Phase 2 Study of Poziotinib in Participants With NSCLC Ha... | NCT03318939 | Trialant
NCT03318939
Sponsor
Spectrum Pharmaceuticals, Inc
Status
Terminated
Last Update Posted
Jun 12, 2026Actual
Enrollment
648Actual
Phase
Phase 2
Conditions
NSCLC
Interventions
Poziotinib
Countries
United States
Belgium
Canada
France
Israel
Italy
Netherlands
Spain
Protocol Section
Identification Module
NCT ID
NCT03318939
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SPI-POZ-202
Secondary IDs
Not provided
Brief Title
Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Official Title
A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)
Acronym
Not provided
Organization
Spectrum Pharmaceuticals, IncINDUSTRY
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic business decision (unrelated to safety)
Expanded Access Info
No
Start Date
Oct 11, 2017Actual
Primary Completion Date
Apr 3, 2023Actual
Completion Date
Apr 3, 2023Actual
First Submitted Date
Oct 10, 2017
First Submission Date that Met QC Criteria
Oct 20, 2017
First Posted Date
Oct 24, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Mar 19, 2026
Results First Submitted that Met QC Criteria
Jun 11, 2026
Results First Posted Date
Jun 12, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 1, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jun 12, 2026Actual
Last Update Submitted Date
Jun 11, 2026
Last Update Posted Date
Jun 12, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Spectrum Pharmaceuticals, IncINDUSTRY
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).
Detailed Description
The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Participant must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible participants will provide written Informed Consent prior to undergoing any study procedures.
Each treatment cycle is 28 calendar days in duration. There will be seven participant cohorts and eligible participants will be enrolled into each cohort in parallel based on epidermal growth factor receptor (EGFR) or human epidermal growth factor receptor 2 (HER2) exon 20 mutation status and prior treatment status:
Cohort 5: Participants who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed (closed to enrollment)
Cohort 6: Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib (closed to enrollment)
Cohort 7: Participants with EGFR or HER2 activating mutations (closed to enrollment)
Toxicity will be assessed based on the grade of the adverse events using CTCAE version 4.03.
On Day 1 of each 28-day cycle, the participant's absolute neutrophil count (ANC) must be ≥1.5×10^9/L and platelet count must be ≥100×10^9/L before administering poziotinib. All participants will be treated until disease progression (except for first progression in Cohort 5), death, intolerable adverse events (AEs), or other protocol-specified reasons for participant withdrawal.
Conditions Module
Conditions
NSCLC
Keywords
EGFR
HER2
Exon 20 insertion mutation
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
648Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Poziotinib 16 mg
Experimental
Participants previously treated for epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) received poziotinib, 16 milligrams (mg), orally, once daily (QD) in each 28-day cycle until disease progression, death, intolerable adverse events (AEs), or for up to a maximum of 35 months, whichever occurs first.
Drug: Poziotinib
Cohort 2: Poziotinib 16 mg
Experimental
Participants previously treated for human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
Drug: Poziotinib
Cohort 3: Poziotinib 16 mg
Experimental
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
Drug: Poziotinib
Cohort 4: Poziotinib 8 mg
Experimental
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, twice daily (BID) in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Poziotinib
Drug
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
Cohort 1: Poziotinib 16 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present.
Up to 3 years
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occur from the first dose of study treatment until 35 (±5) days after the last dose of study treatment.
Other Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) - Exploratory
PFS was defined as the time (in months) from the treatment start date to the first date of documented PD or death. Disease progression was defined as ≥20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Participant must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent
Prior treatment status:
Cohorts 1 and 2: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
Cohorts 3 and 4: Participant is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry.
Cohort 5: Participants who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed
Cohort 6: Participant with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib
Cohort 7: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
Specific mutations:
Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations
Cohort 6: Documented acquired EGFR mutation (tested after osimertinib progression)
Cohort 7: Documented EGFR or HER2 activating mutations
Participant has adequate organ function at Baseline
Key Exclusion Criteria:
Participant has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible (Cohorts 1 and 2).
