Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressin... | NCT02709889 | Trialant
NCT02709889
Sponsor
AbbVie
Status
Terminated
Last Update Posted
Oct 19, 2020Actual
Enrollment
200Actual
Phase
Phase 1Phase 2
Conditions
Malignant Melanoma
Medullary Thyroid Cancer
Glioblastoma
Large-Cell Neuroendocrine Carcinoma
Neuroendocrine Prostate Cancer
High Grade Gastroenteropancreatic Neuroendocrine Carcinoma
Other Neuroendocrine Carcinoma
Other Solid Tumors
Interventions
Rovalpituzumab tesirine
Dexamethasone
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02709889
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SCRX001-006
Secondary IDs
Not provided
Brief Title
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
Official Title
An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Sep 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic considerations
Expanded Access Info
No
Start Date
Sep 23, 2016Actual
Primary Completion Date
Aug 27, 2019Actual
Completion Date
Aug 27, 2019Actual
First Submitted Date
Mar 2, 2016
First Submission Date that Met QC Criteria
Mar 10, 2016
First Posted Date
Mar 16, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 11, 2020
Results First Submitted that Met QC Criteria
Sep 21, 2020
Results First Posted Date
Oct 19, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 21, 2020
Last Update Posted Date
Oct 19, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.
Detailed Description
This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation part A followed by an expansion part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other NEC, and solid tumors other than the above.
Conditions Module
Conditions
Malignant Melanoma
Medullary Thyroid Cancer
Glioblastoma
Large-Cell Neuroendocrine Carcinoma
Neuroendocrine Prostate Cancer
High Grade Gastroenteropancreatic Neuroendocrine Carcinoma
Other Neuroendocrine Carcinoma
Other Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
200Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Rovalpituzumab Tesirine
Experimental
Rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Drug: Rovalpituzumab tesirine
Drug: Dexamethasone
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Rovalpituzumab tesirine
Drug
Rovalpituzumab Tesirine
SC16LD6.5
Dexamethasone
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups
The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.
From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
ORR is defined as percentage of participants whose best overall response was either complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum life expectancy of at least 12 weeks
Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
Adequate hematologic and organ function as confirmed by laboratory values
Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 [PD-1], anti-programmed death-ligand 1 [PD-L1], or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).
Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
Exclusion Criteria:
Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
Recent or ongoing serious infection, including:
Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version [NCI CTCAE] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
Known seropositivity for or active infection by human immunodeficiency virus (HIV).
Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
Women who are pregnant or breastfeeding
Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on pap smear.
Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol
Xie H, Kaye FJ, Isse K, Sun Y, Ramoth J, French DM, Flotte TJ, Luo Y, Saunders LR, Mansfield AS. Delta-Like Protein 3 Expression and Targeting in Merkel Cell Carcinoma. Oncologist. 2020 Sep;25(9):810-817. doi: 10.1634/theoncologist.2019-0877. Epub 2020 May 14.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants were enrolled into a standard 3+3 dose-escalation study within disease-specific cohorts in Part A, and then participants were enrolled into a disease-specific expansion cohort in Part B based on the maximum tolerated dose determined in Part A.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Rovalpituzumab Tesirine 0.2 mg/kg
Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 19, 2018
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
N/A
Intervention Model
Single Group 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
Drug
Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).
Rovalpituzumab Tesirine
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressed disease (PD), taking as reference the smallest sum diameters while on study. SD criteria must have met at least once after study entry at a minimum interval of 42 days (-7 days to allow for scheduled visit window per the protocol).
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Duration of Response (DOR)
DOR is defined as the time from the first assessment on therapy of a CR or PR response (per RECIST v1.1) to the date of progressive disease or death. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have progression were censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Progression Free Survival (PFS)
PFS is defined as the time from the first dose date to the date of disease progression or death. Participants who did not have progression or death are censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Overall Survival (OS)
Overall survival is defined as the time from the first dose date to death for any reason. Subjects who were alive at the clinical data cut-off are censored at the last known alive date. Based on Kaplan-Meier estimates.
