Basket Study of Tucatinib and Trastuzumab in Solid Tumors... | NCT04579380 | Trialant
NCT04579380
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Status
Active, not recruiting
Last Update Posted
Dec 19, 2025Actual
Enrollment
217Actual
Phase
Phase 2
Conditions
Uterine Neoplasms
Uterine Cervical Neoplasms
Biliary Tract Neoplasms
Urologic Neoplasms
Carcinoma, Non-Small-Cell Lung
HER2 Mutations Breast Neoplasms
Interventions
tucatinib
trastuzumab
fulvestrant
Countries
United States
Belgium
Germany
Italy
Japan
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04579380
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SGNTUC-019
Secondary IDs
Not provided
Brief Title
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
Official Title
A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
Acronym
Not provided
Organization
Seagen Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 11, 2021Actual
Primary Completion Date
Nov 1, 2023Actual
Completion Date
Apr 30, 2026Estimated
First Submitted Date
Oct 1, 2020
First Submission Date that Met QC Criteria
Oct 1, 2020
First Posted Date
Oct 8, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Oct 16, 2024
Results First Submitted that Met QC Criteria
Oct 16, 2024
Results First Posted Date
Nov 13, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 3, 2025
Last Update Posted Date
Dec 19, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Seagen, a wholly owned subsidiary of PfizerINDUSTRY
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 trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable).
All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant.
The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.
Detailed Description
There are multiple cohorts in this trial:
5 tumor specific cohorts with HER2 overexpression/amplification (cervical cancer, uterine cancer, biliary tract cancer, urothelial cancer, and non-squamous non-small cell lung cancer [NSCLC])
2 tumor specific cohorts with HER2 mutations (non-squamous NSCLC and breast cancer)
2 cohorts which will enroll all other HER2 amplified/overexpressed solid tumor types (except breast cancer, gastric or gastroesophageal junction adenocarcinoma [GEC], and colorectal cancer [CRC]) or HER2-mutated solid tumor types.
Conditions Module
Conditions
Uterine Neoplasms
Uterine Cervical Neoplasms
Biliary Tract Neoplasms
Urologic Neoplasms
Carcinoma, Non-Small-Cell Lung
HER2 Mutations Breast Neoplasms
Keywords
Cervical cancer
Uterine cancer
Biliary tract cancer
Urothelial cancer
Non-squamous non-small cell lung cancer
Non-squamous NSCLC
Breast cancer
Colorectal cancer
Ampullary cancer
Solid tumors
Solid tumors harboring somatic HER2 mutations
Seattle Genetics
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
217Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tucatinib + Trastuzumab (+ Fulvestrant)
Experimental
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
Drug: tucatinib
Drug: trastuzumab
Drug: fulvestrant
Interventions
Name
Type
Description
Arm Group Labels
Other Names
tucatinib
Drug
300 mg orally twice daily
Tucatinib + Trastuzumab (+ Fulvestrant)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Confirmed Objective Response Rate (cORR) as Assessed by Investigator
Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: at least a greater than or equal to (>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least >=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).
From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
Secondary Outcomes
Measure
Description
Time Frame
Confirmed Disease Control Rate (DCR) as Assessed by Investigator
DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease
Disease progression during or after, or intolerance of, the most recent line of systemic therapy
Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following:
HER2 overexpression/amplification from fresh or archival tumor tissue or blood
Known activating HER2 mutations detected in fresh or archival tumor tissue or blood
Have measurable disease per RECIST v1.1 criteria according to investigator assessment
Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression.
Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab
Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer
History of exposure to a 360 mg/m² doxorubicin-equivalent or >720 mg/m^2 epirubicin-equivalent cumulative dose of anthracyclines
Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial.
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
A total of 217 participants were enrolled into 9 separate cohorts based on tumor histology and HER2 alteration status. All 217 participants were treated. Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.
Recruitment Details
Participants with locally-advanced (LA) unresectable or metastatic solid tumors driven by human epidermal growth factor receptor 2 (HER2) alterations, who were previously treated, were enrolled to receive tucatinib in combination with trastuzumab in this study. Participants with hormone-receptor positive breast cancer also received fulvestrant.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 milligrams (mg) orally (PO) twice daily (BID) from Day 1 of Cycle 1 onwards and trastuzumab 8 milligram per kilograms (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 24, 2024
Oct 16, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Netherlands
Poland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
TUKYSA, ARRY-380, ONT-380
trastuzumab
Drug
Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1
Tucatinib + Trastuzumab (+ Fulvestrant)
Herceptin
fulvestrant
Drug
Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.
