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.
primary_outcome_any_changeAny add/remove/replace under primary outcome measures is critical review priority.
Before
Progression-free survival at 6 months (PFS6) is defined as having a progression-free survival time greater than or equal to 24 weeks at the time of analysis where PFS time is defined as the time from the first dose of ZW25, palbociclib, and/or fulvestrant to the date of documented disease progression (per RECIST 1.1) or death from any cause.
After
The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days).
Progression-free survival at 6 months (PFS6) is defined as having a progression-free survival time greater than or equal to 24 weeks at the time of analysis where PFS time is defined as the time from the first dose of ZW25, palbociclib, and/or fulvestrant to the date of documented disease progression (per RECIST 1.1) or death from any cause.
After
The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days).
{
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2024-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2024-08-13"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2024-08-14"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2024-08-13"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2024-08-14",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
"value": "The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
"value": "6 months from first dose of any study drug to the date of documented disease progression or death"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
"value": "The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
"value": "6 months from first dose of any study drug to the date of documented disease progression or death"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit"
},
{
"op": "remove",
"path": "/annotationSection"
}
]