DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER... | NCT03329690 | Trialant
NCT03329690
Sponsor
Daiichi Sankyo Co., Ltd.
Status
Completed
Last Update Posted
Mar 18, 2022Actual
Enrollment
233Actual
Phase
Phase 2
Conditions
Neoplasm, Gastrointestinal
Interventions
DS-8201a
Physician's Choice
Countries
Japan
South Korea
Protocol Section
Identification Module
NCT ID
NCT03329690
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DS8201-A-J202
Secondary IDs
ID
Type
Description
Link
173727
Registry Identifier
JAPIC CTI
DESTINY-G01
Other Identifier
Daiichi Sankyo and AstraZeneca
Brief Title
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Official Title
A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Acronym
Not provided
Organization
Daiichi SankyoINDUSTRY
Status Module
Record Verification Date
Mar 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2, 2017Actual
Primary Completion Date
Nov 8, 2019Actual
Completion Date
Dec 11, 2020Actual
First Submitted Date
Oct 30, 2017
First Submission Date that Met QC Criteria
Oct 30, 2017
First Posted Date
Nov 6, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 3, 2020
Results First Submitted that Met QC Criteria
Nov 3, 2020
Results First Posted Date
Nov 27, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 17, 2022
Last Update Posted Date
Mar 18, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Daiichi Sankyo Co., Ltd.INDUSTRY
Collaborators
Name
Class
AstraZeneca
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasm, Gastrointestinal
Keywords
Adenocarcinoma Metastatic
Adenocarcinoma of the Stomach
Adenocarcinoma of the Gastroesophageal Junction
HER2 Overexpression
Adenocarcinoma, Locally Advanced
DESTINY - Gastric 01
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
233Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Parallel: DS-8201a
Experimental
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive DS-8201a once every 3 weeks.
Drug: DS-8201a
Parallel: Physician's Choice
Active Comparator
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive monotherapy prescribed by the physician before enrollment.
Drug: Physician's Choice
Exploratory: Naïve HER2 IHC 2+/ISH-
Other
A maximum of 20 non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every three weeks.
Drug: DS-8201a
Exploratory: Naïve HER2 IHC 1+
Other
A maximum of 20 non-randomized patients with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every 3 weeks.
Drug: DS-8201a
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DS-8201a
Drug
DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
Exploratory: Naïve HER2 IHC 1+
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) 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. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.
Baseline to date of first documented objective response (CR or PR), up to 36 months postdose
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.
Baseline to date of first documented objective response, up to 36 months postdose
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
Progression on and after at least 2 prior regimens
Has an adequate tumor sample
Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Exclusion Criteria:
Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
Has a medical history of clinically significant lung disease
Is suspected to have certain other protocol-defined diseases based on imaging at screening period
Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
safety or well-being of the participant or offspring
Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29.
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/
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
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.
Access Criteria
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.
In the Primary Cohort, participants with HER2 overexpressing gastric of GEJ adenocarcinoma were randomized (2:1) to either DS-8201a or physician's choice (irinotecan or paclitaxel). In the Exploratory Cohorts, participants with HER2 IHC 2+/ISH negative advanced gastric or GEJ adenocarcinoma who were naïve to HER2 treatment received DS-8201a.
Recruitment Details
In the Primary Cohort, a total of 188 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment. In the Exploratory Cohorts, a total of 45 non-randomized participants were enrolled and 44 patients received treatment. Study participants for all cohorts were enrolled at clinic sites in South Korea and Japan. Participants took part of the study from November 2, 2017 to Data Cut-Off (DCO) date of December 11, 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
FG001
Physician's Choice Irinotecan
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jul 3, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two randomized investigative arms will run in parallel (DS-8201a and Physician's Choice), with participants who have disease progression after two previous regimens.
