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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004782-39 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).
This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | Experimental | Participants will be randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W). |
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| T-DXd 6.4 mg/kg Q3W | Experimental | Participants will be randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-8201a 5.4 mg/kg Q3W | Drug | DS-8201a for injection will be administered intravenously (IV) at a dose of 5.4 mg/kg every 3 weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer | Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. | 6 months post-dose administration to data cut off, up to 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate by Investigator Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by Investigator assessment based on RECIST version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. ORR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) | Exploratory outcome, results not included in this submission. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items and no item occurs in more than 1 scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Patient questionnaires were assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. |
KEY Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for randomization/registration into the study:
Adults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.
Pathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site.
The following therapies should be included in prior lines of therapy:
Confirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +.
Presence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Has left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.
KEY Exclusion Criteria:
Participants who meet any of the following criteria will be disqualified from entering the study:
Medical history of myocardial infarction (MI) within 6 months before randomization/registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal (ULN) at Screening (as defined by the manufacturer), and without any MI-related symptoms, should have a cardiologic consultation before randomization/registration to rule out MI.
Has a corrected QT interval corrected with Fridericia's formula (QTcF) prolongation to >470 msec (female participants) or >450 msec (male participants) based on the average of the Screening triplicate 12-lead electrocardiograms (ECGs).
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the randomization/registration, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.).
Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren syndrome, sarcoidosis, etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of Screening.
Prior pneumonectomy.
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole-brain radiotherapy and randomization/registration.
Participants with leptomeningeal carcinomatosis.
Has known human immunodeficiency virus (HIV) infection.
Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days before study randomization/registration. Participants with past or resolved hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen (HBsAg) negative (-) and antibody to hepatitis B core antigen (anti-HBc) positive (+).
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
Previous treatment with a DXd-containing antibody-drug conjugate (ADC).
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Norton Cancer Institute Audubon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41487064 | Derived | Raghav K. Trastuzumab deruxtecan in HER2-positive advanced colorectal cancer: a plain language summary of the DESTINY-CRC02 study. Future Oncol. 2026 Jan;22(2):123-135. doi: 10.1080/14796694.2025.2606418. Epub 2026 Jan 5. | |
| 39116902 | Derived | Raghav K, Siena S, Takashima A, Kato T, Van den Eynde M, Pietrantonio F, Komatsu Y, Kawakami H, Peeters M, Andre T, Lonardi S, Yamaguchi K, Tie J, Castro CG, Hsu HC, Strickler JH, Kim TY, Cha Y, Barrios D, Yan Q, Kamio T, Kobayashi K, Boran A, Koga M, Allard JD, Yoshino T. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): primary results from a multicentre, randomised, phase 2 trial. Lancet Oncol. 2024 Sep;25(9):1147-1162. doi: 10.1016/S1470-2045(24)00380-2. Epub 2024 Aug 5. |
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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.
Following adequate study explanation by the investigator or their designee, subjects voluntarily offered signed, informed consent prior to participation in any study procedures.
A total of 122 participants who met all inclusion criteria and no exclusion criteria were randomized/registered to T-DXd treatment in the United States, Asia-Pacific, and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | T-DXd 5.4 mg/kg Q3W | Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W). |
| FG001 | T-DXd 6.4 mg/kg Q3W | Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). |
| 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 | Oct 29, 2020 |
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| DS-8201a 6.4 mg/kg Q3W | Drug | DS-8201a for injection will be administered intravenously (IV) at a dose of 6.4 mg/kg every 3 weeks (Q3W) |
|
|
| From first dose administration to data cut off, up to approximately 19 months |
| Duration of Response Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | DoR, defined as time from the initial response (CR or PR) by BICR and Investigator assessment until documented tumor progression or death from any cause. DoR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | From the first documented evidence of a response (complete or partial) until disease progression or death, up to approximately 19 months. |
| Disease Control Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer | Disease Control Rate (DCR), defined as the proportion of subjects who achieved CR, PR, or SD for a minimum of 6 weeks during study treatment; DCR based on BICR and DCR based on Investigator assessments assessed according to RECIST version 1.1. DCR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | From first dose administration to data cut off, up to approximately 19 months. |
| Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer | Clinical Benefit Rate (CBR), defined as proportion of subjects who achieved CR, PR, or SD for at least 6 months; CBR based on BICR and CBR based on Investigator assessments will both be determined based on RECIST version 1.1. CBR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | From first dose administration to data cut off, up to approximately 19 months. |
