[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658929":3},{"organization":4,"outcomesModule":7,"designInfo":320,"detailedDescription":319,"studyPopulation":323,"armGroups":324,"interventions":341,"overallOfficials":362,"centralContacts":367,"locations":372,"responsibleParty":378,"collaborators":319,"id":380,"slug":381,"hasResults":382,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":382,"sex":388,"minAge":389,"maxAge":319,"enrollmentInfo":390,"targetDuration":319,"studyType":393,"phases":319,"briefSummary":394,"conditions":395,"keywords":400,"overallStatus":411,"whyStopped":319,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":101,"otherOutcomes":319},[9,13,16,19,22,25,28,32,35,39,43,46,49,52,55,58,60,62,65,68,71,74,77,80,83,86,89,92,95,98],{"measure":10,"description":11,"timeFrame":12},"Cohort A: real-world overall survival (rwOS)","The length of time a participant survives, from the point of initiating 1L treatment, using data retrieved retrospectively. Death due to any case will be considered in the definition of rwOS.","From the point of initiating 1L treatment, assessed up to 4 years",{"measure":14,"description":15,"timeFrame":12},"Cohort A: real-world progression-free survival (rwPFS)","The length of time a participant survives without their cancer progressing, from the point of initiating 1L treatment, using data retrieved retrospectively. Progression will be identified according to clinical notes, radiology reports or pathology reports, and death due to any cause will be considered in the definition of rwPFS.",{"measure":17,"description":18,"timeFrame":12},"Cohort A: real-world time to next treatment (rwTTNT)","The length of time until a participant initiates second-line (2L) treatment, from the point of initiating 1L treatment, using data retrieved retrospectively. Death due to any cause will be considered a competing event.",{"measure":20,"description":21,"timeFrame":12},"Cohort A: real-world time to next treatment or death (rwTTNTD)","The length of time a participant survives without initiating 2L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively.",{"measure":23,"description":24,"timeFrame":12},"Cohort A: real-world time to progression (rwTTP)","The length of time until a participant's cancer progresses, from the point of initiating 1L treatment, using data retrieved retrospectively. Progression will be identified according to clinical notes, radiology reports or pathology reports. Death due to any cause will be considered a competing event.",{"measure":26,"description":27,"timeFrame":12},"Cohort A: real-world duration of response (rwDOR)","The length of time a participant responds to 1L treatment without dying or their cancer progressing, from the first record of complete or partial response to 1L treatment, using data retrieved retrospectively. Response will be identified as per clinical assessment, and progression will be identified according to clinical notes, radiology reports or pathology reports. Death due to any cause will be considered in the definition of rwDOR.",{"measure":29,"description":30,"timeFrame":31},"Cohort A: real-world response rate (rwRR)","The percentage of participants who have responded to 1L treatment within 12 months following initiation of 1L treatment, using data retrieved retrospectively. Complete or partial response will be identified as per clinical assessment.","From the point of initiating 1L treatment, assessed up to 12 months",{"measure":33,"description":34,"timeFrame":31},"Cohort A: real-world disease control rate (rwDCR)","The percentage of participants who have either responded to 1L treatment or have achieved stable disease within 12 months following initiation of 1L treatment, using data retrieved retrospectively. Complete response, partial response and stable disease will be identified as per clinical assessment.",{"measure":36,"description":37,"timeFrame":38},"Cohort A: real-world tumor growth rate (rwTGR) prior to 1L treatment","The percentage change in tumor size over the period of time between the second to last and last tumor size record prior to index date. rwTGR will be assessed prior to initiating 1L treatment based on medical history available, using data retrieved retrospectively. Tumor size will be estimated as the sum of the longest diameters of all recorded measurable lesions (primary or metastatic).","Day 1",{"measure":40,"description":41,"timeFrame":42},"Cohort A: rwTGR","The percentage change in tumor size from prior to initiation of 1L treatment, over a period of time. rwTGR will be assessed during 1L treatment using data retrieved retrospectively. Tumor size will be estimated as the sum of the longest diameters of all recorded measurable lesions (primary or metastatic).","From point of initiating 1L treatment, assessed up to 4 years",{"measure":44,"description":45,"timeFrame":12},"Cohort A: number of records of specified adverse events (AEs)","Specified AEs are inclusive of nausea, vomiting, decreased appetite, diarrhea, peripheral sensory neuropathy, anemia, constipation, decreased neutrophil count, fatigue, asthenia, abdominal pain, stomatitis, weight decrease, aspartate aminotransferase increase, platelet count decrease, hypoalbuminemia, white blood cell count decrease and neutropenia.