Two non-randomized exploratory arms will run with HER2 treatment-naive participants.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Exploratory: Naïve HER2 IHC 2+/ISH-
Parallel: DS-8201a
Experimental product
Physician's Choice
Drug
Either:
Irinotecan monotherapy (Starting dosage and usage is 150 mg/m2 biweekly, with dose reduction permitted)
Paclitaxel monotherapy (Starting dosage and usage is 80 mg/m2 weekly, with dose reduction permitted)
Parallel: Physician's Choice
Standard of Care
From the date of randomization to the date of death (due to any cause), up to 36 months postdose
Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
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 was measured for responding subjects (PR or CR) only.
From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose
Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.
From randomization to first documented objective response, up to 36 months postdose
Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.
From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported.
From randomization to first documented objective response, up to 36 months postdose
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
Baseline up to 47 days after last dose, up to 36 months postdose
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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.
Baseline up to 47 days after last dose, up to 36 months postdose
Hirosaki
Aomori
036-8563
Japan
National Cancer Center Hospital East
Kashiwa
Chiba
277-8577
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama
Ehime
791-0280
Japan
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu
Fukuoka
806-8501
Japan
Gunma Prefectural Cancer Center
Ōta
Gunma
373-8550
Japan
Kure Medical Center
Kure
Hiroshima
737-0023
Japan
Hokkaido University Hospital
Sapporo
Hokkaido
060-8648
Japan
Hyogo Cancer Center
Akashi
Hyōgo
673-8558
Japan
Kansai Rosai Hospital
Amagasaki
Hyōgo
660-8511
Japan
Kobe City Medical Center General Hospital
Kobe
Hyōgo
650-0047
Japan
Ibaraki Prefectural Central Hospital
Kasama
Ibaraki
309-1793
Japan
Kanazawa University Hospital
Kanazawa
Ishikawa-ken
920-8641
Japan
Iwate Medical University Hospital
Shiwa-gun
Iwate
028-3695
Japan
Kagawa University Hospital
Kita
Kagawa-ken
761-0793
Japan
St. Marianna University School of Medicine Hospital
Kawasaki
Kanagawa
216-8511
Japan
The Kitasato Institute Kitasato University Hospital
Sagamihara
Kanagawa
252-0375
Japan
Yokohama City University Medical Center
Yokohama
Kanagawa
232-0024
Japan
Kanagawa Cancer Center
Yokohama
Kanagawa
241-8515
Japan
Japanese Red Cross Kyoto Daini Hospital
Kamigyō-ku
Kyoto
602-8026
Japan
Miyagi Cancer Center
Natori-shi
Miyagi
981-1293
Japan
Osaki Citizen Hospital
Ōsaki
Miyagi
989-6183
Japan
Osaka University Hospital
Suita
Osaka
565-0871
Japan
Toyonaka Municipal Hospital
Toyonaka
Osaka
560-8565
Japan
Tochigi Cancer Center
Utsunomiya
Tochigi
320-0834
Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku
Tokyo
113-8677
Japan
National Cancer Center Hospital
Chuo Ku
Tokyo
104-0045
Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-Ku
Tokyo
135-8550
Japan
Showa University Koto Toyosu Hospital
Koto-Ku
Tokyo
135-8577
Japan
Toranomon Hospital
Minato-Ku
Tokyo
105-8470
Japan
Chiba Cancer Center
Chiba
260-8717
Japan
Fukui Prefectural Hospital
Fukui
910-8526
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka
811-1395
Japan
Kyushu University Hospital
Fukuoka
812-8582
Japan
Gifu University Hospital
Gifu
501-1194
Japan
Hiroshima City Asa Citizens Hospital
Hiroshima
731-0293
Japan
Hiroshima Prefectural Hospital
Hiroshima
734-8530
Japan
Kochi Health Sciences Center
Kochi
781-8555
Japan
Niigata Cancer Center Hospital
Niigata
951-8566
Japan
Okayama University Hospital
Okayama
700-8558
Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka
534-0021
Japan
Osaka International Cancer Institute
Osaka
541-8567
Japan
Osaka General Medical Center
Osaka
558-8558
Japan
Kindai University Hospital
Osaka
589-8511
Japan
Saitama Cancer Center
Saitama
362-0806
Japan
Shizuoka Cancer Center
Shizuoka
411-8777
Japan
Shizuoka General Hospital
Shizuoka
420-8527
Japan
Keio University Hospital
Tokyo
160-8582
Japan
National Cancer Center
Ilsan
Gyeonggi-do
10408
South Korea
Chungbuk National University Hospital
Cheongju-si
North Chungcheong
28644
South Korea
Inje University Haeundae Paik Hospital
Busan
48108
South Korea
Dong-A University Hospital
Busan
49201
South Korea
Kyungpook National University Chilgok Hospital
Daegu
41404
South Korea
Chonnam National University Hwasun Hospital
Gwangju
58128
South Korea
Gachon University Gil Medical Center
Incheon
21565
South Korea
Chonbuk National University Hospital
Jeonju
54907
South Korea
Seoul National University Bundang Hospital
Seongnam
13620
South Korea