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Serum Concentrations of Rovalpituzumab Tesirine Over Time
Number of Participants With Anti-therapeutic Antibodies (ATA)
Number of participants treated across each dose level reported to potentially have ATAs against rovalpituzumab tesirine at any time during the study.
Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).
Scottsdale
Arizona
85259
United States
University of California, Los Angeles /ID# 155429
Los Angeles
California
90095
United States
Univ California, San Francisco /ID# 155409
San Francisco
California
94143-2204
United States
Cedars-Sinai Medical Center - West Hollywood /ID# 155428
West Hollywood
California
90048
United States
Univ of Colorado Cancer Center /ID# 155415
Aurora
Colorado
80045
United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 155420
Denver
Colorado
80218
United States
University of Florida - Archer /ID# 155414
Gainesville
Florida
32610
United States
Moffitt Cancer Center /ID# 170220
Tampa
Florida
33612-9416
United States
Emory University Hospital /ID# 155417
Atlanta
Georgia
30322
United States
University of Kentucky Chandler Medical Center /ID# 155423
Lexington
Kentucky
40536
United States
Johns Hopkins University /ID# 155412
Baltimore
Maryland
21287
United States
Massachusetts General Hospital /ID# 155411
Boston
Massachusetts
02114
United States
Dana-Farber Cancer Institute /ID# 171044
Boston
Massachusetts
02215
United States
Mayo Clinic - Rochester /ID# 155416
Rochester
Minnesota
55905-0001
United States
Washington University-School of Medicine /ID# 155425
St Louis
Missouri
63110
United States
Rutgers Cancer Institute of NJ /ID# 162010
New Brunswick
New Jersey
08903
United States
University of New Mexico /ID# 205054
Albuquerque
New Mexico
87102
United States
Roswell Park Comprehensive Cancer Center /ID# 162015
Buffalo
New York
14263
United States
Weill Cornell Medical College /ID# 155418
New York
New York
10021
United States
Duke University Medical Center /ID# 155421
Durham
North Carolina
27710-3000
United States
Univ Hosp Cleveland /ID# 155410
Cleveland
Ohio
44106
United States
Oregon Health and Science University /ID# 162011
Portland
Oregon
97239
United States
Greenville Hospital System /ID# 155427
Greenville
South Carolina
29605
United States
Mary Crowley Cancer Research /ID# 162014
Dallas
Texas
75230
United States
Texas Oncology - Forth Worth /ID# 162045
Fort Worth
Texas
76104-2150
United States
University of Texas MD Anderson Cancer Center /ID# 155413
Houston
Texas
77030
United States
University of Utah /ID# 155426
Salt Lake City
Utah
84112-5500
United States
Virginia Cancer Specialists /ID# 162006
Fairfax
Virginia
22031
United States
Northwest Cancer Specialists, P.C. /ID# 155431
Vancouver
Washington
98684
United States
Part A: Rovalpituzumab Tesirine 0.3 mg/kg
Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
FG002
Part A: Rovalpituzumab Tesirine 0.4 mg/kg
Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
FG003
Part B: Rovalpituzumab Tesirine 0.3 mg/kg
Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
FG00043 subjects
FG00157 subjects
FG00212 subjects
FG00388 subjects
Large Cell Neuroendocrine Carcinoma(NEC)
FG0003 subjects
FG0014 subjects
FG0022 subjects
FG0034 subjects
Neuroendocrine Prostate Cancer
FG0004 subjects
FG0017 subjects
FG0023 subjects
FG0037 subjects
Gastroenteropancreatic NEC
FG0006 subjects
FG0015 subjects
FG0022 subjects
FG00323 subjects
Other NEC
FG00011 subjects
FG00112 subjects
FG0021 subjects
FG0037 subjects
Malignant Melanoma
FG0003 subjects
FG0016 subjects
FG0020 subjects
FG00311 subjects
Medullary Thyroid Cancer
FG0003 subjects
FG0013 subjects
FG0020 subjects
FG0037 subjects
Glioblastoma
FG0004 subjects
FG0014 subjects
FG0021 subjects
FG00314 subjects
Other Solid Tumors
FG0009 subjects
FG00116 subjects
FG0023 subjects
FG00315 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00043 subjects
FG00157 subjects
FG00212 subjects
FG00388 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00011 subjects
FG00110 subjects
FG0022 subjects
FG00312 subjects
Death
FG00025 subjects
FG00138 subjects
FG0024 subjects
FG00344 subjects
Physician Decision
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0035 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
Study Terminated by Sponsor
FG0004 subjects
FG0016 subjects
FG0022 subjects
FG00317 subjects
Other, Not Specified
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0036 subjects
Baseline characteristics are presented by disease-specific cohorts, inclusive of participants in parts A and B.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Large Cell Neuroendocrine Carcinoma
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG001
Neuroendocrine Prostate Cancer
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG002
Gastroenteropancreatic Neuroendocrine Carcinoma
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG003
Other Neuroendocrine Carcinoma
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG004
Malignant Melanoma
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG005
Medullary Thyroid Cancer
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG006
Glioblastoma
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG007
Other Solid Tumors
Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG00121
BG00236
BG00331
BG00420
BG00513
BG00623
BG00743
BG008200
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
< 65 years old
Title
Measurements
BG0007
BG0017
BG00225
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00011
BG00117
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
Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups
The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.
