A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma
Official Title
A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A (Apilimod Dimesylate Capsules) Administered Orally in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Acronym
LAM-002A/NHL
Organization
OrphAI TherapeuticsINDUSTRY
Status Module
Record Verification Date
Aug 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2015
Primary Completion Date
Mar 9, 2020Actual
Completion Date
Mar 30, 2023Actual
First Submitted Date
Oct 29, 2015
First Submission Date that Met QC Criteria
Oct 30, 2015
First Posted Date
Nov 3, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 4, 2024
Results First Submitted that Met QC Criteria
Aug 19, 2024
Results First Posted Date
Aug 22, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 19, 2024
Last Update Posted Date
Aug 22, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
OrphAI TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.
Detailed Description
LAM-002A is supplied as 25-mg or 50-mg capsules and will be administered two times daily or three times daily by mouth in repeated 28-day cycles. Patients will be advised to take the doses at the same time each day.
A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The MTD is defined as the highest dose at which no more than 1 of 6 patients (i.e., < 33%) experiences a dose-limiting toxicity (DLT) in the dose cohort.
Once the dose and schedule are established, additional patients will be treated to better characterize the safety, tolerability,PK, PD, and anti-tumor activity of LAM-002A when administered alone or in combination with rituximab or atezolizumab.
All patients will take LAM-002A two times daily by mouth every day until cancer progression or intolerability.
Drug: LAM-002A
Intermittent monotherapy
Experimental
All patients will receive LAM-002A at escalating dose levels two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
Drug: LAM-002A
LAM-002A + rituximab
Experimental
All patients will receive LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab 375 mg/m2 by vein every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions)
Drug: Rituximab
LAM-002A + atezolizumab
Experimental
All patients will receive LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability
Drug: Atezolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LAM-002A
Drug
25 mg capsules or 50 mg capsules
Continuous monotherapy
Intermittent monotherapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A
MTD was determined by testing increasing doses up to 125 mg twice a day or 75 mg three times a day orally on dose escalation cohorts with 3 to 6 participants each. In the dose escalation, the cohort sizes of 3 to 6 subjects allow evaluation of regimen safety using a standard definition of MTD (ie, the highest starting dose associated with DLT in <33% of subjects during the first cycle of therapy) when administered continuously (daily administration) and then when administered intermittently (repeated courses of 3 days on and 4 days off).
28 days
Secondary Outcomes
Measure
Description
Time Frame
Peak Plasma Concentration (Cmax) of LAM-002A
Evaluation of the peak plasma concentration (Cmax) of LAM-002A and its metabolites in plasma on Day 1 and Day 8.
8 days
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Able to understand and comply with the protocol requirements and has signed the informed consent document.
Confirmed diagnosis of B-cell Non-Hodgkin's lymphoma limited to follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), primary mediastinal B-cell lymphoma (PMBL), or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has progressed and for which standard curative measures do not exist or are no longer effective. Prior therapy must have included a rituximab-based regimen.
Patients with DLBCL: Cancer progression after transplant, or be unwilling, unable or not an appropriate candidate for an autologous stem cell or bone marrow transplant
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of 1 or more lesions that measure at least 2.0 cm in the longest dimension (as assessed radiographically)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
Adequate organ and marrow function.
Able to swallow oral capsules without difficulty.
Acceptable birth control.
Women of childbearing potential : negative pregnancy test
Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral blood) for analysis of potential predictive biomarkers.
Exclusion Criteria:
Patients with central nervous system (CNS) lymphoma are not eligible for the trial unless the disease had been treated and the subject remains without symptoms with no active CNS lymphoma.
Not recovered from toxicity due to all prior therapies.
Other uncontrolled significant illness.
History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of LAM-002A
Major surgery within 28 days prior to first dose of study drug.
Past history of tuberculosis (TB) or active infection with TB, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
Lactation or breast feeding.
Unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee.
This is a shortened list and additional criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Langdon Miller, MD
AI Therapeutics
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clearview Cancer Institute
Huntsville
Alabama
35805
United States
Mayo Clinic
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
This study was conducted at 12 study centers in the United States, 11 of which enrolled subjects to the trial.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
FG001
LAM-002A Continuous Monotherapy - 100 mg BID
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
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Feb 18, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
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
apilimod dimesylate
Rituximab
Drug
375 mg/m2 by vein
LAM-002A + rituximab
rituxan
Atezolizumab
Drug
1200 mg by vein
LAM-002A + atezolizumab
Tecentriq
Evaluation of the Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration (AUClast) of LAM-002ALAM-002A and its metabolites in plasma on Day 1 and Day 8.
8 days
Objective Response Rate
Anti-tumor response as assessed by investigator according to modified Hallek or Lugano Response Criteria by Disease Type and Cohort
1 cycle (28 days) up to a maximum of 24 cycles
Jacksonville
Florida
32224
United States
Winship Cancer Institute at Emory University
Atlanta
Georgia
30322
United States
Horizon Oncology Research, Inc.