Tucatinib + Trastuzumab (+ Fulvestrant)
Faslodex
From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 months)
Duration of Response (DOR) as Assessed by Investigator
DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least >=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD & were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
Progression-Free Survival (PFS) as Assessed by Investigator
PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
Overall Survival (OS)
OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.
From date of start of study treatment until date of death or censoring date (approximately 52.7 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)
Number of Participants With Treatment Emergent Laboratory Test Abnormalities
Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment up to 30 days after the last dose of study treatment. The following laboratory abnormalities were assessed: A-) Hematology: hemoglobin decreased, leukocytes decreased, lymphocytes decreased and increased, neutrophils decreased and platelets decreased; B-) Chemistry: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin decreased and increased, creatinine increased, glomerular filtration rate estimated decreased, glucose decreased, lactate dehydrogenase increased, magnesium increased and decreased, potassium increased and decreased, sodium increased and decreased and total bilirubin increased.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)
Number of Participants With Any Dose Modifications Due to AEs
Dose modification included dose hold, dose reduction, or discontinuation of drugs. Dose reductions or treatment interruption/discontinuation were made at the discretion of the investigator.
From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)
Number of Participants With TEAEs of Special Interest
An adverse event of special interest (AESI) were any serious or nonserious AE that were of scientific or medical concern as defined by the sponsor and specific to the program, for which ongoing monitoring and rapid communication to the sponsor were appropriate. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib, trastuzumab or fulvestrant). AESIs for this study were related to hepatoxicity.
From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)
Maximum Concentration (Cmax) of Tucatinib
Cycle 3 Day 1: anytime within 1-4 hours post-dose
Trough Concentration (Ctrough) of Tucatinib
Cycle 3 Day 1: Predose
Tempe
Arizona
85284
United States
The University of Arizona Cancer Center-North Campus
Tucson
Arizona
85719
United States
City of Hope at Huntington Beach
Huntington Beach
California
92648
United States
City of Hope at Irvine Sand Canyon
Irvine
California
92618
United States
Koman Family Outpatient Pavilion
La Jolla
California
92037
United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla
California
92037
United States
UC San Diego Moores Cancer Center- Investigational Drug Services
La Jolla
California
92037
United States
UC San Diego Moores Cancer Center
La Jolla
California
92037
United States
City of Hope at Long Beach Worsham
Long Beach
California
90808
United States
City of Hope at Long Beach Elm
Long Beach
California
90813
United States
City of Hope at Newport Beach Lido
Newport Beach
California
92663
United States
City of Hope Torrance
Torrance
California
90505
United States
Rocky Mountain Cancer Centers
Aurora
Colorado
80012
United States
Rocky Mountain Cancer Centers
Boulder
Colorado
80303
United States
Rocky Mountain Cancer Centers
Thornton
Colorado
80260
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
Minnesota Oncology Hematology, PA
Coon Rapids
Minnesota
55433
United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park
Minnesota
55426
United States
Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices)
St Louis
Missouri
63108
United States
Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS)
St Louis
Missouri
63110
United States
Washington University School of Medicine - Obstetrics & Gynecology
St Louis
Missouri
63110
United States
Washington University School of Medicine [Patient Clinics]
St Louis
Missouri
63110
United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha
Nebraska
68114
United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha
Nebraska
68130
United States
NYU Langone Health - Long Island (Winthrop Hospital)
Mineola
New York
11501
United States
Perlmutter Cancer Center at NYU Langone GYN Oncology Associates
Mineola
New York
11501
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola
New York
11501
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
New York
10016
United States
NYU Langone Medical Center
New York
New York
10016
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10029
United States
Duke University Medical Center/Duke Cancer Center
Durham
North Carolina
27710
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106
United States
OSU Wexner Medical Center, CarePoint East
Columbus
Ohio
43203
United States
OSU Wexner Medical Center, Ohio State University Hospital East
Columbus
Ohio
43203
United States
OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute
Columbus
Ohio
43210
United States
OSU Wexner Medical Center, Investigational Drug Services(IP Ship to)
Columbus
Ohio
43210
United States
Osu Wexner Medical Center, The Ohio State University Hospital
Columbus
Ohio
43210
United States
OSU Wexner Medical Center, Stephanie Spielman Comprehensive Breast Center
Columbus
Ohio
43212
United States
OSU Wexner Medical Center, Martha Morehouse Medical Plaza
Columbus
Ohio
43221
United States
OSU Wexner Medical Center, OutPatient Care Upper Arlington
Columbus
Ohio
43221
United States
OSU Wexner Medical Center, CarePoint Gahanna
Gahanna
Ohio
43230
United States
OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
Hilliard
Ohio
43026
United States
OSU Wexner Medical Center, Outpatient Care Lewis Center
Lewis Center
Ohio
43035
United States
UH Minoff Health Center at Chagrin Highlands
Orange
Ohio
44122
United States
OSU Wexner Medical Center, Outpatient Care New Albany
Westerville
Ohio
43081
United States
Northwest Cancer Specialists, P.C.