Participant is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks or 5 half lives, whichever is longer; local radiation therapy for bone pain may be allowed
Participant has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully-treated and stable, early-stage prostate cancer, or carcinoma in situ of the cervix or breast without need of treatment
Le X, Cornelissen R, Garassino M, Clarke JM, Tchekmedyian N, Goldman JW, Leu SY, Bhat G, Lebel F, Heymach JV, Socinski MA. Poziotinib in Non-Small-Cell Lung Cancer Harboring HER2 Exon 20 Insertion Mutations After Prior Therapies: ZENITH20-2 Trial. J Clin Oncol. 2022 Mar 1;40(7):710-718. doi: 10.1200/JCO.21.01323. Epub 2021 Nov 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 648 participants were enrolled and dosed with Poziotinib.
Recruitment Details
Participants were enrolled at 62 investigative sites from 11 October 2017 to 03 April 2023.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Poziotinib 16 mg
Participants previously treated for epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) received poziotinib, 16 milligrams (mg), orally, once daily (QD) in each 28-day cycle until disease progression, death, intolerable adverse events (AEs), or for up to a maximum of 35 months, whichever occurs first.
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
Yes
No
No
Study Protocol
Feb 14, 2020
Mar 13, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Each treatment cycle is 28 calendar days in duration. There will be seven participant cohorts and eligible participants will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status and prior treatment status:
Cohort 1: Previously treated participants with EGFR exon 20 insertion mutant positive NSCLC (closed to enrollment)
Cohort 2: Previously treated participants with HER2 exon 20 insertion mutant positive NSCLC (closed to enrollment)
Cohort 5: Participants who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed
Cohort 6: Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib
Cohort 7: Participants with EGFR or HER2 activating mutations
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: Poziotinib
Cohort 4: Poziotinib 16 mg
Experimental
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
Drug: Poziotinib
Cohort 5: Poziotinib 6 mg
Experimental
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
Drug: Poziotinib
Cohort 5: Poziotinib 8mg
Experimental
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
Drug: Poziotinib
Cohort 5: Poziotinib 10 mg
Experimental
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
Drug: Poziotinib
Cohort 5: Poziotinib 12 mg
Experimental
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
Drug: Poziotinib
Cohort 5: Poziotinib 16 mg
Experimental
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
Drug: Poziotinib
Cohort 6: Poziotinib 8 mg
Experimental
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
Drug: Poziotinib
Cohort 6: Poziotinib 16 mg
Experimental
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
Drug: Poziotinib
Cohort 7: Poziotinib 8 mg
Experimental
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
Drug: Poziotinib
Cohort 7: Poziotinib 16 mg
Experimental
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
Drug: Poziotinib
Cohort 2: Poziotinib 16 mg
Cohort 3: Poziotinib 16 mg
Cohort 4: Poziotinib 16 mg
Cohort 4: Poziotinib 8 mg
Cohort 5: Poziotinib 10 mg
Cohort 5: Poziotinib 12 mg
Cohort 5: Poziotinib 16 mg
Cohort 5: Poziotinib 6 mg
Cohort 5: Poziotinib 8mg
Cohort 6: Poziotinib 16 mg
Cohort 6: Poziotinib 8 mg
Cohort 7: Poziotinib 16 mg
Cohort 7: Poziotinib 8 mg
Up to 5 years
Disease Control Rate (DCR)
DCR was defined as percentage of participants with best response of CR, PR, or stable disease (SD) from the first dose of poziotinib to the last tumor assessment on study. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. SD was defined as neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Up to 3 years
Duration of Response (DoR)
DoR was evaluated only for participants who had CR or PR and was defined as the time from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. Disease progression was defined as greater than or equal to (≥) 20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline, if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Up to 3 years
Up to 3 years
Arcadia
California
91007
United States
City of Hope
Duarte
California
91010
United States
UCSD -Moores Cancer Center
La Jolla
California
92093
United States
Pacific Shores Medical Group
Long Beach
California
90813
United States
Los Angeles Hematology Oncology Medical Group
Los Angeles
California
90017
United States
USC/Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
UC Davis Comprehensive Cancer Center
Sacramento
California
95817
United States
UCSF Helen Diller Comprehensive Cancer Center at Mt Zion
San Francisco
California
94115
United States
UCLA Hematology/Oncology
Santa Monica
California
90404
United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance
California
90502
United States
Kaiser Permanente Medical Center
Vallejo
California
94589
United States
Rocky Mountain Cancer Center
Boulder
Colorado
80303
United States
Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale
New Haven
Connecticut
06510
United States
Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
Florida Hospital
Orlando
Florida
32804
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
33612
United States
The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.