Korea University Anam Hospital
Seoul
02841
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Seoul
03722
South Korea
Asan Medical Center
Seoul
05505
South Korea
Gangnam Severance Hospital
Seoul
06273
South Korea
Samsung Medical Center
Seoul
06351
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
06591
South Korea
Chung-Ang University Hospital
Seoul
06973
South Korea
Korea University Guro Hospital
Seoul
08308
South Korea
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.
Yamaguchi K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Shimoyama T, Lee KW, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Shitara K. Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial. J Clin Oncol. 2023 Feb 1;41(4):816-825. doi: 10.1200/JCO.22.00575. Epub 2022 Nov 15.
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
FG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
FG003
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
FG004
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
FG000126 subjects
FG00155 subjects
FG0027 subjects
FG00321 subjects
FG00424 subjects
Received Treatment
FG000125 subjects
FG00155 subjects
FG0027 subjects
FG00320 subjects
FG00424 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG000126 subjects
FG00155 subjects
FG0027 subjects
FG00321 subjects
FG00424 subjects
Type
Comment
Reasons
Progressive disease per RECIST
FG00085 subjects
FG00144 subjects
FG0026 subjects
FG00316 subjects
FG00420 subjects
Clinical progression
FG0007 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG004
Adverse Event
FG00022 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Miscellaneous
FG0006 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Did not receive treatment
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Baseline and demographic characteristics were assessed in the Full Analysis Set.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
BG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
BG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
BG003
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
BG004
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000125
BG00155
BG0027
BG00320
BG00424
BG005231
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00064.2± 10.36
BG00164.9± 10.54
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
South Korea
Title
Measurements
BG00026
BG00111
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) 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. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.
Objective response rate was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
Posted
Count of Participants
Participants
Baseline to date of first documented objective response (CR or PR), up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
OG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
Units
Counts
Participants
OG000126
OG00155
OG0027
OG003
Title
Denominators
Categories
Unconfirmed ORR, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00061
OG0017
OG0021
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Cochran-Mantel-Haenszel
CMH test with region as a stratification factor
<0.0001
Superiority
Primary
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.
Best overall response was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
Posted
Count of Participants
Participants
Baseline to date of first documented objective response, up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Secondary
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.
Duration of survival and overall survival were assessed in the Intent-to-Treat Analysis Set.
Posted
Median
Full Range
months
From the date of randomization to the date of death (due to any cause), up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
OG002
Physician's Choice Paclitaxel
Secondary
Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Progression-free survival (PFS) was assessed in the Intent-to-Treat Analysis Set.
Posted
Median
95% Confidence Interval
months
From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
Secondary
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
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 was measured for responding subjects (PR or CR) only.
Duration of response (DOR) was assessed in the Full Analysis Set.
Posted
Median
Full Range
months
From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
Secondary
Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Disease control rate (DCR) was assessed in the Intent-to-Treat Set.
Posted
Count of Participants
Participants
Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
Secondary
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.
Best overall response was assessed in the Exploratory Cohorts in the Intent-to-Treat Analysis Set.