Portland
Oregon
97213
United States
Northwest Cancer Specialists, P.C.
Portland
Oregon
97227
United States
Northwest Cancer Specialists, P.C.
Tigard
Oregon
97223
United States
UPMC Hillman Cancer Center - Washington
Washington
Pennsylvania
15301
United States
Prisma Health Cancer Institute
Boiling Springs
South Carolina
29316
United States
Prisma Health Cancer Institute
Easley
South Carolina
29640
United States
Prisma Health Cancer Institute
Greenville
South Carolina
29605
United States
Prisma Health Cancer Institute
Greenville
South Carolina
29615
United States
Prisma Health Cancer Institute
Greer
South Carolina
29650
United States
Prisma Health Cancer Institute
Seneca
South Carolina
29672
United States
Tennessee Oncology, PLLC
Gallatin
Tennessee
37066
United States
Tennessee Oncology, PLLC
Hendersonville
Tennessee
37075
United States
Tennessee Oncology, PLLC
Nashville
Tennessee
37203
United States
Tennessee Oncology, PLLC
Shelbyville
Tennessee
37160
United States
Texas oncology-West Texas
Abilene
Texas
79606
United States
US Oncology Investigational Product Center (IPC)
Irving
Texas
75063
United States
US Oncology Investigational Products Center (IPC)
Irving
Texas
75063
United States
US Oncology lnvestigational Products Center (IPC)
Irving
Texas
75063
United States
Texas Oncology - Central South
Waco
Texas
76712
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City
Utah
84112
United States
Virginia Cancer Specialists, PC
Alexandria
Virginia
22304
United States
Virginia Cancer Specialists, PC
Arlington
Virginia
22205
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Virginia Cancer Specialists, PC
Gainesville
Virginia
20155
United States
Fred Hutchinson Cancer Center
Seattle
Washington
98109
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
Northwest Cancer Specialists, P.C.
Vancouver
Washington
98684
United States
1 S Park St Medical Center
Madison
Wisconsin
53715
United States
University of Wisconsin Clinical Science Center
Madison
Wisconsin
53792
United States
Grand Hopital de Charleroi
Charleroi
Hainaut
B- 6060
Belgium
Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
Universitair Ziekenhuis Antwerpen
Edegem
2650
Belgium
AZ Groeninge
Kortrijk
8500
Belgium
CHU de Liege
Liège
4000
Belgium
AZ Sint-Maarten
Mechelen
2800
Belgium
Charite Universitatsmedizin Berlin
Berlin
12203
Germany
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
Milan
Milan
20141
Italy
Aichi Cancer Center Hospital
Nagoya
Aichi-ken
464-8681
Japan
National Cancer Center Hospital East
Kashiwa-shi
Chiba
277-8577
Japan
St. Marianna University School of Medicine Hospital
Kawasaki
Kanagawa
216-8511
Japan
Kindai University Hospital
Osakasayama-shi
Osaka
589-8511
Japan
National Cancer Center Hospital
Cho-ku
Tokyo
104-0045
Japan
The Cancer Institute Hospital of JFCR
Tokyo
135-8550
Japan
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
13620
South Korea
Severance Hospital Yonsei University Health System
Seoul
Other
03722
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Institut Catala d'Oncologia Hospitalet
L'Hospitalet de Llobregat
Other
8908
Spain
Cetir Centre Medic
Barcelona
08029
Spain
Hospital ClÃnico Universitario de Valencia. Fundación Investigación ClÃnico de Valencia.