\n\nAn AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.",{"measure":47,"description":48,"timeFrame":12},"Cohort A: duration of specified AEs","The total length of time a participant has a record of experiencing a specified AE occurrence during 1L treatment, using data retrieved retrospectively.",{"measure":50,"description":51,"timeFrame":12},"Cohort A: time to first specified AE record","The length of time until a participant experiences each of the specified AEs above during 1L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively.",{"measure":53,"description":54,"timeFrame":12},"Cohort A: number of participants with serious adverse events (SAEs)","SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and\u002For cause death and which are experienced during 1L treatment.\n\nEvents will be identified from participant records retrieved retrospectively; there is no requirement for the events to be explicitly linked to 1L treatment.",{"measure":56,"description":57,"timeFrame":12},"Cohort A: number of SAEs experienced per participant","SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and\u002For cause death and which are experienced during 1L treatment.\n\nEvents will be identified from participant records retrieved retrospectively.",{"measure":59,"description":57,"timeFrame":12},"Cohort A: number of specific SAE",{"measure":61,"description":57,"timeFrame":12},"Cohort A: number of records per participant of specific SAE",{"measure":63,"description":64,"timeFrame":12},"Cohort A: time to first SAE record","The length of time until a participant experiences a SAE during 1L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively.",{"measure":66,"description":67,"timeFrame":12},"Cohort A: number of participants with inpatient hospitalizations","Number of inpatient hospitalizations during 1L treatment, as recorded up to end of 1L treatment (inclusive), using data retrieved retrospectively.",{"measure":69,"description":70,"timeFrame":12},"Cohort A: number of inpatient hospitalizations with ICU stay per participant","Number of inpatients hospitalizations per participant with ICU stay during 1L treatment, as recorded from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively.",{"measure":72,"description":73,"timeFrame":12},"Cohort A: number of inpatient hospitalizations with admission via accident and emergency (A&E) per participant","Number of inpatients hospitalizations per participant with admission via A\\&E during 1L treatment, as recorded from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively.",{"measure":75,"description":76,"timeFrame":12},"Cohort A: duration of inpatient hospitalizations","Average duration (in days) of inpatient hospitalization during 1L treatment, as derived according to the difference between admission and discharge dates for all inpatient hospitalizations from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively. One participant may experience more than one hospitalization and may contribute multiple times for this variable.",{"measure":78,"description":79,"timeFrame":12},"Cohort A: primary diagnoses associated with inpatient hospitalizations","Primary diagnoses associated with inpatient hospitalizations during 1L treatment, as recorded using diagnosis codes (International Classification of Diseases, 10th revision \\[ICD-10\\] codes, or equivalent as available in each data source), using data retrieved retrospectively. A participant can have multiple diagnoses per inpatient hospitalization and multiple inpatient hospitalization.",{"measure":81,"description":82,"timeFrame":12},"Cohort A: number of participants receiving at least one antiemetic","Number of participants with prescriptions or dispensations of any antiemetic drug from 1 day before index date (inclusive) to the end of 1L treatment (inclusive), using data retrieved retrospectively.",{"measure":84,"description":85,"timeFrame":12},"Cohort A: number of antiemetics prescribed or dispensed to participants","Number of records of prescriptions or dispensations of any antiemetic drug from 1 day before index date (inclusive) to the end of 1L treatment (inclusive), using data retrieved retrospectively.",{"measure":87,"description":88,"timeFrame":12},"Cohort A: time to prescription or dispensation of any antiemetic drugs","Time from index date to first prescription or dispensation of antiemetic drugs during 1L treatment, using data retrieved retrospectively.",{"measure":90,"description":91,"timeFrame":38},"Cohort A: type of antiemetic drug received immediately prior to 1L treatment","Type of antiemetic drug prescribed immediately prior to 1L treatment, as recorded 1 day before index date (inclusive) based on medical history available, using data retrieved retrospectively.",{"measure":93,"description":94,"timeFrame":12},"Cohort A: type of antiemetic drug received","Type of antiemetic drug prescribed during 1L treatment, as recorded to the end of 1L treatment (inclusive), using data retrieved retrospectively.",{"measure":96,"description":97,"timeFrame":38},"Cohort A: antiemetic drugs received immediately prior to 1L treatment","Antiemetic drugs prescribed immediately prior to 1L treatment, as recorded 1 day before index date (inclusive) based on medical history available, using data retrieved retrospectively.",{"measure":99,"description":100,"timeFrame":12},"Cohort A: antiemetic drugs received","Antiemetic drugs prescribed during 1L treatment, as recorded to the end of 1L treatment (inclusive), using data retrieved