| Progression Free Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | Progression Free Survival (PFS) defined as the time from date of randomization/registration until first objective radiographic tumor progression or death from any cause, based on BICR and Investigator assessment according to RECIST version 1.1. PFS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | From randomization to data cut off, up to approximately 19 months. |
| Overall Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | Overall Survival (OS) defined as the time from date of randomization/ registration until death from any cause, according to RECIST version 1.1. OS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | From randomization to data cut off, up to approximately 19 months. |
| Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | A Treatment-emergent Adverse Events (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 initiating the study drug until 47 days after the last dose of the study drug. Serious AEs with an onset or worsening 48 days or more after the last dose of study drug, if considered related to study treatment. are also TEAEs. TEAEs were assessed in the Safety Analysis Set at data cut-off date of 01 Nov 2022. | From first dose administration to data cut off, up to approximately 19 months. |
| Serum Concentration of T-DXd | Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022. | C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI) |
| Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody | Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022. | C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI) |
| Serum Concentration of Active Metabolite MAAA-1181a | Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022. | C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI) |
| Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) in Participants Who Were Administered T-DXd | Immunogenicity will be assessed through characterization of incidence and titer of Anti-drug Antibodies (ADAs), the number and percentage of subjects positive for NAb of T-DXd by dose level will also be determined. ADAs and NAbs were assessed in the Immunogenicity Analysis Set at data cut-off date of 01 Nov 2022. | From baseline to data cut off, up to approximately 19 months |
| From baseline to data cut off, up to approximately 19 months. |
| Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Colorectal Cancer 29 (QLQ-CR29) | Exploratory outcome, results not included in this submission. EORTC QLQ-CR29 is designed to be administered in addition to EORTC QLQ-C30. The EORTC QLQ-CR29 is a specific questionnaire for Colorectal Cancer. Scale from 0 to 100, A higher scale represents better function and a higher quality of life. | From baseline to data cut off, up to approximately 19 months |
| Patient-Reported Outcomes (PROs) in the EuroQol Questionnaire (EQ) of 5 Dimensions (5D) on a Standardized 5- Level (5L) Descriptive Health Status Scale (EQ-5D-5L) | Exploratory outcome, results not included in this submission. The EQ-5D-5L is self-administered and consists of 2 parts, the EQ-5D-5L descriptive system and the EQ-visual analogue scale. On each dimension, a score of 1 indicates no patient problems in that dimension, 2 indicates slight problems in that dimension, 3 indicates moderate problems in that dimension, 4 indicates severe problems in that dimension and 5 indicates extreme problems in that dimension. | From baseline to data cut off, up to approximately 19 months |
| Patient-Reported Outcomes (PROs) in Patient's Global Impression of Treatment Tolerability (PGI-TT) | Exploratory outcome, results not included in this submission. The PGI-TT item is included to assess how a patient perceives the overall tolerability of the study treatment over the past 7 days. This is a single-item questionnaire, and patients will rate the bother associated with any treatment-related symptoms using response options ranging from "Not at all" to "Very much". | From baseline to data cut off, up to approximately 19 months |
| Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIS) | Exploratory outcome, results not included in this submission. The PGIS item is included to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. This is a single-item questionnaire, and patients will choose the response that best describes the severity of their overall cancer symptoms with options ranging from "No Symptoms" to "Very Severe". | From baseline to data cut off, up to approximately 19 months |
| Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIC) | Exploratory outcome, results not included in this submission. The PGIC item is included to assess how a patient perceives their overall change in health status since the start of study treatment. This is a single-item questionnaire, and patients will choose from response options ranging from "Much Better" to "Much Worse". | From baseline to data cut off, up to approximately 19 months |
| Inpatient Healthcare Resource Utilization | Exploratory outcome, results not included in this submission. The impact of treatment and disease on healthcare resource use (including inpatient admissions, intensive care unit admissions, and length of stay in hospital) will be captured/collected in this study on an event-driven basis. | From baseline to data cut off, up to approximately 19 months |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Memorial Sloan Kettering Cancer Center (MSKCC) | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Sarah Cannon (Tennessee Oncology - Nashville) | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Flinders Medical Centre (FMC) | Bedford Park | Australia |
| Blacktown Hospital | Blacktown | Australia |
| Royal Brisbane & Women's Hospital | Brisbane | Australia |
| Monash Medical Centre | Clayton | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Australia |
| UCL St-Luc | Brussels | Belgium |
| UZ Antwerpen | Edegem | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| Hopital Jean Minjoz | Besançon | France |
| Hopital Edouard Herriot | Lyon | France |
| ICM-Val d'Aurelle | Montpellier | France |
| University Hospital of nantes | Nantes | France |
| Centre Antoine Lacassagne | Nice | France |
| Hopital St Antoine | Paris | France |
| Centre de Lutte Contre le Cancer CLCC - Institut Curie | Saint-Cloud | France |
| Chu Toulouse | Toulouse | France |
| Asst Grande Ospedale Metropolitano Niguarda | Milan | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy |
| Istituto Oncologico Veneto Irccs | Padova | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy |
| Aienda Ospedaliera San Camillo Forlanini | Rome | Italy |
| Azienda ULSS 8 Berica | Vicenza | Italy |
| Aichi Cancer Center Hospital | Aichi | Japan |
| National Cancer Center Hospital East | Chiba | Japan |
| National Hospital Organization Shikoku Cancer Center | Ehime | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Japan |
| Hokkaido University Hospital | Hokkaido | Japan |
| Kanagawa Cancer Center | Kanagawa | Japan |
| Kindai University Hospital | Osaka | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | Japan |