Valencia
46010
Spain
Ascires Eresa Campanar
Valencia
46015
Spain
Hospital Vithas Valencia 9 de Octubre
Valencia
46015
Spain
Sarah Cannon Research Institute UK
London
Budapest
W1G 6AD
United Kingdom
Diagnostic Centre
London
Others
W1G 7AF
United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton
Surrey
SM2 5PT
United Kingdom
Guy's Hospital
London
SE1 9RT
United Kingdom
Jonathan Poon
London
SE1 9RT
United Kingdom
The Royal Marsden NHS Foundation Trust
London
SW3 6JJ
United Kingdom
The Harley Street Clinic
London
W1G 8BJ
United Kingdom
Radiology
London
W1G 8PP
United Kingdom
Derived
Nakamura Y, Mizuno N, Sunakawa Y, Canon JL, Galsky MD, Hamilton E, Hayashi H, Jerusalem G, Kim ST, Lee KW, Kankeu Fonkoua LA, Monk BJ, Nguyen D, Oh DY, Okines A, O'Malley DM, Pohlmann P, Reck M, Shin SJ, Sudo K, Takahashi S, Van Marcke C, Yu EY, Groisberg R, Ramos J, Tan S, Stinchcombe TE, Bekaii-Saab T. Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study. J Clin Oncol. 2023 Dec 20;41(36):5569-5578. doi: 10.1200/JCO.23.00606. Epub 2023 Sep 26.
FG001
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG002
Tucatinib+Trastuzumab (Cohort 3)
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG003
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG004
Tucatinib+Trastuzumab (Cohort 5)
Participants with non-squamous non-small cell lung cancer (NSCLC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG005
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or gastroesophageal junction adenocarcinoma [GEC], and colorectal cancer [CRC]) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG006
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG007
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg intramuscular (IM) once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG008
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
FG00011 subjects
FG00131 subjects
FG00230 subjects
FG00325 subjects
FG00412 subjects
FG00531 subjects
FG00613 subjects
FG00731 subjects
FG00833 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG00011 subjects
FG00131 subjects
FG00230 subjects
FG00325 subjects
FG00412 subjects
FG00531 subjects
FG00613 subjects
FG00731 subjects
FG00833 subjects
Type
Comment
Reasons
Death
FG0009 subjects
FG00122 subjects
FG00222 subjects
FG00317 subjects
FG0046 subjects
FG00521 subjects
FG00610 subjects
FG00711 subjects
FG00825 subjects
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG004
Ongoing
FG0002 subjects
FG0016 subjects
FG0024 subjects
FG0038 subjects
FG004
The Full Analysis Set (FAS) included all participants who were enrolled in the study and received any amount of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG001
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG002
Tucatinib+Trastuzumab (Cohort 3)
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG003
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG004
Tucatinib+Trastuzumab (Cohort 5)
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG005
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG006
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG007
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG008
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00131
BG00230
BG00325
BG00412
BG00531
BG00613
BG00731
BG00833
BG009217
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
BG00053.6± 15.3
BG00167.6± 7.4
BG00266.4± 10.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00131
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Confirmed Objective Response Rate (cORR) as Assessed by Investigator
Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: at least a greater than or equal to (>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least >=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).
The Response-Evaluable analysis set includes all participants with measurable disease who meet the following 3 criteria: (1) had a baseline disease assessment, (2) received study treatment, and (3) had post-baseline disease assessment or discontinued treatment due to documented disease progression or clinical progression.
Posted
Number
90% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
ID
Title
Description
OG000
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG001
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG002
Tucatinib+Trastuzumab (Cohort 3)
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG003
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Units
Counts
Participants
OG00011
OG00130
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG00027.3(7.9 to 56.4)
OG00113.3(4.7 to 28.0)
OG00246.7(30.8 to 63.0)
OG003
Secondary
Confirmed Disease Control Rate (DCR) as Assessed by Investigator
DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.
Not Posted
Nov 2025
From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 months)
Participants
Secondary
Duration of Response (DOR) as Assessed by Investigator
DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least >=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD & were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
Not Posted
Nov 2025
From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
Participants
Secondary
Progression-Free Survival (PFS) as Assessed by Investigator
PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
Not Posted
Nov 2025
From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
Participants
Secondary
Overall Survival (OS)
OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.
Not Posted
Nov 2025
From date of start of study treatment until date of death or censoring date (approximately 52.7 months)
Participants
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.
