Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity
is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip
the pipeline's suppression passes); the authoritative classification is the stored
event record.
secondary_outcome_any_changeAny add/remove/replace under secondary outcome measures is high review priority.
Before
{
"measure": "Contralateral breast cancer (invasive or DCIS)",
"timeFrame": "Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer, assessed up to 10 years",
"description": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions."
}
secondary_outcome_any_changeAny add/remove/replace under secondary outcome measures is high review priority.
Before
{
"measure": "Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) in women who were premenopausal at the time of study entry",
"timeFrame": "18 months",
"description": "Amenorrhea will be summarized by treatment arm in terms of incidence rates and the ranges, medians, and quantiles of duration."
}
secondary_outcome_any_changeAny add/remove/replace under secondary outcome measures is high review priority.
After
{
"measure": "Contralateral breast cancer (invasive or DCIS)",
"timeFrame": "Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer, assessed up to 10 years",
"description": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions."
}
secondary_outcome_any_changeAny add/remove/replace under secondary outcome measures is high review priority.
After
{
"measure": "Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) in women who were premenopausal at the time of study entry",
"timeFrame": "18 months",
"description": "Amenorrhea will be summarized by treatment arm in terms of incidence rates and the ranges, medians, and quantiles of duration."
}
Other registry fieldsChanges outside the current high-signal rule families.Triage: Uncategorized2 ops
[
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2018-03-02"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2018-03-05"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
"value": {
"measure": "Contralateral breast cancer (invasive or DCIS)",
"timeFrame": "Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer, assessed up to 10 years",
"description": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
"value": {
"measure": "Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) in women who were premenopausal at the time of study entry",
"timeFrame": "18 months",
"description": "Amenorrhea will be summarized by treatment arm in terms of incidence rates and the ranges, medians, and quantiles of duration."
}
}
]