retrospectively.",[102,105,108,111,114,117,120,123,126,129,132,135,138,141,144,147,150,153,156,159,162,165,168,171,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234,237,240,243,246,249,252,255,258,261,264,267,270,273,276,279,282,285,288,291,294,297,300,303,306,309,312,315],{"measure":103,"description":104,"timeFrame":38},"Cohort A demographic characteristics: age","Age as recorded or derived based on participant birth date, date of diagnosis, and 1L treatment initiation, using data retrieved retrospectively.",{"measure":106,"description":107,"timeFrame":38},"Cohort A demographic characteristics: sex","Sex as recorded at any time in participant records (female, male, or missing\u002Funknown), using data retrieved retrospectively.",{"measure":109,"description":110,"timeFrame":38},"Cohort A demographic characteristics: race or ethnicity","Ethnicity or race (Asian, black, mixed, or multiple ethnic groups, white, other ethnic group, or missing\u002Funknown), as recorded at any time in participant records, using data retrieved retrospectively.",{"measure":112,"description":113,"timeFrame":38},"Cohort A demographic characteristics: country","Country of treatment site, as derived according to the country in which the data source is located, using data retrieved retrospectively.",{"measure":115,"description":116,"timeFrame":38},"Cohort A demographic characteristics: socioeconomic status","Socioeconomic status as derived from available variables recorded any time prior to an including the index date, using data retrieved retrospectively.",{"measure":118,"description":119,"timeFrame":38},"Cohort A clinical characteristics: alcohol consumption","Alcohol consumption, as recorded any time between diagnosis of la\u002Fm G\u002FGEJ adenocarcinoma (inclusive) and index date (inclusive), using data retrieved retrospectively.",{"measure":121,"description":122,"timeFrame":38},"Cohort A clinical characteristics: smoking status","Smoking status, as recorded any time between diagnosis of la\u002Fm G\u002FGEJ adenocarcinoma (inclusive) and index date (inclusive), using data retrieved retrospectively.",{"measure":124,"description":125,"timeFrame":38},"Cohort A clinical characteristics: body mass index (BMI)","BMI (in kg\u002Fm\\^2) at index date, as recorded or as derived according to the formula weight\u002Fheight using the closest measurements of weight (kg) and height (m) which are recorded prior to and including the index date. Weight measurements must be no more than 1 year prior to the index date; height measurements will be considered from the start of participant records (18.5 = underweight, 18.5 to \\\u003C25.0 = normal weight, 25.0 to \\\u003C30 = pre-obesity, ≥30 = obesity, or missing\u002Funknown), using data retrieved retrospectively.",{"measure":127,"description":128,"timeFrame":38},"Cohort A clinical characteristics: disease stage (TNM)","Disease stage at initial diagnosis of G\u002FGEJ adenocarcinoma and at la\u002Fm diagnosis of G\u002FGEJ adenocarcinoma, as recorded according to 7th or 8th American Joint Committee on Cancer (AJCC) TNM classification (TXNXMX), using data retrieved retrospectively.",{"measure":130,"description":131,"timeFrame":38},"Cohort A clinical characteristics: disease stage (numeric)","Disease stage at initial diagnosis of G\u002FGEJ adenocarcinoma and at la\u002Fm diagnosis of G\u002FGEJ adenocarcinoma, as recorded according to the numeric classification (0, I, II, III, IV, or missing\u002Funknown), using data retrieved retrospectively.",{"measure":133,"description":134,"timeFrame":38},"Cohort A clinical characteristics: tumor grade","Histological grade of primary tumor at initial diagnosis of G\u002FGEJ adenocarcinoma, as recorded (1 = low grade, 2 = moderate grade, 3 = high grade, or missing\u002Funknown), using data retrieved retrospectively.",{"measure":136,"description":137,"timeFrame":38},"Cohort A clinical characteristics: histotype at initial diagnosis","Histotype of primary tumor at initial diagnosis of G\u002FGEJ adenocarcinoma, as recorded using the Lauren classification (intestinal, diffuse, mixed, other, missing\u002Funknown), using data retrieved retrospectively.",{"measure":139,"description":140,"timeFrame":38},"Cohort A clinical characteristics: site of primary tumor","Site of primary tumor at initial diagnosis of G\u002FGEJ adenocarcinoma, as recorded (gastric or gastroesophageal junction), using data retrieved retrospectively.",{"measure":142,"description":143,"timeFrame":38},"Cohort A clinical characteristics: size of primary tumor at initial diagnosis","Size (in mm) of primary tumor at initial diagnosis of G\u002FGEJ adenocarcinoma, as recorded, using data retrieved retrospectively.",{"measure":145,"description":146,"timeFrame":38},"Cohort A clinical characteristics: Eastern Cooperative Oncology Group (ECOG) performance status","ECOG performance status at index date, as recorded from la\u002Fm diagnosis (inclusive) to index date (inclusive), using data retrieved retrospectively. Any participant with a score of 5 (i.e., dead) will have their value reported as missing\u002Funknown. Lower scores represent an increased ability to carry out the daily living activities.",{"measure":148,"description":149,"timeFrame":38},"Cohort A clinical characteristics: Charlson Comorbidity Index (CCI)","CCI score at index date, as derived according to medical diagnoses, including comorbid conditions, recorded using ICD-10 codes or data source equivalent any time prior to and including the index date, using data retrieved retrospectively (0, 1, 