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
Phase II: To assess the progression free survival of patients with HER2-negative metastatic breast cancer treated with single-agent amrubicin as second- or third-line therapy. (Phase II will use the amrubicin dose determined in Phase I).
After
Phase II: Assess progression-free survival (PFS) of patients with HER2-negative metastatic breast cancer treated with single-agent amrubicin as second- or third-line therapy. (Phase II will use the amrubicin dose determined in Phase I).
DesignTrial model, phase, allocation, masking, arms, or interventions.Triage: High1 ops
secondary_outcome_any_changeAny add/remove/replace under secondary outcome measures is high review priority.
Before
To determine the toxicity (including cardiotoxicity) of amrubicin when given as second- or third-line treatment for HER2-negative metastatic breast cancer.
After
Determine toxicity (including cardiotoxicity) of amrubicin when given as second- or third-line treatment for HER2-negative metastatic breast cancer.
secondary_outcome_any_changeAny add/remove/replace under secondary outcome measures is high review priority.
Before
To determine the OS of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment.
After
Determine overall survival (OS) of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment.
secondary_outcome_any_changeAny add/remove/replace under secondary outcome measures is high review priority.
Before
To determine the response rate of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment
After
Determine response rate (RR) of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment
Other registry fieldsChanges outside the current high-signal rule families.Triage: Uncategorized3 ops
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2013-12"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2013-12-02"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2013-12-04"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 77
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Phase I: Evaluate the maximum tolerated dose (MTD) and tolerability of amrubicin monotherapy in HER2-negative metastatic breast cancer"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Phase II: Assess progression-free survival (PFS) of patients with HER2-negative metastatic breast cancer treated with single-agent amrubicin as second- or third-line therapy. (Phase II will use the amrubicin dose determined in Phase I)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Determine toxicity (including cardiotoxicity) of amrubicin when given as second- or third-line treatment for HER2-negative metastatic breast cancer."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Determine overall survival (OS) of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Determine response rate (RR) of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment"
}
]