Posted
Count of Participants
Participants
From randomization to first documented objective response, up to 36 months postdose
ID
Title
Description
OG000
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG001
Secondary
Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.
Time to treatment failure (TTF) was assessed in the Full Analysis Set.
Posted
Median
95% Confidence Interval
months
From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
OG002
Secondary
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported.
Objective response rate (ORR) and best overall response (BOR) were assessed in the Response Evaluable Set.
Posted
Count of Participants
Participants
From randomization to first documented objective response, up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
Secondary
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Posted
Mean
Standard Deviation
ug/mL
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG002
Secondary
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Posted
Mean
Standard Deviation
ng/mL
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG002
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Secondary
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for AUClast DS-8201a and total anti-HER2 antibody for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.
Posted
Mean
Standard Deviation
ug*d/mL
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
Secondary
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for MAAA-1181a for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.
Posted
Mean
Standard Deviation
ng*d/mL
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
Secondary
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Posted
Median
Full Range
hours
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG002
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Secondary
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Pharmacokinetic parameters were assessed in patients with available data in the Pharmacokinetic Analysis Set.
Posted
Mean
Standard Deviation
days
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG002
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Secondary
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
Adverse events were assessed in the Safety Analysis Set.
Posted
Count of Participants
Participants
Baseline up to 47 days after last dose, up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
Secondary
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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.
Adverse events were assessed in the Safety Analysis Set.
Posted
Count of Participants
Participants
Baseline up to 47 days after last dose, up to 36 months postdose
ID
Title
Description
OG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
OG002
Physician's Choice Paclitaxel
Time Frame
Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
Description
A TEAE is defined as an adverse event (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. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
98
125
58
125
125
125
EG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
46
55
15
55
54
55
EG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
4
7
1
7
7
7
EG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
50
62
16
62
61
62
EG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
16
20
6
20
20
20
EG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
21
24
11
24
24
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG0030 affected62 at risk
EG0040 affected20 at risk
EG0050 affected24 at risk
Sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0002 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0002 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Biliary sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Device-related infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0002 affected125 at risk
EG0010 affected55 at risk
EG0021 affected7 at risk
EG003
Pericarditis malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected125 at risk
EG0012 affected55 at risk
EG0020 affected7 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG00013 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Embolism
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0005 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Anal stenosis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Pyloric stenosis
Congenital, familial and genetic disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Disease progression
General disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0012 affected55 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Condition aggravated
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
General physical health deterioration
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0012 affected55 at risk
EG0020 affected7 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Cataract
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Glaucoma
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG00011 affected125 at risk
EG0014 affected55 at risk
EG0021 affected7 at risk
EG0035 affected62 at risk
EG0041 affected20 at risk
EG0052 affected24 at risk
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0007 affected125 at risk
EG0011 affected55 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0006 affected125 at risk
EG0011 affected55 at risk
EG0021 affected7 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0006 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0004 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0003 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0021 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected125 at risk