2, 3, ≥4, or missing\u002Funknown) where lower scores represent lower comorbidity.",{"measure":151,"description":152,"timeFrame":38},"Cohort A clinical characteristics: comorbidities","Comorbidities (hypertension, diabetes mellitus, ulcerative digestive tract disease, dyslipidemia, other gastrointestinal disease, cardiovascular disease, and chronic kidney disease) recorded (yes, no) prior to and including index date, defined by 1 or more ICD-10 codes, using data retrieved retrospectively.",{"measure":154,"description":155,"timeFrame":38},"Cohort A clinical characteristics: number of metastatic sites","Number of metastatic sites at index date, as derived from ICD-10 codes or data source equivalent recorded any time prior to and including the index date (0, 1, 2, 3, …), using data retrieved retrospectively.",{"measure":157,"description":158,"timeFrame":38},"Cohort A clinical characteristics: number of metastatic lesions","Number of metastatic lesions at index date, as derived from participant records any time prior to and including the index date (0, 1, 2, 3, …), using data retrieved retrospectively.",{"measure":160,"description":161,"timeFrame":38},"Cohort A clinical characteristics: location of metastatic sites","Metastatic sites (liver, lymph node, lung, peritoneum, bone, large intestine or rectum, other specified, or other unspecified site) recorded (yes, no) defined by 1 or more ICD-10 codes or data source equivalent from diagnosis of la\u002Fm disease until index date, using data retrieved retrospectively.",{"measure":163,"description":164,"timeFrame":38},"Cohort A clinical characteristics: systemic anti-cancer therapy (SACT)","SACT received prior to index date, as recorded from initial diagnosis of G\u002FGEJ adenocarcinoma (any stage, inclusive) until index date (exclusive), using data retrieved retrospectively.",{"measure":166,"description":167,"timeFrame":38},"Cohort A clinical characteristics: type\u002Fintention of SACT","Type\u002Fintention of SACT (neoadjuvant SACT only, adjuvant SACT only, both neoadjuvant and adjuvant SACT \\[perioperative\\], no prior SACT) received prior to index date, as derived according to the dates of SACT and surgery records from initial diagnosis of G\u002FGEJ adenocarcinoma (any stage, inclusive) until index date (exclusive), using data retrieved retrospectively.",{"measure":169,"description":170,"timeFrame":38},"Cohort A clinical characteristics: neoadjuvant SACT regimen","Neoadjuvant SACT regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.",{"measure":172,"description":173,"timeFrame":38},"Cohort A clinical characteristics: adjuvant SACT regimen","Adjuvant SACT regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.",{"measure":175,"description":176,"timeFrame":38},"Cohort A clinical characteristics: perioperative SACT regimen","Perioperative SACT regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.",{"measure":178,"description":179,"timeFrame":38},"Cohort A clinical characteristics: chemoradiation therapy","Chemoradiation received prior to index date, as recorded or derived according to records of chemotherapy and radiation therapy which overlap and which are recorded between the date of initial diagnosis of G\u002FGEJ adenocarcinoma (inclusive, any stage) until index date (exclusive), using data retrieved retrospectively.",{"measure":181,"description":182,"timeFrame":38},"Cohort A clinical characteristics: chemoradiation therapy regimen","Chemoradiation therapy regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.",{"measure":184,"description":185,"timeFrame":38},"Cohort A clinical characteristics: radiation therapy","Radiation therapy received prior to index date, as recorded from the date of initial diagnosis of G\u002FGEJ adenocarcinoma (inclusive, any stage) until index date (exclusive), using data retrieved retrospectively.",{"measure":187,"description":188,"timeFrame":38},"Cohort A clinical characteristics: type of radiation therapy","Type of radiation therapy received prior to index date, as recorded, using data retrieved retrospectively.",{"measure":190,"description":191,"timeFrame":38},"Cohort A clinical characteristics: prior gastrectomy","Gastrectomy received prior to index date, as recorded from the date of initial diagnosis of G\u002FGEJ adenocarcinoma (inclusive, any stage) until index date (exclusive) (yes or no), using data retrieved retrospectively.",{"measure":193,"description":194,"timeFrame":38},"Cohort A clinical characteristics: type of gastrectomy","Type of gastrectomy received prior to index date, as recorded (partial, total, other, no gastrectomy), using data retrieved retrospectively.",{"measure":196,"description":197,"timeFrame":38},"Cohort A clinical characteristics: time from gastrectomy to index date","Among those who have received gastrectomy, time from gastrectomy until index, as derived from the date of gastrectomy and the index date, using data retrieved retrospectively.",{"measure":199,"description":200,"timeFrame":38},"Cohort A biomarker characteristics: HER2 expression level","HER2 expression level at index date, as recorded (none \\[IHC 0\\], low \\[IHC 1+\\], indeterminate \\[IHC 2+\\], high \\[IHC 3+\\], or missing\u002Funknown), using data retrieved retrospectively. Specimens from any primary cancer or metastatic biopsy sites are allowed.",{"measure":202,"description":203,"timeFrame":38},"Cohort A biomarker characteristics: CLDN18.2 status","CLDN18.2 status