Lafayette
Indiana
47905
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
New York University School of Medicine
New York
New York
10016
United States
Weill Cornell Medical College
New York
New York
10021
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Virginia Cancer Specialists
Fairfax
Virginia
22031
United States
Virginia Mason Medical Center
Seattle
Washington
98101
United States
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
FG002
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
FG003
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
FG004
LAM-002A Intermittent Monotherapy - 150 mg BID
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
FG005
LAM-002A Continuous Monotherapy - 125 mg
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
FG006
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses).
Rituximab: 375 mg/m^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
FG007
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability
Atezolizumab: 1200 mg by vein
FG0003 subjects
FG0018 subjects
FG0025 subjects
FG0034 subjects
FG0043 subjects
FG00520 subjects
FG00612 subjects
FG0077 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0063 subjects
FG0070 subjects
NOT COMPLETED
FG0003 subjects
FG0018 subjects
FG0025 subjects
FG0034 subjects
FG0043 subjects
FG00519 subjects
FG0069 subjects
FG0077 subjects
Type
Comment
Reasons
Disease Progression
FG0003 subjects
FG0017 subjects
FG0020 subjects
FG0032 subjects
FG0042 subjects
FG00512 subjects
FG0065 subjects
FG0075 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Leukocytosis
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Substantial noncompliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full analysis set=All subjects who received ≥1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
BG001
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
BG002
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
BG003
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
BG004
LAM-002A Intermittent Monotherapy - 150 mg BID
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
BG005
LAM-002A Continuous Monotherapy - 125 mg
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
BG006
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses).
Rituximab: 375 mg/m^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
BG007
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability
Atezolizumab: 1200 mg by vein
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0018
BG0025
BG0034
BG0043
BG00520
BG00612
BG0077
BG00862
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
Age Category
Title
Measurements
<65 years
BG0002
BG0013
BG0021
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
White
BG0003
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity
Title
Measurements
Not Hispanic/Latino
BG0003
BG0018
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0, fully active, able to carry on all predisease performance without restrictions
BG0000
BG0015
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
Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A
MTD was determined by testing increasing doses up to 125 mg twice a day or 75 mg three times a day orally on dose escalation cohorts with 3 to 6 participants each. In the dose escalation, the cohort sizes of 3 to 6 subjects allow evaluation of regimen safety using a standard definition of MTD (ie, the highest starting dose associated with DLT in <33% of subjects during the first cycle of therapy) when administered continuously (daily administration) and then when administered intermittently (repeated courses of 3 days on and 4 days off).
Full analysis set=All subjects who receive ≥1 dose of study drug.
Posted
Number
mg BID
28 days
ID
Title
Description
OG000
All Participants
All participants who received at least 1 dose of LAM-002A, either at 50 mg BID, 100 mg BID, 150 mg BID, 75 mg TID, or 125 mg BID.
Units
Counts
Participants
OG00040
Title
Denominators
Categories
Title
Measurements
OG000125
Secondary
Peak Plasma Concentration (Cmax) of LAM-002A
Evaluation of the peak plasma concentration (Cmax) of LAM-002A and its metabolites in plasma on Day 1 and Day 8.
The PK population included all evaluable subjects who were dosed and had sufficient concentration-time data to estimate ≥1 of the planned PK parameters, as determined by the study pharmacokineticist.
Posted
Mean
Standard Deviation
ng/mL
8 days
ID
Title
Description
OG000
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG001
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG002
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG003
Secondary
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
Evaluation of the Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration (AUClast) of LAM-002ALAM-002A and its metabolites in plasma on Day 1 and Day 8.
The PK population included all evaluable subjects who were dosed and had sufficient concentration-time data to estimate ≥1 of the planned PK parameters, as determined by the study pharmacokineticist.
Posted
Mean
Standard Deviation
h*ng/mL
8 days
ID
Title
Description
OG000
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG001
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG002
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
Secondary
Objective Response Rate
Anti-tumor response as assessed by investigator according to modified Hallek or Lugano Response Criteria by Disease Type and Cohort
Full Analysis Set: All participants who received ≥1 dose of study drug.
Posted
Count of Participants
Participants
1 cycle (28 days) up to a maximum of 24 cycles
ID
Title
Description
OG000
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG001
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG002
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG003
LAM-002A Continuous Monotherapy - 75 mg TID
Time Frame
Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Description
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
0
3
0
3
3
3
EG001
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
1
8
3
8
8
8
EG002
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
1
5
1
5
5
5
EG003
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
0
4
2
4
4
4
EG004
LAM-002A Intermittent Monotherapy - 150 mg BID
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
0
3
0
3
3
3
EG005
LAM-002A Continuous Monotherapy - 125 mg BID
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
3
20
9
20
20
20
EG006
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses).