Not Posted
Nov 2025
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)
Participants
Secondary
Number of Participants With Treatment Emergent Laboratory Test Abnormalities
Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment up to 30 days after the last dose of study treatment. The following laboratory abnormalities were assessed: A-) Hematology: hemoglobin decreased, leukocytes decreased, lymphocytes decreased and increased, neutrophils decreased and platelets decreased; B-) Chemistry: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin decreased and increased, creatinine increased, glomerular filtration rate estimated decreased, glucose decreased, lactate dehydrogenase increased, magnesium increased and decreased, potassium increased and decreased, sodium increased and decreased and total bilirubin increased.
Not Posted
Nov 2025
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)
Participants
Secondary
Number of Participants With Any Dose Modifications Due to AEs
Dose modification included dose hold, dose reduction, or discontinuation of drugs. Dose reductions or treatment interruption/discontinuation were made at the discretion of the investigator.
Not Posted
Nov 2025
From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)
Participants
Secondary
Number of Participants With TEAEs of Special Interest
An adverse event of special interest (AESI) were any serious or nonserious AE that were of scientific or medical concern as defined by the sponsor and specific to the program, for which ongoing monitoring and rapid communication to the sponsor were appropriate. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib, trastuzumab or fulvestrant). AESIs for this study were related to hepatoxicity.
Not Posted
Nov 2025
From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)
Participants
Secondary
Maximum Concentration (Cmax) of Tucatinib
The Pharmacokinetic (PK) analysis set included all participants in the safety set from whom at least one evaluable PK assessment was reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Cycle 3 Day 1: anytime within 1-4 hours post-dose
ID
Title
Description
OG000
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG001
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG002
Tucatinib+Trastuzumab (Cohort 3)
Secondary
Trough Concentration (Ctrough) of Tucatinib
The PK analysis set included all participants in the safety set from whom at least one evaluable PK assessment was reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Cycle 3 Day 1: Predose
ID
Title
Description
OG000
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG001
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG002
Tucatinib+Trastuzumab (Cohort 3)
Time Frame
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
Description
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
9
11
5
11
10
11
EG001
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
22
31
11
31
30
31
EG002
Tucatinib+Trastuzumab (Cohort 3)
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure
22
30
13
30
29
30
EG003
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
17
25
9
25
23
25
EG004
Tucatinib+Trastuzumab (Cohort 5)
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
6
12
2
12
12
12
EG005
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
21
31
9
31
29
31
EG006
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
10
13
7
13
13
13
EG007
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
11
31
8
31
31
31
EG008
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
25
33
14
33
30
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected33 at risk
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Optic neuropathy
Eye disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Retinal detachment
Eye disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Asthenia
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Fatigue
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pain
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0026 events2 affected30 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Haemobilia
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0023 events1 affected30 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Influenza
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Liver abscess
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Meningitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Sepsis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Septic shock
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Urostomy complication
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Amylase increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Weight decreased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Syncope
Nervous system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Device occlusion
Product Issues
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Bronchial artery aneurysm
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypotension
Vascular disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v26.0
Systematic Assessment
EG0003 events3 affected11 at risk
EG0018 events6 affected31 at risk
EG0024 events4 affected30 at risk
EG00313 events7 affected25 at risk
EG0040 events0 affected12 at risk
EG0055 events5 affected31 at risk
EG0062 events2 affected13 at risk
EG0073 events3 affected31 at risk
EG0085 events5 affected33 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v26.0
Systematic Assessment
EG0003 events1 affected11 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dry eye
Eye disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Eye irritation
Eye disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0015 events5 affected31 at risk
EG0025 events5 affected30 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0002 events1 affected11 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG00012 events7 affected11 at risk
EG00120 events16 affected31 at risk
EG00218 events12 affected30 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG00010 events6 affected11 at risk
EG00116 events13 affected31 at risk
EG0026 events6 affected30 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0014 events4 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG00010 events5 affected11 at risk
EG00114 events12 affected31 at risk
EG0026 events4 affected30 at risk
