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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516158-22-00 | Other Identifier | EU-CTR Number | |
| 2020-002368-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
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This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-DXd | Experimental | T-DXd monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Drug | Trastuzumab deruxtecan (T-DXd) by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR) | Confirmed ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR), as determined by ICR per RECIST v1.1. A CR was defined as disappearance of all target lesions (TLs) and PR was defined as at least a 30% decrease in the sum of the diameters (dms) of TL, taking as reference the baseline sum of diameters as long as criteria for PD were not met. An ICR of all radiological imaging data was carried out using RECIST v1.1. All images were collected centrally. The imaging scans were reviewed by 2 independent radiologists and were adjudicated, if required. | Tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) as Per RECIST v1.1 Using ICR and Investigator Assessment | DoR was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression (date of progression-free survival [PFS] event or censoring - date of first response + 1). The DoR was calculated using Kaplan-Meier technique. | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Santa Rosa | California | 95403 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38710187 | Derived | Li BT, Meric-Bernstam F, Bardia A, Naito Y, Siena S, Aftimos P, Anderson I, Curigliano G, de Miguel M, Kalra M, Oh DY, Park JO, Postel-Vinay S, Rha SY, Satoh T, Spanggaard I, Michelini F, Smith A, Machado KK, Saura C; DESTINY-PanTumor01 study group. Trastuzumab deruxtecan in patients with solid tumours harbouring specific activating HER2 mutations (DESTINY-PanTumor01): an international, phase 2 study. Lancet Oncol. 2024 Jun;25(6):707-719. doi: 10.1016/S1470-2045(24)00140-2. Epub 2024 May 3. | |
| 37597578 |
| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
The study consisted of a screening period (up to 28 days), treatment period until progressive disease (PD) and a follow-up period for participants who discontinued study treatment due to PD or other reason. A total of 102 participants received treatment in this study.
This Phase II multicenter, open-label study was conducted in participants with unresectable and/or metastatic solid tumors harboring human epidermal growth factor receptor 2 (HER2) activating mutations regardless of tumor histology at 29 investigational sites in 9 countries. First participant was enrolled on 30 Dec 2020, last participant was enrolled on 24 May 2022 and data cut-off (DCO) date was 25 Jan 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Deruxtecan (T-DXd) | Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 milligram/kilogram (mg/kg) via intravenous (IV) infusion on Day 1 of each cycle (21 days), every 3 weeks until response evaluation criteria in solid tumors (RECIST) version (v) 1.1 -defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met. |
| 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 | Yes | No | No | Study Protocol | Jul 20, 2020 | Jan 22, 2024 |
Not provided
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None (open-label)
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| Disease Control Rate (DCR) as Per RECIST v1.1 Using ICR and Investigator Assessment | DCR at 6 weeks was defined as the percentage of participants who had the best objective response (BoR) of confirmed CR or PR, or who had stable disease (SD) (without subsequent cancer therapy), for at least 5 weeks after first dose of study treatment. DCR at 12 weeks was defined as the percentage of patients who had the BoR of confirmed CR or PR, or who had SD (without subsequent cancer therapy), for at least 11 weeks after first dose of study treatment. CR was defined as disappearance of all TL and PR was defined as at least a 30% decrease in sum of the dms of TL, taking as reference the baseline sum of dms as long as criteria for PD were not met. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (>=20% increase in sum of dms of TLs and an absolute increase of >=5 millimeters, taking as reference smallest sum of dms since treatment started including baseline sum of dms). CI was calculated using Clopper-Pearson method. | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
| PFS as Per RECIST v1.1 Using ICR and Investigator Assessment | PFS was defined as the time from first dose of study treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from assigned therapy or received another anti-cancer therapy prior to progression (i.e. date of PFS event or censoring - date of first dose + 1). PFS was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method. | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
| Percentage of Participants Alive and Progression-Free at 6 and 12 Months as Per RECIST v1.1 Using ICR and Investigator Assessment | Percentage of participants alive and progression-free at 6 and 12 months are reported. It was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method. | At Months 6 and 12 |
| Confirmed ORR as Per RECIST v1.1 Using Investigator Assessment | Confirmed ORR was defined as the percentage of participants who had a confirmed CR or PR as determined by investigator per RECIST v1.1. A CR was defined as disappearance of all TLs and PR was defined as >=30% decrease in the sum of the dms of TL, taking as reference the baseline sum of dms as long as criteria for PD were not met. | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
