects
FG00413 subjects
FG0054 subjects
FG00626 subjects
FG0079 subjects
FG00820 subjects
FG00914 subjects
FG01019 subjects
COMPLETED
FG0001 subjects
FG0016 subjects
FG0025 subjects
FG0034 subjects
FG0049 subjects
FG0052 subjects
FG00612 subjects
FG0075 subjects
FG0089 subjects
FG0095 subjects
FG0107 subjects
NOT COMPLETED
FG00023 subjects
FG00113 subjects
FG0027 subjects
FG0032 subjects
FG0046 subjects
FG0053 subjects
FG00616 subjects
FG0075 subjects
FG00813 subjects
FG00911 subjects
FG01013 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
BG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00119
BG00212
BG0036
BG00415
BG0055
BG00628
BG00710
BG00822
BG00916
BG01020
BG011177
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00019
BG00115
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00024
BG00119
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Events
Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
All participants who received any study drug.
Posted
Count of Participants
Participants
No
Baseline up to 2.89 years
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG00024
OG00119
OG00212
OG003
Title
Denominators
Categories
Any SAE
Title
Measurements
OG00016
OG00112
OG0023
OG003
Primary
Objective Response Rate (ORR) (Part 2 Expansion)
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.
Part 2 mITT participants that were evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline to PD or Death due to Any Cause (Up to 1.54 years)
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Secondary
Objective Response Rate (ORR) (Part 1 Escalation)
Percentage of pts who achieved an objective response of Complete Response (CR) or Partial Response (PR). Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Modified RECIST (mRECIST) used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target les
Part 1 mITT participants that were evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline to PD or Death due to Any Cause (Up to 0.92 years)
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Secondary
Duration of Response (DOR)
Time from CR or PR to the earliest documented evidence of PD or death due to any cause. Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
mITT participants that had CR or PR and were evaluable for this outcome measure.
Posted
Median
90% Confidence Interval
months
Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Secondary
Time to Progression (TTP)
Time from first dose of study drug to the earliest documented evidence of PD. Per RECIST v1.1, PD defined as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
mITT participants that were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
months
First Dose of Study Drug to PD (Up to 2.61 years)
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Secondary
Progression-free-survival (PFS)
Time from first dose of study drug to the earliest documented evidence of PD or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. PD per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
mITT participants that were evaluable for this outcome measure.
Posted
Median
90% Confidence Interval
months
First Dose of Study Drug to PD or Death due to Any Cause (Up to 2.61 years)
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Secondary
Overall Survival (OS)
Time from first dose of study drug to date of death due to any cause. Participants who were still alive or who were lost to follow-up will be censored at the date of last contact.
mITT participants that were evaluable for this outcome measure.
Posted
Median
90% Confidence Interval
months
First Dose of Study Drug to Death due to Any Cause (Up to 2.82 years)
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG003
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Measure the Cmax
Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliter (ng/mL)
Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG000
Secondary
PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)
Measure the AUC 0-6 hours
Part 1 participants who received any study drug and had evaluable AUC data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour times nanograms per hour (h*ng/mL)
Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
ID
Title
Description
OG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
OG001
Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG000
Time Frame
Baseline up to 2.89 years
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
7
24
16
24
23
24
EG001
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxelIV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
3
20
9
20
20
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected28 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected22 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected20 at risk
Angina pectoris
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Gastrointestinal necrosis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Asthenia
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Death
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Fatigue
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Gait disturbance
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Incarcerated hernia
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
COVID-19
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Peritonsillitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Sepsis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0013 events3 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Septic shock
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0003 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Noninfective encephalitis
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Seizure
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Syncope
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginal swelling
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected12 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0022 events1 affected12 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Embolism
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypotension
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0006 events5 affected24 at risk
EG00111 events5 affected19 at risk
EG0023 events1 affected12 at risk
EG0033 events3 affected6 at risk
EG0042 events2 affected15 at risk
EG0053 events2 affected5 at risk
EG00613 events5 affected28 at risk
EG0079 events2 affected10 at risk
EG0081 events1 affected22 at risk
EG0096 events5 affected16 at risk
EG01028 events8 affected20 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0002 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0027 events2 affected12 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected12 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Tricuspid valve disease