EG003
Asthenia
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Chills
General disorders
MedDRA v26.0
Systematic Assessment
EG0005 events4 affected11 at risk
EG0015 events5 affected31 at risk
EG0027 events7 affected30 at risk
EG003
Fatigue
General disorders
MedDRA v26.0
Systematic Assessment
EG0003 events2 affected11 at risk
EG00112 events12 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Gait disturbance
General disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Infusion site extravasation
General disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Localised oedema
General disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Malaise
General disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0025 events5 affected30 at risk
EG003
Oedema peripheral
General disorders
MedDRA v26.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Pain
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA v26.0
Systematic Assessment
EG0004 events3 affected11 at risk
EG0015 events4 affected31 at risk
EG00221 events13 affected30 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Cystitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Device related infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Paronychia
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events3 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Viral infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Wound infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0002 events1 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0004 events3 affected11 at risk
EG0017 events6 affected31 at risk
EG0028 events8 affected30 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0004 events4 affected11 at risk
EG0015 events4 affected31 at risk
EG00213 events8 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events2 affected31 at risk
EG0027 events6 affected30 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v26.0
Systematic Assessment
EG0006 events5 affected11 at risk
EG0018 events7 affected31 at risk
EG0028 events8 affected30 at risk
EG003
Blood sodium decreased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Coronavirus test positive
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Platelet count decreased
Investigations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Weight decreased
Investigations
MedDRA v26.0
Systematic Assessment
EG0004 events4 affected11 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0004 events4 affected11 at risk
EG00110 events10 affected31 at risk
EG0027 events6 affected30 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0015 events4 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Monoclonal gammopathy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D002577
Uterine Cervical Diseases
D004067
Digestive System Neoplasms
D001660
Biliary Tract Diseases
D004066
Digestive System Diseases
D052801
Male Urogenital Diseases
D014570
Urologic Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D007414
Intestinal Neoplasms
D005770
Gastrointestinal Neoplasms
D005767
Gastrointestinal Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
D012002
Rectal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000705452
tucatinib
D000068878
Trastuzumab
D000077267
Fulvestrant
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D004958
Estradiol
D004963
Estrenes
D004962
Estranes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D045166
Estradiol Congeners
D012739
Gonadal Steroid Hormones
D042341
Gonadal Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
FG0060 subjects
FG0071 subjects
FG0082 subjects
5 subjects
FG0058 subjects
FG0063 subjects
FG00719 subjects
FG0086 subjects
67.5
± 11.6
BG00469.7± 11.1
BG00562.7± 10.7
BG00671.3± 9.5
BG00761.3± 10.3
BG00863.8± 10.5
BG00964.9± 11.0
15
BG0036
BG0044
BG00520
BG0066
BG00731
BG00816
BG009140
Male
BG0000
BG0010
BG00215
BG00319
BG0048
BG00511
BG0067
BG0070
BG00817
BG00977
1
BG0032
BG0041
BG0052
BG0060
BG0072
BG0081
BG00910
Not Hispanic or Latino
BG00011
BG00129
BG00226
BG00317
BG0048
BG00525
BG0069
BG00724
BG00830
BG009179
Unknown or Not Reported
BG0000
BG0011
BG0023
BG0036
BG0043
BG0054
BG0064
BG0075
BG0082
BG00928
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0006
BG0019
BG00223
BG0035
BG0043
BG00520
BG0061
BG00711
BG00823
BG009101
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Black or African American
BG0001
BG0014
BG0021
BG0032
BG0040
BG0050
BG0061
BG0071
BG0080
BG00910
White
BG0004
BG00118
BG0023
BG00312
BG0046
BG0055
BG0067
BG00715
BG0088
BG00978
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Unknown or Not Reported
BG0000
BG0010
BG0023
BG0036
BG0043
BG0056
BG0064
BG0074
BG0082
BG00928
OG004
Tucatinib+Trastuzumab (Cohort 5)
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG005
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG006
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG007
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG008
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
25
OG00412
OG00531
OG00613
OG00731
OG00829
8.0
(1.4 to 23.1)
OG0048.3(0.4 to 33.9)
OG00522.6(11.1 to 38.3)
OG0060(0.0 to 20.6)
OG00741.9(26.9 to 58.2)
OG00810.3(2.9 to 24.6)
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG003
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG004
Tucatinib+Trastuzumab (Cohort 5)
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG005
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG006
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG007
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG008
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Units
Counts
Participants
OG00011
OG00127
OG00229
OG00322
OG00412
OG00527
OG00613
OG00730
OG00829
Title
Denominators
Categories
Title
Measurements
OG000488.2± 104.9
OG001483.1± 53.5
OG002319.2± 116.2
OG003275.9± 122.8
OG004437.2± 60.0
OG005330.4± 164.2
OG006207.7± 344.6
OG007393.2± 255.6
OG008242.9± 155.1
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG003
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG004
Tucatinib+Trastuzumab (Cohort 5)
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG005
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG006
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG007
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
OG008
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.