Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-06-25"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-07-14"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/otherOutcomes",
"value": [
{
"measure": "Fcgamma Receptor Polymorphism",
"timeFrame": "From baseline to up to 24 months",
"description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions."
},
{
"measure": "Change in HER2 mRNA Level",
"timeFrame": "From baseline to 24 months",
"description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy."
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/type",
"value": "OTHER_PRE_SPECIFIED"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title",
"value": "Fcgamma Receptor Polymorphism"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description",
"value": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame",
"value": "From baseline to up to 24 months"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/type",
"value": "OTHER_PRE_SPECIFIED"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/title",
"value": "Change in HER2 mRNA Level"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/description",
"value": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame",
"value": "From baseline to 24 months"
}
]