EG0010 affected55 at risk
EG0021 affected7 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected125 at risk
EG0010 affected55 at risk
EG0020 affected7 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0006 affected125 at risk
EG0013 affected55 at risk
EG0020 affected7 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0002 affected125 at risk
EG0012 affected55 at risk
EG0021 affected7 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
OG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
Units
Counts
Participants
OG000126
OG00155
OG0027
OG00362
Title
Denominators
Categories
Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00011
OG0010
OG0020
OG0030
Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00010
OG0010
OG0020
OG003
Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00050
OG0017
OG0021
OG003
Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00051
OG0017
OG0021
OG003
Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00046
OG00127
OG0023
OG003
Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00047
OG00127
OG0023
OG003
Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00015
OG00118
OG0020
OG003
Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00015
OG00118
OG0020
OG003
Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0004
OG0013
OG0023
OG003
Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0003
OG0013
OG0023
OG003
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00010
OG0010
OG0020
OG003
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0009
OG0010
OG0020
OG003
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00041
OG0016
OG0021
OG003
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00041
OG0016
OG0021
OG003
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00055
OG00128
OG0023
OG003
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00057
OG00128
OG0023
OG003
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00015
OG00118
OG0020
OG003
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00015
OG00118
OG0020
OG003
Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0005
OG0013
OG0023
OG003
Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0004
OG0013
OG0023
OG003
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000126
OG00155
OG0027
OG00362
OG00421
OG00522
Title
Denominators
Categories
Duration of survival follow up, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0008.0(0.4 to 23.1)
OG0017.1(0.3 to 20.3)
OG0025.5(2.0 to 14.3)
OG0037.0(0.3 to 20.3)
OG0047.3(0.2 to 19.6)
OG0058.4(1.8 to 14.8)
Duration of survival follow up, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00012.3(0.4 to 33.2)
OG0018.4(0.3 to 29.3)
OG00214.3(2.0 to 22.1)
OG003
Overall survival, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00012.5(0.4 to 23.1)
OG0018.4(0.3 to 20.3)
OG00214.3(2.0 to 14.3)
OG003
Overall survival, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00012.6(0.4 to 33.2)
OG0018.6(0.3 to 29.3)
OG00214.3(2.0 to 22.1)
OG003
OG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000126
OG00155
OG0027
OG00362
OG00421
OG00522
Title
Denominators
Categories
PFS, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0005.6(4.3 to 6.9)
OG0012.8(2.0 to 4.3)
OG0024.9(2.0 to NA)Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.
OG0033.5(2.0 to 4.3)
OG0044.4(2.7 to 7.1)
OG0052.8(1.5 to 4.3)
PFS, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0005.6(4.3 to 6.9)
OG0012.8(2.0 to 4.3)
OG0024.9(2.0 to NA)Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.
OG003
OG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG00061
OG0017
OG0021
OG0038
OG0047
OG0054
Title
Denominators
Categories
Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)
ParticipantsOG00061
ParticipantsOG0017
ParticipantsOG0021
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0054
Title
Measurements
OG0008.4(0 to 21.0)
OG0014.1(0 to 4.9)
OG0023.9(3.9 to 3.9)
OG003
Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)
ParticipantsOG00061
ParticipantsOG0017
ParticipantsOG0021
ParticipantsOG003
Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG003
Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)
ParticipantsOG00050
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG003
OG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000126
OG00155
OG0027
OG00362
OG00421
OG00522
Title
Denominators
Categories
DCR, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG000107
OG00134
OG0024
OG00338
OG00417
OG00515
DCR, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG000108
OG00134
OG0024
OG003
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0000
OG0010
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0000
OG0010
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0005
OG0012
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0005
OG0012
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00012
OG00113
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00012
OG00113
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0003
OG0016
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0003
OG0016
Inevaluable, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0001
OG0011
Inevaluable, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0001
OG0011
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00155
OG0027
OG00362
OG00420
OG00522
Title
Denominators
Categories
TTF, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0004.2(3.9 to 5.1)
OG0012.6(1.6 to 2.8)
OG0022.9(1.1 to 6.8)
OG0032.6(1.6 to 2.8)