| National Cancer Center Hospital | Tokyo | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | Japan |
| National Cancer Center (NCC) | Goyang-si | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | South Korea |
| Hospital Clinico y Provincial de Barcelona | Barcelona | Spain |
| Hospital Universitari Vall dHebron | Barcelona | Spain |
| Clinica Universitaria de Navarra - Madrid | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital KMUH | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital CGMH - Kaohsiung Branch | Taoyuan | Taiwan |
| Chang Gung Memorial Hospital-LinKou | Taoyuan | Taiwan |
| Beatson Glasgow | Glasgow | United Kingdom |
| The Royal Marsden Hospital | London | United Kingdom |
| UCLH Trust | London | United Kingdom |
| The Christie | Manchester | United Kingdom |
| The Royal Marsden Hospital | Sutton | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
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| ID | Title | Description |
|---|---|---|
| BG000 | T-DXd 5.4 mg/kg Q3W | Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W). |
| BG001 | T-DXd 6.4 mg/kg Q3W | Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Mean | Standard Deviation | years |
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| Sex: Female, Male | The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Count of Participants | 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 Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer | Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. | ORR was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months post-dose administration to data cut off, up to 20 months |
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| Secondary | Confirmed Objective Response Rate by Investigator Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by Investigator assessment based on RECIST version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. ORR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | ORR was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose administration to data cut off, up to approximately 19 months |
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| Secondary | Duration of Response Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | DoR, defined as time from the initial response (CR or PR) by BICR and Investigator assessment until documented tumor progression or death from any cause. DoR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | DoR was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Posted | Median | 95% Confidence Interval | months | From the first documented evidence of a response (complete or partial) until disease progression or death, up to approximately 19 months. |
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| Secondary | Disease Control Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer | Disease Control Rate (DCR), defined as the proportion of subjects who achieved CR, PR, or SD for a minimum of 6 weeks during study treatment; DCR based on BICR and DCR based on Investigator assessments assessed according to RECIST version 1.1. DCR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | DCR was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose administration to data cut off, up to approximately 19 months. |
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| Secondary | Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer | Clinical Benefit Rate (CBR), defined as proportion of subjects who achieved CR, PR, or SD for at least 6 months; CBR based on BICR and CBR based on Investigator assessments will both be determined based on RECIST version 1.1. CBR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | CBR was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose administration to data cut off, up to approximately 19 months. |
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| Secondary | Progression Free Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | Progression Free Survival (PFS) defined as the time from date of randomization/registration until first objective radiographic tumor progression or death from any cause, based on BICR and Investigator assessment according to RECIST version 1.1. PFS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | PFS was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Posted | Median | 95% Confidence Interval | month | From randomization to data cut off, up to approximately 19 months. |
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| Secondary | Overall Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | Overall Survival (OS) defined as the time from date of randomization/ registration until death from any cause, according to RECIST version 1.1. OS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | OS was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W. | Posted | Median | 95% Confidence Interval | months | From randomization to data cut off, up to approximately 19 months. |
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| Secondary | Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer | A Treatment-emergent Adverse Events (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 initiating the study drug until 47 days after the last dose of the study drug. Serious AEs with an onset or worsening 48 days or more after the last dose of study drug, if considered related to study treatment. are also TEAEs. TEAEs were assessed in the Safety Analysis Set at data cut-off date of 01 Nov 2022. | The Safety Analysis Set (SAS) included all randomized/registered subjects who received at least 1 dose of study treatment. Subjects were summarized according to treatment received. | Posted | Number | percentage of participants | From first dose administration to data cut off, up to approximately 19 months. |
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| Other Pre-specified | Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) | Exploratory outcome, results not included in this submission. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items and no item occurs in more than 1 scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Patient questionnaires were assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022. | Exploratory outcome, results not included in this submission | Posted | From baseline to data cut off, up to approximately 19 months. |
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| Other Pre-specified | Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Colorectal Cancer 29 (QLQ-CR29) | Exploratory outcome, results not included in this submission. EORTC QLQ-CR29 is designed to be administered in addition to EORTC QLQ-C30. The EORTC QLQ-CR29 is a specific questionnaire for Colorectal Cancer. Scale from 0 to 100, A higher scale represents better function and a higher quality of life. | Exploratory outcome, results not included in this submission | Posted | From baseline to data cut off, up to approximately 19 months |
