Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2023-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-01-11"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-02-10"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2023-01-11"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Overall Survival (OS) in Participants With HER2-low Breast Cancer (All Patients)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
"value": {
"measure": "Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)",
"timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
"description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
"value": {
"measure": "Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years",
"description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (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.\nORR is defined as the number of participants with complete and partial responses."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
"value": {
"measure": "Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)",
"timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years",
"description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (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.\nORR is defined as the number of participants with complete and partial responses."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
"value": {
"measure": "Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years",
"description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
"value": {
"measure": "Duration of Response in Participants With HER2-low Breast Cancer (All Patients)",
"timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years",
"description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
}
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li>Is the age of majority in their country</li><li><p>Has pathologically documented breast cancer that:</p><ol><li>Is unresectable or metastatic</li><li>Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)</li><li>Is HR-positive or HR-negative</li><li>Has progressed on, and would no longer benefit from, endocrine therapy</li><li>Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting</li><li>Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)</li></ol></li><li>Has documented radiologic progression (during or after most recent treatment)</li><li><p>Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:</p><ol><li>assessment of HER2 status</li><li>assessment of post-treatment status</li></ol></li><li>Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1</li><li>Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions</li><li>Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)</li></ul><p>Exclusion Criteria:</p><ul><li>Is ineligible for all options in the physician's choice arm</li><li>Has breast cancer ever assessed with high-HER2 expression</li><li>Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate</li><li>Has uncontrolled or significant cardiovascular disease</li><li>Has spinal cord compression or clinically active central nervous system metastases</li><li>Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening</li><li>Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study</li></ul>"
},
{
"op": "add",
"path": "/protocolSection/referencesModule/references/0",
"value": {
"pmid": "35665782",
"type": "RESULT",
"citation": "Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/NEJMoa2203690. Epub 2022 Jun 5."
}
},
{
"op": "remove",
"path": "/protocolSection/referencesModule/references/8"
},
{
"op": "replace",
"path": "/protocolSection/ipdSharingStatementModule/infoTypes/2",
"value": "ICF"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "CTRinfo@dsi.com",
"phone": "908-992-6400",
"title": "Contact for Clinical Trial Information",
"organization": "Daiichi Sankyo"
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": false
}
},
"adverseEventsModule": {
"timeFrame": "Treatment-emergent adverse events (TEAEs) were collected from the time of signing the main informed consent form up to 40 days (+7 days) after the last treatment, whether observed by the investigator or reported by the participant, up to approximately 3 years in the Safety Analysis Set.",
"description": "The Safety Analysis Set included all randomized participants who received at least 1 dose of treatment.\nAn adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with that product.\nA TEAE was an AE that occurred, having been absent before the first dose of study drug, or worsened in severity or seriousness after initiating study drug up to 47 days after the last dose of the study drug.",
"eventGroups": [
{
"id": "EG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.",
"otherNumAtRisk": 371,
"deathsNumAtRisk": 371,
"otherNumAffected": 369,
"seriousNumAtRisk": 371,
"deathsNumAffected": 148,
"seriousNumAffected": 103
},
{
"id": "EG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
"otherNumAtRisk": 172,
"deathsNumAtRisk": 172,
"otherNumAffected": 169,
"seriousNumAtRisk": 172,
"deathsNumAffected": 88,
"seriousNumAffected": 43
}
],
"otherEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 139
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 45
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Neutropenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 49
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 31
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Thrombocytopenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 23
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 4
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 282
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 52
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 150
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 23
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 126
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 38
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Diarrhoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 100
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 38
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Stomatitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 41
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 17
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 35
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 8
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 34
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 11
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Abdominal pain upper",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 31
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 13
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Dry mouth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 26
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Gastrooesophageal reflux disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 23
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Abdominal distension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 20
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 5
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 110
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 50
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 70
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 25
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 46
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 22
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Malaise",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 33
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 11
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Oedema peripheral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 25
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 10
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 29
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 6
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Medication error",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 11
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Aspartate aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 92
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 42
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Neutrophil count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 81
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 62
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "White blood cell count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 78
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 49
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 75
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 43
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Platelet count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 73
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 12
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Weight decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 60
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 14
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Blood alkaline phosphatase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 36
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 5
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Lymphocyte count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 29
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 12
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
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{
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"term": "Adenocarcinoma gastric",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 1
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Metastases to meninges",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
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}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Epilepsy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
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}
],
"organSystem": "Nervous system disorders",
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},
{
"term": "Movement disorder",
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{
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},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Hypoglycaemic coma",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Confusional state",
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{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Hydronephrosis",
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{
"groupId": "EG000",
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"numAffected": 2
},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Renal colic",
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{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Renal failure",
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{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Ureteric obstruction",
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{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Interstitial lung disease",
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{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Pneumonitis",
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{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 7
},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Dyspnoea",
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{
"groupId": "EG000",
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"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Pleural effusion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Cough",
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{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
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"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Haemoptysis",
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{
"groupId": "EG000",
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"numAffected": 1
},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Hydrothorax",
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{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Pulmonary embolism",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Pulmonary toxicity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Respiratory failure",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Hypoxia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Social problem",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Social circumstances",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Embolism",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Hypotension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
},
{
"term": "Superior vena cava occlusion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 371,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 172,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
}
],
"armsReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
},
"frequencyThreshold": "5",
"allCauseMortalityReviewUnit": {
"resetReasons": [
"The number of participants at risk appears inconsistent with data here or in other parts of the record."