Winter Haven
Florida
33881
United States
University Cancer & Blood Center, LLC
Athens
Georgia
30607
United States
CTCA - Southeastern Regional Medical Center
Newnan
Georgia
30265
United States
CTCA - Midwestern Regional Medical Center
Zion
Illinois
60099
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
21287
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Minnesota Oncology Hematology, P.A.
Minneapolis
Minnesota
55404
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg
Mississippi
39401
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
NYU Langone Medical Center
New York
New York
10016
United States
Weill Cornell Medical College
New York
New York
10065
United States
North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists
Port Jefferson Station
New York
11776
United States
Montefiore Einstein Medical Center for Cancer Care
The Bronx
New York
10461
United States
North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists
The Bronx
New York
10469
United States
Duke University Medical Center
Durham
North Carolina
27710
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
The Ohio State University
Columbus
Ohio
43210
United States
Oklahoma Cancer Specialists and Research Institute, LLC
Gustave Roussy Oncology Institute, Department of Medical Oncology
Villejuif
France
Soroka Medical Center
Beersheba
Israel
Rambam Healthcare Campus
Haifa
Israel
Hadassah Medical Center
Jerusalem
Israel
Rabin Medical Center
Petah Tikva
Israel
National Cancer Institute, IRCCS, Department of Medical Oncology
Milan
Italy
Santa Maria delle Croci Hospital
Ravenna
Italy
National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1
Rome
Italy
Erasmus Medical Center
Rotterdam
Netherlands
University Hospital Germans Trias i Pujol, Department of Medical Oncology
Barcelona
Spain
University Hospital 12 de Octubre
Madrid
Spain
FG001
Cohort 2: Poziotinib 16 mg
Participants previously treated for human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
FG002
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
FG003
Cohort 4: Poziotinib 8 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, twice daily (BID) in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
FG004
Cohort 4: Poziotinib 16 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
FG005
Cohort 5: Poziotinib 6 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
FG006
Cohort 5: Poziotinib 8mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
FG007
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
FG008
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
FG009
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
FG010
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
FG011
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
FG012
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
FG013
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
FG000115 subjects
FG00190 subjects
FG00280 subjects
FG00333 subjects
FG00447 subjects
FG00538 subjects
FG006125 subjects
FG00735 subjects
FG00825 subjects
FG00926 subjects
FG0107 subjects
FG0111 subjects
FG01217 subjects
FG0139 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG000114 subjects
FG00190 subjects
FG00278 subjects
FG00333 subjects
FG00446 subjects
FG00538 subjects
FG006125 subjects
FG00735 subjects
FG00825 subjects
FG00926 subjects
FG0107 subjects
FG0111 subjects
FG01217 subjects
FG0139 subjects
Type
Comment
Reasons
Adverse Event
FG00016 subjects
FG00113 subjects
FG0029 subjects
FG0033 subjects
FG0041 subjects
FG0053 subjects
FG00616 subjects
FG0075 subjects
FG0083 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0122 subjects
FG0131 subjects
Initiation of Non-Protocol Therapy
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Disease Progression
FG00061 subjects
FG00153 subjects
FG00251 subjects
FG00321 subjects
FG004
Withdrawal by Subject
FG00014 subjects
FG0015 subjects
FG0028 subjects
FG0031 subjects
FG004
Delay of Poziotinib Administration For More Than 28 Days Since Last Administration
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Investigator Decision
FG0004 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG00014 subjects
FG00110 subjects
FG0027 subjects
FG0031 subjects
FG004
Reason Not Specified
FG0002 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG004
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Poziotinib 16 mg
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
BG001
Cohort 2: Poziotinib 16 mg
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
BG002
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
BG003
Cohort 4: Poziotinib 8 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
BG004
Cohort 4: Poziotinib 16 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
BG005
Cohort 5: Poziotinib 6 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
BG006
Cohort 5: Poziotinib 8mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
BG007
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
BG008
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
BG009
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
BG010
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
BG011
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
BG012
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
BG013
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000115
BG00190
BG00280
BG00333
BG00447
BG00538
BG006125
BG00735
BG00825
BG00926
BG0107
BG0111
BG01217
BG0139
BG014648
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.2± 12.38
BG00160.0± 11.69
BG00259.9± 10.44
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00077
BG00158
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0011
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
Objective Response Rate (ORR)
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present.
