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
The patient-level primary outcome for this objective is pCR, which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.
The patient is assessed at the time of surgery for whether they achieved pCR=yes.
They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.
After
The patient-level primary outcome for this objective is pathological Complete Response (pCR), which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.
The patient is assessed at the time of surgery for whether they achieved pCR=yes.
They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.
Pathological Complete Response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0N0 or ypTisN0 in the AJCC staging system for staging solid tumors in the neoadjuvant setting that was described in a 2014 FDA Guidance for Industry).
Other registry fieldsChanges outside the current high-signal rule families.Triage: Uncategorized3 ops
The patient-level primary outcome for this objective is pCR, which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.
The patient is assessed at the time of surgery for whether they achieved pCR=yes.
They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.
After
The patient-level primary outcome for this objective is pathological Complete Response (pCR), which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.
The patient is assessed at the time of surgery for whether they achieved pCR=yes.
They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.
Pathological Complete Response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0N0 or ypTisN0 in the AJCC staging system for staging solid tumors in the neoadjuvant setting that was described in a 2014 FDA Guidance for Industry).
Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2024-05"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2024-05-28"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2024-06-10"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "The patient-level primary outcome for this objective is pathological Complete Response (pCR), which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.\nThe patient is assessed at the time of surgery for whether they achieved pCR=yes.\nThey have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.\nPathological Complete Response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0N0 or ypTisN0 in the AJCC staging system for staging solid tumors in the neoadjuvant setting that was described in a 2014 FDA Guidance for Industry)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
"value": "The patient-level primary outcome for this objective is pathological Complete Response (pCR), which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.\nThe patient is assessed at the time of surgery for whether they achieved pCR=yes.\nThey have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.\nPathological Complete Response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0N0 or ypTisN0 in the AJCC staging system for staging solid tumors in the neoadjuvant setting that was described in a 2014 FDA Guidance for Industry)."
}
]