]
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "331",
"groupId": "OG000"
},
{
"value": "163",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "10.1",
"groupId": "OG000",
"lowerLimit": "9.5",
"upperLimit": "11.5"
},
{
"value": "5.4",
"groupId": "OG001",
"lowerLimit": "4.4",
"upperLimit": "7.1"
}
]
}
]
}
],
"analyses": [
{
"pValue": "<0.0001",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Cox Proportional Hazard",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.5085",
"ciLowerLimit": "0.4012",
"ciUpperLimit": "0.6444",
"pValueComment": "Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor/CDK status, as defined by IXRS.",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
"description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Progression-free survival (PFS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set."
},
{
"type": "SECONDARY",
"title": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "373",
"groupId": "OG000"
},
{
"value": "184",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "9.9",
"groupId": "OG000",
"lowerLimit": "9.0",
"upperLimit": "11.3"
},
{
"value": "5.1",
"groupId": "OG001",
"lowerLimit": "4.2",
"upperLimit": "6.8"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
"description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Progression-free survival (PFS) was assessed in the Full Analysis Set."
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "331",
"groupId": "OG000"
},
{
"value": "163",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "23.9",
"groupId": "OG000",
"lowerLimit": "20.8",
"upperLimit": "24.8"
},
{
"value": "17.5",
"groupId": "OG001",
"lowerLimit": "15.2",
"upperLimit": "22.4"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years",
"description": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Overall survival (OS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set."
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS) in Participants With HER2-low Breast Cancer (All Patients)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "373",
"groupId": "OG000"
},
{
"value": "184",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "23.4",
"groupId": "OG000",
"lowerLimit": "20.0",
"upperLimit": "24.8"
},
{
"value": "16.8",
"groupId": "OG001",
"lowerLimit": "14.5",
"upperLimit": "20.0"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years",
"description": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Overall survival (OS) was assessed in the Full Analysis Set."
},
{
"type": "SECONDARY",
"title": "Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "331",
"groupId": "OG000"
},
{
"value": "163",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "9.6",
"groupId": "OG000",
"lowerLimit": "8.4",
"upperLimit": "10.0"
},
{
"value": "4.2",
"groupId": "OG001",
"lowerLimit": "3.4",
"upperLimit": "4.9"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
"description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Progression-free survival (PFS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The Measure Type appears inaccurate."
]
}
},
{
"type": "SECONDARY",
"title": "Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "373",
"groupId": "OG000"
},
{
"value": "184",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "8.8",
"groupId": "OG000",
"lowerLimit": "8.3",
"upperLimit": "9.8"
},
{
"value": "4.2",
"groupId": "OG001",
"lowerLimit": "3.0",
"upperLimit": "4.5"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
"description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Progression-free survival (PFS) was assessed in the Full Analysis Set.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The Measure Type appears inaccurate."