As-Treated Population included all participants who received at least one dose of study medication. Data for efficacy outcome measure was planned to be collected and analyzed combined (all doses) for cohorts 4,5, 6, and 7.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 years
ID
Title
Description
OG000
Cohort 1: Poziotinib 16 mg
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
OG001
Cohort 2: Poziotinib 16 mg
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
OG002
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
OG003
Cohort 4: Poziotinib
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
OG004
Cohort 5: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg/ 8 mg BID or 10 mg/ 12 mg/ 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
OG005
Cohort 6: Poziotinib
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
Units
Counts
Participants
OG000115
OG00190
OG00280
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.9(8.2 to 21.6)
OG00127.8(18.9 to 38.2)
OG0020(0 to 0)
OG003
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occur from the first dose of study treatment until 35 (±5) days after the last dose of study treatment.
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
Posted
Count of Participants
Participants
Up to 5 years
ID
Title
Description
OG000
Cohort 1: Poziotinib 16 mg
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
OG001
Cohort 2: Poziotinib 16 mg
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
OG002
Cohort 3: Poziotinib 16 mg
Secondary
Disease Control Rate (DCR)
DCR was defined as percentage of participants with best response of CR, PR, or stable disease (SD) from the first dose of poziotinib to the last tumor assessment on study. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. SD was defined as neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
As-Treated Population included all participants who received at least one dose of study medication. Data for efficacy outcome measure was planned to be collected and analyzed combined (all doses) for cohorts 4,5, 6, and 7.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 years
ID
Title
Description
OG000
Cohort 1: Poziotinib 16 mg
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
OG001
Cohort 2: Poziotinib 16 mg
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
Secondary
Duration of Response (DoR)
DoR was evaluated only for participants who had CR or PR and was defined as the time from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. Disease progression was defined as greater than or equal to (≥) 20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline, if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
As-Treated Population included all participants who received at least one dose of study medication. Data for efficacy outcome measure was planned to be collected and analyzed combined (all doses) for cohorts 4,5, 6, and 7.
Posted
Median
95% Confidence Interval
months
Up to 3 years
ID
Title
Description
OG000
Cohort 1: Poziotinib 16 mg
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
OG001
Other Pre-specified
Progression-free Survival (PFS) - Exploratory
PFS was defined as the time (in months) from the treatment start date to the first date of documented PD or death. Disease progression was defined as ≥20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Not Posted
Up to 3 years
Participants
Time Frame
Up to 5 years
Description
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
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
Cohort 1: Poziotinib 16 mg
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
16
115
50
115
115
115
EG001
Cohort 2: Poziotinib 16 mg
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
16
90
36
90
90
90
EG002
Cohort 3: Poziotinib, 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
14
80
35
80
80
80
EG003
Cohort 4: Poziotinib 8 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
6
33
12
33
33
33
EG004
Cohort 4: Poziotinib 16 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
8
47
18
47
47
47
EG005
Cohort 5: Poziotinib 6 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
11
38
13
38
37
38
EG006
Cohort 5: Poziotinib 8mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
24
125
38
125
124
125
EG007
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
7
35
10
35
35
35
EG008
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
14
25
14
25
25
25
EG009
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
4
26
12
26
26
26
EG010
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
1
7
1
7
6
7
EG011
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
0
1
0
1
1
1
EG012
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
6
17
9
17
17
17
EG013
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
5
9
3
9
9
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0015 affected90 at risk
EG0021 affected80 at risk
EG0030 affected33 at risk
EG0043 affected47 at risk
EG0050 affected38 at risk
EG0063 affected125 at risk
EG0070 affected35 at risk
EG0080 affected25 at risk
EG0091 affected26 at risk
EG0100 affected7 at risk
EG0110 affected1 at risk
EG0121 affected17 at risk
EG0130 affected9 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0012 affected90 at risk
EG0021 affected80 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected115 at risk
EG0010 affected90 at risk
EG0023 affected80 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected115 at risk
EG0016 affected90 at risk
EG0022 affected80 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0012 affected90 at risk
EG0020 affected80 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0014 affected90 at risk
EG0024 affected80 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0010 affected90 at risk
EG0022 affected80 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0014 affected90 at risk
EG0022 affected80 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0010 affected90 at risk
EG0022 affected80 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0024 affected80 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0012 affected90 at risk
EG0021 affected80 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0014 affected90 at risk
EG0020 affected80 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0022 affected80 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0021 affected80 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0021 affected80 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0021 affected80 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0013 affected90 at risk
