Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2023-05"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2024-03"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-05-25"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-06-15"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2023-05-25"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2023-06-15",
"type": "ACTUAL"
}
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
"value": {
"measure": "Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
"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."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
"value": {
"measure": "Number of Overall Survival Events (Deaths)",
"timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
"value": {
"measure": "Overall Survival (OS) in All Patients",
"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."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/otherOutcomes",
"value": [
{
"measure": "All-Cause Mortality",
"timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years",
"description": "All-cause mortality is defined as all anticipated and unanticipated deaths due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study."
}
]
},
{
"op": "add",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/1",
"value": {
"type": "Full Analysis Set (All Randomized Patients)",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "373"
},
{
"groupId": "FG001",
"numSubjects": "184"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/2",
"value": {
"type": "Safety Analysis Set (All Randomized Patients Who Received at Least 1 Dose of Study Treatment)",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "371"
},
{
"groupId": "FG001",
"numSubjects": "172"
}
]
}
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4",
"value": {
"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 were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over 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."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5",
"value": {
"type": "SECONDARY",
"title": "Number of Overall Survival Events (Deaths)",
"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 were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over 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": "149",
"groupId": "OG000"
},
{
"value": "90",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years",
"unitOfMeasure": "events (deaths)",
"reportingStatus": "POSTED",
"populationDescription": "Overall survival events (deaths) were analyzed in the Full Analysis Set (defined as all randomized participants)."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6",
"value": {
"type": "SECONDARY",
"title": "Overall Survival (OS) in 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 were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over 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 (defined as all randomized participants)."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11",
"value": {
"type": "OTHER_PRE_SPECIFIED",
"title": "All-Cause Mortality",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "371",
"groupId": "OG000"
},
{
"value": "172",
"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 were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over 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": "148",
"groupId": "OG000"
},
{
"value": "88",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years",
"description": "All-cause mortality is defined as all anticipated and unanticipated deaths due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "All-cause mortality was assessed in the Safety Analysis Set."
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/timeFrame",
"value": "Adverse events (AEs) 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."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/description",
"value": "All-cause mortality was assessed in all participants who were randomized (Full Analysis Set).\nPlease refer to the other prespecified outcome measure that also reports all-cause mortality from the Safety Analysis Set.\nOther AEs and SAEs were assessed in the Safety Analysis Set.\nThe Physician's Choice (PC) treatment was based on the label approved in each country.\nAs prespecified in the protocol for safety analysis, the PC group was combined for an appropriate sample size for the comparator group."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
"value": 149
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk",
"value": 373
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected",
"value": 90
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk",
"value": 184
},
{
"op": "remove",
"path": "/resultsSection/adverseEventsModule/armsReviewUnit"
},
{
"op": "remove",
"path": "/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "remove",
"path": "/reviewUnit"
}
]