Safety Analysis Set: participants who received any amount of study drug. Presented by NEC/Non-NEC groups, inclusive of participants in parts A and B.
Posted
Number
participants
From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).
ID
Title
Description
OG000
NEC: 0.2 mg/kg
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
NEC: 0.3 mg/kg
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG002
NEC: 0.4 mg/kg
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG003
NEC: Any Dose
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Units
Counts
Participants
OG00024
OG00169
OG0028
OG003
Title
Denominators
Categories
≥ 1 TEAE
Title
Measurements
OG00024
OG00169
OG0028
OG003
Secondary
Objective Response Rate (ORR)
ORR is defined as percentage of participants whose best overall response was either complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
ID
Title
Description
OG000
Large Cell Neuroendocrine Carcinoma
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
Neuroendocrine Prostate Cancer
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Secondary
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressed disease (PD), taking as reference the smallest sum diameters while on study. SD criteria must have met at least once after study entry at a minimum interval of 42 days (-7 days to allow for scheduled visit window per the protocol).
Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
ID
Title
Description
OG000
Large Cell Neuroendocrine Carcinoma
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
Neuroendocrine Prostate Cancer
Secondary
Duration of Response (DOR)
DOR is defined as the time from the first assessment on therapy of a CR or PR response (per RECIST v1.1) to the date of progressive disease or death. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have progression were censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
Full Analysis Set: All enrolled participants who received any amount of study drug. Responders (CR or PR response). Presented by disease-specific groups, inclusive of participants in parts A and B.
Posted
Median
95% Confidence Interval
months
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
ID
Title
Description
OG000
Large Cell Neuroendocrine Carcinoma
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
Neuroendocrine Prostate Cancer
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Secondary
Progression Free Survival (PFS)
PFS is defined as the time from the first dose date to the date of disease progression or death. Participants who did not have progression or death are censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B.
Posted
Median
95% Confidence Interval
months
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
ID
Title
Description
OG000
Large Cell Neuroendocrine Carcinoma
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
Neuroendocrine Prostate Cancer
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG002
Secondary
Overall Survival (OS)
Overall survival is defined as the time from the first dose date to death for any reason. Subjects who were alive at the clinical data cut-off are censored at the last known alive date. Based on Kaplan-Meier estimates.
Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B.
Posted
Median
95% Confidence Interval
months
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
ID
Title
Description
OG000
Large Cell Neuroendocrine Carcinoma
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
Neuroendocrine Prostate Cancer
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG002
Gastroenteropancreatic Neuroendocrine Carcinoma
Secondary
Serum Concentrations of Rovalpituzumab Tesirine Over Time
Participants who received at least 1 dose of study drug and had an assessment at given time point. Presented by dose-specific groups, inclusive of participants in parts A and B.
Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
0.3 mg/kg
Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG002
0.4 mg/kg
Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Secondary
Number of Participants With Anti-therapeutic Antibodies (ATA)
Number of participants treated across each dose level reported to potentially have ATAs against rovalpituzumab tesirine at any time during the study.