at index date, defined as moderate (IHC 2+) to strong (IHC 3+) membranous staining in ≥75% of tumor cells, as recorded any time prior to and including the index date (negative, positive or not tested), using data retrieved retrospectively.",{"measure":205,"description":206,"timeFrame":38},"Cohort A biomarker characteristics: CLDN18.2 expression level","CLDN18.2 expression level at index date, as recorded (moderate to strong staining in 0% to \\\u003C25% of cells, moderate to strong staining in ≥25% and \\\u003C50% of cells, moderate to strong staining in ≥50% and \\\u003C75% of cells, moderate to strong staining in ≥75% of cells, missing\u002Funknown, or not tested), using data retrieved retrospectively.",{"measure":208,"description":209,"timeFrame":38},"Cohort A biomarker characteristics: programmed death-ligand 1 (PD-L1) tested","PD-L1 tested at index date, as recorded any point prior to and including the index date (yes or no), using data retrieved retrospectively.",{"measure":211,"description":212,"timeFrame":38},"Cohort A biomarker characteristics: combined positive score (CPS)","CPS at index date, as recorded any point prior to and including the index date (\\\u003C1, 1 to \\\u003C5, 5 to \\\u003C10, ≥10, or not tested), using data retrieved retrospectively.",{"measure":214,"description":215,"timeFrame":38},"Cohort A biomarker characteristics: tumor area positivity (TAP)","TAP at index date, as recorded any point prior to and including the index date (\\\u003C1, 1 to \\\u003C5, 5 to \\\u003C10, ≥10, or not tested), using data retrieved retrospectively.",{"measure":217,"description":218,"timeFrame":38},"Cohort A biomarker characteristics: tumor proportion score (TPS)","TPS at index date, as recorded any point prior to and including the index date (\\\u003C1%, 1 to \\\u003C50%,\n\n≥50%, not tested), using data retrieved retrospectively.",{"measure":220,"description":221,"timeFrame":38},"Cohort A biomarker characteristics: mismatch repair deficient (dMMR) status","dMMR status at index date, as derived from IHC or MSI testing results any time prior to and including the index date (deficient, proficient or not tested), using data retrieved retrospectively.",{"measure":223,"description":224,"timeFrame":38},"Cohort A biomarker characteristics: Epstein-Barr virus (EBV) status","EBV status at index date, as recorded any point prior to and including the index date (EBV-positive, EBV-negative or not tested), using data retrieved retrospectively.",{"measure":226,"description":227,"timeFrame":38},"Cohort A biomarker characteristics: Fibroblast Growth Factor Receptor 2b (FGFR2b) expression levels","FGFR2b expression level at index date, as recorded any point prior to and including the index date (none, \\\u003C10% of tumor cells with moderate\u002Fstrong staining \\[IHC 2+ or 3+\\], ≥10% of tumor cells with moderate\u002Fstrong staining \\[IHC 2+ or 3+\\], or not tested), using data retrieved retrospectively.",{"measure":229,"description":230,"timeFrame":38},"Cohort A biomarker testing patterns: immunohistochemistry (IHC) platform","IHC platform used to determine PD-L1 and CLDN18.2 status at index date, as recorded any point prior to and including the index date (Ventana, Dako, Leica, other, missing\u002Funknown, or not tested), using data retrieved retrospectively.",{"measure":232,"description":233,"timeFrame":38},"Cohort A biomarker testing patterns: IHC antibody clone","Antibody clone used for IHC testing to determine PD-L1 (22C3, 28-8, SP263, other, missing\u002Funknown, or not tested) and CLDN18.2 (43-14A, 34H14L15, 14F8, 43-14A, LS-B16145, other, missing\u002Funknown, not tested) status at index date, as recorded, using data retrieved retrospectively.",{"measure":235,"description":236,"timeFrame":38},"Cohort A biomarker testing patterns: number of biomarker tests performed","Number of HER2 and CLDN18.2 tests prior to and including index date, as recorded (1, 2, 3, …, or missing\u002Funknown), using data retrieved retrospectively.",{"measure":238,"description":239,"timeFrame":38},"Cohort A biomarker testing patterns: number of positive biopsy samples used for determination of biomarker status","Number of positive biopsy samples used for determination of HER2 and CLDN18.2 status at index date, as recorded (1, 2, 3, …, missing\u002Funknown, or not tested), using data retrieved retrospectively.",{"measure":241,"description":242,"timeFrame":38},"Cohort A biomarker testing patterns: relative timing of tests","Time from HER2 test request until CLDN18.2 test request and from PD-L1 test request until CLDN18.2 test request, as derived (CLDN18.2 test request prior to HER2 test request, HER2 test request prior to CLDN18.2 test request, or simultaneous; CLDN18.2 test request prior to PD-L1 test request, PD-L1 test request prior to CLDN18.2 test request, or simultaneous), using data retrieved retrospectively.",{"measure":244,"description":245,"timeFrame":38},"Cohort A biomarker testing patterns: time from test to treatment initiation","Time from most recent biomarker test request and report until zolbetuximab initiation, using data retrieved retrospectively.",{"measure":247,"description":248,"timeFrame":38},"Cohort A treatment patterns: 1L regimen received","1L treatment regimen received, as recorded or as derived according to a line of therapy algorithm, using data retrieved retrospectively.",{"measure":250,"description":251,"timeFrame":12},"Cohort A treatment