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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001512-34 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.
They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer:
The study will enroll about 80 participants. Sites will be in North America and the European Union.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer will be treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Drug | Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported. | Up to 16 months (data cut-off) |
| Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported. | Up to 23 months (data cut-off) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| USC Norris Comprehensive Cancer Center Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208007 | Derived | Kapil A, Failmezger H, Fu Y, Spitzmuller A, Chan J, Haneder S, Shumilov A, Barkell A, Oguma T, Inaki K, Suto F, Allard J, Lee J, Lambert AW, Schick M, Barrett JC, Schmidt G, Sade H, Gustavson M, Carroll D, Cecchi F. Human Epidermal Growth Factor Receptor 2 Quantification Using Computational Pathology to Identify Novel Biomarkers for Trastuzumab Deruxtecan-Treated Human Epidermal Growth Factor Receptor 2-Positive Gastric Cancer. JCO Precis Oncol. 2026 May;10(5):e2500823. doi: 10.1200/PO-25-00823. Epub 2026 May 28. | |
| 41294268 |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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A total of 79 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at clinic centers in United States, Spain, Italy, United Kingdom, and Belgium.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Deruxtecan | Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2020 |
Not provided
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|
| Up to 16 months (data cut-off) |
| Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. | Up to 23 months (data cut-off) |
| Progression-Free Survival (PFS) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. | Up to 16 months (data cut-off) |
| Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported. | Up to 16 months (data cut-off) |
| Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported. | Up to 23 months (data cut-off) |
| Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause. | Up to 16 months (data cut-off) |
| Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause. | Up to 23 months (data cut-off) |
| Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review. | Up to 16 months (data cut-off) |
| Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review. | Up to 23 months (data cut-off) |
| Los Angeles |
| California |
| 90033 |
| United States |
| Pacific Cancer Care | Monterey | California | 93940 | United States |
| UCLA Health | Santa Monica | California | 90404 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| MidState Medical Center | Meriden | Connecticut | 06451 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06052 | United States |
| Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06511 | United States |
| Miami Cancer Institute, Baptist Health South Florida | Miami | Florida | 33176 | United States |
| University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM | Chicago | Illinois | 60637 | United States |
| Kansas University Cancer Center | Kansas City | Kansas | 66205 | United States |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Alvin J. Siteman Cancer Center Washington University | St Louis | Missouri | 63110 | United States |
| Northwell Health Cancer Institute | Lake Success | New York | 11042 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington/Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| UCL St-Luc | Brussels | 1200 | Belgium |
| Hopital de Jolimont | Haine-Saint-Paul | 7100 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Azienda Ospedaliero Universitaria di Modena Policlinico | Modena | 41124 | Italy |
| Oncology Institute Veneto IOVIRCCS | Padua | 35128 | Italy |
| Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO) | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Institut Catalan de Oncologia Hospital Duran i Reynals | Barcelona | 8908 | Spain |
| Hospital la Paz | Madrid | 28046 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Biomedical Research Institute Hospital de Valencia | Valencia | 46010 | Spain |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0RE | United Kingdom |
| The Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| The Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Van Cutsem E. Trastuzumab deruxtecan in HER2-positive stomach or gastroesophageal junction cancer: a plain language summary of the DESTINY-Gastric02 study. Future Oncol. 2025 Dec;21(29):3691-3700. doi: 10.1080/14796694.2025.2567230. Epub 2025 Nov 26. |
| 37329891 | Derived | Van Cutsem E, di Bartolomeo M, Smyth E, Chau I, Park H, Siena S, Lonardi S, Wainberg ZA, Ajani J, Chao J, Janjigian Y, Qin A, Singh J, Barlaskar F, Kawaguchi Y, Ku G. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): primary and updated analyses from a single-arm, phase 2 study. Lancet Oncol. 2023 Jul;24(7):744-756. doi: 10.1016/S1470-2045(23)00215-2. Epub 2023 Jun 14. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab Deruxtecan | Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported. | Objective response rate was assessed in the Full Analysis Set at data cut-off date of 09 April 2021. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 16 months (data cut-off) |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported. | Objective response rate was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 23 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. | Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021. | Posted | Median | 95% Confidence Interval | months | Up to 16 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. | Progression-free survival (PFS) was assessed in the Full Analysis Set data at cut-off date of 08 Nov 2021 | Posted | Median | 95% Confidence Interval | months | Up to 23 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. | Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021. | Posted | Median | 95% Confidence Interval | months | Up to 16 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported. | Objective response rate was assessed in the Full Analysis Set at data cut-off date of 09 April 2021. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 16 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported. | Objective response rate was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 23 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause. | Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021. | Posted | Median | 95% Confidence Interval | months | Up to 16 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause. | Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021. | Posted | Median | 95% Confidence Interval | months | Up to 23 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review. | Duration of Response (DOR) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021. | Posted | Median | 95% Confidence Interval | months | Up to 16 months (data cut-off) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma | Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review. | Duration of Response (DOR) was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021. | Posted | Median | 95% Confidence Interval | months | Up to 23 months (data cut-off) |
|
|
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab Deruxtecan | Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons. | 46 | 79 | 37 | 79 | 79 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Lymphangiosis Carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Basal Ganglia Infarction | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Animal Bite | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Exposure To Communicable Disease | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Device Occlusion | Product Issues | MedDRA (23.0) | Systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 1-908-992-6400 | CTRinfo@dsi.com |
| Oct 15, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Italy |
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| United Kingdom |
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| Spain |
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