Participants who received at least 1 dose of study drug with available ATA data. Presented by dose-specific groups, inclusive of participants in parts A and B.
Posted
Number
participants
Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).
ID
Title
Description
OG000
0.2 mg/kg
Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG001
0.3 mg/kg
Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG002
0.4 mg/kg
Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Time Frame
From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).
Description
No participants with malignant melanoma (MM) or medullary thyroid cancer (MTC) received the rovalpituzumab tesirine 0.4 mg/kg dose.
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
0.2_mg_kg_(LCNEC)
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
1
3
2
3
3
3
EG001
0.2_mg_kg_(NEPC)
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
3
4
3
4
4
4
EG002
0.2_mg_kg_(GEPNEC)
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle.
Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
5
6
2
6
6
6
EG003
0.2_mg_kg_(Other_NEC)
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
9
11
9
11
11
11
EG004
0.2_mg_kg_(MM)
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
3
3
2
3
3
3
EG005
0.2_mg_kg_(MTC)
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
0
3
1
3
3
3
EG006
0.2_mg_kg_(GBM)
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
4
4
2
4
4
4
EG007
0.2_mg_kg_(Other_Solid)
Participants with other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
6
9
5
9
8
9
EG008
0.3_mg_kg_(LCNEC)
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
6
8
6
8
8
8
EG009
0.3_mg_kg_(NEPC)
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11
14
8
14
14
14
EG010
0.3_mg_kg_(GEPNEC)
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle.
Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
16
28
15
28
27
28
EG011
0.3_mg_kg_(Other_NEC)
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
12
19
10
19
19
19
EG012
0.3_mg_kg_(MM)
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
10
17
8
17
16
17
EG013
0.3_mg_kg_(MTC)
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
3
10
3
10
10
10
EG014
0.3_mg_kg_(GBM)
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
13
18
8
18
18
18
EG015
0.3_mg_kg_(Other_Solid)
Participants with other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
25
31
19
31
31
31
EG016
0.4_mg_kg_(GBM)
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
0
1
0
1
1
1
EG017
0.4_mg_kg_(GEPNEC)
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle.
Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
2
2
2
2
2
2
EG018
0.4_mg_kg_(LCNEC)
Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
0
2
1
2
2
2
EG019
0.4_mg_kg_(NEPC)
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
2
3
2
3
3
3
EG020
0.4_mg_kg_(Other_NEC)
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
0
1
0
1
1
1
EG021
0.4_mg_kg_(Other_Solid)
Participants with other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
2
3
3
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected11 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected14 at risk
EG0100 events0 affected28 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected17 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected18 at risk
EG0150 events0 affected31 at risk
EG0160 events0 affected1 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected2 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected1 at risk
EG0210 events0 affected3 at risk
Pancytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Generalised oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Clostridial sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Device related infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Liver function test increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Troponin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Embolism
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Subclavian artery thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0005 events2 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG00317 events4 affected11 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected9 at risk
EG0082 affected8 at risk
EG0095 affected14 at risk
EG01010 affected28 at risk
EG0116 affected19 at risk
EG0123 affected17 at risk
EG0131 affected10 at risk
EG0141 affected18 at risk
EG01526 events14 affected31 at risk
EG0160 events0 affected1 at risk
EG0171 events1 affected2 at risk
EG0180 events0 affected2 at risk
EG0194 events2 affected3 at risk
EG0200 events0 affected1 at risk
EG0211 events1 affected3 at risk
Hypercoagulation
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Diplopia
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye irritation
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye pain
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye swelling
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Orbital oedema
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Photophobia
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Uveitis
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0024 events2 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected6 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events2 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lip haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Malabsorption