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| Other Pre-specified | Patient-Reported Outcomes (PROs) in the EuroQol Questionnaire (EQ) of 5 Dimensions (5D) on a Standardized 5- Level (5L) Descriptive Health Status Scale (EQ-5D-5L) | Exploratory outcome, results not included in this submission. The EQ-5D-5L is self-administered and consists of 2 parts, the EQ-5D-5L descriptive system and the EQ-visual analogue scale. On each dimension, a score of 1 indicates no patient problems in that dimension, 2 indicates slight problems in that dimension, 3 indicates moderate problems in that dimension, 4 indicates severe problems in that dimension and 5 indicates extreme problems in that dimension. | Exploratory outcome, results not included in this submission | Posted | From baseline to data cut off, up to approximately 19 months |
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| Other Pre-specified | Patient-Reported Outcomes (PROs) in Patient's Global Impression of Treatment Tolerability (PGI-TT) | Exploratory outcome, results not included in this submission. The PGI-TT item is included to assess how a patient perceives the overall tolerability of the study treatment over the past 7 days. This is a single-item questionnaire, and patients will rate the bother associated with any treatment-related symptoms using response options ranging from "Not at all" to "Very much". | Exploratory outcome, results not included in this submission | Posted | From baseline to data cut off, up to approximately 19 months |
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| Other Pre-specified | Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIS) | Exploratory outcome, results not included in this submission. The PGIS item is included to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. This is a single-item questionnaire, and patients will choose the response that best describes the severity of their overall cancer symptoms with options ranging from "No Symptoms" to "Very Severe". | Exploratory outcome, results not included in this submission | Posted | From baseline to data cut off, up to approximately 19 months |
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| Other Pre-specified | Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIC) | Exploratory outcome, results not included in this submission. The PGIC item is included to assess how a patient perceives their overall change in health status since the start of study treatment. This is a single-item questionnaire, and patients will choose from response options ranging from "Much Better" to "Much Worse". | Exploratory outcome, results not included in this submission | Posted | From baseline to data cut off, up to approximately 19 months |
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| Other Pre-specified | Inpatient Healthcare Resource Utilization | Exploratory outcome, results not included in this submission. The impact of treatment and disease on healthcare resource use (including inpatient admissions, intensive care unit admissions, and length of stay in hospital) will be captured/collected in this study on an event-driven basis. | Exploratory outcome, results not included in this submission | Posted | From baseline to data cut off, up to approximately 19 months |
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| Secondary | Serum Concentration of T-DXd | Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022. | The PK Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of T-DXd and had measurable serum concentrations of T-DXd. Subjects were analyzed according to the treatment received | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/L | C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI) |
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| Secondary | Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody | Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022. | The PK Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of T-DXd and had measurable serum concentrations of T-DXd. Subjects were analyzed according to the treatment received | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/L | C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI) |
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| Secondary | Serum Concentration of Active Metabolite MAAA-1181a | Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022. | The PK Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of T-DXd and had measurable serum concentrations of T-DXd. Subjects were analyzed according to the treatment received | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI) |
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| Secondary | Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) in Participants Who Were Administered T-DXd | Immunogenicity will be assessed through characterization of incidence and titer of Anti-drug Antibodies (ADAs), the number and percentage of subjects positive for NAb of T-DXd by dose level will also be determined. ADAs and NAbs were assessed in the Immunogenicity Analysis Set at data cut-off date of 01 Nov 2022. | The Immunogenicity Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of the study drug and who had at least 1 baseline or postbaseline immunogenicity assessment. Subjects were analyzed according to the treatment received. | Posted | Number | percentage of participants | From baseline to data cut off, up to approximately 19 months |
|
|
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, up to approximately 44 months. For Final Results, data was collected up until 04 Dec 2024.
Safety parameters were collected, analyzed, and reported based on the dosage of treatment drug administered as specified in the study protocol, therefore as 2 arms, T-DXd 5.4 mg/kg Q3W and T-DXd 6.4 mg/kg Q3W.
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 | T-DXd 5.4 mg/kg Q3W | Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W). | 26 | 83 | 21 | 83 | 81 | 83 |
| EG001 | T-DXd 6.4 mg/kg Q3W | Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). | 13 | 39 | 12 | 39 | 38 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA25.1 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA25.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Inferior vena cava syndrome | Vascular disorders | MedDRA25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA25.1 | Systematic Assessment |
| |
| Dysgeusia | General disorders | MedDRA25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sanyko, Inc | 908-992-6400 | CTRinfo@dsi.com |
| Nov 1, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
Not provided
Not provided
Not provided
| >=65 years |
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| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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