OG0043.7(1.7 to 5.5)
OG0052.2(1.4 to 3.0)
TTF, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0004.3(3.9 to 5.4)
OG0012.6(1.6 to 2.8)
OG0022.9(1.1 to 6.8)
OG003
OG001
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
OG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0003
OG0010
OG0020
OG003
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0004
OG0010
OG0020
OG003
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00046
OG0015
OG0021
OG003
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00047
OG0015
OG0021
OG003
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00053
OG00128
OG0021
OG003
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00051
OG00128
OG0021
OG003
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00015
OG00116
OG0022
OG003
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00015
OG00116
OG0022
OG003
Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0002
OG0012
OG0021
OG003
Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0002
OG0012
OG0021
OG003
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00120
OG00224
Title
Denominators
Categories
Cmax: DS-8201a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000127± 28.4
OG001119± 29.1
OG002127± 24.5
Cmax: DS-8201a, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
Cmax: Total Anti-HER2 antibody, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000
Cmax: Total Anti-HER2 antibody, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
Ctrough: DS-8201a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000
Ctrough: DS-8201a, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
Ctrough: Total Anti-HER2 antibody, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000
Ctrough: Total Anti-HER2 antibody, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00120
OG00224
Title
Denominators
Categories
Cmax: MAAA-1181a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG00012.1± 4.79
OG00113.3± 8.52
OG00213.3± 7.37
Cmax: MAAA-1181a, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
Ctrough: MAAA-1181a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000
Ctrough: MAAA-1181a Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
OG002
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00120
OG00224
Title
Denominators
Categories
AUClast: DS-8201a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000611± 150
OG001572± 143
OG002545± 160
AUClast: DS-8201a, Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AUClast: Total Anti-HER2 antibody, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000
AUClast: Total Anti-HER2 antibody, Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AUC21d: DS-8201a, Cycle 1
ParticipantsOG000124
ParticipantsOG00120
ParticipantsOG00223
Title
Measurements
OG000
AUC21d: DS-8201a, Cycle 3
ParticipantsOG00066
ParticipantsOG00110
ParticipantsOG00210
Title
Measurements
OG000
AUC21d: Total Anti-HER2 antibody, Cycle 1
ParticipantsOG000121
ParticipantsOG00120
ParticipantsOG00222
Title
Measurements
OG000
AUC21d: Total Anti-HER2 antibody, Cycle 3
ParticipantsOG00066
ParticipantsOG00111
ParticipantsOG0029
Title
Measurements
OG000
OG002
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00120
OG00224
Title
Denominators
Categories
AUClast: MAAA-1181a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG00046.7± 16.3
OG00153.4± 42.7
OG00244.5± 22.5
AUClast: MAAA-1181a, Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AUC21d: MAAA-1181a, Cycle 1
ParticipantsOG000107
ParticipantsOG00119
ParticipantsOG00222
Title
Measurements
OG000
AUC21d: MAAA-1181a, Cycle 3
ParticipantsOG00054
ParticipantsOG00110
ParticipantsOG0028
Title
Measurements
OG000
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00120
OG00224
Title
Denominators
Categories
DS-8201a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG0003.93(0 to 7.15)
OG0013.90(1.58 to 7.12)
OG0023.89(1.53 to 7.08)
DS-8201a, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
Total Anti-HER2 antibody, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000
Total Anti-HER2 antibody, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
MAAA-1181a, Cycle 1
ParticipantsOG000125
ParticipantsOG00120
ParticipantsOG00224
Title
Measurements
OG000
MAAA-1181a, Cycle 3
ParticipantsOG00069
ParticipantsOG00111
ParticipantsOG00211
Title
Measurements
OG000
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000124
OG00120
OG00223
Title
Denominators
Categories
DS-8201a, Cycle 1
ParticipantsOG000124
ParticipantsOG00120
ParticipantsOG00223
Title
Measurements
OG0005.77± 1.37
OG0015.54± 1.08
OG0025.52± 1.17
DS-8201a, Cycle 3
ParticipantsOG00066
ParticipantsOG00110
ParticipantsOG00210
Title
Measurements
OG000
Total Anti-HER2 antibody, Cycle 1
ParticipantsOG000121
ParticipantsOG00120
ParticipantsOG00222
Title
Measurements
OG000
Total Anti-HER2 antibody, Cycle 3
ParticipantsOG00066
ParticipantsOG00111
ParticipantsOG0029
Title
Measurements
OG000
MAAA-1181a, Cycle 1
ParticipantsOG00098
ParticipantsOG00117
ParticipantsOG00222
Title
Measurements
OG000
MAAA-1181a, Cycle 3
ParticipantsOG00050
ParticipantsOG00110
ParticipantsOG0027
Title
Measurements
OG000
OG002
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00155
OG0027
OG00362
OG00420
OG00524
Title
Denominators
Categories
Any TEAE, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG000125
OG00154
OG0027
OG00361
OG00420
OG00524
Any TEAE, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG000125
OG00154
OG0027
OG003
Drug-related TEAEs, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG000122
OG00151
OG0025
OG003
Drug-related TEAEs, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG000122