]
}
},
{
"type": "SECONDARY",
"title": "Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "331",
"groupId": "OG000"
},
{
"value": "163",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"title": "BICR: Complete response",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Partial response",
"categories": [
{
"measurements": [
{
"value": "164",
"groupId": "OG000"
},
{
"value": "26",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Stable disease",
"categories": [
{
"measurements": [
{
"value": "115",
"groupId": "OG000"
},
{
"value": "81",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Progressive disease",
"categories": [
{
"measurements": [
{
"value": "26",
"groupId": "OG000"
},
{
"value": "34",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Not evaluable",
"categories": [
{
"measurements": [
{
"value": "14",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Complete response",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Partial response",
"categories": [
{
"measurements": [
{
"value": "163",
"groupId": "OG000"
},
{
"value": "30",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Stable disease",
"categories": [
{
"measurements": [
{
"value": "124",
"groupId": "OG000"
},
{
"value": "80",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Progressive disease",
"categories": [
{
"measurements": [
{
"value": "28",
"groupId": "OG000"
},
{
"value": "34",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Not evaluable",
"categories": [
{
"measurements": [
{
"value": "11",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Objective response rate",
"categories": [
{
"measurements": [
{
"value": "175",
"groupId": "OG000"
},
{
"value": "27",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Objective response rate",
"categories": [
{
"measurements": [
{
"value": "168",
"groupId": "OG000"
},
{
"value": "30",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years",
"description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (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.\nORR is defined as the number of participants with complete and partial responses.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Best overall response and confirmed objective response rate were assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"Information within the measure appears inconsistent."
]
}
},
{
"type": "SECONDARY",
"title": "Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "373",
"groupId": "OG000"
},
{
"value": "184",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"title": "BICR: Complete response",
"categories": [
{
"measurements": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Partial response",
"categories": [
{
"measurements": [
{
"value": "183",
"groupId": "OG000"
},
{
"value": "28",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Stable disease",
"categories": [
{
"measurements": [
{
"value": "129",
"groupId": "OG000"
},
{
"value": "91",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Progressive disease",
"categories": [
{
"measurements": [
{
"value": "31",
"groupId": "OG000"
},
{
"value": "41",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Not evaluable",
"categories": [
{
"measurements": [
{
"value": "17",
"groupId": "OG000"
},
{
"value": "22",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Complete response",
"categories": [
{
"measurements": [
{
"value": "6",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Partial response",
"categories": [
{
"measurements": [
{
"value": "187",
"groupId": "OG000"
},
{
"value": "31",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Stable disease",
"categories": [
{
"measurements": [
{
"value": "135",
"groupId": "OG000"
},
{
"value": "93",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Progressive disease",
"categories": [
{
"measurements": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Not evaluable",
"categories": [
{
"measurements": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "20",
"groupId": "OG001"
}
]
}
]
},
{
"title": "BICR: Objective response rate",
"categories": [
{
"measurements": [
{
"value": "195",
"groupId": "OG000"
},
{
"value": "30",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Investigator: Objective response rate",
"categories": [
{
"measurements": [
{
"value": "193",
"groupId": "OG000"
},
{
"value": "31",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years",
"description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (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.\nORR is defined as the number of participants with complete and partial responses.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Best overall response and confirmed objective response rate were assessed in the Full Analysis Set.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"Information within the measure appears inconsistent."
]
}
},
{
"type": "SECONDARY",
"title": "Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "331",
"groupId": "OG000"
},
{
"value": "163",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"title": "BICR: DoR",
"categories": [
{
"measurements": [
{
"value": "10.7",
"groupId": "OG000",
"lowerLimit": "8.5",
"upperLimit": "13.7"
},
{
"value": "6.8",
"groupId": "OG001",
"lowerLimit": "6.5",
"upperLimit": "9.9"
}
]
}
]
},
{
"title": "Investigator: DoR",
"categories": [
{
"measurements": [
{
"value": "8.3",
"groupId": "OG000",
"lowerLimit": "7.1",
"upperLimit": "11.1"
},
{
"value": "5.6",
"groupId": "OG001",
"lowerLimit": "3.6",
"upperLimit": "6.8"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years",
"description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Duration of response was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set."