patterns: duration of 1L treatment","Duration of 1L treatment, measured from the index date to the earliest of date of 1L discontinuation (i.e., discontinuation of all components of 1L), date of initiation of 2L treatment, date of death due to any case or start of new treatment), date of loss to follow-up or end of study period, plus 1 day, using data retrieved retrospectively.",{"measure":253,"description":254,"timeFrame":12},"Cohort A treatment patterns: real-world time to treatment discontinuation (rwTTD)","Time from index date to the date of 1L discontinuation, using data retrieved retrospectively. Participants who did not discontinue 1L will be censored at the earliest of date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.",{"measure":256,"description":257,"timeFrame":12},"Cohort A treatment patterns: reasons for 1L treatment discontinuation","Reasons for discontinuation of 1L treatment, as recorded (disease progression, death, toxicity, adverse reaction, other, multiple reasons, missing\u002F unknown, did not discontinue treatment), using data retrieved retrospectively.",{"measure":259,"description":260,"timeFrame":12},"Cohort A treatment patterns: dosing schedule","Dosing schedule of 1L zolbetuximab treatment, as recorded or derived based on administration dates and recorded 1L treatment doses (every 2 weeks, every 3 weeks, other, or missing\u002F unknown), using data retrieved retrospectively.",{"measure":262,"description":263,"timeFrame":12},"Cohort A treatment patterns: number of participants with dose modifications","Number of participants with at least one recorded 1L dose modification relative to the initial dose (yes or no), using data retrieved retrospectively.",{"measure":265,"description":266,"timeFrame":12},"Cohort A treatment patterns: reason for dose modification","Reason for the first dose modification during 1L treatment as recorded (AE, SAE, disease progression, participant factors \\[e.g., weight loss\\], drug interactions, other, multiple reasons, missing\u002Funknown, no dose modification), using data retrieved retrospectively.",{"measure":268,"description":269,"timeFrame":12},"Cohort A treatment patterns: direction of dose modification","The direction of change (increase, decrease, both increase and decrease \\[regardless of order\\], no dose modification) in 1L dose level, as derived per participant, using data retrieved retrospectively.",{"measure":271,"description":272,"timeFrame":12},"Cohort A treatment patterns: number of dose modifications per participant","Total number of dose modifications experienced during 1L treatment per participant, as recorded, using data retrieved retrospectively.",{"measure":274,"description":275,"timeFrame":12},"Cohort A treatment patterns: time to first dose modification","Time from index date to the date of first recorded 1L dose modification. Participants without any recorded dose modification in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.",{"measure":277,"description":278,"timeFrame":12},"Cohort A treatment patterns: number of dose interruptions","Any record of an interruption in dosage during 1L treatment, as recorded or derived according to observed gaps between treatment cycles (yes or no), using data retrieved retrospectively.",{"measure":280,"description":281,"timeFrame":12},"Cohort A treatment patterns: reason for dose interruption","Reason for first dose interruption during 1L treatment, as recorded (AE, disease progression, participant factors \\[e.g., weight loss\\], drug interactions, other, multiple reasons, missing\u002Funknown, no dose interruption), using data retrieved retrospectively.",{"measure":283,"description":284,"timeFrame":12},"Cohort A treatment patterns: number of dose interruptions per participant","Total number of dose interruptions experienced per participant during 1L treatment, as recorded, using data retrieved retrospectively.",{"measure":286,"description":287,"timeFrame":12},"Cohort A treatment patterns: time to first dose interruption","Time from index date to the date of first recorded 1L dose interruption. Participants without any recorded dose interruption in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.",{"measure":289,"description":290,"timeFrame":12},"Cohort A treatment patterns: number of infusion rate reductions","Reduction in infusion rate of intravenous (IV) 1L treatment, as recorded, using data retrieved retrospectively.",{"measure":292,"description":293,"timeFrame":12},"Cohort A treatment patterns: reason for infusion rate reduction","Reason for first infusion rate reduction during 1L treatment, as recorded, using data retrieved retrospectively.",{"measure":295,"description":296,"timeFrame":12},"Cohort A treatment patterns: time to first administration with infusion rate reduction","Time from index date to the date of first administration with infusion rate reduction during 1L. Participants without any recorded infusion rate reduction in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.",{"measure":298,"description":299,"timeFrame":12},"Cohort A treatment patterns: infusion interruption","Any record of interruption in IV 1L treatment (e.g. temporary or permanent halting of an IV infusion), any time from index date (inclusive) to end of 1L treatment (inclusive) (yes, no record), using data retrieved retrospectively.",{"measure":301,"description":302,"timeFrame":12},"Cohort A treatment patterns: reason for infusion