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cataract
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dry eye
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Eye pain
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Eyelid cyst
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Glaucoma
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0023 events3 affected12 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Macular hole
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Night blindness
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ocular hypertension
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Papilloedema
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Photopsia
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vision blurred
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0017 events4 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0004 events3 affected24 at risk
EG0016 events6 affected19 at risk
EG0022 events2 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0018 events7 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0006 events6 affected24 at risk
EG0013 events3 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0004 events3 affected24 at risk
EG0013 events3 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0011 events1 affected19 at risk
EG0022 events2 affected12 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Internal hernia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0008 events7 affected24 at risk
EG0013 events3 affected19 at risk
EG0023 events2 affected12 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0005 events5 affected24 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Tongue blistering
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0004 events4 affected24 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Asthenia
General disorders
MedDRA v24.1
Systematic Assessment
EG0004 events3 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Axillary pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Catheter site haematoma
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Chest discomfort
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Chills
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Fatigue
General disorders
MedDRA v24.1
Systematic Assessment
EG00012 events9 affected24 at risk
EG00110 events6 affected19 at risk
EG0029 events7 affected12 at risk
EG003
Feeling jittery
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Gait disturbance
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Generalised oedema
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Implant site pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Influenza like illness
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Localised oedema
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Malaise
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA v24.1
Systematic Assessment
EG0005 events5 affected24 at risk
EG0011 events1 affected19 at risk
EG0023 events3 affected12 at risk
EG003
Pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Peripheral swelling
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0023 events2 affected12 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Food allergy
Immune system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Abscess oral
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Alveolar osteitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
COVID-19
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Candida infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cystitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Eye infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Fungal infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hordeolum
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nail infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0003 events1 affected24 at risk
EG0013 events2 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Paronychia
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Parotitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rash pustular
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Sepsis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Skin infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0004 events4 affected24 at risk
EG0016 events4 affected19 at risk
EG0022 events1 affected12 at risk
EG003
Urinary tract infection fungal
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cystitis radiation
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0003 events2 affected24 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Incision site rash
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Radiation oesophagitis
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0005 events5 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Blood albumin decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Blood chloride decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Blood creatine increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Blood urea increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Carbon dioxide increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Haematocrit decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Heart rate increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
International normalised ratio decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
International normalised ratio increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Monocyte count increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0022 events1 affected12 at risk
EG003
Neutrophil count increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Platelet count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Protein total decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Reticulocyte count increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urine leukocyte esterase positive
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urine output decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Weight decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Weight increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
White blood cell count increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
White blood cells urine positive
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0005 events5 affected24 at risk
EG0012 events2 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0003 events2 affected24 at risk