EG0021 affected80 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0013 affected90 at risk
EG0021 affected80 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0014 affected90 at risk
EG0025 affected80 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0011 affected90 at risk
EG0023 affected80 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0011 affected90 at risk
EG0022 affected80 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0013 affected90 at risk
EG0020 affected80 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0023 affected80 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Lung consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Melaena
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Sudden death
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0012 affected90 at risk
EG0020 affected80 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0012 affected90 at risk
EG0020 affected80 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Eye pain
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Face oedema
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Haematoma
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0021 affected80 at risk
EG003
Pancreatitis relapsing
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Staphylococcus test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Superior vena cava occlusion
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0021 affected80 at risk
EG003
General physical health deterioration
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Embolism
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0023 affected80 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Troponin increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Vascular graft thrombosis
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Type III immune complex mediated reaction
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Euthanasia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Device occlusion
Product Issues
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Gastroenteritis radiation
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Coronavirus test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Ascites
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Coccidioidomycosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Pleural infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Death
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Distributive shock
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00094 affected115 at risk
EG00175 affected90 at risk
EG00270 affected80 at risk
EG00329 affected33 at risk
EG00439 affected47 at risk
EG00532 affected38 at risk
EG006111 affected125 at risk
EG00729 affected35 at risk
EG00822 affected25 at risk
EG00922 affected26 at risk
EG0105 affected7 at risk
EG0110 affected1 at risk
EG01217 affected17 at risk
EG0137 affected9 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00083 affected115 at risk
EG00160 affected90 at risk
EG00264 affected80 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00071 affected115 at risk
EG00162 affected90 at risk
EG00251 affected80 at risk
EG003
Paronychia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00057 affected115 at risk
EG00138 affected90 at risk
EG00253 affected80 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00056 affected115 at risk
EG00135 affected90 at risk
EG00233 affected80 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG00043 affected115 at risk
EG00136 affected90 at risk
EG00233 affected80 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00043 affected115 at risk
EG00128 affected90 at risk
EG00225 affected80 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG00040 affected115 at risk
EG00129 affected90 at risk
EG00235 affected80 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00035 affected115 at risk
EG00132 affected90 at risk
EG00230 affected80 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00034 affected115 at risk
EG00130 affected90 at risk
EG00234 affected80 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG00033 affected115 at risk
EG00119 affected90 at risk
EG00215 affected80 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00030 affected115 at risk
EG00116 affected90 at risk
EG00223 affected80 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00030 affected115 at risk
EG00120 affected90 at risk
EG00221 affected80 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00030 affected115 at risk
EG00124 affected90 at risk
EG00222 affected80 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG00021 affected115 at risk
EG0015 affected90 at risk
EG0026 affected80 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00021 affected115 at risk
EG00114 affected90 at risk
EG00220 affected80 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG00020 affected115 at risk
EG00121 affected90 at risk
EG0027 affected80 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG00020 affected115 at risk
EG00116 affected90 at risk
EG00214 affected80 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG00020 affected115 at risk
EG00112 affected90 at risk
EG0028 affected80 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00018 affected115 at risk
EG00118 affected90 at risk
EG00224 affected80 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG00018 affected115 at risk
EG00114 affected90 at risk
EG00221 affected80 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00018 affected115 at risk
EG0019 affected90 at risk
EG00212 affected80 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG00017 affected115 at risk
EG00110 affected90 at risk
EG0029 affected80 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00016 affected115 at risk
EG0017 affected90 at risk
EG0028 affected80 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00016 affected115 at risk
EG00116 affected90 at risk
EG00217 affected80 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG00015 affected115 at risk
EG0018 affected90 at risk
EG00219 affected80 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG00014 affected115 at risk
EG00116 affected90 at risk
EG00213 affected80 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG00014 affected115 at risk
EG0018 affected90 at risk
EG0026 affected80 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00013 affected115 at risk
EG00120 affected90 at risk