interruption","Reason for first infusion interruption during 1L treatment, as recorded (AE, participant factors, other, multiple reasons, missing\u002Funknown, no infusion interruption), using data retrieved retrospectively.",{"measure":304,"description":305,"timeFrame":12},"Cohort A treatment patterns: time to first infusion interruption","Time from index date to the date of first administration with infusion interruption during 1L. Participants without any recorded infusion rate reduction in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.",{"measure":307,"description":308,"timeFrame":12},"Cohort A treatment patterns: relative dose intensity","Relative dose intensity of zolbetuximab for each 1L treatment cycle, as derived from the actual dosage received divided by the planned dosage, using data retrieved retrospectively.",{"measure":310,"description":311,"timeFrame":12},"Cohort A treatment patterns: BMI at each 1L treatment cycle","BMI at each 1L treatment cycle, as recorded or derived from the closest measurements of height and weight (kg\u002Fm\\^2). Weight measurements must be recorded from initiation of the previous treatment cycle (exclusive) to initiation of the current treatment cycle (inclusive); height measurements will be considered from the start of participant records (18.5 = underweight, 18.5 to \\\u003C25.0 = normal weight, 25.0 to \\\u003C30 = pre-obesity, ≥30 = obesity, or missing\u002Funknown), using data retrieved retrospectively.",{"measure":313,"description":314,"timeFrame":12},"Cohort A treatment patterns: body surface area (BSA) at each 1L treatment cycle","BSA at each 1L treatment cycle, as recorded or derived according to the formula 0.007184\\*height 0.725\\* weight 0.425 using the closest measurements of weight (kg) and height (m). Weight measurements must be recorded from initiation of the previous treatment cycle (exclusive) to initiation of the current treatment cycle (inclusive); height measurements will be considered from the start of participant records (1.5 to \\\u003C1.75, 1.75 to \\\u003C2.00, 2.00 to \\\u003C2.25, 2.25 to \\\u003C2.5, \\>=2.5, or missing\u002Funknown), using data retrieved retrospectively.",{"measure":316,"description":317,"timeFrame":318},"Cohort A treatment patterns: 2L treatment regimen received","2L treatment regimen received (mono- or combination therapy), as recorded or derived according to a line of therapy algorithm (mono- or combination therapy), using data retrieved retrospectively.","From the point of initiating 2L treatment, assessed up to 4 years",null,{"allocation":319,"interventionModel":319,"interventionModelDescription":319,"primaryPurpose":319,"observationalModel":321,"timePerspective":322,"maskingInfo":319},"COHORT","RETROSPECTIVE","Four registries or databases and at least 9 electronic medical record (EMR)-enabled sites will be used as data sources for this study. The study population will include participants with la\u002Fm HER2(-) and CLDN18.2(+) G\u002FGEJ adenocarcinoma treated in 1L with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy. A wider population of participants with la\u002Fm HER2(-) and CLDN18.2(+) G\u002FGEJ adenocarcinoma, including those treated with other 1L treatments, will also be explored, as well as participants treated off-label with zolbetuximab.",[325,332,337],{"label":326,"type":319,"description":327,"interventionNames":328},"Cohort A: zolbetuximab with platinum-fluoropyrimidine chemotherapy","Participants with human epidermal growth factor receptor 2-negative (HER2\\[-\\]) and claudin-18 isoform 2-positive (CLDN18.2\\[+\\]) locally advanced unresectable or metastatic (la\u002Fm) gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma who received first-line (1L) treatment with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy.",[329,330,331],"Drug: Zolbetuximab Exposure","Drug: Platinum-based Chemotherapy Exposure","Drug: Fluoropyrimidine-based Chemotherapy Exposure",{"label":333,"type":319,"description":334,"interventionNames":335},"Cohort B: 1L treatment which did not contain zolbetuximab","Participants with HER2(-) and CLDN18.2(+) la\u002Fm G\u002FGEJ adenocarcinoma who received 1L treatment which did not contain zolbetuximab.",[336],"Drug: 1L Treatment Not Containing Zolbetuximab Exposure",{"label":338,"type":319,"description":339,"interventionNames":340},"Cohort C: off-label treatment with zolbetuximab","Participants with G\u002FGEJ adenocarcinoma who received off-label treatment with zolbetuximab.",[329],[342,350,354,358],{"type":343,"name":344,"description":345,"armGroupLabels":346,"otherNames":347},"DRUG","Zolbetuximab Exposure","Real-world exposure to zolbetuximab.",[326,338],[348,349],"Vyloy","IMAB362",{"type":343,"name":351,"description":352,"armGroupLabels":353,"otherNames":319},"Platinum-based Chemotherapy Exposure","Real-world exposure to platinum-based chemotherapy.",[326],{"type":343,"name":355,"description":356,"armGroupLabels":357,"otherNames":319},"1L Treatment Not Containing Zolbetuximab Exposure","Real-world exposure to 1L treatment not containing zolbetuximab.",[333],{"type":343,"name":359,"description":360,"armGroupLabels":361,"otherNames":319},"Fluoropyrimidine-based Chemotherapy Exposure","Real-world exposure to fluoropyrimidine-based chemotherapy.",[326],[363],{"name":364,"affiliation":365,"role":366},"Central Contact","Astellas Pharma Europe