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0024 events2 affected6 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pancreatic failure
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Catheter site pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Catheter site vesicles
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Early satiety
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Effusion
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Face oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Facial pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0026 events3 affected6 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Generalised oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hernia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Infusion site erythema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Injection site reaction
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Localised oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mass
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events1 affected6 at risk
EG003
Pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Tenderness
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ocular icterus
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Portal fibrosis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Immunodeficiency
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Paronychia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Perineal cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Purulent discharge
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Heart rate increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Troponin I increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Weight increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0024 events2 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fluid intake reduced
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected6 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vitamin B6 deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypercreatinaemia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Asterixis
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral haematoma
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Device occlusion
Product Issues
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Compulsions
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Proteinuria
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Renal vein thrombosis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Penile pain
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Perineal pain
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Scrotal erythema
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sexual dysfunction
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acquired diaphragmatic eventration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea paroxysmal nocturnal
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hiccups
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events2 affected6 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nail bed disorder
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events1 affected6 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected6 at risk
EG003
Toxic erythema of chemotherapy
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG005
Non-NEC: 0.3 mg/kg
Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG006
Non-NEC: 0.4 mg/kg
Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG007
Non-NEC: Any Dose
Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
101
OG00419
OG00576
OG0064
OG00799
101
OG00418
OG00575
OG0064
OG00797
≥ 1 TEAE, Grade 3-4
Title
Measurements
OG00020
OG00140
OG0025
OG00365
OG00410
OG00538
OG0064
OG00752
≥ 1 TEAE, Grade 5
Title
Measurements
OG0001
OG00113
OG0022
OG00316
OG0043
OG0058
OG0060
OG00711
≥ 1 Serious TEAE
Title
Measurements
OG00016
OG00139
OG0025
OG00360
OG00410
OG00538
OG0063
OG00751
≥ 1 Serious TEAE, Grade 3-4
Title
Measurements
OG00016
OG00124
OG0023
OG00343
OG0046
OG00525
OG0063
OG00734
≥ 1 Serious TEAE, Grade 5
Title
Measurements
OG0000
OG00113
OG0022
OG00315
OG0043
OG0058
OG0060
OG00711
≥ 1 Drug-Related (DR) Serious TEAE
Title
Measurements
OG0006
OG00120
OG0023
OG00329
OG0043
OG00514
OG0063
OG00720
≥ 1 DR Serious TEAE, Grade 3-4
Title
Measurements
OG0006
OG00115
OG0021
OG00322
OG0043
OG0058
OG0063
OG00714
≥ 1 DR Serious TEAE, Grade 5
Title
Measurements
OG0000
OG0012
OG0022
OG0034
OG0040
OG0052
OG0060
OG0072
≥ 1 DR TEAE
Title
Measurements
OG00021
OG00164
OG0028
OG00393
OG00416
OG00568
OG0064
OG00788
≥ 1 DR TEAE, Grade 3-4
Title
Measurements
OG00014
OG00143
OG0023
OG00360
OG0046
OG00527
OG0064
OG00737
≥ 1 DR TEAE, Grade 5
Title
Measurements
OG0000
OG0012
OG0022
OG0034
OG0040
OG0052
OG0060
OG0072
≥1 TEAE Leading to Study Drug Discontinuation (DC)
Title
Measurements
OG0004
OG00115
OG0025
OG00324
OG0045
OG00510
OG0062
OG00714
≥ 1 TEAE Leading to Study Drug DC, Grade 3-4
Title
Measurements
OG0002
OG00111
OG0022
OG00315
OG0044
OG0054
OG0062
OG0078
≥1 TEAE Leading to Study Drug DC, Grade 5
Title
Measurements
