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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.
Plain-language summary
Manual review pending.
Rules fired
arms_or_interventions_change
Value signals
None recorded.
Provenance
Source ctgov_internal_history
Fetched 2026-06-18 18:59:25+00
Raw hash 1d1ae03748bb213462303228d30c7604622cd58f92c5821252fca06758762059 Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High Arm Intervention Change Operation 5
Matched rules arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Before
Biological: IMP321 After
Biological: IMP321 (eftilagimod alpha) replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High Arm Intervention Change Operation 6
Matched rules arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. After
IMP321 (eftilagimod alpha) Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 2 ops replace /protocolSection/contactsLocationsModule/locations/11/status
Triage: Uncategorized Uncategorized Operation 7
replace /protocolSection/contactsLocationsModule/locations/20/status
Triage: Uncategorized Uncategorized Operation 8
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized Uncategorized Operation 2
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized Uncategorized Operation 3
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized Uncategorized Operation 4
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized Uncategorized Operation 1
Before
IMP321 as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma After
IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma Raw JSON Patch [
{
"op": "replace",
"path": "/protocolSection/identificationModule/briefTitle",
"value": "IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2018-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2018-07-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2018-07-11"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
"value": "Biological: IMP321 (eftilagimod alpha)"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/name",
"value": "IMP321 (eftilagimod alpha)"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/11/status",
"value": "WITHDRAWN"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/20/status",
"value": "WITHDRAWN"
}
]