Ltd.","STUDY_DIRECTOR",[368],{"name":365,"role":369,"phone":370,"phoneExt":319,"email":371},"CONTACT","+1-800-888-7704","Astellas.registration@astellas.com",[373],{"facility":374,"status":319,"city":375,"state":319,"zip":319,"country":376,"countryCode":377,"cosmosGeoPoint":319,"geoPoint":319,"contacts":319},"Research Institution","Alberta","Canada","CA",{"type":379,"investigatorFullName":319,"investigatorTitle":319,"investigatorAffiliation":319,"oldNameTitle":319,"oldOrganization":319},"SPONSOR","100658929","zolbetuximab-and-other-cancer-treatments-in-people-with-advanced-gastric-or-gej-cancer-in-clinical-practice-radiance-100658929",false,"NCT07858500","Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)","Real-world Clinical Outcomes, Patient Characteristics, and Treatment Patterns Among Patients With Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2-negative, Claudin-18 Isoform 2-positive Gastric or Gastroesophageal Junction Adenocarcinoma Treated With Zolbetuximab or Other First Line Treatments: A Cohort Study Using Secondary Data in Europe and Canada","RADIANCE","Inclusion Criteria:\n\nCohorts A, B and C:\n\n* Incident diagnosis of G\u002FGEJ adenocarcinoma, as identified according to ICD-10 diagnosis codes (C16.x, C15.2, C15.5, C15.8, C15.9) and ICD for Oncology Third Edition (ICD-O-3) morphology codes (8140-8149, 8160-8162, 8190-8221, 8260-8337, 8350 8551, 8570-8576, 8940-8941) or data source equivalent.\n* At least 18 years of age at the date of 1L treatment initiation.\n\nCohorts A and B:\n\n* Evidence of unresectable stage 3 or stage 4 disease.\n* Evidence of HER2(-) tumor any time prior to and including the date of 1L treatment initiation.\n* Evidence of CLDN18.2-positive tumor, defined as ≥75% of tumor cells showing moderate (2+) or strong (3+) membranous staining by IHC, assessed prior to or on the date of 1L treatment initiation.\n\nCohort A only:\n\n* 1L treatment with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy which begins during the patient enrolment period.\n\nCohort B only:\n\n* 1L treatment that does not include zolbetuximab which begins during the patient enrolment period.\n\nCohort C only:\n\n* Zolbetuximab administered during the patient enrolment period under any of the following off-label conditions:\n\n  * NOT delivered in 1L for la\u002Fm disease and\u002For\n  * NOT delivered in combination with platinum-fluoropyrimidine doublet, and\u002For\n  * Delivered in combination with any systemic anti-cancer treatment that is not platinum-fluoropyrimidine doublet, and\u002For\n  * NOT delivered to a patient with evidence of HER2(-) tumor any time prior to and including the date of zolbetuximab initiation, and\u002For\n  * NOT delivered to a patient with evidence of CLDN18.2(+)-positive tumor, defined as ≥75% of tumor cells demonstrating moderate (2+) or strong (3+) membranous staining by IHC, assessed prior to or on the date of zolbetuximab initiation.\n\nExclusion Criteria:\n\nCohorts A, B and C:\n\n* Evidence of any other primary malignancy in the 5 years prior to and including the index date, as identified according to ICD-10 codes or data source equivalent and excluding non-melanoma skin cancer (ICD-10 code C44.x).\n\nCohort A only:\n\n* Evidence that 1L treatment with zolbetuximab was received as part of a clinical trial.\n\nCohort B only:\n\n* Evidence that 1L treatment was received as part of a clinical trial.\n\nCohort C only:\n\n* Evidence that zolbetuximab was received as part of a clinical trial.","ALL","18 Years",{"count":391,"type":392},1000,"ESTIMATED","OBSERVATIONAL","There is an unmet medical need to treat people with advanced cancer in the stomach, or where the food pipe joins the stomach. These conditions are known as advanced gastric cancer or advanced gastroesophageal cancer (GEJ for short).\n\nZolbetuximab is an approved treatment for people with advanced stomach (gastric) cancer or advanced GEJ cancer. Some people with stomach or GEJ cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab works by attaching to the Claudin 18.2 protein in their tumor. This switches on the body's immune system to attack the tumor.\n\nThe main aim of the study is to collect information about zolbetuximab and other cancer treatments in people with advanced gastric or GEJ cancer. This includes safety information, how long people respond to treatment and how long people live for without their cancer getting worse.\n\nThis study is about collecting information only. This is known as an observational study. The individual's doctor decides on treatment, not the sponsor (Astellas).\n\nThis study will use information from European and Canadian health registries and databases to learn more about people with advanced gastric or GEJ cancers who used zolbetuximab and other cancer treatments. The entire study will last about 4 years.",[396,397,398,399],"Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer","Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer","Metastatic Gastric Adenocarcinoma or Cancer","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma",[401,402,403,404,405,406,349,407,408,409,410],"Human Epidermal Growth Factor Receptor 2","HER2","HER2 Negative","Claudin-18 Isoform 2-positive","CLDN18.2+","zolbetuximab","Gastric cancer","Adenocarcinoma","Gastric adenocarcinoma","Gastroesophageal Junction cancer","NOT_YET_RECRUITING","2026-09-29",{"date":414,"type":415},"2026-10-05","ACTUAL",{"date":417,"type":392},"2026-10-31",{"date":419,"type":392},"2029-06-30",{"name":365,"class":6},1]