OG0000
OG0011
OG0022
OG0033
OG0041
OG0052
OG0060
OG0072
≥ 1 DR TEAE Leading to Study Drug DC
Title
Measurements
OG0004
OG00110
OG0024
OG00318
OG0042
OG00510
OG0062
OG00714
≥ 1 DR TEAE Leading to Study Drug DC, Grade 3-4
Title
Measurements
OG0002
OG0017
OG0021
OG00310
OG0042
OG0054
OG0062
OG0078
≥ 1 DR TEAE Leading to Study Drug DC, Grade 5
Title
Measurements
OG0000
OG0011
OG0022
OG0033
OG0040
OG0052
OG0060
OG0072
≥ 1 TEAE Leading to Dose Reduction
Title
Measurements
OG0000
OG0017
OG0022
OG0039
OG0040
OG0057
OG0060
OG0077
≥ 1 TEAE Leading to Dose Reduction, Grade 3-4
Title
Measurements
OG0000
OG0015
OG0021
OG0036
OG0040
OG0054
OG0060
OG0074
≥ 1 TEAE Leading to Dose Reduction, Grade 5
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
Gastroenteropancreatic Neuroendocrine Carcinoma
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG003
Other Neuroendocrine Carcinoma
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG004
Malignant Melanoma
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG005
Medullary Thyroid Cancer
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG006
Glioblastoma
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG007
Other Solid Tumors
Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Units
Counts
Participants
OG00013
OG00121
OG00236
OG00331
OG00420
OG00513
OG00623
OG00743
Title
Denominators
Categories
Title
Measurements
OG0007.7(0.2 to 36.0)
OG0014.8(0.1 to 23.8)
OG00213.9(4.7 to 29.5)
OG00322.6(9.6 to 41.1)
OG00410.0(1.2 to 31.7)
OG00515.4(1.9 to 45.4)
OG0064.3(0.1 to 21.9)
OG0074.7(0.6 to 15.8)
Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG002
Gastroenteropancreatic Neuroendocrine Carcinoma
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG003
Other Neuroendocrine Carcinoma
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG004
Malignant Melanoma
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG005
Medullary Thyroid Cancer
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG006
Glioblastoma
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG007
Other Solid Tumors
Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Units
Counts
Participants
OG00013
OG00121
OG00236
OG00331
OG00420
OG00513
OG00623
OG00743
Title
Denominators
Categories
Title
Measurements
OG00076.9(46.2 to 95.0)
OG00176.2(52.8 to 91.8)
OG00263.9(46.2 to 79.2)
OG00361.3(42.2 to 78.2)
OG00460.0(36.1 to 80.9)
OG00576.9(46.2 to 95.0)
OG00630.4(13.2 to 52.9)
OG00746.5(31.2 to 62.3)
OG002
Gastroenteropancreatic Neuroendocrine Carcinoma
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG003
Other Neuroendocrine Carcinoma
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG004
Malignant Melanoma
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG005
Medullary Thyroid Cancer
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG006
Glioblastoma
Participants with glioblastoma (GBM) who received rovalpituzumab rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG007
Other Solid Tumors
Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Units
Counts
Participants
OG0002
OG0014
OG0029
OG0038
OG0043
OG0052
OG0061
OG0073
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.
OG0013.0(2.8 to 3.1)
OG0022.6(0.5 to 3.7)
OG0036.7(2.0 to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.
OG004NA(2.9 to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.
OG005NA(4.5 to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.
OG0064.6(NA to NA)1 participant analyzed
OG0073.9(0.4 to 4.1)
Gastroenteropancreatic Neuroendocrine Carcinoma
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG003
Other Neuroendocrine Carcinoma
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG004
Malignant Melanoma
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG005
Medullary Thyroid Cancer
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG006
Glioblastoma
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG007
Other Solid Tumors
Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Units
Counts
Participants
OG00013
OG00121
OG00236
OG00331
OG00420
OG00513
OG00623
OG00743
Title
Denominators
Categories
Title
Measurements
OG0004.6(1.2 to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.
OG0014.5(2.5 to 5.7)
OG0023.3(2.3 to 5.0)
OG0033.1(1.3 to 6.0)
OG0042.9(1.3 to 3.7)
OG00511.7(1.3 to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.
OG0061.4(1.3 to 2.5)
OG0072.1(1.3 to 3.3)
Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG003
Other Neuroendocrine Carcinoma
Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG004
Malignant Melanoma
Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG005
Medullary Thyroid Cancer
Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG006
Glioblastoma
Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
OG007
Other Solid Tumors
Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Units
Counts
Participants
OG00013
OG00121
OG00236
OG00331
OG00420
OG00513
OG00623
OG00743
Title
Denominators
Categories
Title
Measurements
OG0007.7(2.4 to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.
OG0015.7(2.7 to 7.3)
OG0026.7(3.9 to 9.7)
OG0036.6(4.3 to 12.2)
OG0047.5(3.6 to 9.2)
OG005NA(6.0 to NA)NA=Not Estimable. Statistic could not be estimated due to an insufficient number of participants with progressive disease.