| Overall Survival (OS) | OS was defined as the time from the date of first dose of study treatment administration until death due to any cause regardless of whether the patient withdrew from therapy or received another anti-cancer therapy (i.e. date of death or censoring - date of first dose + 1). OS was calculated using the Kaplan-Meier technique. CI for median OS derived based on the Brookmeyer-Crowley method. | From the date of first treatment administration up to death, approximately 24 months |
| Percentage of Participants Alive at 6 and 12 Months | Percentage of participants alive at 6 and 12 months are reported. It was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method. | At Months 6 and 12 |
| Serum Concentrations of T-DXd and Total Anti-HER2 Antibody | Serum samples were collected at specified timepoints to determine serum concentrations of T-DXd and total anti-HER2 antibody. | Pre-infusion and 15 minutes post-infusion in Cycles 1, 2 and 4 and 5 hours post-infusion in Cycle 1 (each cycle 21 days) |
| Serum Concentrations of Deruxtecan (MAAA-1181a) | Serum samples were collected at specified timepoints to determine serum concentrations of MAAA-1181a. | Pre-infusion and 15 minutes post-infusion in Cycles 1, 2 and 4 and 5 hours post-infusion in Cycle 1 (each cycle 21 days) |
| Percentage of Participants With Anti-Drug Antibodies (ADA) to T-DXd | Blood samples were collected to evaluate the presence of ADAs for T-DXd using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as the percentage of participants who were evaluable for ADA and were treatment-emergent ADA-positive. Treatment-emergent ADA was defined as either treatment-induced (baseline ADA negative, post-baseline ADA positive) or treatment-boosted ADA. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to >=2 fold during the study period. Persistently positive was defined as >=2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having >=1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive. | Up to approximately 24 months |
| Muncie |
| Indiana |
| 47303 |
| United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Middletown | New Jersey | 07748 | United States |
| Research Site | Commack | New York | 11725 | United States |
| Research Site | Harrison | New York | 10604 | United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Anderlecht | 1070 | Belgium |
| Research Site | Toronto | CA | M5G 2M9 | Canada |
| Research Site | Copenhagen | 2100 | Denmark |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Lyon | 69008 | France |
| Research Site | Villejuif | 94805 | France |
| Research Site | Milan | 20141 | Italy |
| Research Site | Milan | 20162 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Suita-shi | 565-0871 | Japan |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | 28050 | Spain |
| Research Site | Pamplona | 31008 | Spain |
| Research Site | Seville | 41013 | Spain |
| Derived |
| Jhaveri K, Eli LD, Wildiers H, Hurvitz SA, Guerrero-Zotano A, Unni N, Brufsky A, Park H, Waisman J, Yang ES, Spanggaard I, Reid S, Burkard ME, Vinayak S, Prat A, Arnedos M, Bidard FC, Loi S, Crown J, Bhave M, Piha-Paul SA, Suga JM, Chia S, Saura C, Garcia-Saenz JA, Gambardella V, de Miguel MJ, Gal-Yam EN, Rapael A, Stemmer SM, Ma C, Hanker AB, Ye D, Goldman JW, Bose R, Peterson L, Bell JSK, Frazier A, DiPrimeo D, Wong A, Arteaga CL, Solit DB. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial. Ann Oncol. 2023 Oct;34(10):885-898. doi: 10.1016/j.annonc.2023.08.003. Epub 2023 Aug 18. |
| Redacted SAP | View source |
| Redacted CSP | View source |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) consisted of all participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T-DXd | Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR) | Confirmed ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR), as determined by ICR per RECIST v1.1. A CR was defined as disappearance of all target lesions (TLs) and PR was defined as at least a 30% decrease in the sum of the diameters (dms) of TL, taking as reference the baseline sum of diameters as long as criteria for PD were not met. An ICR of all radiological imaging data was carried out using RECIST v1.1. All images were collected centrally. The imaging scans were reviewed by 2 independent radiologists and were adjudicated, if required. | The FAS consisted of all participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) as Per RECIST v1.1 Using ICR and Investigator Assessment | DoR was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression (date of progression-free survival [PFS] event or censoring - date of first response + 1). The DoR was calculated using Kaplan-Meier technique. | The FAS consisted of all participants who received at least 1 dose of study treatment. Participants with response were evaluated. | Posted | Median | Inter-Quartile Range | months | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) as Per RECIST v1.1 Using ICR and Investigator Assessment | DCR at 6 weeks was defined as the percentage of participants who had the best objective response (BoR) of confirmed CR or PR, or who had stable disease (SD) (without subsequent cancer therapy), for at least 5 weeks after first dose of study treatment. DCR at 12 weeks was defined as the percentage of patients who had the BoR of confirmed CR or PR, or who had SD (without subsequent cancer therapy), for at least 11 weeks after first dose of study treatment. CR was defined as disappearance of all TL and PR was defined as at least a 30% decrease in sum of the dms of TL, taking as reference the baseline sum of dms as long as criteria for PD were not met. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (>=20% increase in sum of dms of TLs and an absolute increase of >=5 millimeters, taking as reference smallest sum of dms since treatment started including baseline sum of dms). CI was calculated using Clopper-Pearson method. | The FAS consisted of all participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