EG00211 affected80 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG00012 affected115 at risk
EG0018 affected90 at risk
EG00211 affected80 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00011 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG00010 affected115 at risk
EG0010 affected90 at risk
EG0025 affected80 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG00010 affected115 at risk
EG0017 affected90 at risk
EG0029 affected80 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG00010 affected115 at risk
EG0016 affected90 at risk
EG00210 affected80 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00010 affected115 at risk
EG0015 affected90 at risk
EG0026 affected80 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG00010 affected115 at risk
EG0017 affected90 at risk
EG00213 affected80 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00010 affected115 at risk
EG0019 affected90 at risk
EG00213 affected80 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00010 affected115 at risk
EG0010 affected90 at risk
EG0026 affected80 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0009 affected115 at risk
EG0018 affected90 at risk
EG0029 affected80 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0009 affected115 at risk
EG0017 affected90 at risk
EG0027 affected80 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0009 affected115 at risk
EG0010 affected90 at risk
EG0026 affected80 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0009 affected115 at risk
EG0018 affected90 at risk
EG00216 affected80 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0009 affected115 at risk
EG0018 affected90 at risk
EG0027 affected80 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0009 affected115 at risk
EG0015 affected90 at risk
EG0027 affected80 at risk
EG003
Pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0009 affected115 at risk
EG0010 affected90 at risk
EG0028 affected80 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected115 at risk
EG0014 affected90 at risk
EG0024 affected80 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0008 affected115 at risk
EG0018 affected90 at risk
EG0026 affected80 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0008 affected115 at risk
EG0017 affected90 at risk
EG0026 affected80 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0008 affected115 at risk
EG0010 affected90 at risk
EG0025 affected80 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0008 affected115 at risk
EG0014 affected90 at risk
EG00216 affected80 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0008 affected115 at risk
EG0018 affected90 at risk
EG0025 affected80 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0010 affected90 at risk
EG0022 affected80 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0011 affected90 at risk
EG0021 affected80 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0017 affected90 at risk
EG00211 affected80 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0016 affected90 at risk
EG0021 affected80 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0015 affected90 at risk
EG0027 affected80 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0013 affected90 at risk
EG0025 affected80 at risk
EG003
Chills
General disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0018 affected90 at risk
EG0025 affected80 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0012 affected90 at risk
EG0023 affected80 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected115 at risk
EG0010 affected90 at risk
EG0023 affected80 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0006 affected115 at risk
EG0016 affected90 at risk
EG0025 affected80 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected115 at risk
EG0016 affected90 at risk
EG0025 affected80 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected115 at risk
EG0016 affected90 at risk
EG0024 affected80 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected115 at risk
EG0010 affected90 at risk
EG0025 affected80 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected115 at risk
EG0010 affected90 at risk
EG0022 affected80 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected115 at risk
EG0017 affected90 at risk
EG0026 affected80 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0013 affected90 at risk
EG0020 affected80 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0016 affected90 at risk
EG0028 affected80 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0007 affected115 at risk
EG0017 affected90 at risk
EG0025 affected80 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0010 affected90 at risk
EG0021 affected80 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 affected115 at risk
EG0013 affected90 at risk
EG0024 affected80 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0014 affected90 at risk
EG0024 affected80 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0024 affected80 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0011 affected90 at risk
EG0024 affected80 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0011 affected90 at risk
EG0024 affected80 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0011 affected90 at risk
EG0024 affected80 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0014 affected90 at risk
EG0024 affected80 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0012 affected90 at risk
EG0020 affected80 at risk
EG003
Blood urea increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected115 at risk
EG0011 affected90 at risk
EG0020 affected80 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected115 at risk
EG0011 affected90 at risk
EG0023 affected80 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0010 affected90 at risk
EG0022 affected80 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0012 affected90 at risk
EG0022 affected80 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected115 at risk
EG0010 affected90 at risk
EG0024 affected80 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0012 affected90 at risk
EG0020 affected80 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0012 affected90 at risk
EG0020 affected80 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected115 at risk
EG0013 affected90 at risk
EG0020 affected80 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected115 at risk
EG0010 affected90 at risk
EG0020 affected80 at risk
EG003
Early termination of trial due to business reasons, not related to safety.