},
{
"type": "SECONDARY",
"title": "Duration of Response in Participants With HER2-low Breast Cancer (All Patients)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "373",
"groupId": "OG000"
},
{
"value": "184",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "OG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"classes": [
{
"title": "BICR: DoR",
"categories": [
{
"measurements": [
{
"value": "10.7",
"groupId": "OG000",
"lowerLimit": "8.5",
"upperLimit": "13.2"
},
{
"value": "6.8",
"groupId": "OG001",
"lowerLimit": "6.0",
"upperLimit": "9.9"
}
]
}
]
},
{
"title": "Investigator: DoR",
"categories": [
{
"measurements": [
{
"value": "8.3",
"groupId": "OG000",
"lowerLimit": "7.0",
"upperLimit": "9.9"
},
{
"value": "5.6",
"groupId": "OG001",
"lowerLimit": "3.7",
"upperLimit": "6.6"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years",
"description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Duration of response was assessed in the Full Analysis Set."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "FG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "373"
},
{
"groupId": "FG001",
"numSubjects": "184"
}
]
},
{
"type": "COMPLETED",
"comment": "Ongoing as of 11 Jan 2022",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "58"
},
{
"groupId": "FG001",
"numSubjects": "3"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "315"
},
{
"groupId": "FG001",
"numSubjects": "181"
}
]
}
],
"dropWithdraws": [
{
"type": "Progressive disease as per RECIST v1.1",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "220"
},
{
"groupId": "FG001",
"numSubjects": "130"
}
]
},
{
"type": "Adverse Event",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "60"
},
{
"groupId": "FG001",
"numSubjects": "14"
}
]
},
{
"type": "Withdrawal by Subject",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "12"
},
{
"groupId": "FG001",
"numSubjects": "11"
}
]
},
{
"type": "Clinical progression by investigator",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "10"
},
{
"groupId": "FG001",
"numSubjects": "8"
}
]
},
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "5"
},
{
"groupId": "FG001",
"numSubjects": "2"
}
]
},
{
"type": "Physician Decision",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "4"
},
{
"groupId": "FG001",
"numSubjects": "3"
}
]
},
{
"type": "Other",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "2"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Randomized, but not treated",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "2"
},
{
"groupId": "FG001",
"numSubjects": "12"
}
]
}
]
}
],
"recruitmentDetails": "A total of 557 participants were enrolled and randomized to treatment at 161 study sites in the United States (27 study sites), Japan (18 sites), France (16 sites), China (15 sites), Italy (13 sites), Spain (12 sites), Greece (8 sites), Portugal (8 sites), Republic of Korea (8 sites), Israel (6 sites), Switzerland (6 sites), Austria (4 sites), Belgium (4 sites), Russia (3 sites), Sweden (3 sites), Taiwan (3 sites), Unted Kingdom (3 sites), Canada (2 sites), and Hungary (2 sites).",
"preAssignmentDetails": "All participants had been previously treated with at least 1 and no more than 2 prior lines of chemotherapy in the recurrent or metastatic setting."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "373",
"groupId": "BG000"
},
{
"value": "184",
"groupId": "BG001"
},
{
"value": "557",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Trastuzumab Deruxtecan (T-DXd)",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes."
},
{
"id": "BG001",
"title": "Physician's Choice",
"description": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines."
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Categorical",
"classes": [
{
"categories": [
{
"title": "<=18 years",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
},
{
"title": "Between 18 and 65 years",
"measurements": [
{
"value": "290",
"groupId": "BG000"
},
{
"value": "136",
"groupId": "BG001"
},
{
"value": "426",
"groupId": "BG002"
}
]
},
{
"title": ">=65 years",
"measurements": [
{
"value": "83",
"groupId": "BG000"
},
{
"value": "48",
"groupId": "BG001"
},
{
"value": "131",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "56.5",
"spread": "10.6",
"groupId": "BG000"
},
{
"value": "56.5",
"spread": "11.5",
"groupId": "BG001"
},
{
"value": "56.5",
"spread": "10.9",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "371",
"groupId": "BG000"
},
{
"value": "184",
"groupId": "BG001"
},
{
"value": "555",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "White",
"categories": [
{
"measurements": [
{
"value": "176",
"groupId": "BG000"
},
{
"value": "91",
"groupId": "BG001"
},
{
"value": "267",
"groupId": "BG002"
}
]
}
]
},
{
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"groupId": "BG000"
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{
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}
]
}
]
},
{
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"groupId": "BG000"
},
{
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"groupId": "BG001"
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{
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"groupId": "BG002"
}
]
}
]
},
{
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]
}
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{
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}
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{
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}
]
}
],
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"unitOfMeasure": "Participants"
}
],
"populationDescription": "Baseline characteristics were assessed in the Full Analysis Set.\nThe Full Analysis Set included all participants randomized into the study, including those who did not receive a dose of study treatment.\nParticipants were analyzed according to the treatments and strata assigned at randomization."
}
}
},
{
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"unpostedAnnotation": {
"unpostedEvents": [
{
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"type": "RESET"
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],
"unpostedResponsibleParty": "Daiichi Sankyo, Inc."
}
}
}
},
{
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"typeAbbrev": "Prot_SAP",
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],
"reviewUnit": {
"resetReasons": [
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]
}
}
}
}
]