| |||||||||||||||||||||||||||
| Secondary | PFS as Per RECIST v1.1 Using ICR and Investigator Assessment | PFS was defined as the time from first dose of study treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from assigned therapy or received another anti-cancer therapy prior to progression (i.e. date of PFS event or censoring - date of first dose + 1). PFS was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method. | The FAS consisted of all participants who received at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | months | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive and Progression-Free at 6 and 12 Months as Per RECIST v1.1 Using ICR and Investigator Assessment | Percentage of participants alive and progression-free at 6 and 12 months are reported. It was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method. | The FAS consisted of all participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Confirmed ORR as Per RECIST v1.1 Using Investigator Assessment | Confirmed ORR was defined as the percentage of participants who had a confirmed CR or PR as determined by investigator per RECIST v1.1. A CR was defined as disappearance of all TLs and PR was defined as >=30% decrease in the sum of the dms of TL, taking as reference the baseline sum of dms as long as criteria for PD were not met. | The FAS consisted of all participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose of study treatment administration until death due to any cause regardless of whether the patient withdrew from therapy or received another anti-cancer therapy (i.e. date of death or censoring - date of first dose + 1). OS was calculated using the Kaplan-Meier technique. CI for median OS derived based on the Brookmeyer-Crowley method. | The FAS consisted of all participants who received at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | months | From the date of first treatment administration up to death, approximately 24 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive at 6 and 12 Months | Percentage of participants alive at 6 and 12 months are reported. It was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method. | The FAS consisted of all participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Concentrations of T-DXd and Total Anti-HER2 Antibody | Serum samples were collected at specified timepoints to determine serum concentrations of T-DXd and total anti-HER2 antibody. | The Pharmacokinetic (PK) Analysis set consisted of all participants who received at least 1 dose of study treatment and had at least 1 post-dose evaluable PK data point. The population was defined by the study pharmacokineticist and the statistician prior to any PK analyses being performed. Only those participants with data available are reported. | Posted | Mean | Standard Deviation | microgram/milliliter (mL) | Pre-infusion and 15 minutes post-infusion in Cycles 1, 2 and 4 and 5 hours post-infusion in Cycle 1 (each cycle 21 days) |
|
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| Secondary | Serum Concentrations of Deruxtecan (MAAA-1181a) | Serum samples were collected at specified timepoints to determine serum concentrations of MAAA-1181a. | The Pharmacokinetic (PK) Analysis set consisted of all participants who received at least 1 dose of study treatment and had at least 1 post-dose evaluable PK data point. The population was defined by the study pharmacokineticist and the statistician prior to any PK analyses being performed. Only those participants with data available are reported. | Posted | Mean | Standard Deviation | ng/mL | Pre-infusion and 15 minutes post-infusion in Cycles 1, 2 and 4 and 5 hours post-infusion in Cycle 1 (each cycle 21 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADA) to T-DXd | Blood samples were collected to evaluate the presence of ADAs for T-DXd using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as the percentage of participants who were evaluable for ADA and were treatment-emergent ADA-positive. Treatment-emergent ADA was defined as either treatment-induced (baseline ADA negative, post-baseline ADA positive) or treatment-boosted ADA. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to >=2 fold during the study period. Persistently positive was defined as >=2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having >=1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive. | Participants in the ADA-evaluable set consisted of all participants in the Safety Analysis set (SAF- All participants who received at least 1 dose of study treatment) with a non-missing baseline ADA result and at least 1 non-missing post-baseline ADA result. | Posted | Number | percentage of participants | Up to approximately 24 months |
|
Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 47 days following the date of last dose of study treatment or before the initiation of first subsequent anti-cancer therapy following discontinuation of study treatment (whichever occurred first), up to DCO date of 25 Jan 2023 (approximately 24 months)
The SAF consisted of all participants who received at least 1 dose of study treatment.
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 | Description (Arm-group) | 58 | 102 | 36 | 102 | 96 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Shock hypoglycaemic | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2023 | Jan 22, 2024 | SAP_001.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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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