BG01134.0± NASince only one participant was included in this arm group, standard deviation was not evaluable.
BG01263.0± 11.35
BG01361.3± 6.14
BG01459.9± 5.59
45
BG00316
BG00425
BG00523
BG00685
BG00726
BG00819
BG00919
BG0105
BG0111
BG01215
BG0134
BG014418
Male
BG00038
BG00132
BG00235
BG00317
BG00422
BG00515
BG00640
BG0079
BG0086
BG0097
BG0102
BG0110
BG0122
BG0135
BG014230
0
BG0030
BG0043
BG0053
BG0062
BG0072
BG0081
BG0092
BG0100
BG0110
BG0120
BG0130
BG01423
Not Hispanic or Latino
BG000110
BG00185
BG00280
BG00333
BG00444
BG00535
BG006123
BG00733
BG00824
BG00924
BG0107
BG0111
BG01217
BG0139
BG014625
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
Asian
Title
Measurements
BG00018
BG00112
BG00215
BG0034
BG0047
BG0053
BG00617
BG0072
BG0080
BG0092
BG0103
BG0110
BG0125
BG0130
BG01488
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0001
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0143
Black or African American
Title
Measurements
BG00012
BG0014
BG0021
BG0031
BG0043
BG0055
BG00612
BG0073
BG0083
BG0090
BG0100
BG0110
BG0121
BG0131
BG01446
White
Title
Measurements
BG00077
BG00170
BG00261
BG00327
BG00435
BG00528
BG00690
BG00727
BG00821
BG00921
BG0104
BG0111
BG01211
BG0138
BG014481
Other
Title
Measurements
BG0007
BG0013
BG0022
BG0031
BG0042
BG0052
BG0066
BG0072
BG0081
BG0093
BG0100
BG0110
BG0120
BG0130
BG01429
OG006
Cohort 7: Poziotinib
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
80
OG004248
OG0058
OG00626
39
(28 to 50)
OG0040(0 to 0)
OG0050(0 to 0)
OG0060(0 to 0)
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
OG003
Cohort 4: Poziotinib 8 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
OG004
Cohort 4: Poziotinib 16 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg QD, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
OG005
Cohort 5: Poziotinib 6 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
OG006
Cohort 5: Poziotinib 8mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
OG007
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
OG008
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
OG009
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
OG010
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
OG011
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
OG012
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
OG013
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
Units
Counts
Participants
OG000115
OG00190
OG00280
OG00333
OG00447
OG00538
OG006125
OG00735
OG00825
OG00926
OG0107
OG0111
OG01217
OG0139
Title
Denominators
Categories
Title
Measurements
OG000115
OG00190
OG00280
OG00333
OG00447
OG00537
OG006124
OG00735
OG00825
OG00926
OG0106
OG0111
OG01217
OG0139
OG002
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
OG003
Cohort 4: Poziotinib
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
OG004
Cohort 5: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg/ 8 mg BID or 10 mg/ 12 mg/ 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
OG005
Cohort 6: Poziotinib
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
OG006
Cohort 7: Poziotinib
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
Units
Counts
Participants
OG000115
OG00190
OG00280
OG00380
OG004248
OG0058
OG00626
Title
Denominators
Categories
Title
Measurements
OG00067.8(58.5 to 76.2)
OG00170(59.4 to 79.2)
OG0020(0 to 0)
OG00373(61 to 82)
OG0040(0 to 0)
OG0050(0 to 0)
OG0060(0 to 0)
Cohort 2: Poziotinib 16 mg
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
OG002
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
OG003
Cohort 4: Poziotinib
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
OG004
Cohort 5: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg/ 8 mg BID or 10 mg/ 12 mg/ 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
OG005
Cohort 6: Poziotinib
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
OG006
Cohort 7: Poziotinib
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.