EG0014 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0003 events2 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0005 events4 affected24 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0016 events3 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0003 events2 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0013 events2 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0006 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0023 events2 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected12 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0008 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0006 events2 affected24 at risk
EG0012 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0011 events1 affected19 at risk
EG0022 events2 affected12 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0006 events5 affected24 at risk
EG0016 events4 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0003 events2 affected24 at risk
EG0013 events3 affected19 at risk
EG0022 events2 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0022 events2 affected12 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0006 events5 affected24 at risk
EG0017 events6 affected19 at risk
EG0023 events3 affected12 at risk
EG003
Presyncope
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Syncope
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Depression
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vaginal fistula
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Vulvovaginal inflammation
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0005 events4 affected24 at risk
EG0012 events2 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0007 events4 affected24 at risk
EG0018 events5 affected19 at risk
EG0025 events3 affected12 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Paranasal sinus hyposecretion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0003 events2 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0004 events4 affected24 at risk
EG0016 events4 affected19 at risk
EG0022 events2 affected12 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nail bed tenderness
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0013 events3 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0004 events3 affected24 at risk
EG0014 events3 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0013 events3 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Embolism
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Flushing
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected19 at risk
EG0023 events3 affected12 at risk
EG003
Hot flush
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0022 events2 affected12 at risk
EG003
Hypotension
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected12 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected12 at risk
EG003
Trial terminated on May 23, 2022, due to development program termination.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG00010
OG0016
OG00213
OG0034
OG00426
OG0059
OG00620
OG00714
OG00819
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 25.9)
OG00116.7(0.9 to 58.2)
OG0027.7(0.4 to 31.6)
OG00325.0(1.3 to 75.1)
OG00430.8(16.3 to 48.7)
OG00511.1(0.6 to 42.9)
OG00620.0(7.1 to 40.1)
OG00735.7(15.3 to 61.0)
OG0085.3(0.3 to 22.6)
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG00018
OG00114
Title
Denominators
Categories
Title
Measurements
OG00016.7(4.7 to 37.7)
OG00121.4(6.1 to 46.6)
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG0003
OG0013
OG0020
OG0031
OG0041
OG0051
OG0068
OG0071
OG0084
OG0095
OG0101
Title
Denominators
Categories
Title
Measurements
OG00011.1(NA to NA)The 90% Confidence Interval (CI) was not estimable due to insufficient number of events.
OG001NA(NA to NA)DOR median and 90% CI were not estimable due to insufficient number of events.
OG0036.9(NA to NA)The 90% CI was not estimable due to insufficient number of events.
OG0047.4(NA to NA)The 90% CI was not estimable due to insufficient number of events.
OG005NA(NA to NA)DOR median and 90% CI were not estimable due to insufficient number of events.
OG0066.5(5.4 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0075.5(NA to NA)The 90% CI was not estimable due to insufficient number of events.
OG008NA(4.6 to NA)DOR median and 90% CI were not estimable due to insufficient number of events.
OG0098.8(7.4 to NA)The 90% CI was not estimable due to insufficient number of events.
OG010NA(NA to NA)DOR median and 90% CI were not estimable due to insufficient number of events.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG00018
OG00114
OG00210
OG0036
OG00413
OG0054
OG00626
OG0079
OG00820
OG00914
OG01019
Title
Denominators
Categories
Title
Measurements
OG00014.7(3.7 to NA)The 90% CI was not estimable due to insufficient number of events.
OG001NA(1.8 to NA)TTP median and 90% CI were not estimable due to insufficient number of events.
OG0026.4(1.8 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0035.3(1.3 to 8.7)
OG0043.7(1.9 to 6.4)
OG005NA(1.8 to NA)TTP median and 90% CI were not estimable due to insufficient number of events.
OG0069.1(7.2 to 17.3)
OG0079.0(3.6 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0086.2(3.7 to NA)The 90% CI was not estimable due to insufficient number of events.
Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG00018
OG00114
OG00210
OG0036
OG00413
OG0054
OG00626
OG0079
OG00820
OG00914
OG01019
Title
Denominators
Categories
Title
Measurements
OG0006.5(3.7 to 14.7)
OG001NA(1.7 to NA)PFS median and 90% CI were not estimable due to insufficient number of events.
OG0026.4(1.8 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0035.3(1.3 to 8.7)
OG0043.7(1.9 to 6.4)
OG005NA(1.8 to NA)PFS median and 90% CI were not estimable due to insufficient number of events.
OG0069.1(7.2 to 17.3)
OG0077.7(3.6 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0086.2(1.8 to NA)The 90% CI was not estimable due to insufficient number of events.
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
Units
Counts
Participants
OG00018
OG00114
OG00210
OG0036
OG00413
OG0054
OG00626
OG0079
OG00820
OG00914
OG01019
Title
Denominators
Categories
Title
Measurements
OG000NA(5.2 to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG001NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG002NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG003NA(5.4 to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG004NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG005NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG006NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG007NA(6.3 to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG008NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG009NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG010NA(5.1 to NA)OS median and 90% CI were not estimable due to insufficient number of events.