Rituximab: 375 mg/m^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
0
12
5
12
12
12
EG007
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability
Atezolizumab: 1200 mg by vein
3
7
6
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG004
Pancreatitis
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Disease progression
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lung infection
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Pneumocystis jirovecii pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lethargy
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood sodium decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected8 at risk
EG0023 affected5 at risk
EG0033 affected4 at risk
EG0040 affected3 at risk
EG0059 affected20 at risk
EG0066 affected12 at risk
EG0076 affected7 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected8 at risk
EG0022 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0023 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected8 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Sensitivity of teeth
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected8 at risk
EG0022 affected5 at risk
EG003
Asthenia
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0021 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Chills
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected8 at risk
EG0020 affected5 at risk
EG003
Disease progression
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Gait disturbance
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Adverse drug reaction
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Chest pain
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Eye complication associated with device
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Face oedema
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Oedema
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pain
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Injection site bruising
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hemoglobin decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected8 at risk
EG0020 affected5 at risk
EG003
Blood sodium decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected8 at risk
EG0022 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected8 at risk
EG0020 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected8 at risk
EG0020 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Blood potassium decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0022 affected5 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0023 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood glucose increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Blood albumin decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Blood calcium decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood glucose decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood uric acid increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0022 affected5 at risk
EG003
Ammonia increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Blood potassium increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Blood sodium increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Cardiac murmur
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Weight increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
White blood cell count increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Blood calcium increased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected8 at risk
EG0020 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0022 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0021 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Seizure
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Ageusia
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Asterixis
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Ataxia
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Lethargy
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Candida infection
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected8 at risk
EG0020 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Eye infection
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected8 at risk
EG0020 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0021 affected5 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Vitamin K deficiency
Metabolism and nutrition disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0022 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Agitation
Psychiatric disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Right ventricular enlargement
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Sinus arrhythmia
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Haemangioma of liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Cataract
Eye disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0021 affected5 at risk
EG003
Eye pain
Eye disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Diplopia
Eye disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected8 at risk
EG0020 affected5 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Sinus operation
Surgical and medical procedures
MedDRA Version 19.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected8 at risk
EG0020 affected5 at risk
EG003
Participants receiving LAM-002A with a regimen of 125 mg BID were accrued to both dose escalation (N=6) and then dose expansion (N=14), the results for the combined total (N=20) for this group is presented. Additionally, a MTD for the intermittent dosing regimen (3 days on and 4 days off every 7 days) was not established due to the shift of the trial to the dose expansion (monotherapy or combination therapy); the intermittent regimen was not further pursued after 3 subjects had been accrued.
1, restricted in physically strenuous activity but ambulatory and able to do light or sedentary work
BG0003
BG0013
BG0023
BG0032
BG0042
BG00511
BG0069
BG0076
BG00839
2, ambulatory and capable of all self-care but unable to work. Up more than 50% of waking hours
BG0000
BG0010
BG0021
BG0031
BG0040
BG0052
BG0060
BG0070
BG0084
3, capable of only limited self-care, confined to bed or chair more than 50% of waking hours
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0081
LAM-002A Continuous Monotherapy - 125 mg BID
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG004
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG005
LAM-002A Intermittent Monotherapy - 150 mg
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
Units
Counts
Participants
OG0003
OG0013
OG0028
OG0036
OG0045
OG0053
Title
Denominators
Categories
Apilimod - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG000117± 69.6
OG001158± 61.6
OG002263± 168
OG003
Apilimod - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0036
STA-5908 - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
STA-5908 - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0035
STA-5944 - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
STA-5944 - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0035
STA-6048 - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
STA-6048 - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0035
OG003
LAM-002A Continuous Monotherapy - 125 mg BID
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG004
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG005
LAM-002A Intermittent Monotherapy - 150 mg BID
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
Units
Counts
Participants
OG0003
OG0013
OG0028
OG0036
OG0045
OG0053
Title
Denominators
Categories
Apilimod - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG000238± 88.1
OG001583± 290
OG002515± 221
OG003
Apilimod - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0035
STA-5944 - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
STA-5944 - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0035
STA-5908 - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
STA-5908 - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0035
STA-6048 - Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0036
STA-6048 - Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0035
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG004
LAM-002A Intermittent Monotherapy - 150 mg BID
All participants received LAM-002A at escalating dose levels two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG005
LAM-002A Continuous Monotherapy - 125 mg
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability.
LAM-002A: 25 mg capsules or 50 mg capsules
OG006
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses).
Rituximab: 375 mg/m^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
OG007
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability
Atezolizumab: 1200 mg by vein
Units
Counts
Participants
OG0003
OG0018
OG0025
OG0034
OG0043
OG00520
OG00612
OG0077
Title
Denominators
Categories
DLBCL (diffuse large B-cell lymphoma)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0041
ParticipantsOG0059
ParticipantsOG0062
ParticipantsOG0074
Title
Measurements
OG0000
OG0010
OG0020
OG003
FL (follicular lymphoma)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
MZL (marginal zone lymphoma)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
MCL (mantle cell lymphoma)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
CLL/SLL (chronic lymphocytic leukemia/ small lymphocytic lymphoma)