OG00151
OG0025
OG003
Serious TEAEs, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00055
OG00114
OG0021
OG003
Serious TEAEs, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00058
OG00115
OG0021
OG003
Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00027
OG0015
OG0020
OG003
Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00031
OG0015
OG0020
OG003
TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00019
OG0014
OG0020
OG003
TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00023
OG0014
OG0020
OG003
Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00012
OG0013
OG0020
OG003
Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00015
OG0013
OG0020
OG003
TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00040
OG00121
OG0020
OG003
TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00040
OG00121
OG0020
OG003
Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00038
OG00121
OG0020
OG003
Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00038
OG00121
OG0020
OG003
TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00078
OG00120
OG0023
OG003
TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00079
OG00120
OG0023
OG003
Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00064
OG00117
OG0022
OG003
Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00065
OG00117
OG0022
OG003
TEAEs associated with death, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0008
OG0011
OG0021
OG003
TEAEs associated with death, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0009
OG0011
OG0021
OG003
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
OG003
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
OG004
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
OG005
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
Units
Counts
Participants
OG000125
OG00155
OG0027
OG00362
OG00420
OG00524
Title
Denominators
Categories
Any TEAE, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG000125
OG00154
OG0027
OG00361
OG00420
OG00524
Any TEAE, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG000125
OG00154
OG0027
OG003
Nausea, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00079
OG00127
OG0022
OG003
Nausea, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00079
OG00127
OG0022
OG003
Decreased appetite, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00075
OG00127
OG0021
OG003
Decreased appetite, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00076
OG00127
OG0021
OG003
Neutrophil count decreased, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00077
OG00118
OG0023
OG003
Neutrophil count decreased, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00079
OG00118
OG0023
OG003
Anaemia, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00071
OG00117
OG0022
OG003
Anaemia, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00071
OG00117
OG0022
OG003
White blood cell count decreased, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00047
OG00118
OG0023
OG003
White blood cell count decreased, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00049
OG00118
OG0023
OG003
Platelet count decreased, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00047
OG0014
OG0020
OG003
Platelet count decreased, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00048
OG0014
OG0020
OG003
Malaise, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00043
OG0019
OG0021
OG003
Malaise, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00044
OG0019
OG0021
OG003
Diarrhoea, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00040
OG00120
OG0020
OG003
Diarrhoea, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00041
OG00120
OG0020
OG003
Vomiting, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00033
OG0015
OG0020
OG003
Vomiting, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00033
OG0015
OG0020
OG003
Constipation, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00030
OG00113
OG0021
OG003
Constipation, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00031
OG00113
OG0022
OG003
Pyrexia, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00030
OG0018
OG0022
OG003
Pyrexia, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00031
OG0018
OG0022
OG003
Fatigue, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00027
OG00115
OG0020
OG003
Fatigue, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00027
OG00115
OG0020
OG003
Alopecia, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00028
OG0018
OG0021
OG003
Alopecia, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00028
OG0018
OG0021
OG003
Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00027
OG0012
OG0020
OG003
Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00030
OG0012
OG0020
OG003
Weight decreased, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00017
OG0015
OG0020
OG003
Weight decreased, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00019
OG0015
OG0020
OG003
Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00018
OG0017
OG0021
OG003
Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00018
OG0017
OG0021
OG003
Oedema peripheral, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG00013
OG0010
OG0020
OG003
Oedema peripheral, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG00015
OG0010
OG0020
OG003
Dysgeusia, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0009
OG0014
OG0020
OG003
Dysgeusia, 36 months (DCO: Dec 11, 2020)
Title
Measurements
OG0009
OG0014
OG0020
OG003
Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019)
Title
Measurements
OG0004
OG0010
OG0022
OG003
Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020)